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1. Global multi-societies endorsement of the MAFLD definition

Author

Mohamed Alboraie, Tawesak Tanwandee, Xiaoyuan Xu, Dafina Nikolova, Enrique Carrera Estupiñan, Hasmik Ghazinyan, Sameer Alawadhi, Ponsiano Ocama, Gulnara Aghayeva, Alejandro Piscoya, Taghreed Farahat, Pramendra Prasad, Cosmas Rinaldi Adithya Lesmana, Shashank R Joshi, Said Al-Busafi, Vladimir Milivojevic, Violet Kayamba, Yeong Yeh Lee, Shahinul Alam, Chengwei Tang, Wei-Fen Xie, Moutaz Derbala, Yuemin Nan, Dennis Ndububa, Hongting Zheng, Jiajun Zhao, Nawal Alkhalidi, Yahya Ghanem, Phunchai Charatcharoenwitthaya, Mamun Mahtab, Nagwa N. Hegazy, Edford Sinkala, Cecil Kwaku Dovia, Moussa Ali Mahamat, Mortada El-Shabrawi, Dao Viet Hang, Shlomo Vinker, Bilal Hotayt, Mohammed Tahiri, Pavel Bogomolov, Nawal Afredj, Inass Shaltout, Reda Elwakil, Abd Elkhalek Hamed, Lubna Kamani, Maheeba Abdulla, Constant Assi, Oidov Baatarkhuu, Munira Al Tarrah, Yousef Ajlouni, Bounena Abidine, Christopher Muñoz, Mohammad Ali, Emad Salama, Abdelaziz Elamin, Iqbal Ahmad Memon, Aram Mirijanyan, Sajjad Jamil, Alexander V. Nersesov, Nseabasi Ekanem, Waseem Hamoudi, Bisi Bright, Teresa Casanovas, Ewaoche Itodo, Esther A Torres, Maja Karin, Enver Zerem, Svetlana Turcan, Audrius Dulskas, Iulianna Lupasco, Alina Jucov, Christian Tzeuton, Roger Sombie, Kateryna Lapshyna, Andrriy Dorofeyev, Yaw A Awuku, Hilal Ünalmış Duda, Rijimra Ande, Nehal El Koofy, Naglaa Kamal, Ziyan Pan, Angela Peltec, Liang Qiao, Andry Lalaina Rinà Rakotozafindrabe, Ahmed Salama, Reham Soliman, Badre Wafaa, Marinela Debu, Eileen A Micah, Gamal Shiha, Mohammed Eslam, and Yasser Fouad

Subjects
Specialties of internal medicine, RC581-951
Published
2024
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2. Cost-utility analysis of atezolizumab combined with bevacizumab for unresectable hepatocellular carcinoma in Thailand.

Author

Supachaya Sriphoosanaphan, Witthawat Pantumongkol, Wantanee Kulpeng, Chanchai Charonpongsuntorn, Tawesak Tanwandee, Wattana Sukeepaisarnjaroen, Abhasnee Sobhonslidsuk, and Pisit Tangkijvanich

Subjects
Medicine, Science
Abstract

BackgroundClinical trials have proven the efficacy and safety of atezolizumab combined with bevacizumab (A+B) in treating unresectable hepatocellular carcinoma (uHCC). This study aimed to assess the cost-utility of A+B compared to best supportive care (BSC) among uHCC patients in Thailand.MethodsWe conducted a cost-utility analysis from a societal perspective. We used a three-state Markov model to estimate relevant costs and health outcomes over the lifetime horizon. Local cost and utility data from Thai patients were applied. All costs were adjusted to 2023 values using the consumer price index. We reported results as incremental cost-effectiveness ratios (ICERs) in United States dollars ($) per quality-adjusted life year (QALY) gained. We discounted future costs and outcomes at 3% per annum. We then performed one-way sensitivity analysis and probabilistic sensitivity analysis to assess parameter uncertainty. The budget impact was conducted to estimate the financial burden from the governmental perspective over a five-year period.ResultsCompared to BSC, A+B provided a better health benefit with 0.8309 QALY gained at an incremental lifetime cost of $45,357. The ICER was $54,589 per QALY gained. The result was sensitive to the hazard ratios for the overall survival and progression-free survival of A+B. At the current Thai willingness-to-pay (WTP) threshold of $4,678 per QALY gained, the ICER of A+B remained above the threshold. The projected budgetary requirements for implementing A+B in the respective first and fifth years would range from 8.2 to 27.9 million USD.ConclusionAlthough A+B yielded the highest clinical benefit compared with BSC for the treatment of uHCC patients, A+B is not cost-effective in Thailand at the current price and poses budgetary challenges.

Published
2024
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3. Utility of combining PIVKA-II and AFP in the surveillance and monitoring of hepatocellular carcinoma in the Asia-Pacific region

Author

Do Young Kim, Bao Nguyen Toan, Chee-Kiat Tan, Irsan Hasan, Lyana Setiawan, Ming-Lung Yu, Namiki Izumi, Nguyen Nguyen Huyen, Pierce Kah-Hoe Chow, Rosmawati Mohamed, Stephen Lam Chan, Tawesak Tanwandee, Teng-Yu Lee, Thi Thanh Nguyen Hai, Tian Yang, Woo-Chang Lee, and Henry Lik Yuen Chan

Subjects
pivka-ii, alpha-fetoprotein, carcinoma, hepatocellular, consensus, biomarkers, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Even though the combined use of ultrasound (US) and alpha-fetoprotein (AFP) is recommended for the surveillance of hepatocellular carcinoma (HCC), the utilization of AFP has its challenges, including accuracy dependent on its cut-off levels, degree of liver necroinflammation, and etiology of liver disease. Though various studies have demonstrated the utility of protein induced by vitamin K absence II (PIVKA-II) in surveillance, treatment monitoring, and predicting recurrence, it is still not recommended as a routine biomarker test. A panel of 17 experts from Asia-Pacific, gathered to discuss and reach a consensus on the clinical usefulness and value of PIVKA-II for the surveillance and treatment monitoring of HCC, based on six predetermined statements. The experts agreed that PIVKA-II was valuable in the detection of HCC in AFP-negative patients, and could potentially benefit detection of early HCC in combination with AFP. PIVKA-II is clinically useful for monitoring curative and intra-arterial locoregional treatments, outcomes, and recurrence, and could potentially predict microvascular invasion risk and facilitate patient selection for liver transplant. However, combining PIVKA-II with US and AFP for HCC surveillance, including small HCC, still requires more evidence, whilst its role in detecting AFP-negative HCC will potentially increase as more patients are treated for hepatitis-related HCC. PIVKA-II in combination with AFP and US has a clinical role in the Asia-Pacific region for surveillance. However, implementation of PIVKA-II in the region will have some challenges, such as requiring standardization of cut-off values, its cost-effectiveness and improving awareness among healthcare providers.

Published
2023
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4. Safety, pharmacokinetics, and antiviral activity of the capsid inhibitor AB‐506 from Phase 1 studies in healthy subjects and those with hepatitis B

Author

Man‐Fung Yuen, Elina Berliba, Wattana Sukeepaisarnjaroen, Sang Hoon Ahn, Tawesak Tanwandee, Young‐Suk Lim, Yoon Jun Kim, Kittiyod Poovorawan, Pisit Tangkijvanich, Christian Schwabe, Timothy Eley, Joanne Brown, Amy C. H. Lee, Emily P. Thi, Bhavna Paratala, Nagraj Mani, Michael J. Sofia, Gaston Picchio, Karen D. Sims, and Edward J. Gane

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract AB‐506 is a potent, pan‐genotypic small molecule capsid inhibitor that inhibits hepatitis B virus (HBV) pregenomic RNA encapsidation. We assessed the safety, pharmacokinetics, and antiviral activity of AB‐506 in two randomized, double‐blinded Phase 1 studies in healthy subjects (HS) and subjects with chronic HBV infection (CHB). Single ascending and multiple doses of AB‐506 or placebo (30–1000 mg or 400 mg daily for 10 days) were assessed in HS. AB‐506 or placebo was assessed at either 160 mg or 400 mg daily for 28 days in subjects with CHB. A second follow‐up study examined AB‐506 or placebo at 400 mg daily for 28 days in 14 Caucasian and 14 East‐Asian HS. Twenty‐eight days of AB‐506 at 160 mg and 400 mg produced mean HBV‐DNA declines from baseline of 2.1 log10 IU/ml and 2.8 log10 IU/ml, respectively. Four subjects with CHB (all Asian) had Grade 4 alanine aminotransferase (ALT) elevations (2 at each dose) as HBV DNA was declining; three events led to treatment discontinuation. In the second follow‐up study, 2 Asian HS had serious transaminitis events leading to treatment and study termination. No subjects had bilirubin elevations or signs of hepatic decompensation. Conclusion: AB‐506 demonstrated mean HBV‐DNA declines of >2 log10; however, transient but severe ALT flares were observed in 4 Asian subjects with CHB. In the follow‐up study in HS, 2 additional Asian HS had Grade 4 flares, suggesting that AB‐506 hepatotoxicity contributed to the ALT elevations. The AB‐506 development program was terminated because of these findings.

Published
2022
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5. Discovery of a haptoglobin glycopeptides biomarker panel for early diagnosis of hepatocellular carcinoma

Author

Mahdokht Kohansal-Nodehi, Magdalena Swiatek-de Lange, Konstantin Kroeniger, Vinzent Rolny, Glòria Tabarés, Teerha Piratvisuth, Tawesak Tanwandee, Satawat Thongsawat, Wattana Sukeepaisarnjaroen, Juan Ignacio Esteban, Marta Bes, Bruno Köhler, Henry Lik-Yuen Chan, and Holger Busskamp

Subjects
haptoglobin, glycosylation, biomarker, glycoproteomics, hepatocellular carcinoma, diagnostics, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

BackgroundThere is a need for new serum biomarkers for early detection of hepatocellular carcinoma (HCC). Haptoglobin (Hp) N-glycosylation is altered in HCC, but the diagnostic value of site-specific Hp glycobiomarkers is rarely reported. We aimed to determine the site-specific glycosylation profile of Hp for early-stage HCC diagnosis.MethodHp glycosylation was analyzed in the plasma of patients with liver diseases (n=57; controls), early-stage HCC (n=50) and late-stage HCC (n=32). Hp phenotype was determined by immunoblotting. Hp was immunoisolated and digested into peptides. N-glycopeptides were identified and quantified using liquid chromatography–mass spectrometry. Cohort samples were compared using Wilcoxon rank-sum (Mann-Whitney U) tests. Diagnostic performance was assessed using receiver operating characteristic (ROC) curves and area under curve (AUC).ResultsSignificantly higher fucosylation, branching and sialylation of Hp glycans, and expression of high-mannose glycans, was observed as disease progressed from cirrhosis to early- and late-stage HCC. Several glycopeptides demonstrated high values for early diagnosis of HCC, with an AUC of 93% (n=1), >80% (n=3), >75% (n=13) and >70% (n=11), compared with alpha-fetoprotein (AFP; AUC of 79%). The diagnostic performance of the identified biomarkers was only slightly affected by Hp phenotype.ConclusionWe identified a panel of Hp glycopeptides that are significantly differentially regulated in early- and late-stage HCC. Some glycobiomarkers exceeded the diagnostic value of AFP (the most commonly used biomarker for HCC diagnosis). Our findings provide evidence that glycobiomarkers can be effective in the diagnosis of early HCC – individually, as a panel of glycopeptides or combined with conventional serological biomarkers.

Published
2023
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6. Multimarker Panels for Detection of Early Stage Hepatocellular Carcinoma: A Prospective, Multicenter, Case‐Control Study

Author

Teerha Piratvisuth, Tawesak Tanwandee, Satawat Thongsawat, Wattana Sukeepaisarnjaroen, Juan Ignacio Esteban, Marta Bes, Bruno Köhler, Ying He, Magdalena Swiatek‐de Lange, David Morgenstern, and Henry Lik‐Yuen Chan

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Hepatocellular carcinoma (HCC), the sixth most common cancer worldwide, has an incidence rate equal to mortality. Over 80% of HCC cases occur within a high‐risk population, mainly patients with both cirrhosis and chronic hepatitis B or C. With a 5‐year survival rate ranging from 90% for early stage HCC, there is a high medical need for the early detection of HCC. In this study, we systematically evaluated biomarkers mentioned in international guidelines and peer‐reviewed literature for HCC surveillance and diagnosis with the aim of identifying combinations that display high sensitivity and specificity for early stage HCC. Fifty biomarkers were measured in the first sample panel, panel A (n = 110), and subjected to univariate analysis. Of these, 35 biomarkers (38 assays) from panel A and an additional 13 biomarkers from the literature were prioritized for subsequent multivariate evaluation with lasso regression and exhaustive search of two‐ to four‐biomarker combinations (panel B). Panel B included 1,081 samples from patients with HCC (n = 308) or with chronic liver diseases (n = 740). Among all patients, 61.0% had hepatitis B, 32.9% had hepatitis C, and 60.5% had cirrhosis; 40.6% of patients with HCC had early stage cancer. Protein induced by vitamin K absence‐II (PIVKA‐II; also known as des‐gamma‐carboxy prothrombin [DCP]) and alpha‐fetoprotein (AFP) demonstrated the best clinical performance, both individually and in combination, and the addition of a third biomarker (Lens culinaris agglutinin‐reactive fraction of AFP [AFP‐L3], cartilage oligomeric matrix protein [COMP], insulin‐like growth factor‐binding protein 3 [IGFBP3], or matrix metalloproteinase 3 [MMP3]) further increased sensitivity for the detection of both early stage and all‐stage HCC. The addition of age and sex to the three‐biomarker panel resulted in an improved diagnostic performance. Conclusion: The combination of AFP and PIVKA‐II, with either IGFBP3, COMP or MMP3, plus age and sex, demonstrated the best performance for the detection of early‐ and all‐stage HCC. These novel panels performed similar to that of the GALAD score (sex [gender], age, plus serum levels of AFP, AFP‐L3 and DCP [PIVKA‐II]), a promising screening tool developed for HCC detection.

Published
2022
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7. Acute‐on‐chronic liver failure: Epidemiology, prognosis, and outcome of a multicenter study in Thai population

Author

Sakkarin Chirapongsathorn, Tongluk Teerasarntipan, Krit Tipchaichatta, Tanita Suttichaimongkol, Naichaya Chamroonkul, Chalermrat Bunchorntavakul, Sith Siramolpiwat, Siwaporn Chainuvati, Abhasnee Sobhonslidsuk, Apinya Leerapun, Teerha Piratvisuth, Wattana Sukeepaisarnjaroen, Tawesak Tanwandee, and Sombat Treeprasertsuk

Subjects
acute‐on‐chronic liver failure, cirrhosis, organ failure, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background and Aim Acute‐on‐chronic liver failure (ACLF) leads to multi‐organ failure related to high mortality rates. This study aimed to gather epidemiological data and validate a scoring system to predict mortality in ACLF. Methods This retrospective cohort study collected data from multicenter tertiary care hospitals in Thailand. A total of 638 hospitalized patients (acute decompensated liver disease [ADLD], 292 patients; ACLF, 346 patients) from January 2019 to June 2020 were enrolled in this study. We compared the mortality rate at days 30 and 90 between patients with ADLD and ACLF. Areas under the receiver operating characteristic (AUROC) curves of chronic liver failure–sequential organ failure assessment (CLIF‐SOFA) and other existing scoring systems were compared among patients with ACLF. Results The incidence of patients with ACLF was 54%. The main cause of chronic liver disease was alcohol (38%), with sepsis (50%) as the most common precipitating factor. ACLF with coagulopathy (AUROC 0.58, 95% confidence interval [CI]: 0.52–0.64), metabolic acidosis (AUROC 0.58, 95% CI: 0.52–0.64), and high aspartate aminotransferase (AST) (AUROC 0.59, 95% CI: 0.53–0.66) were associated with high 30‐day mortality. The 30‐day mortality rate of patients with acute decompensation and patients with ACLF was 46 and 58%, respectively. Respiratory system (P = 0.001) failure was the major end result in ACLF and constituted a significant factor to predict mortality. The AUROC of CLIF‐SOFA score was superior to that of the other predicted score (AUROC 0.64, 95% CI: 0.585–0.704). Conclusion Patients with ACLF with more organ failure and high CLIF‐SOFA score were associated with high short‐term mortality. Future studies should include an ACLF prospective registry to confirm these finding.

Published
2022
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8. Effect of a 12-week home-based exercise training program on aerobic capacity, muscle mass, liver and spleen stiffness, and quality of life in cirrhotic patients: a randomized controlled clinical trial

Author

Pavapol Sirisunhirun, Wimolrak Bandidniyamanon, Yonworanat Jrerattakon, Kobkun Muangsomboon, Pornpoj Pramyothin, Supot Nimanong, Tawesak Tanwandee, Phunchai Charatcharoenwitthaya, Siwaporn Chainuvati, and Watcharasak Chotiyaputta

Subjects
Home-based exercise, Cirrhosis, Aerobic capacity, Sarcopenia, Health-related quality of life, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background Physical inactivity and sarcopenia are two important predictors associated with increased morbidity and mortality in patients with cirrhosis. At present, the benefit of a home-based exercise training program is not well established in cirrhotic patients. The main objective of this study was to evaluate the effect of a 12-week home-based exercise training program on aerobic capacity in cirrhotic patients. Methods This is a randomized controlled study. Patients with compensated cirrhosis were randomized by a block of 4 with concealed allocation to the home-based exercise training (n = 20) or control (n = 20). Both groups received protein supplementation (9 g/day) for 12 weeks. The home-based exercise training program included several aerobic/isotonic moderate-intensity continuous training exercises for 40 min per session, at least four times a week, with a total duration of 12 weeks. The heart rate was continuously monitored using a Garmin® watch. In the control group, patients received exercise instruction without active encouragement and continuous monitoring. The primary outcome was a change in the 6-min walk test from baseline. Secondary outcomes were the difference in thigh muscle thickness, liver stiffness, spleen stiffness, and quality of life. Results A total of 40 patients were enrolled prospectively. The mean age was 56.3 ± 7.8 years, with a male predominance of 65%. The mean body mass index was 25.23 ± 3.0 kg/m2, and all were Child–Pugh A. Chronic hepatitis B or C was the primary cause of cirrhosis. The baseline values were a 6-min walk test of 475 ± 70 m, liver stiffness of 15.3 ± 9.3 kPa, spleen stiffness of 29.8 ± 21.7 kPa, and thigh muscle thickness (average compression index) of 0.64 ± 0.2 cm/m2. All baseline characteristics between the two groups were not different except the mean muscle mass which was significantly higher in the home-based exercise training group (p = 0.03, 95% CI 0.01 to 0.17). At the end of the study, no significant difference in the 6-min walk test was observed (p = 0.36, 95% CI −15.5 to 41.7). Liver stiffness measurement significantly improved in both groups, but no significant difference between groups was demonstrated (p = 0.77, 95% CI −1.3 to 1.8). Thigh muscle thickness was not different between groups. The fatigue domain of the quality of life index was significantly improved in the home-based exercise training group compared with the control group (p = 0.05, 95% CI 0.00 to 0.67). No adverse events occurred in a home-based exercise training program. Conclusions A 12-week moderate-intensity home-based exercise training program in compensated cirrhotic patients significantly improved the fatigue domain of the quality of life index without an increase in adverse events. However, no benefit in terms of aerobic capacity, thigh muscle mass, liver stiffness, and spleen stiffness was demonstrated. Trial registration: Thai Clinical Trials Registry number TCTR20190926002, 26/09/2019 (Retrospectively registered).

Published
2022
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9. A Comparison of Clinical Manifestations and Outcomes between Acute Sporadic Hepatitis A and Hepatitis E Infections in Thailand

Author

Sirajuk Khongviwatsathien, Wajana Thaweerat, Thanapat Atthakitmongkol, Watcharasak Chotiyaputta, and Tawesak Tanwandee

Subjects
clinical presentation, hepatitis A, hepatitis E, outcome, Thailand, Microbiology, QR1-502
Abstract

Hepatitis A virus (HAV) and hepatitis E virus (HEV) infections often present as acute hepatitis with prodromal symptoms. These infections, transmitted via the oral–enteral route, constitute significant public health challenges, particularly in developing countries with subpar sanitary systems. The aim of the study was to describe the clinical manifestations, laboratory findings, and outcomes of hepatitis A and hepatitis E infections in Thailand. We conducted a retrospective chart review and analysis of 152 patients diagnosed with acute hepatitis A or hepatitis E from January 2007 to August 2018 at Siriraj Hospital. The hepatitis E cohort was older with a greater prevalence of comorbidities (hypertension, diabetes mellitus, chronic kidney disease, chronic hepatitis B, and post-kidney transplantation status) than the hepatitis A cohort. While the majority of hepatitis A patients presented with fever (98%) and jaundice (96%), these symptoms were less pronounced in hepatitis E patients. Furthermore, hepatitis A patients exhibited significantly higher aminotransferase and total bilirubin levels. However, clinical outcomes, such as hospitalization rates, progression to acute liver failure, and mortality, were comparable across both groups. In conclusion, although the clinical manifestations of hepatitis A and hepatitis E were similar, fever and jaundice were more prevalent and aminotransferase and bilirubin levels were higher in the HAV-infected group.

Published
2023
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10. Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study

Author

Phunchai Charatcharoenwitthaya, Virasak Wongpaitoon, Piyawat Komolmit, Wattana Sukeepaisarnjaroen, Pisit Tangkijvanich, Teerha Piratvisuth, Theeranun Sanpajit, Chinnavat Sutthivana, Chalermrat Bunchorntavakul, Abhasnee Sobhonslidsuk, Soonthorn Chonprasertsuk, Chotipong Siripipattanamongkol, Supatsri Sethasine, Tawesak Tanwandee, and The THASL Collaborating Group for the Study of the Use of Direct-acting Antivirals for Chronic Hepatitis C

Subjects
Hepatitis C, Sofosbuvir, Daclatasvir, Velpatasvir, Effectiveness, Safety, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6. Methods We analyzed data from 1021 patients with HCV infection (506 with genotype 1; 16 with genotype 2; 314 with genotype 3; 13 with genotype 4; 166 with genotype 6) who received 12 to 24 weeks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasvir (n = 57), with or without ribavirin in 12 centers across Thailand to estimate sustained virologic response at post-treatment week 12 (SVR12). Results Overall, SVR12 rate was 98.0% (95% confidence interval [CI], 96.7–98.8%) with daclatasvir plus sofosbuvir, 97.9% (95% CI, 94.8–99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1–99.0%) with sofosbuvir/velpatasvir. SVR12 was achieved by 99.2% (95% CI, 97.9–99.7%) of subjects with genotype 1 infection, 100% (95% CI, 78.5–100%) of those with genotype 2 infection, 96.7% (95% CI, 94.0–98.2%) of those with genotype 3 infection, 90.9% (95% CI, 62.3–98.4%) of those with genotype 4 infection, and 96.7% (95% CI 92.5–98.6%) of those with genotype 6 infection. Patients with advanced liver disease were at risk of treatment failure. Only four patients discontinued treatment before week 4 due to non-hepatic adverse events. Conclusions In this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials.

Published
2020
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11. A Novel and Simplified Score for Determining Treatment Eligibility for Patients with Chronic Hepatitis B

Author

Tanawat Geeratragool, Pisit Tangkijvanich, Supot Nimanong, Siwaporn Chainuvati, Phunchai Charatcharoenwitthaya, Tawesak Tanwandee, and Watcharasak Chotiyaputta

Subjects
hepatitis b, treatment, score, simplification, Thailand, Microbiology, QR1-502
Abstract

Background: International guidelines for hepatitis B infection (HBV) recommend initiating antiviral treatment based on viral replication with inflammation or fibrosis. HBV viral loads and liver fibrosis measurements are not widely available in resource-limited countries. Aim: To develop a novel scoring system for the initiation of antiviral treatment in HBV-infected patients. Methods: We examined 602 and 420 treatment-naïve, HBV mono-infected patients for derivation and validation cohorts. We performed regression analysis to identify parameters associated with the initiation of antiviral treatment based on the European Association for the Study of the Liver (EASL) guidelines. The novel score was developed based on these parameters. Results: The novel score (HePAA) was based on HBeAg (hepatitis B e-antigen), the platelet count, alanine transaminase, and albumin. The HePAA score showed excellent performance, with AUROC values of 0.926 (95% CI, 0.901–0.950) for the derivation cohort and 0.872 (95% CI, 0.833–0.910) for the validation cohort. The optimal cutoff was ≥3 points (sensitivity, 84.9%; specificity, 92.6%). The HePAA score performed better than the World Health Organization (WHO) criteria and the Risk Estimation for HCC in Chronic Hepatitis B (REACH-B) score, and it performed similarly to the Treatment Eligibility in Africa for HBV (TREAT-B) score. Conclusions: The HePAA scoring system is simple and accurate for chronic hepatitis B treatment eligibility in resource-limited countries.

Published
2023
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12. Validation of prognostic scores predicting mortality in acute liver decompensation or acute-on-chronic liver failure: A Thailand multicenter study

Author

Tongluk Teerasarntipan, Kessarin Thanapirom, Sakkarin Chirapongsathorn, Tanita Suttichaimongkol, Naichaya Chamroonkul, Chalermrat Bunchorntavakul, Sith Siramolpiwat, Siwaporn Chainuvati, Abhasnee Sobhonslidsuk, Apinya Leerapun, Teerha Piratvisuth, Wattana Sukeepaisarnjaroen, Tawesak Tanwandee, and Sombat Treeprasertsuk

Subjects
Medicine, Science
Abstract

Background & objectives Cirrhosis patients with worsening of the liver function are defined as acute decompensation (AD) and those who develop extrahepatic organ failure are defined as acute-on-chronic liver failure (ACLF). Both AD and ACLF have an extremely poor prognosis. However, information regarding prognostic predictors is still lacking in Asian populations. We aimed to identify prognostic factors for 30-day and 90-day mortality in cirrhosis patients who develop AD with or without ACLF. Methods We included 9 tertiary hospitals from Thailand in a retrospective observational study enrolling hospitalized cirrhosis patients with AD. ACLF was diagnosed according to the EASL-CLIF criteria, which defined as AD patients who have kidney failure or a combination of at least two non-kidney organ failure. Outcomes were clinical parameters and prognostic scores associated with mortality evaluated at 30 days and 90 days. Results Between 2015 and 2020, 602 patients (301 for each group) were included. The 30-day and 90-day mortality rates of ACLF vs. AD were 57.48% vs. 25.50% (pConclusions Regarding Thai patients, the CLIF-C OF score was the best predictor for 30-day and 90-day mortalities in ACLF patients, while appropriate prognostic factors for AD patients remained inconclusive.

Published
2022

13. Novel Aspects in the Management of Hepatocellular Carcinoma

Author

Yongyut Sirivatanauksorn, Walailak Chaiyasoot, Krisdee Prabhasavat, and Tawesak Tanwandee

Subjects
Management, Hepatocellular Carcinoma, Medicine
Abstract

Hepatocellular carcinoma (HCC) is one of the commonest cancers in Thailand, which usually develops on a background of cirrhosis. We report a multimodal approach to the management of HCC. Though surgical treatment is the only opportunity for curing HCC, it is only feasible in a minority of patients. Various non-surgical treatment modalities have been developed and used extensively, but their efficacy is far from satisfactory and the prospect for the development of more effective treatments is dismal. Multidisciplinary treatment such as the combination of transcatheter oily chemoembolization and percutaneous ethanol injection appears to be the current trend of management for nonresectable HCC, and improvement in survival can be achieved compared to single mode treatment. Portal vein embolization is useful in patient in need of wide hepatectomy to induce pre-operative hypertrophy of future remnant liver, which would have been insufficient for safe resection. Moreover, intra-arterial 131-Iodine-Lipiodol given after curative resection significantly decreased the rate of recurrence and increased disease-free and overall survival in patients with HCC.

Published
2020

14. A phase II study of the efficacy and safety of the MET inhibitor capmatinib (INC280) in patients with advanced hepatocellular carcinoma

Author

Shukui Qin, Stephen Lam Chan, Wattana Sukeepaisarnjaroen, Guohong Han, Su Pin Choo, Virote Sriuranpong, Hongming Pan, Thomas Yau, Yabing Guo, Minshan Chen, Zhenggang Ren, Jianming Xu, Chia-Jui Yen, Zhong-Zhe Lin, Luigi Manenti, Yi Gu, Yongjian Sun, Ralph Tiedt, Lu Hao, Wenjie Song, and Tawesak Tanwandee

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: The objectives of this phase II study were to determine the clinical activity of the MET tyrosine kinase inhibitor capmatinib (INC280) in patients with MET-dysregulated advanced hepatocellular carcinoma (HCC) and to assess the safety, pharmacokinetics, and correlation of biomarkers with the response. Methods: This phase II, open-label, single-arm study evaluated twice daily (BID) oral capmatinib in a dose-determining stage, utilizing a Bayesian Logistic Regression Model (BLRM) subject to Escalation with Overdose Control criteria, safety, pharmacokinetics, and pharmacodynamic information to determine a recommended dose for expansion (RDE) evaluating efficacy in patients with MET-dysregulated HCC. Results: A total of 38 patients received treatment. In the dose-determining stage, patients received capmatinib 300 mg BID capsules ( n = 8), and in the expansion, patients received 600 mg BID capsules ( n = 28) or 400 mg BID tablets ( n = 2) based on the BLRM and other relevant clinical data. No predefined qualifying adverse events (AEs) were observed during the first 28 days of treatment, and the RDE was 600 mg BID capsules (equivalent pharmacokinetics to 400 mg BID tablets). The most common any causality AEs were nausea (42%), vomiting (37%), and diarrhea (34%). In the expansion stage, in a subgroup of 10 patients with MET-high HCC, the overall response rate was 30%, including 1 durable complete response (>600 days) and 2 partial responses [1 durable (>600 days)]. Conclusions: Single agent capmatinib at the RDE is tolerable with a manageable safety profile. Antitumor activity was seen in a subset of patients with MET-dysregulated (MET-high) HCC. Trial registration: ClinicalTrials.gov: NCT01737827. https://clinicaltrials.gov/ct2/show/NCT01737827

Published
2019
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15. Efficacy of telbivudine with conditional tenofovir intensification in patients with chronic hepatitis B: results from the 2-year roadmap strategy

Author

Teerha Piratvisuth, Piyawat Komolmit, Henry LY Chan, Tawesak Tanwandee, Wattana Sukeepaisarnjaroen, Mário G Pessoa, Eduardo Fassio, Suzane K Ono, Fernando Bessone, Jorge Daruich, Stefan Zeuzem, Michael Manns, Alkaz Uddin, Yuhong Dong, and Aldo Trylesinski

Subjects
chronic hepatitis B, glomerular filtration rate, hepatitis B e antigen, intensification, roadmap, telbivudine, tenofovir, virologic breakthrough, Therapeutics. Pharmacology, RM1-950
Abstract

Background: A 2-year roadmap study was conducted to evaluate the efficacy and safety of tenofovir intensification at Week 24 in patients with chronic hepatitis B (CHB) receiving telbivudine. Scope: A prospective multicenter study was conducted in treatment-naive patients with hepatitis B e antigen (HBeAg)- positive CHB. All patients received telbivudine (600 mg/day) until Week 24. Thereafter, patients with detectable hepatitis B virus (HBV) DNA (≥300 copies/mL) were administered tenofovir (300 mg/day) plus telbivudine, and patients with undetectable HBV DNA continued telbivudine monotherapy until Week 104. The primary endpoint was the proportion of patients with undetectable HBV DNA (

Published
2016
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16. Validation of the prognostic models in acute-on-chronic liver failure precipitated by hepatic and extrahepatic insults.

Author

Kotchakon Maipang, Pichanun Potranun, Siwaporn Chainuvati, Supot Nimanong, Watcharasak Chotiyaputta, Tawesak Tanwandee, and Phunchai Charatcharoenwitthaya

Subjects
Medicine, Science
Abstract

BackgroundPatients with acute-on-chronic liver failure (ACLF) precipitated by hepatic injury and extrahepatic insults had distinct clinical phenotypes, and prognosis. This study aimed to validate prognostic models for ACLF and to explore their discriminative abilities in ACLF population categorized by the etiologies of precipitating events.MethodsThis study collected data from 343 consecutive cirrhotic patients hospitalized with the diagnosis of ACLF according to the EASL-CLIF-Consortium definition. The discrimination abilities of prognostic models at the onset of ACLF were tested with the concordance index and area under the receiver operating characteristic curve.ResultsAmong the entire cohort, 103 patients survived with medical management, nine patients were transplanted, and 231 patients died without liver transplantation. The predictive accuracy of the Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) for 28-day mortality was similar to the CLIF Consortium Organ Failure (CLIF-C OF) but significantly higher than the CLIF Consortium ACLF, the Child-Turcotte-Pugh, the model for end-stage liver disease (MELD), the MELD-sodium, the integrated MELD, and the Acute Physiology and Chronic Health Evaluation II. Of note, 44 patients had acute hepatic insult triggering ACLF (hepatic-ACLF), 244 were exclusively precipitated by bacterial infection or gastrointestinal bleeding (extrahepatic-ACLF), and 55 cases had no any identifiable potential precipitating events. Patients with hepatic-ACLF had significantly higher 28-day mortality than extrahepatic-ACLF patients. The CLIF-SOFA and CLIF-C OF displayed the highest accuracy significantly outperforming other scoring systems in predicting mortality among patients with hepatic-ACLF and those with extrahepatic-ACLF.ConclusionThe CLIF-SOFA and simpler CLIF-C OF are reliable measures of mortality risk in ACLF patients precipitated by either hepatic or extrahepatic insults. Both validated models could be used to stratify the risk of death and improve management of ACLF.

Published
2019
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17. Genetic variation in the vitamin D pathway CYP2R1 gene predicts sustained HBeAg seroconversion in chronic hepatitis B patients treated with pegylated interferon: A multicenter study.

Author

Kessarin Thanapirom, Sirinporn Suksawatamnuay, Wattana Sukeepaisarnjareon, Tawesak Tanwandee, Phunchai Charatcharoenwitthaya, Satawat Thongsawat, Apinya Leerapun, Teerha Piratvisuth, Rattana Boonsirichan, Chalermrat Bunchorntavakul, Chaowalit Pattanasirigool, Bubpha Pornthisarn, Supot Tantipanichtheerakul, Ekawee Sripariwuth, Woramon Jeamsripong, Teeranan Sanpajit, Yong Poovorawan, and Piyawat Komolmit

Subjects
Medicine, Science
Abstract

Evidence of a role of vitamin D in the immune system is increasing. Low serum vitamin D is associated with increased hepatitis B virus replication. Genome-wide association study (GWAS) data has revealed a number of the single nucleotide polymorphisms (SNPs) within the vitamin D synthetic pathway that affect vitamin D functions. We aimed to determine the association between SNPs in the vitamin D gene cascade and response to pegylated interferon (PegIFN) therapy in hepatitis B e-antigen (HBeAg)-positive patients. One hundred and eleven patients treated for 48 weeks with PegIFN-alfa 2a at 13 hospitals were retrospectively evaluated. Thirteen SNPs derived from vitamin D cascade-related genes, including DHCR7 (rs12785878), CYP27B1 (rs10877012), CYP2R1 (rs2060793, rs12794714), GC (rs4588, rs7041, rs222020, rs2282679), and VDR (FokI, BsmI, Tru9I, ApaI, TaqI), were genotyped. Thirty-one patients (27.9%) seroconverted to HBeAg after 24 weeks of treatment. Multivariate analysis found pretreatment qHBsAg 2 times the upper limit of normal (OR = 3.83, 95% CI: 1.31-11.22, P = 0.014) predicted sustained HBeAg seroconversion after completion of PegIFN treatment. HBV DNA during study period tended to be lower with the rs12794714 CYP2R1 TT than the non-TT genotype. The rs12794714 CYP2R1 polymorphism may be a useful pretreatment factor predictive of sustained HBeAg seroconversion after PegIFN therapy. This study provides evidence that not only vitamin D level but also genetic variation of CYP2R1 in the vitamin D cascade influences host immune response in chronic HBV infection.

Published
2017
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18. 52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B.

Author

Teerha Piratvisuth, Piyawat Komolmit, Tawesak Tanwandee, Wattana Sukeepaisarnjaroen, Henry L Y Chan, Mário G Pessôa, Eduardo Fassio, Suzane K Ono, Fernando Bessone, Jorge Daruich, Stefan Zeuzem, Hugo Cheinquer, Rashidkhan Pathan, Yuhong Dong, and Aldo Trylesinski

Subjects
Medicine, Science
Abstract

The Roadmap concept is a therapeutic framework in chronic hepatitis B for the intensification of nucleoside analogue monotherapy based on early virologic response. The efficacy and safety of this approach applied to telbivudine treatment has not been investigated.A multinational, phase IV, single-arm open-label study (ClinicalTrials.gov ID NCT00651209) was undertaken in HBeAg-positive, nucleoside-naive adult patients with chronic hepatitis B. Patients received telbivudine (600 mg once-daily) for 24 weeks, after which those with undetectable serum HBV DNA (

Published
2013
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19. Global multi-societies endorsement of the MAFLD definition.

Author

Alboraie, Mohamed, Tawesak Tanwandee, Xiaoyuan Xu, Nikolova, Dafina, Estupiñan, Enrique Carrera, Ghazinyan, Hasmik, Alawadhi, Sameer, Ocama, Ponsiano, Aghayeva, Gulnara, Piscoya, Alejandro, Farahat, Taghreed, Prasad, Pramendra, Lesmana, Cosmas Rinaldi Adithya, Joshi, Shashank R., Al-Busafi, Said, Milivojevic, Vladimir, Kayamba, Violet, Yeong Yeh Lee, Alam, Shahinul, and Chengwei Tang

Subjects
FAMILY medicine, MEDICAL personnel, MEDICAL laboratory science, FATTY liver, PEDIATRIC gastroenterology
Abstract

The article "Global multi-societies endorsement of the MAFLD definition" published in the Annals of Hepatology by Mohamed Alboraie et al. presents an open letter signed by over 80 professional societies from 75 countries endorsing the term metabolic (dysfunction) associated fatty liver disease (MAFLD) as an appropriate term for fatty liver diseases associated with metabolic dysregulation. The endorsement is based on evidence supporting the practicality and usefulness of the MAFLD definition for patient awareness and management, with studies showing it achieves an optimal balance between sensitivity and specificity compared to other proposed definitions. The term MAFLD is seen as striking the right balance between lack of stigma and easy communication without medicalizing disease names, aligning well with other diseases across the metabolic dysregulation spectrum and facilitating communication with various stakeholders. The transition to MAFLD is believed to have positive consequences in raising awareness about the condition among patients, healthcare professionals, and health systems worldwide. The article emphasizes the importance of avoiding unjustified abrupt changes in nomenclature and definitions to achieve greater standardization and move towards a more coherent framework for understanding, diagnosing, and treating fatty liver disease. [Extracted from the article]

Published
2024
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20. APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy

Author

Lau, George, Yu, Ming-Lung, Wong, Grace, Thompson, Alexander, Ghazinian, Hasmik, Hou, Jin-Lin, Piratvisuth, Teerha, Jia, Ji-Dong, Mizokami, Masashi, Cheng, Gregory, Chen, Guo-Feng, Liu, Zhen-Wen, Baatarkhuu, Oidov, Cheng, Ann Lii, Ng, Woon Leung, Lau, Patrick, Mok, Tony, Chang, Jer-Ming, Hamid, Saeed, Dokmeci, A. Kadir, Gani, Rino A., Payawal, Diana A., Chow, Pierce, Park, Joong-Won, Strasser, Simone I., Mohamed, Rosmawaiti, Win, Khin Maung, Tawesak, Tanwandee, Sarin, Shiv Kumar, and Omata, Masao

Published
2021
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21. A multi-society Delphi consensus statement on new fatty liver disease nomenclature

Author

Mary E, R, Jeffrey V, L, Vlad, R, Sven M, F, Arun J, S, Fasiha, K, Diana, R, Manal F, A, Quentin M, A, Juan Pablo, A, Marco, A, Ramon, B, Ulrich, B, Jerome, B, Elisabetta, B, Christopher, B, Graciela E, C, Abhijit, C, Helena, C, Donna, C, Kenneth, C, Mohamed, E, Samuel, K, Wayne, E, Jiangao, F, Samer, G, Cynthia D, G, Stephen A, H, Seung Up, K, Bart, K, Marko, K, Kris, K, Florence, L, Rohit, L, Robert, M, Timothy R, M, Elisabeth, P, Michael, R, Manuel, R, Marcelo, S, Shivaram Prasad, S, Silvia C, S, C Wendy, S, Dina, T, Luca, V, Miriam B, V, Vincent, W, Stavra, X, Yusuf, Y, Zobair, Y, Ansley, H, Marcela, V, Newsome, NVeeral Ajmeral, P, Alazawi, W, Alkhatry, M, Alkhouri, N, Allen, A, Allison, M, Alswat, K, R Alvares-da-Silva, M, Alves-Bezerra, M, J Armstrong, M, Arufe, D, Aschner, P, Baffy, G, Bansal, M, Bedossa, P, Belfort, R, Berg, T, Berzigotti, A, Betel, M, Bianco, C, Brass, C, L Brosgart, C, Matthews Brunt, E, Buti, M, Caldwell, S, Carr, R, Casanovas, T, Castera, L, Caussy, C, Cerda, E, Chalasani, N, Kheong Chan, W, Charatcharoenwitthaya, P, Charlton, M, Cheung, A, Chiodi, D, Chung, R, Cohen, D, Corey, K, P Cotrim, H, Crespo, J, Dassanayake, A, Davidson, N, De Knegt, R, De Ledinghen, V, Demir, M, Diaz, S, Mae Diehl, A, Dimmig, B, Dirchwolf, M, Duseja, A, Dvorak, K, Ekstedt, M, El Wakil, R, Lucía Ferraz, M, Friedman, S, Fuchs, M, Gastaldelli, A, Geerts, A, Geier, A, Girala, M, Goh, G, Goossens, N, Graupera, I, Hagström, H, Henry, Z, Hunyady, B, Hutchison, A, Isaacs, S, Jornayvaz, F, Kemp, C, Kile, D, Kim, W, Kleiner, D, Kohli, R, Kugelmas, M, Lavine, J, Lazo, M, Leite, N, Lozano, A, Luukkonen, P, Macedo, P, Mansour, D, Mantzoros, C, Marchesini, G, Marciano, S, Martinez, K, Vladimirova Mateva, L, M Mato, J, Mccary, A, Miele, L, Mikolasevic, I, Miller, V, Moreno, R, Moylan, C, Nakajima, A, Charles Nault, J, Norris, S, Noureddin, M, P Oliveira, C, Ong, A, Padilla, M, Pais, R, Panduro, A, K Panigrahi, M, Papatheodoridis, G, Pelusi, S, Pérez, M, Perez Escobar, J, Perseghin, G, Pessoa, M, Petta, S, Pinzani, M, Platon Lupsor, M, Rabiee, A, Romeo, S, Rotman, Y, Rowe, I, Salupere, R, Satapathy, S, M Schattenberg, J, Schaufert, W, Schnabl, B, Seim, L, Serfaty, L, Shapiro, D, K Singal, A, Skladany, L, Stefan, N, Stine, J, Sundaram, S, Svegliati-Baroni, G, Szabo, G, Tacke, F, Tanwandee, T, Targher, G, Terrault, N, Tetri, B, Thiele, M, Tisthammer, B, Torre Delgadillo, A, Trauner, M, Tsochatzis, E, Van Kleef, L, Van Mil, S, Vanwagner, L, Antonio Velarde Ruiz Velasco, J, Vesterhus, M, Vilar-Gomez, E, Watt, K, Wattacheril, J, Wilkins, F, Willemse, J, Zekry, A, Zelber-Sagi, S, Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Philip NVeeral Ajmeral, William Alazawi, Maryam Alkhatry, Naim Alkhouri, Alina Allen, Michael Allison, Khalid Alswat, Mario R Alvares-da-Silva, Michele Alves-Bezerra, Matthew J Armstrong, Diego Arufe, Pablo Aschner, Gyorgy Baffy, Meena Bansal, Pierre Bedossa, Renata Belfort, Thomas Berg, Annalisa Berzigotti, Michael Betel, Cristiana Bianco, Clifford Brass, Carol L Brosgart, Elizabeth Matthews Brunt, Maria Buti, Steve Caldwell, Rotonya Carr, Teresa Casanovas, Laurent Castera, Cyrielle Caussy, Eira Cerda, Naga Chalasani, Wah Kheong Chan, Phunchai Charatcharoenwitthaya, Michael Charlton, Amanda Cheung, Daniela Chiodi, Ray Chung, David Cohen, Kathleen Corey, Helma P Cotrim, Javier Crespo, Anuradha Dassanayake, Nicholas Davidson, Robert De Knegt, Victor De Ledinghen, Münevver Demir, Sebastian Diaz, Anna Mae Diehl, Bruce Dimmig, Melisa Dirchwolf, Ajay Duseja, Karel Dvorak, Mattias Ekstedt, Reda El Wakil, María Lucía Ferraz, Scott Friedman, Michael Fuchs, Amalia Gastaldelli, Anja Geerts, Andreas Geier, Marcos Girala, George Goh, Nicolas Goossens, Isabel Graupera, Hannes Hagström, Zachary Henry, Bela Hunyady, Alan Hutchison, Scott Isaacs, François Jornayvaz, Cynthia Kemp, Denise Kile, Won Kim, David Kleiner, Rohit Kohli, Marcelo Kugelmas, Joel Lavine, Mariana Lazo, Nathalie Leite, Adelina Lozano, Panu Luukkonen, Paula Macedo, Dina Mansour, Christos Mantzoros, Giulio Marchesini, Sebastián Marciano, Kim Martinez, Lyudmila Vladimirova Mateva, Jose M Mato, Alexis McCary, Luca Miele, Ivana Mikolasevic, Veronica Miller, Rosalba Moreno, Cynthia Moylan, Atsushi Nakajima, Jean Charles Nault, Suzanne Norris, Mazen Noureddin, C P Oliveira, Arlin Ong, Martín Padilla, Raluca Pais, Arturo Panduro, Manas K Panigrahi, George Papatheodoridis, Serena Pelusi, Marlene Pérez, Juanita Perez Escobar, Gianluca Perseghin, Mario Pessoa, Salvatore Petta, Massimo Pinzani, Monica Platon Lupsor, Atoosa Rabiee, Stefano Romeo, Yaron Rotman, Ian Rowe, Riina Salupere, Sanjaya Satapathy, Jörn M Schattenberg, Wendy Schaufert, Bernd Schnabl, Lynn Seim, Lawrence Serfaty, David Shapiro, Ashwani K Singal, Lubomir Skladany, Norbert Stefan, Jonathan Stine, Shikha Sundaram, Gianluca Svegliati-Baroni, Gyonzgi Szabo, Frank Tacke, Tawesak Tanwandee, Giovanni Targher, Norah Terrault, Brent Tetri, Maja Thiele, Baron Tisthammer, Aldo Torre Delgadillo, Michael Trauner, Emmanuel Tsochatzis, Laurens Van Kleef, Saskia Van Mil, Lisa VanWagner, Jose Antonio Velarde Ruiz Velasco, Mette Vesterhus, Eduardo Vilar-Gomez, Kymberly Watt, Julia Wattacheril, Fonda Wilkins, José Willemse, Amany Zekry, Shira Zelber-Sagi, Mary E, R, Jeffrey V, L, Vlad, R, Sven M, F, Arun J, S, Fasiha, K, Diana, R, Manal F, A, Quentin M, A, Juan Pablo, A, Marco, A, Ramon, B, Ulrich, B, Jerome, B, Elisabetta, B, Christopher, B, Graciela E, C, Abhijit, C, Helena, C, Donna, C, Kenneth, C, Mohamed, E, Samuel, K, Wayne, E, Jiangao, F, Samer, G, Cynthia D, G, Stephen A, H, Seung Up, K, Bart, K, Marko, K, Kris, K, Florence, L, Rohit, L, Robert, M, Timothy R, M, Elisabeth, P, Michael, R, Manuel, R, Marcelo, S, Shivaram Prasad, S, Silvia C, S, C Wendy, S, Dina, T, Luca, V, Miriam B, V, Vincent, W, Stavra, X, Yusuf, Y, Zobair, Y, Ansley, H, Marcela, V, Newsome, NVeeral Ajmeral, P, Alazawi, W, Alkhatry, M, Alkhouri, N, Allen, A, Allison, M, Alswat, K, R Alvares-da-Silva, M, Alves-Bezerra, M, J Armstrong, M, Arufe, D, Aschner, P, Baffy, G, Bansal, M, Bedossa, P, Belfort, R, Berg, T, Berzigotti, A, Betel, M, Bianco, C, Brass, C, L Brosgart, C, Matthews Brunt, E, Buti, M, Caldwell, S, Carr, R, Casanovas, T, Castera, L, Caussy, C, Cerda, E, Chalasani, N, Kheong Chan, W, Charatcharoenwitthaya, P, Charlton, M, Cheung, A, Chiodi, D, Chung, R, Cohen, D, Corey, K, P Cotrim, H, Crespo, J, Dassanayake, A, Davidson, N, De Knegt, R, De Ledinghen, V, Demir, M, Diaz, S, Mae Diehl, A, Dimmig, B, Dirchwolf, M, Duseja, A, Dvorak, K, Ekstedt, M, El Wakil, R, Lucía Ferraz, M, Friedman, S, Fuchs, M, Gastaldelli, A, Geerts, A, Geier, A, Girala, M, Goh, G, Goossens, N, Graupera, I, Hagström, H, Henry, Z, Hunyady, B, Hutchison, A, Isaacs, S, Jornayvaz, F, Kemp, C, Kile, D, Kim, W, Kleiner, D, Kohli, R, Kugelmas, M, Lavine, J, Lazo, M, Leite, N, Lozano, A, Luukkonen, P, Macedo, P, Mansour, D, Mantzoros, C, Marchesini, G, Marciano, S, Martinez, K, Vladimirova Mateva, L, M Mato, J, Mccary, A, Miele, L, Mikolasevic, I, Miller, V, Moreno, R, Moylan, C, Nakajima, A, Charles Nault, J, Norris, S, Noureddin, M, P Oliveira, C, Ong, A, Padilla, M, Pais, R, Panduro, A, K Panigrahi, M, Papatheodoridis, G, Pelusi, S, Pérez, M, Perez Escobar, J, Perseghin, G, Pessoa, M, Petta, S, Pinzani, M, Platon Lupsor, M, Rabiee, A, Romeo, S, Rotman, Y, Rowe, I, Salupere, R, Satapathy, S, M Schattenberg, J, Schaufert, W, Schnabl, B, Seim, L, Serfaty, L, Shapiro, D, K Singal, A, Skladany, L, Stefan, N, Stine, J, Sundaram, S, Svegliati-Baroni, G, Szabo, G, Tacke, F, Tanwandee, T, Targher, G, Terrault, N, Tetri, B, Thiele, M, Tisthammer, B, Torre Delgadillo, A, Trauner, M, Tsochatzis, E, Van Kleef, L, Van Mil, S, Vanwagner, L, Antonio Velarde Ruiz Velasco, J, Vesterhus, M, Vilar-Gomez, E, Watt, K, Wattacheril, J, Wilkins, F, Willemse, J, Zekry, A, Zelber-Sagi, S, Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Philip NVeeral Ajmeral, William Alazawi, Maryam Alkhatry, Naim Alkhouri, Alina Allen, Michael Allison, Khalid Alswat, Mario R Alvares-da-Silva, Michele Alves-Bezerra, Matthew J Armstrong, Diego Arufe, Pablo Aschner, Gyorgy Baffy, Meena Bansal, Pierre Bedossa, Renata Belfort, Thomas Berg, Annalisa Berzigotti, Michael Betel, Cristiana Bianco, Clifford Brass, Carol L Brosgart, Elizabeth Matthews Brunt, Maria Buti, Steve Caldwell, Rotonya Carr, Teresa Casanovas, Laurent Castera, Cyrielle Caussy, Eira Cerda, Naga Chalasani, Wah Kheong Chan, Phunchai Charatcharoenwitthaya, Michael Charlton, Amanda Cheung, Daniela Chiodi, Ray Chung, David Cohen, Kathleen Corey, Helma P Cotrim, Javier Crespo, Anuradha Dassanayake, Nicholas Davidson, Robert De Knegt, Victor De Ledinghen, Münevver Demir, Sebastian Diaz, Anna Mae Diehl, Bruce Dimmig, Melisa Dirchwolf, Ajay Duseja, Karel Dvorak, Mattias Ekstedt, Reda El Wakil, María Lucía Ferraz, Scott Friedman, Michael Fuchs, Amalia Gastaldelli, Anja Geerts, Andreas Geier, Marcos Girala, George Goh, Nicolas Goossens, Isabel Graupera, Hannes Hagström, Zachary Henry, Bela Hunyady, Alan Hutchison, Scott Isaacs, François Jornayvaz, Cynthia Kemp, Denise Kile, Won Kim, David Kleiner, Rohit Kohli, Marcelo Kugelmas, Joel Lavine, Mariana Lazo, Nathalie Leite, Adelina Lozano, Panu Luukkonen, Paula Macedo, Dina Mansour, Christos Mantzoros, Giulio Marchesini, Sebastián Marciano, Kim Martinez, Lyudmila Vladimirova Mateva, Jose M Mato, Alexis McCary, Luca Miele, Ivana Mikolasevic, Veronica Miller, Rosalba Moreno, Cynthia Moylan, Atsushi Nakajima, Jean Charles Nault, Suzanne Norris, Mazen Noureddin, C P Oliveira, Arlin Ong, Martín Padilla, Raluca Pais, Arturo Panduro, Manas K Panigrahi, George Papatheodoridis, Serena Pelusi, Marlene Pérez, Juanita Perez Escobar, Gianluca Perseghin, Mario Pessoa, Salvatore Petta, Massimo Pinzani, Monica Platon Lupsor, Atoosa Rabiee, Stefano Romeo, Yaron Rotman, Ian Rowe, Riina Salupere, Sanjaya Satapathy, Jörn M Schattenberg, Wendy Schaufert, Bernd Schnabl, Lynn Seim, Lawrence Serfaty, David Shapiro, Ashwani K Singal, Lubomir Skladany, Norbert Stefan, Jonathan Stine, Shikha Sundaram, Gianluca Svegliati-Baroni, Gyonzgi Szabo, Frank Tacke, Tawesak Tanwandee, Giovanni Targher, Norah Terrault, Brent Tetri, Maja Thiele, Baron Tisthammer, Aldo Torre Delgadillo, Michael Trauner, Emmanuel Tsochatzis, Laurens Van Kleef, Saskia Van Mil, Lisa VanWagner, Jose Antonio Velarde Ruiz Velasco, Mette Vesterhus, Eduardo Vilar-Gomez, Kymberly Watt, Julia Wattacheril, Fonda Wilkins, José Willemse, Amany Zekry, and Shira Zelber-Sagi

Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panellists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms “nonalcoholic” and “fatty” were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction–associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction–associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction–associated steatotic liver disease, who consume greater amounts of alcohol per week (140–350 g/wk and 210–420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and non-stigmati

Published
2023

22. Contextual and individual factors associated with knowledge, awareness and attitude on liver diseases: A large‐scale Asian study

Author

Sang Hoon Ahn, Venus Tsang, Akash Shukla, Henry Lik-Yuen Chan, Pham Thi Thu Thuy, Asad Choudhry, Mei Hsuan Lee, Rosmawati Mohamed, Shikha Singh, Janus P Ong, Jin Youn, Tawesak Tanwandee, Rino Alvani Gani, Chee-Kiat Tan, and Boon Leong Neo

Subjects
Health Knowledge, Attitudes, Practice, medicine.medical_specialty, education.field_of_study, Asia, Hepatology, business.industry, Liver Diseases, Public health, Knowledge level, Mortality rate, Multilevel model, Population, Disease, Infectious Diseases, Surveys and Questionnaires, Virology, Scale (social sciences), medicine, Humans, Mass Screening, Household income, education, business, Demography
Abstract

There are limited data to provide better understanding of the knowledge/awareness of general population towards liver health in Asia. We sought to identify the knowledge gaps and attitudes towards liver health and liver diseases as well as evaluate associated individual-level and macro-level factors based on contextual analysis. An online survey assessing knowledge, awareness and attitudes towards liver health and disease was conducted among 7500 respondents across 11 countries/territories in Asia. A liver index was created to measure the respondents' knowledge level and the degree of awareness and attitudes. Multilevel logistic regression was performed to identify individual factors and contextual effects that were associated with liver index. The overall liver index (0-100-point scale) was 62.4 with 6 countries/territories' liver indices greater than this. In the multilevel model, the inclusion of geographical information could explain for 9.6% of the variation. Residing in a country/territory with higher HBV prevalence (80% IOR: 1.20-2.79) or higher HCV death rate (80% IOR: 1.35-3.13) increased the individual probability of obtaining a high overall liver index. Individual factors like age, gender, education, household income, disease history and health screening behaviour were also associated with liver index (all p-values0.001). The overall liver index was positively associated with the two macro-level factors viz. HBV prevalence and HCV death rate. There is a need to formulate policies especially in regions of lower HBV prevalence and HCV death rate to further improve the knowledge, awareness and attitudes of the general public towards liver diseases.

Published
2021
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23. A multi-society Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip NVeeral Ajmeral, William Alazawi, Maryam Alkhatry, Naim Alkhouri, Alina Allen, Michael Allison, Khalid Alswat, Mario R Alvares-da-Silva, Michele Alves-Bezerra, Matthew J Armstrong, Diego Arufe, Pablo Aschner, Gyorgy Baffy, Meena Bansal, Pierre Bedossa, Renata Belfort, Thomas Berg, Annalisa Berzigotti, Michael Betel, Cristiana Bianco, Clifford Brass, Carol L Brosgart, Elizabeth Matthews Brunt, Maria Buti, Steve Caldwell, Rotonya Carr, Teresa Casanovas, Laurent Castera, Cyrielle Caussy, Eira Cerda, Naga Chalasani, Wah Kheong Chan, Phunchai Charatcharoenwitthaya, Michael Charlton, Amanda Cheung, Daniela Chiodi, Ray Chung, David Cohen, Kathleen Corey, Helma P Cotrim, Javier Crespo, Anuradha Dassanayake, Nicholas Davidson, Robert De Knegt, Victor De Ledinghen, Münevver Demir, Sebastian Diaz, Anna Mae Diehl, Bruce Dimmig, Melisa Dirchwolf, Ajay Duseja, Karel Dvorak, Mattias Ekstedt, Reda El Wakil, María Lucía Ferraz, Scott Friedman, Michael Fuchs, Amalia Gastaldelli, Anja Geerts, Andreas Geier, Marcos Girala, George Goh, Nicolas Goossens, Isabel Graupera, Hannes Hagström, Zachary Henry, Bela Hunyady, Alan Hutchison, Scott Isaacs, François Jornayvaz, Cynthia Kemp, Denise Kile, Won Kim, David Kleiner, Rohit Kohli, Marcelo Kugelmas, Joel Lavine, Mariana Lazo, Nathalie Leite, Adelina Lozano, Panu Luukkonen, Paula Macedo, Dina Mansour, Christos Mantzoros, Giulio Marchesini, Sebastián Marciano, Kim Martinez, Lyudmila Vladimirova Mateva, Jose M Mato, Alexis McCary, Luca Miele, Ivana Mikolasevic, Veronica Miller, Rosalba Moreno, Cynthia Moylan, Atsushi Nakajima, Jean Charles Nault, Suzanne Norris, Mazen Noureddin, C P Oliveira, Arlin Ong, Martín Padilla, Raluca Pais, Arturo Panduro, Manas K Panigrahi, George Papatheodoridis, Serena Pelusi, Marlene Pérez, Juanita Perez Escobar, Gianluca Perseghin, Mario Pessoa, Salvatore Petta, Massimo Pinzani, Monica Platon Lupsor, Atoosa Rabiee, Stefano Romeo, Yaron Rotman, Ian Rowe, Riina Salupere, Sanjaya Satapathy, Jörn M Schattenberg, Wendy Schaufert, Bernd Schnabl, Lynn Seim, Lawrence Serfaty, David Shapiro, Ashwani K Singal, Lubomir Skladany, Norbert Stefan, Jonathan Stine, Shikha Sundaram, Gianluca Svegliati-Baroni, Gyonzgi Szabo, Frank Tacke, Tawesak Tanwandee, Giovanni Targher, Norah Terrault, Brent Tetri, Maja Thiele, Baron Tisthammer, Aldo Torre Delgadillo, Michael Trauner, Emmanuel Tsochatzis, Laurens Van Kleef, Saskia Van Mil, Lisa VanWagner, Jose Antonio Velarde Ruiz Velasco, Mette Vesterhus, Eduardo Vilar-Gomez, Kymberly Watt, Julia Wattacheril, Fonda Wilkins, José Willemse, Amany Zekry, Shira Zelber-Sagi, Mary E, R, Jeffrey V, L, Vlad, R, Sven M, F, Arun J, S, Fasiha, K, Diana, R, Manal F, A, Quentin M, A, Juan Pablo, A, Marco, A, Ramon, B, Ulrich, B, Jerome, B, Elisabetta, B, Christopher, B, Graciela E, C, Abhijit, C, Helena, C, Donna, C, Kenneth, C, Mohamed, E, Samuel, K, Wayne, E, Jiangao, F, Samer, G, Cynthia D, G, Stephen A, H, Seung Up, K, Bart, K, Marko, K, Kris, K, Florence, L, Rohit, L, Robert, M, Timothy R, M, Elisabeth, P, Michael, R, Manuel, R, Marcelo, S, Shivaram Prasad, S, Silvia C, S, C Wendy, S, Dina, T, Luca, V, Miriam B, V, Vincent, W, Stavra, X, Yusuf, Y, Zobair, Y, Ansley, H, Marcela, V, Newsome, NVeeral Ajmeral, P, Alazawi, W, Alkhatry, M, Alkhouri, N, Allen, A, Allison, M, Alswat, K, R Alvares-da-Silva, M, Alves-Bezerra, M, J Armstrong, M, Arufe, D, Aschner, P, Baffy, G, Bansal, M, Bedossa, P, Belfort, R, Berg, T, Berzigotti, A, Betel, M, Bianco, C, Brass, C, L Brosgart, C, Matthews Brunt, E, Buti, M, Caldwell, S, Carr, R, Casanovas, T, Castera, L, Caussy, C, Cerda, E, Chalasani, N, Kheong Chan, W, Charatcharoenwitthaya, P, Charlton, M, Cheung, A, Chiodi, D, Chung, R, Cohen, D, Corey, K, P Cotrim, H, Crespo, J, Dassanayake, A, Davidson, N, De Knegt, R, De Ledinghen, V, Demir, M, Diaz, S, Mae Diehl, A, Dimmig, B, Dirchwolf, M, Duseja, A, Dvorak, K, Ekstedt, M, El Wakil, R, Lucía Ferraz, M, Friedman, S, Fuchs, M, Gastaldelli, A, Geerts, A, Geier, A, Girala, M, Goh, G, Goossens, N, Graupera, I, Hagström, H, Henry, Z, Hunyady, B, Hutchison, A, Isaacs, S, Jornayvaz, F, Kemp, C, Kile, D, Kim, W, Kleiner, D, Kohli, R, Kugelmas, M, Lavine, J, Lazo, M, Leite, N, Lozano, A, Luukkonen, P, Macedo, P, Mansour, D, Mantzoros, C, Marchesini, G, Marciano, S, Martinez, K, Vladimirova Mateva, L, M Mato, J, Mccary, A, Miele, L, Mikolasevic, I, Miller, V, Moreno, R, Moylan, C, Nakajima, A, Charles Nault, J, Norris, S, Noureddin, M, P Oliveira, C, Ong, A, Padilla, M, Pais, R, Panduro, A, K Panigrahi, M, Papatheodoridis, G, Pelusi, S, Pérez, M, Perez Escobar, J, Perseghin, G, Pessoa, M, Petta, S, Pinzani, M, Platon Lupsor, M, Rabiee, A, Romeo, S, Rotman, Y, Rowe, I, Salupere, R, Satapathy, S, M Schattenberg, J, Schaufert, W, Schnabl, B, Seim, L, Serfaty, L, Shapiro, D, K Singal, A, Skladany, L, Stefan, N, Stine, J, Sundaram, S, Svegliati-Baroni, G, Szabo, G, Tacke, F, Tanwandee, T, Targher, G, Terrault, N, Tetri, B, Thiele, M, Tisthammer, B, Torre Delgadillo, A, Trauner, M, Tsochatzis, E, Van Kleef, L, Van Mil, S, Vanwagner, L, Antonio Velarde Ruiz Velasco, J, Vesterhus, M, Vilar-Gomez, E, Watt, K, Wattacheril, J, Wilkins, F, Willemse, J, Zekry, A, Zelber-Sagi, S, and Vincent Wai-Sun, W

Subjects
steatotic liver disease, MASLD, alcohol, steatohepatiti, MetALD, NASH, nonalcoholic, Delphi, Fatty liver disease, NAFLD, cardiometabolic, nomenclature, mafld, type 2 diabetes, MED/13 - ENDOCRINOLOGIA
Abstract

Unlabelled: The principal limitations of the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. Methods: A modified Delphi process was led by three large pan-national liver associations. Consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. Results: A total of 236 panellists from 56 countries participated in four online surveys and two hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83% and 78%, respectively. 74% of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms 'non-alcoholic' and 'fatty' were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease (SLD) was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction-associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least one of five cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic SLD. A new category, outside pure MASLD, termed MetALD was selected to describe those with MASLD who consume greater amounts of alcohol per week (140 to 350g/week and 210 to 420g/week for females and males respectively). Conclusions: The new nomenclature and diagnostic criteria are widely supported, non-stigmatising and can improve awareness and patient identification.

Published
2023

24. Clinical Study of Single‐Stranded Oligonucleotide RO7062931 in Healthy Volunteers and Patients With Chronic Hepatitis B

Author

Henry Lik-Yuen Chan, Ben Fillippo Krippendorff, Wendy Cheng, Cynthia Wat, Hyung Joon Kim, Vedran Pavlovic, Young-Suk Lim, Rémi Kazma, Annabelle Lemenuel-Diot, Tien Huey Lim, Miriam Triyatni, Tawesak Tanwandee, Sudip Das, Joseph F. Grippo, Man-Fung Yuen, Won Kim, Tsung Hui Hu, Apinya Leerapun, Dong Joon Kim, Henrik Mueller, Bernadette Surujbally, Edward Gane, Simon Buatois, and Yuchen Zhang

Subjects
Adult, Male, Hepatitis B virus, medicine.medical_specialty, HBsAg, Acetylgalactosamine, Sustained Virologic Response, Oligonucleotides, Asialoglycoprotein Receptor, Placebo, Gastroenterology, Hepatitis B, Chronic, Pharmacokinetics, Internal medicine, Healthy volunteers, medicine, Humans, Adverse effect, Hepatitis B Surface Antigens, Hepatology, business.industry, Middle Aged, Oligonucleotides, Antisense, Healthy Volunteers, Regimen, HBeAg, Pharmacodynamics, RNA, Viral, Female, business
Abstract

Background and aims RO7062931 is an N-acetylgalactosamine (GalNAc)-conjugated single-stranded locked nucleic acid oligonucleotide complementary to HBV RNA. GalNAc conjugation targets the liver through the asialoglycoprotein receptor (ASGPR). This two-part phase 1 study evaluated the safety, pharmacokinetics, and pharmacodynamics of RO7062931 in healthy volunteers and patients with chronic hepatitis B (CHB) who were virologically suppressed. Approach and results Part 1 was a single ascending dose study in healthy volunteers randomized to receive a single RO7062931 dose (0.1-4.0 mg/kg), or placebo. Part 2 was a multiple ascending dose study in patients with CHB randomized to receive RO7062931 at 0.5, 1.5, or 3.0 mg/kg or placebo every month for a total of 2 doses (Part 2a) or RO7062931 at 3.0 mg/kg every 2 weeks, 3.0 mg/kg every week (QW), or 4.0 mg/kg QW or placebo for a total of 3-5 doses (Part 2b). Sixty healthy volunteers and 59 patients received RO7062931 or placebo. The majority of adverse events (AEs) reported were mild in intensity. Common AEs included self-limiting injection site reactions and influenza-like illness. Supradose-proportional increases in RO7062931 plasma exposure and urinary excretion occurred at doses ≥3.0 mg/kg. In patients with CHB, RO7062931 resulted in dose-dependent and time-dependent reduction in HBsAg versus placebo. The greatest HBsAg declines from baseline were achieved with the 3.0 mg/kg QW dose regimen (mean nadir ~0.5 log10 IU/mL) independent of HBeAg status. Conclusions RO7062931 is safe and well tolerated at doses up to 4.0 mg/kg QW. Supradose-proportional exposure at doses of 3.0-4.0 mg/kg was indicative of partial saturation of the ASGPR-mediated liver uptake system. Dose-dependent declines in HBsAg demonstrated target engagement with RO7062931.

Published
2021
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25. Transition rates to cirrhosis and liver cancer by age, gender, disease and treatment status in Asian chronic hepatitis B patients

Author

Yasuhito Tanaka, Cheng Hao Tseng, Soung Won Jeong, Min Sun Kwak, Jae-Jun Shim, Grace Lai-Hung Wong, Man-Fung Yuen, Joseph Hoang, Michael Cheung, Christopher Wong, Yong Kyun Cho, Rui Huang, Changqing Zhao, Hyunwoo Oh, Ming-Lung Yu, Matt Liu, Hwai I. Yang, Sang Bong Ahn, Chao Wu, Dae Won Jun, Tai-Chung Tseng, Edward Gane, Qing Xie, Jian Zhang, Chien-Hung Chen, Dong Hyun Lee, Chung Feng Huang, Tawesak Tanwandee, Satoshi Yasuda, Hirokazu Takahashi, Ming Lun Yeh, Jia-Horng Kao, Masaru Enomoto, Pei-Chien Tsai, Eileen L. Yoon, Eiichi Ogawa, Chris Cunningham, Yao-Chun Hsu, Ritsuzo Kozuka, Clifford Wong, Teerapat Ungtrakul, Hidenori Toyoda, Yuichiro Eguchi, Jiayi Li, Jae Yoon Jeong, Hyo Suk Lee, Mindie H. Nguyen, Chia-Yen Dai, Sung Eun Kim, Cheng Yuan Peng, Huy N. Trinh, and Ramsey Cheung

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, Incidence (epidemiology), medicine.disease, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Hepatocellular carcinoma, Epidemiology, medicine, 030211 gastroenterology & hepatology, Liver cancer, Viral hepatitis, business, Disease burden
Abstract

Increasing hepatitis-related mortality has reignited interest to fulfill the World Health Organization’s goal of viral hepatitis elimination by 2030. However, economic barriers have enabled only 28% of countries to implement countermeasures. Given the high disease burden among Asians, we aimed to present age, sex, disease activity and treatment-specific annual progression rates among Asian chronic hepatitis B (CHB) patients to inform health economic modeling efforts and cost-effective public health interventions. We analyzed 18,056 CHB patients from 36 centers across the U.S. and seven countries/regions of Asia Pacific (9530 treated; 8526 untreated). We used Kaplan–Meier methods to estimate annual incidence of cirrhosis and hepatocellular carcinoma (HCC). Active disease was defined by meeting the APASL treatment guideline criteria. Over a median follow-up of 8.55 years, there were 1178 incidences of cirrhosis and 1212 incidences of HCC (297 without cirrhosis, 915 with cirrhosis). Among the 8526 untreated patients (7977 inactive, 549 active), the annual cirrhosis and HCC incidence ranged from 0.26% to 1.30% and 0.04% to 3.80% in inactive patients, and 0.55 to 4.05% and 0.19 to 6.03% in active patients, respectively. Of the 9530 treated patients, the annual HCC rates ranged 0.03–1.57% among noncirrhotic males and 2.57–6.93% among cirrhotic males, with lower rates for females. Generally, transition rates increased with age, male sex, the presence of fibrosis/cirrhosis, and active disease and/or antiviral treatment. Using data from a large and diverse real-world cohort of Asian CHB patients, the study provided detailed annual transition rates to inform practice, research and public health planning.

Published
2021
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29. APASL practical recommendations for the management of hepatocellular carcinoma in the era of COVID-19

Author

Osamu Yokosuka, Rino Alvani Gani, Hitoshi Maruyama, Tawesak Tanwandee, George Lau, Masao Omata, Shiv Kumar Sarin, Shuichiro Shiina, Laurentius A Lesmana, Hiroaki Nagamatsu, A. Kadir Dokmeci, and Diana A. Payawal

Subjects
Asymptomatically infected, medicine.medical_specialty, Carcinoma, Hepatocellular, Facemask, Psychological intervention, Chronic liver disease, Systemic therapy, CT screening for COVID-19, 03 medical and health sciences, 0302 clinical medicine, Personal protective equipment, Internal medicine, Diagnosis, Pandemic, medicine, Humans, Intensive care medicine, Hospital preparedness, Surveillance, Hepatology, business.industry, Liver Neoplasms, COVID-19, The novel coronavirus, medicine.disease, Triage, Aerosol generating procedure, Colorectal surgery, Treatment, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Original Article, 030211 gastroenterology & hepatology, Asian-Pacific, business, Liver cancer, Decision-making
Abstract

BackgroundCOVID-19 has been giving the devastating impact on the current medical care system. There are quite many guidelines on COVID-19, but only a few on the management of hepatocellular carcinoma (HCC) during COVID-19 pandemic.AimsWe develop these recommendations to preserve adequate clinical practice for the management of HCC.MethodsExperts of HCC in the Asia–Pacific region exchanged opinions via webinar, and these recommendations were formed.ResultsClose contact should be minimized to reduce possible exposure of both medical staff and patients to the novel coronavirus. To prevent transmission of the virus, meticulous hygiene measures are important. With the decrease in regular medical service, the medical staff may be mobilized to provide COVID-19-related patient care. However, diagnosis and treatment of HCC should not be delayed because of COVID-19 pandemic. The management of HCC should be the same as in non-pandemic circumstances. HCC is highly malignant, thus it is recommended not to delay curative treatment such as surgery and ablation. However, a kind of triage is necessary even among patients with HCC when resources are insufficient for all to be treated. Curative treatments should be periodized and cytoreductive or non-curative treatment such as vascular interventions and systemic therapy may be postponed until it can be performed safely with sufficient resources. For patients with confirmed or suspected to be infected with the novel coronavirus, diagnosis and treatment should be postponed until the virus is eliminated or they are confirmed as not being infected with it.ConclusionsThese are collection of measures implemented by front-line medical professionals. We would evolve these recommendations over time as more real-world data becomes available.

Published
2020
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30. Pre-existing liver disease is associated with poor outcome in patients with SARS CoV2 infection; The APCOLIS Study (APASL COVID-19 Liver Injury Spectrum Study)

Author

Wasim Jafri, Lau Ing Soo, Shiv Kumar Sarin, Eslam Saber Esmail, J.S. Hwang, Tserendorj Chinbayar, Osamu Yokosuka, Arvinder S. Soin, Ian Homer Y. Cua, Chun-Yu Lin, Opass Putcharoen, Akash Shukla, Wan-Long Chuang, Sang Hoon Ahn, Ashok Choudhury, Oidov Baatarkhuu, Apichat Kaewdech, Teerha Piratvisuth, Xiaolong Qi, Chang Dong Yeo, Rino Alvani Gani, Mai Khalaf, Manoj K. Sharma, Sombat Treeprasertsuk, Shahinul Alam, Sherief Abd-Elsalam, Uzziel Romar Alonzo, Masao Omata, Vijay Pal Dara, Hery Djagat Purnomo, Diana A. Payawal, Jeong Ill Suh, Dong Ji, Hitendra K. Garg, Soo-Young Park, Salisa Wejnaruemarn, Mamun Al Mahtab, Ming-Hua Zheng, Kemal Fariz Kalista, Badamnachin Batsukh, Imelda Maria Loho, Tawesak Tanwandee, George K. K. Lau, Lovkesh Anand, S. G. Tan, Pravin Rathi, and Jun Gi Park

Subjects
Liver Cirrhosis, Male, medicine.medical_specialty, Asia, Cirrhosis, Pneumonia, Viral, Chronic liver disease, Risk Assessment, Gastroenterology, Betacoronavirus, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Liver Function Tests, Risk Factors, Internal medicine, Acute liver injury, medicine, Humans, Decompensation, Pandemics, Liver injury, Hepatology, medicine.diagnostic_test, SARS CoV2, SARS-CoV-2, business.industry, Fatty liver, Patient Acuity, COVID-19, Acute-On-Chronic Liver Failure, Middle Aged, Prognosis, medicine.disease, 030220 oncology & carcinogenesis, Disease Progression, Original Article, Female, 030211 gastroenterology & hepatology, Coronavirus Infections, business, Liver function tests
Abstract

Background and Aims: COVID-19 is a dominant pulmonary disease, with multisystem involvement, depending upon co morbidities. Its profile in patients with pre-existing chronic liver disease (CLD) is largely unknown. We studied the liver injury patterns of SARS-Cov-2 in CLD patients, with or without cirrhosis. Methods: Data was collected from 13 Asian countries on patients with CLD, known or newly diagnosed, with confirmed COVID-19. Result: Altogether, 228 patients [185 CLD without cirrhosis and 43 with cirrhosis] were enrolled, with comorbidities in nearly 80%. Metabolism associated fatty liver disease (113, 61%) and viral etiology (26, 60%) were common. In CLD without cirrhosis, diabetes [57.7% vs 39.7%, OR=2.1(1.1-3.7), p=0.01] and in cirrhotics, obesity, [64.3% vs. 17.2%, OR=8.1(1.9-38.8), p=0.002) predisposed more to liver injury than those without these. Forty three percent of CLD without cirrhosis presented as acute liver injury and 20% cirrhotics presented with either acute-on-chronic liver failure [5(11.6%)] or acute decompensation [4(9%)]. Liver related complications increased (p In decompensated cirrhotics, the liver injury was progressive in 57% patients, with 43% mortality. Rising bilirubin and AST/ALT ratio predicted mortality among cirrhosis. Conclusions: SARS-Cov-2 infection causes significant liver injury in CLD patients, decompensating one fifth of cirrhosis, and worsening the clinical status of the already decompensated. The CLD patients with diabetes and obesity are more vulnerable and should be closely monitored.

Published
2020
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31. An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia

Author

Mukul Rastogi, Diana A. Payawal, Jose D. Sollano, Zahid Yasin Hashmi, Do Duy Cuong, Michael Charlton, Khin Maung Win, Wattana Sukeepaisarnjaroen, Kaushal Madan, Khin Pyone Kyi, Kyaw Soe Tun, Pham Tran Dieu Hien, Win Naing, Tawesak Tanwandee, Rosmawati Mohamed, Bekhbold Dashtseren, Cosmas Rinaldi A Lesmana, Ganbolor Jargalsaikhan, Pham Thi Thu Thuy, K Singh, Rino Alvani Gani, Altaf Alam, Akash Shukla, Mohd. Salih, Ian Homer Y. Cua, Davadoorj Duger, Neeraj Saraf, and Teerha Piratvisuth

Subjects
medicine.medical_specialty, Hepatitis B virus, Asia, Review, medicine.disease_cause, Tenofovir alafenamide, Antiviral Agents, law.invention, 03 medical and health sciences, 0302 clinical medicine, Hepatitis B, Chronic, Randomized controlled trial, law, Internal medicine, Drug Resistance, Viral, medicine, Humans, Tenofovir, Randomized Controlled Trials as Topic, Alanine, Nucleoside analogue, business.industry, Incidence (epidemiology), Gastroenterology, Lamivudine, Entecavir, Hepatology, 030220 oncology & carcinogenesis, Nucleoside analogs, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The use of guideline-recommended nucleos(t)ide analogs with high barrier to resistance, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), is one of the key interventions for curbing HBV infection and associated morbidity in Asia. However, there are some challenges to the use of ETV and TDF; while ETV is associated with high resistance in lamivudine (LAM)-exposed (especially LAM-refractory) patients; bone and renal safety issues are a major concern with TDF. Hence, a panel of twenty-eight expert hepatologists from Asia convened, reviewed the literature, and developed the current expert opinion-based review article for the use of TAF in the resource-constrained settings in Asia. This article provides a comprehensive review of two large, phase 3, double-blind, randomized controlled trials of TAF versus TDF in HBeAg-negative (study 0108) and HBeAg-positive (study 0110) chronic HBV patients (> 70% Asians). These studies revealed as follows: (1) non-inferiority for the proportion of patients who had HBV DNA

Published
2020

32. 2018 Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C in Chronic Kidney Disease Guideline Implementation: Asia Summit Conference Report

Author

Siu Ka Mak, Cheuk-Chun Szeto, Chi Bon Leung, Hong Liu, Hon-Lok Tang, Ming-Lung Yu, Yock Young Dan, SL Lui, Chiu-Ching Huang, Sunita Bavanandan, Kai Ming Chow, Michael Cheung, Philip Kam-Tao Li, Wanhong Lu, Eng-Kiong Yeoh, James Fung, Talerngsak Kanjanabuch, Tawesak Tanwandee, Michel Jadoul, Hyeong Cheon Park, Angela Yee-Moon Wang, Ching Kong Loo, Rosmawati Mohamed, Ching-Lung Lai, Boon Wee Teo, Kunitoshi Iseki, Grace Lai-Hung Wong, Man Ching Law, Jidong Jia, Vincent Wai-Sun Wong, Eiichiro Kanda, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, and UCL - (SLuc) Service de néphrologie

Subjects
Mainland China, medicine.medical_specialty, 030232 urology & nephrology, kidney transplantation, Infection control, 030204 cardiovascular system & hematology, Meeting Report, Direct-acting antiviral, Southeast asian, Kidney transplantation, 03 medical and health sciences, 0302 clinical medicine, Chronic kidney disease, medicine, geography, direct-acting antiviral, Summit, geography.geographical_feature_category, business.industry, Hepatitis C, Guideline, medicine.disease, infection control, Nephrology, Family medicine, dialysis, business, Dialysis, chronic kidney disease, Kidney disease
Abstract

In 2018, Kidney Disease: Improving Global Outcomes (KDIGO) published a clinical practice guideline on the prevention, diagnosis, evaluation, and treatment of hepatitis C virus (HCV) infection in chronic kidney disease (CKD). The guideline synthesized recent advances, especially in HCV therapeutics and diagnostics, and provided clinical recommendations and suggestions to aid healthcare providers and improve care for CKD patients with HCV. To gain insight into the extent that the 2018 guideline has been adopted in Asia, KDIGO convened an HCV Implementation Summit in Hong Kong. Participants included nephrologists, hepatologists, and nurse consultants from 8 Southeast Asian countries or regions with comparable high-to-middle economic ranking by the World Bank: mainland China, Hong Kong, Japan, Malaysia, Singapore, South Korea, Taiwan, and Thailand. Through presentations and discussions, meeting participants described regional practice patterns related to the KDIGO HCV in CKD guideline, identified barriers to implementing the guideline, and developed strategies for overcoming the barriers in Asia and around the world.

Published
2020

33. Prognostic Relevance of Metabolic Dysfunction-associated Steatohepatitis for Patients with Chronic Hepatitis B

Author

Manus Rugivarodom, Ananya Pongpaibul, Siwaporn Chainuvati, Supot Nimanong, Watcharasak Chotiyaputta, Tawesak Tanwandee, and Phunchai Charatcharoenwitthaya

Subjects
Hepatology
Abstract

Metabolic dysfunction-associated fatty liver disease (MAFLD) is prevalent in patients with chronic hepatitis B (CHB). The effect of the histologic MAFLD phenotype on long-term CHB outcomes is unknown. We performed a longitudinal study to determine the prognostic relevance of biopsy-proven hepatic steatosis and steatohepatitis for CHB patients.Clinical and laboratory data were obtained from CHB patients who underwent liver biopsy during 2002-2008 and were treated with antiviral drugs. A hepatopathologist reviewed the biopsy specimens. Cox proportional hazards regression was used to estimate the adjusted hazard ratio (aHR) of outcomes, including all-cause mortality, liver transplantation, and liver-related events.In accordance with Brunt's classification, 408 patients had steatohepatitis (Metabolic dysfunction-associated steatohepatitis increased the risk of long-term mortality/transplantation and liver-related events in CHB patients.

Published
2022

34. Comprehensive evaluation of microRNA as a biomarker for the diagnosis of hepatocellular carcinoma

Author

Juliane Malik, Martin Klammer, Vinzent Rolny, Henry Lik-Yuen Chan, Teerha Piratvisuth, Tawesak Tanwandee, Satawat Thongsawat, Wattana Sukeepaisarnjaroen, Juan Ignacio Esteban, Marta Bes, Bruno Köhler, Magdalena Swiatek-de Lange, Institut Català de la Salut, [Malik J, Klammer M, Rolny V] Roche Diagnostics GmbH, Penzberg, Germany. [Chan HLY] Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. [Piratvisuth T] NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Hat Yai, Thailand. [Tanwandee T] Division of Gastroenterology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. [Esteban JI] Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Carcinoma, Hepatocellular, Vitamin K, Nucleic Acids, Nucleotides, and Nucleosides::Antisense Elements (Genetics)::RNA, Antisense::MicroRNAs [CHEMICALS AND DRUGS], neoplasias::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias hepáticas::carcinoma hepatocelular [ENFERMEDADES], Otros calificadores::/diagnóstico [Otros calificadores], Biological Factors::Biomarkers [CHEMICALS AND DRUGS], factores biológicos::biomarcadores [COMPUESTOS QUÍMICOS Y DROGAS], Lectins, Other subheadings::/diagnosis [Other subheadings], Biomarkers, Tumor, Humans, Prospective Studies, Protein Precursors, Early Detection of Cancer, MicroARN, Liver Neoplasms, Gastroenterology, General Medicine, MicroRNAs, Neoplasms::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Liver Neoplasms::Carcinoma, Hepatocellular [DISEASES], Fetge - Càncer - Diagnòstic, Case-Control Studies, Marcadors bioquímics, Prothrombin, nucleótidos y nucleósidos de ácidos nucleicos::elementos antisentido (genética)::ARN antiparalelo::microARN [COMPUESTOS QUÍMICOS Y DROGAS], alpha-Fetoproteins, Biomarkers
Abstract

Carcinoma; Diagnosis; MicroRNAs Carcinoma; Diagnóstico; MicroARN Carcinoma; Diagnòstic; MicroARN Background: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. Current guidelines for HCC management recommend surveillance of high-risk patients every 6 mo using ultrasonography. Serum biomarkers, like alpha-fetoprotein (AFP), protein induced by vitamin K absence/antagonist-II (PIVKA-II) and lectin-reactive AFP, show suboptimal performance for detection of HCC, which is crucial for successful resection or treatment. Thus, there is a significant need for new biomarkers to aid early diagnosis of HCC. Studies have shown that the expression level of human microRNAs (miRNAs), a small, non-coding RNA species released into the blood, can serve as an early marker for various diseases, including HCC. Aim: To evaluate the diagnostic role of miRNAs in HCC as single markers, signatures or in combination with known protein biomarkers. Methods: Our prospective, multicenter, case-control study recruited 660 participants (354 controls with chronic liver disease and 306 participants with HCC) and employed a strategy of initial screening by two independent methods, real-time quantitative PCR (n = 60) and next-generation sequencing (n = 100), to assess a large number of miRNAs. The results from the next-generation sequencing and real-time quantitative PCR screening approaches were then combined to select 26 miRNAs (including two putative novel miRNAs). Those miRNAs were analyzed for their diagnostic potential as single markers or in combination with other miRNAs or established protein biomarkers AFP and PIVKA-II via real-time quantitative PCR in training (n = 200) and validation cohorts (n = 300). Results: We identified 26 miRNAs that differentiated chronic liver disease controls from (early) HCC via two independent discovery approaches. Three miRNAs, miR-21-5p (miR-21), miR-320a and miR-186-5p, were selected by both methods. In the training cohort, only miR-21, miR-320d and miR-423 could significantly distinguish (Q < 0.05) between the HCC and chronic liver disease control groups. In the multivariate setting, miR-21 with PIVKA-II was selected as the best combination, resulting in an area under the curve of 0.87 for diagnosis and area under the curve of 0.74 for early diagnosis of HCC. In the validation cohort, only miR-21 and miR-423 could be confirmed as potential HCC biomarkers. A combination of miRNAs did not perform better than any single miRNA. Improvement of PIVKA-II performance through combination with miRNAs could not be confirmed in the validation panel. Two putative miRs, put-miR-6 and put-miR-99, were tested in the training and validation panels, but their expression could only be detected in very few samples and at a low level (cycle threshold between 31.24 and 34.97). Conclusion: miRNAs alone or as a signature in combination with protein biomarkers AFP and PIVKA-II do not improve the diagnostic performance of the protein biomarkers.

Published
2022

35. Economic Evaluation of Oral Nucleos(t)ide Analogues for Patients with Chronic Hepatitis B in Thailand

Author

Piyameth Dilokthornsakul, Ratree Sawangjit, Pisit Tangkijvanich, Maneerat Chayanupatkul, Tawesak Tanwandee, Wattana Sukeepaisarnjaroen, Pajaree Sriuttha, and Unchalee Permsuwan

Subjects
Economics and Econometrics, Hepatitis B, Chronic, Treatment Outcome, Health Policy, Adenine, Cost-Benefit Analysis, Organophosphonates, Humans, General Medicine, Tenofovir, Thailand, Antiviral Agents
Abstract

Nucleos(t)ide analogues (NAs) are the main drug category used in the treatment of chronic hepatitis B (CHB). There is a need to update the economic evaluation of CHB treatment.This study aimed to determine the cost effectiveness of NAs for CHB in Thailand.We used a lifetime Markov model undertaken from a societal perspective. Tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), entecavir (ETV) with TDF or TAF as rescue medications, and lamivudine (LAM) with TDF or TAF rescue medications were compared with best supportive care (BSC). We performed a network meta-analysis to estimate the treatment effects of each NA on hepatitis B surface antigen (HBsAg) loss in an Asian population and performed an additional literature review to identify inputs. We calculated incremental cost-effectiveness ratios (ICERs) per quality-adjusted life-years (QALYs) and performed sensitivity analyses.Compared with BSC, all NAs could improve patients' QALYs, with results ranging from 4.04 to 4.25 QALYs gained. TAF, TDF, LAM/TAF, and LAM/TDF yielded lower total lifetime costs than BSC, ranging from - $US1387 to - 814, whereas ETV/TAF and ETV/TDF yielded higher total lifetime costs than BSC, ranging from $US4965 to 4971. The ICER was $US1230/QALY for ETV/TDF and $US1228/QALY for ETV/TAF. Full incremental analysis showed that the ICER for LAM/TAF was $US1720/QALY compared with TAF.At current prices, TAF, TDF, LAM/TAF, and LAM/TDF are dominant options, and ETV/TAF or ETV/TDF are cost-effective options. LAM/TAF is the most cost-effective option, followed by TAF.

Published
2022

36. Global multi-stakeholder endorsement of the MAFLD definition

Author

Nahum Méndez-Sánchez, Elisabetta Bugianesi, Robert G Gish, Frank Lammert, Herbert Tilg, Mindie H Nguyen, Shiv K Sarin, Núria Fabrellas, Shira Zelber-Sagi, Jian-Gao Fan, Gamal Shiha, Giovanni Targher, Ming-Hua Zheng, Wah-Kheong Chan, Shlomo Vinker, Takumi Kawaguchi, Laurent Castera, Yusuf Yilmaz, Marko Korenjak, C Wendy Spearman, Mehmet Ungan, Melissa Palmer, Mortada El-Shabrawi, Hans-Juergen Gruss, Jean-François Dufour, Anil Dhawan, Heiner Wedemeyer, Jacob George, Luca Valenti, Yasser Fouad, Manuel Romero‐Gomez, Mohammed Eslam, Maria Lorena Abate, Bahaa Abbas, Ahmed Amr Abbassy, Waleed Abd El Ghany, Amira Abd Elkhalek, Emad Abd ElMajeed, Mohammad Abdalgaber, Mohamed AbdAllah, Marwa Abdallah, Nourhan Abdallah, Shereen Abdelaleem, Yasser Abdelghani, Wael Abdelghany, Safaa Mohamed Abdelhalim, Wafaa Abdelhamid, Nehal Abdelhamid, Nadia A. Abdelkader, Elsayed Abdelkreem, Aly Mohamed Abdelmohsen, Awny Ali Abdelrahman, Sherief M Abd-elsalam, Doaa Abdeltawab, Abdulbaset Abduh, Nada Abdulhakam, Maheeba Abdulla, Navid Abedpoor, Ludovico Abenavoli, Fredrik Åberg, Omala Ablack, Mostafa Abo elftouh, Yousry Esam-Eldin Abo-Amer, Ashraf Aboubkr, Alaa Aboud, Amr M. Abouelnaga, Galal A. Aboufarrag, Ashraf Aboutaleb, Leticia Abundis, Gupse Adalı, Enrique Adames, Leon Adams, Danjuma Adda, Noor Adel, Nada Adel, Muhammad Adel Sayed, Taiba Jibril Afaa, Nawal Afredj, Gulnara Aghayeva, Alessio Aghemo, Carlos A. Aguilar-Salinas, Golo Ahlenstiel, Walid Ahmady, Wafaa Ahmed, Amira Ahmed, Samah Nasser Ahmed, Heba Mostafa Ahmed, Rasha Ahmed, Elmar Aigner, Mesut Akarsu, Maisam Akroush, Umit Akyuz, Mamun Al Mahtab, Tahani Al Qadiri, Yusriya Al Rawahi, Razzaq AL rubaee, Muna Al Saffar, Shahinul Alam, Zaid Al-Ani, Agustín Albillos, Mohamed Alboraie, Said Al-Busafi, Mohamed Al-Emam, Jawaher Alharthi, Kareem Ali, Basma Abdelmoez Ali, Mohammad Ali, Raja Affendi Raja Ali, Anna Alisi, Ali Raad AL-Khafaji, Maryam Alkhatry, Rocio Aller, Yahya Almansoury, Khalid Al-Naamani, Alaa Alnakeeb, Anna Alonso, Saleh A. Alqahtani, Leina Alrabadi, Khalid Alswat, Mahir Altaher, Turki Altamimi, Jose Altamirano, Mario R. Alvares-da-Silva, Elsragy Adel M. Aly, Amgad Alzahaby, Ahmed Alzamzamy, Keisuke Amano, Maysa A. Amer, Mona A. Amin, Sayed A. Amin, Ashraf A. Amir, Javier Ampuero, Noha Anas, Pietro Andreone, Soa Fy Andriamandimby, Mahmoud Anees, Peltec Angela, Manal Antonios, Wael Arafat, Jose Moreno Araya, Juan Armendariz-Borunda, Matthew J. Armstrong, Hassan Ashktorab, Patricia Aspichueta, Fathia Assal, Mira Atef, Dina Attia, Hoda Atwa, Reham Awad, Mohyeldeen Abd Elaziz Awad, Sally Awny, Obafemi Awolowo, Yaw Asante Awuku, Ibrahim Ayada, Than Than Aye, Sherif Ayman, Hedy Ayman, Hesham Ayoub, Hosny M. Azmy, Romiro P. Babaran, Omneya Badreldin, Ahmed Badry, İbrahim Halil Bahçecioğlu, Amira Bahour, Jiajia Bai, Yasemin Balaban, Muthuswamy Balasubramanyam, Khaled Bamakhrama, Jesus M Banales, Babu Bangaru, Jianfeng Bao, Jorge Suazo Barahona, Salma Barakat, Sandra Maria Barbalho, Bikwa Barbra, Beatriz Barranco, Francisco Barrera, Ulrich Baumann, Shamardan Bazeed, Eva Bech, Aourarh Benayad, Andreas Benesic, David Bernstein, Fernando Bessone, Susie Birney, Cyrille Bisseye, Martin Blake, Bilal Bobat, Leonilde Bonfrate, Dmitry S Bordin, Francisco Bosques-Padilla, Jerome Boursier, Boushab Mohamed Boushab, David Bowen, Patricia Medina Bravo, Paul N Brennan, Bisi Bright, Ilse Broekaert, Xabier Buque, Diego Burgos-Santamaría, Julio Burman, Luca Busetto, Chris D. Byrne, Patricia Anne I. Cabral-Prodigalidad, Guillermo Cabrera-Alvarez, Wei Cai, Francesca Cainelli, Ali Riza Caliskan, Ali Canbay, Ana Cano-Contreras, Hai-Xia Cao, Zhujun Cao, Andres Carrion, Francesca Carubbi, Teresa Casanovas, Marlen Ivón Castellanos Fernández, Jin Chai, Siew Pheng Chan, Phunchai Charatcharoenwitthaya, Norberto Chavez-Tapia, Kazuaki Chayama, Jinjun Chen, Lin Chen, Zhong-Wei Chen, Huiting Chen, Sui-Dan Chen, Qiang Chen, Yaxi Chen, Gang Chen, En-Quang Chen, Fei Chen, Pei-Jer Chen, Robert Cheng, Wendy Cheng, Jack Tan Wei Chieh, Imad Chokr, Evangelos Cholongitas, Ashok Choudhury, Abhijit Chowdhury, Evaristus Sunday Chukwudike, Stefano Ciardullo, Michelle Clayton, Karine Clement, Marie Michelle Cloa, Cecilia Coccia, Cristina Collazos, Massimo Colombo, Arif Mansur Cosar, Helma Pinchemel Cotrim, Joris Couillerot, Alioune Coulibaly, Gonzalo Crespo, Javier Crespo, Maria Cruells, Ian Homer Y. Cua, Hesham K. Dabbous, George N Dalekos, Patricia D'Alia, Li Dan, Viet Hang Dao, Mostafa Darwish, Christian Datz, Milagros B Davalos-Moscol, Heba Dawoud, Blanca Olaechea de Careaga, Robert de Knegt, Victor de Ledinghen, Janaka de Silva, Nabil Debzi, Marie Decraecker, Elvira Del Pozo, Teresa C Delgado, Manuel Delgado-Blanco, Łukasz Dembiński, Adilson Depina, Moutaz Derbala, Hailemichael Desalegn, Christèle Desbois-Mouthon, Mahmoud Desoky, Anouk Dev, Agostino Di Ciaula, Moisés Diago, Ibrahima Diallo, Luis Antonio Díaz, Melisa Dirchwolf, Paola Dongiovanni, Andrriy Dorofeyev, Xiaoguang Dou, Mark W. Douglas, Michael Doulberis, Cecil K. Dovia, Adam Doyle, Ivana Dragojević, Joost PH Drenth, Xuefei Duan, Audrius Dulskas, Dan L Dumitrascu, Oliver Duncan, Vincent Dusabejambo, Rev. Shem N.A. Dwawhi, Sho Eiketsu, Doaa El Amrousy, Ahmed El Deeb, Ghada El Deriny, Hesham Salah El Din, Salwa El Kamshishy, Mohamed El Kassas, Maissa El Raziky, Osama A Elagamy, Wafaa Elakel, Dina Elalfy, Hanaa Elaraby, Heba ElAwady, Reda Elbadawy, Hanaa Hassan Eldash, Manal S. Eldefrawy, Carol Lezama Elecharri, Amel Elfaramawy, Mohammed Elfatih, Mahmoud Elfiky, Mohamed Elgamsy, Mohamed Elgendy, Mohamed A. El-Guindi, Nagi Elhussieny, Ahmed Maher Eliwa, Zeineb Elkabbany, Hesham El-Khayat, Nehal M. El-Koofy, Alaa Elmetwalli, Amr Elrabat, Fathiya El-Raey, Fatma Elrashdy, Medhat Elsahhar, Esraa M. Elsaid, Shimaa Elsayed, Hany Elsayed, Aly Elsayed, Amr M. Elsayed, Hamdy Elsayed, Magdy El-Serafy, Ahmed M. Elsharkawy, Reem Yehia Elsheemy, Eman Elsayed Elshemy, Sara Elsherbini, Naglaa Eltoukhy, Reda Elwakil, Ola Emad, Shaimaa Emad, Mohamed Embabi, Ilkay Ergenç, Tatiana Ermolova, Gamal Esmat, Doaa M. Esmat, Enrique Carrera Estupiñan, Said Ettair, Tcaciuc Eugen, Mohammed Ezz-Eldin, Lidia Patricia Valdivieso Falcón, Yu-Chen Fan, Samah Fandari, Mahmoud Farag, Taghreed Mohamed Farahat, Eman M. Fares, Michael Fares, Eduardo Fassio, Hayam Fathy, Dina Fathy, Wael Fathy, Soheir Fayed, Dan Feng, Gong Feng, Miguel Fernández-Bermejo, Cristina Targa Ferreira, Javier Díaz Ferrer, Alastair Forbes, Rabab Fouad, Hanan M. Fouad, Tove Frisch, Hideki Fujii, Shuhei Fukunaga, Shinya Fukunishi, Hacer Fulya, Masato Furuhashi, Yasmine Gaber, Augusto Jose G. Galang, Jacqueline Cordova Gallardo, Rocío Galloso, Mahmoud Gamal, Reham Gamal, Hadeel Gamal, Jian Gan, Anar Ganbold, Xin Gao, George Garas, Tony Garba, Miren García-Cortes, Carmelo García-Monzón, Javier García-Samaniego, Amalia Gastaldelli, Manuel Gatica, Elizabeth Gatley, Tamar Gegeshidze, Bin Geng, Hasmik Ghazinyan, Salma Ghoneem, Luca Giacomelli, Gianluigi Giannelli, Edoardo G. Giannini, Matthew Giefer, Pere Ginès, Marcos Girala, Pablo J Giraudi, George Boon-Bee Goh, Ahmed Ali Gomaa, Benbingdi Gong, Dina Hilda C. Gonzales, Humberto C. Gonzalez, Maria Saraí Gonzalez-Huezo, Isabel Graupera, Ivica Grgurevic, Henning Grønbæk, Xuelian Gu, Lin Guan, Ibrahima Gueye, Alice Nanelin Guingané, Ozen Oz Gul, Cuma Bulent Gul, Qing Guo, Pramendra Prasad Gupta, Ahmet Gurakar, Juan Carlos Restrepo Gutierrez, Ghada Habib, Azaa Hafez, Emilia Hagman, Eman Halawa, Osama Hamdy, Abd Elkhalek Hamed, Dina H. Hamed, Saeed Hamid, Waseem Hamoudi, Yu Han, James Haridy, Hanan Haridy, David C H Harris Harris, Michael Hart, Fuad Hasan, Almoutaz Hashim, Israa Hassan, Ayman Hassan, Essam Ali Hassan, Adel Ahmed Hassan, Magda Shehata Hassan, Fetouh Hassanin, Alshymaa Hassnine, John Willy Haukeland, Amr Ismael M. Hawal, Jinfan He, Qiong He, Yong He, Fang-Ping He, Mona Hegazy, Adham Hegazy, Osama Henegil, Nelia Hernández, Manuel Hernández-Guerra, Fatima Higuera-de-la-Tijera, Ibrahim Hindy, Keisuke Hirota, Lee Chi Ho, Alexander Hodge, Mohamed Hosny, Xin Hou, Jiao-Feng Huang, Yan Huang, Zhifeng Huang, Yuan Huang, Ang Huang, Xiao-Ping Huang, Sheng Hui-ping, Bela Hunyady, Mennatallah A. Hussein, Osama Hussein, Shahinaz Mahmoud Hussien, Luis Ibáñez-Samaniego, Jamal Ibdah, Luqman Ibrahim, Miada Ibrahim, Ibrahim Ibrahim, Maria E. Icaza-Chávez, Sahar Idelbi, Ramazan Idilman Idilman, Mayumi Ikeda, Giuseppe Indolfi, Federica Invernizzi, Iram Irshad, Hasan Mohamed Ali Isa, Natacha Jreige Iskandar, Abdulrahman Ismaiel, Mariam Ismail, Zulkifli Ismail, Faisal Ismail, Hideki Iwamoto, Kathryn Jack, Rachael Jacob, Fuad Jafarov, Wasim Jafri, Helen Jahshan, Prasun K Jalal, Ligita Jancoriene, Martin Janicko, Hiruni Jayasena, Meryem Jefferies, Vivekanand Jha, Fanpu Ji, Yaqiu Ji, Jidong Jia, Changtao Jiang, Ni Jiang, Zong-zhe Jiang, Xing Jin, Yi Jin, Xu Jing, Qian Jingyu, Maia Jinjolava, FX Himawan Haryanto Jong, Alina Jucov, Ibecheole Julius, Mona Kaddah, Yoshihiro Kamada, Abobakr kamal, Enas Mohamed Kamal, Ashraf Sayed Kamel, Jia-Horng Kao, Maja Karin, Thomas Karlas, Mohammad Kashwaa, Leolin Katsidzira, Eda Kaya, M.Azzam Kayasseh, Bernadette Keenan, Caglayan Keklikkiran, William Keml, Deia K. Khalaf, Rofida Khalefa, Sherin Khamis, Doaa Khater, Hamed khattab, Anatoly Khavkin, Olga Khlynova, Nabil Khmis, Nazarii Kobyliak, Apostolos Koffas, Kazuhiko Koike, Kenneth Y.Y. Kok, Tomas Koller, Narcisse Patrice Komas, Nataliya V. Korochanskaya, Yannoula Koulla, Shunji Koya, Colleen Kraft, Bledar Kraja, Marcin Krawczyk, Mohammad Shafi Kuchay, Anand V Kulkarni, Ashish Kumar, Manoj Kumar, Sulaiman Lakoh, Philip Lam, Ling Lan, Naomi F. Lange, Kamran Bagheri Lankarani, Nicolas Lanthier, Kateryna Lapshyna, Sameh A. Lashen, Konang Nguieguia Justine Laure, Leonid Lazebnik, Didier Lebrec, Samuel S. Lee, Way Seah Lee, Yeong Yeh Lee, Diana Julie Leeming, Nathalie Carvalho Leite, Roberto Leon, Cosmas Rinaldi Adithya Lesmana, Junfeng Li, Qiong Li, Jun Li, Yang-Yang Li, Yufang Li, Lei Li, Min Li, Yiling li, Huiqing Liang, Tang Lijuan, Seng Gee Lim, Lee-Ling Lim, Shumei Lin, Han-Chieh Lin, Rita Lin, Rania Lithy, Yaru Liu, Yuanyuan Liu, Xin Liu, Wen-Yue Liu, Shourong Liu, Ken Liu, Tian Liu, Amedeo Lonardo, Mariana Bravo López, Eva López-Benages, Patricio Lopez-Jaramillo, Huimin Lu, Lun Gen Lu, Yan Lu, John Lubel, Rashid Lui, Iulianna Lupasco, Elena Luzina, Xiao-Hui Lv, Kate Lynch, Hong-Lei Ma, Mariana Verdelho Machado, Nonso Maduka, Katerina Madzharova, Russellini Magdaong, Sanjiv Mahadeva, Amel Mahfouz, Nik Ritza Kosai Nik Mahmood, Eman Mahmoud, Mohamed Mahrous, Rakhi Maiwall, Ammar Majeed, Avik Majumdar, Loey Mak, Madiha M Maklouf, Reza Malekzadeh, Claudia Mandato, Alessandra Mangia, Jake Mann, Hala Hussien Mansour, Abdellah Mansouri, Alessandro Mantovani, Jun qian Mao, Flor Maramag, Giulio Marchesini, Claude Marcus, Rui António Rocha Tato Marinho, Maria L Martinez-Chantar, Antonieta A. Soares Martins, Rana Marwan, Karen Frances Mason, Ghadeer Masoud, Mohamed Naguib Massoud, Maria Amalia Matamoros, Rosa Martín Mateos, Asmaa Mawed, Jean Claude Mbanya, Charles Mbendi, Lone McColaugh, Duncan McLeod, Juan Francisco Rivera Medina, Ahmed Megahed, Mai Mehrez, Iqbal Memon, Shahin Merat, Randy Mercado, Ahmed Mesbah, Taoufik Meskini, Mayada Metwally, Rasha Metwaly, Lei Miao, Eileen Micah, Luca Miele, Vladimir Milivojevic, Tamara Milovanovic, Yvonne L. Mina, Milan Mishkovik, Amal Mishriki, Tim Mitchell, Alshaimaa Mohamed, Mona Mohamed, Sofain Mohamed, Shady Mohammed, Ahmed Mohammed, Viswanathan Mohan, Sara Mohie, Aalaa Mokhtar, Reham Moniem, Mabel Segura Montilla, Jose Antonio Orozco Morales, María María Sánchez Morata, Jose Maria Moreno-Planas, Silvia Morise, Sherif Mosaad, Mohamed Moselhy, Alaa Mohamed Mostafa, Ebraheem Mostafa, Nezha Mouane, Nasser Mousa, Hamdy Mahfouz Moustafa, Abeer Msherif, Kate Muller, Christopher Munoz, Ana Beatriz Muñoz-Urribarri, Omar Alfaro Murillo, Feisul Idzwan Mustapha, Emir Muzurović, Yehia Nabil, Shaymaa Nafady, Ayu Nagamatsu, Atsushi Nakajima, Dan Nakano, Yuemin Nan, Fabio Nascimbeni, Mirella S. Naseef, Nagwa Nashat, Taran Natalia, Francesco Negro, Alexander V. Nersesov, Manuela Neuman, Masolwa Ng'wanasayi, Yan Ni, Amanda Nicoll, Takashi Niizeki, Dafina Nikolova, Wang Ningning, Madunil Niriella, K.A Nogoibaeva, Rozeena Nordien, Catherine O Sullivan, James O'Beirne, Solomon Obekpa, Ponsiano Ocama, Missiani Ochwoto, Michael Promise Ogolodom, Olusegun Ojo, Nana Okrostsvaridze, Claudia P. Oliveira, Raul Contreras Omaña, Omneya M. Omar, Hanaa Omar, Mabroka Omar, Salma Omran, Reham Omran, Marian Muse Osman, Nevin Owise, Theobald Owusu-Ansah, P. Martín Padilla- Machaca, Sirish Palle, Ziyan Pan, Xiao-Yan Pan, Qiuwei Pan, Apostolis Papaefthymiou, Feliciano Chanana Paquissi, Gabriella Par, Arit Parkash, Diana Payawal, Kevork M. Peltekian, Xuebin Peng, Liang Peng, Ying Peng, Rahul Pengoria, Martina Perez, José Luis Pérez, Norma Marlene Pérez, Marcello Persico, Mário Guimarães Pessoa, Salvatore Petta, Mathew Philip, Maria Corina Plaz Torres, Naveen Polavarapu, Jaime Poniachik, Piero Portincasa, Chunwen Pu, Tuğrul Pürnak, Edhie Purwanto, Xiaolong Qi, Xingshun Qi, Zibing Qian, Zhao Qiang, Zengpei Qiao, Liang Qiao, Alberto Queiroz, Atoosa Rabiee, Manal Radwan, Alain Marcel Rahetilahy, Yasmin Ramadan, Dina Ramadan, Anis Safura Ramli, Grant A. Ramm, Ao Ran, Ivan Rankovic, Huiying RAO, Sara Raouf, Sayantan Ray, Nancy Reau, Ahmed Refaat, Thomas Reiberger, Jose M Remes-Troche, Eira Cerda Reyes, Ben Richardson, Ezequiel Ridruejo, Sergio Riestra Jimenez, Ibrahim Rizk, Stuart Roberts, Juan Pablo Roblero, Jorge Alberto Prado Robles, Don Rockey, Manuel Rodríguez, Heriberto Rodríguez Hernández, Eva Román, Fernando Gomes Romeiro, Stefano Romeo, Jose Miguel Rosales-Zabal, Georgina R. Roshdi, Natalia Rosso, Andres Ruf, Patricia Cordero Ruiz, Nelia R. Runes, Andrea Ruzzenente, Marno Ryan, Ahmed Saad, Eman BE Sabbagh, Meriam Sabbah, Shimaa Saber, Reham Sabrey, Ramy Sabry, Maysaa Abdallah Saeed, Dina Said, Ebada M Said, Mohammad Amin Sakr, Yara Salah, Rabab Maamoun Salama, Asmaa Salama, Hussein Saleh, Ahmed Saleh, Ahmed Salem, Ahmed Thabet Salem, Alkassoum Salifou, Aso Faeq Salih, Abdallah Salman, Hanen Samouda, Faisal Sanai, Juan Francisco Sánchez-Ávila, Lakshumanan Sanker, Tomoya Sano, Miquel Sanz, Tobokalova Saparbu, Rohit Sawhney, Fatma Sayed, Sayed A. Sayed, Ashraf Othman Sayed, Manar Sayed, Giada Sebastiani, Laura Secadas, Khawaja Qamaruddin Sediqi, Sameh Seif, Nady Semida, Ebubekir Şenateş, Elena Daniela Serban, Lawrence Serfaty, Wai-Kay Seto, Ikram Sghaier, Min Sha, Hamada M. Shabaan, Lobna Shalaby, Inass Shaltout, Ala I. Sharara, Vishal Sharma, Isaac Thom Shawa, Ahmed Shawkat, Nehal Shawky, Osama Shehata, Sinead Sheils, Abate Bane Shewaye, Guojun Shi, Junping Shi, Shigeo Shimose, Tomotake Shirono, Lan Shou, Ananta Shrestha, Guanghou Shui, William Sievert, Solveig Sigurdardottir, Mostafa Mohamed Sira, Riyadh Siradj, Cecilia Sison, Linda Smyth, Reham Soliman, Jose D Sollano, Roger Sombie, Mark Sonderup, Siddharth Sood, German Soriano, Catherine A M Stedman, Oksana Stefanyuk, Davor Štimac, Simone Strasser, Pavel Strnad, Katherine Stuart, Wen Su, Minghua Su, Yoshio Sumida, Shuji Sumie, Dan-Qin Sun, Jing Sun, Hiroyuki Suzuki, Gianluca Svegliati-Baroni, Mohamed Osman Swar, S. TAHARBOUCHT, Zenab Taher, Saori Takamura, Lin Tan, Soek-Siam Tan, Tawesak Tanwandee, Sara Tarek, Ghelimici Tatiana, Federica Tavaglione, Gina Y. Tecson, Hoi-Poh Tee, Rolf Teschke, Mostafa Tharwat, Vo Duy Thong, Mark Thursz, Tulari Tine, Claudio Tiribelli, Ieva Tolmane, Jing Tong, Marco Tongo, Mamdouh Torkie, Aldo Torre, Esther A Torres, Meri Trajkovska, Sombat Treeprasertsuk, Tsubasa Tsutsumi, Thomas Tu, Josep A. Tur, Dilara Turan, Svetlana Turcan, Svetlana Turkina, Engin Tutar, Christian Tzeuton, Rose Ugiagbe, Ahmet Uygun, Michele Vacca, Pietro Vajro, David Van der Poorten, Laurens A. 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Xu, A, Xu, C, Yan, H, Yang, J, Yang, R, Yang, Y, Yang, Q, Yang, N, Yao, J, Yara, J, Yaras, S, Yilmaz, N, Younes, R, Younes, H, Young, S, Youssef, F, Yu, Y, Yu, M, Yuan, J, Yue, Z, Yuen, M, Yun, W, Yurukova, N, Zakaria, S, Zaky, S, Zaldastanishvili, M, Zapata, R, Zare, N, Zerem, E, Zeriban, N, Zeshuai, X, Zhang, H, Zhang, X, Zhang, Y, Zhang, W, Zhang, Z, Zhao, J, Zhao, R, Zhao, H, Zheng, C, Zheng, Y, Zheng, R, Zheng, T, Zheng, K, Zhou, X, Zhou, Y, Zhou, H, Zhou, L, Zhu, L, Zhu, Y, Zhu, P, Ziada, E, Ziring, D, Ziyi, L, Zou, S, Zou, Z, Zou, H, Zuart Ruiz, R, and Global Multi-Stakeholder Consensus on the Redefinition of Fatty Liver Disease

Subjects
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], Hepatology, Non-alcoholic Fatty Liver Disease, NAFLD, consensu, Gastroenterology, MAFLD, definition, Humans, MAFLD, NAFLD, Human medicine
Abstract

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2022
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37. Multimarker Panels for Detection of Early Stage Hepatocellular Carcinoma: A Prospective, Multicenter, Case-Control Study

Author

Magdalena Swiatek-De Lange, Wattana Sukeepaisarnjaroen, David Morgenstern, Juan Ignacio Esteban, Marta Bes, Tawesak Tanwandee, Ying He, Satawat Thongsawat, Teerha Piratvisuth, Henry Lik-Yuen Chan, Bruno Köhler, Institut Català de la Salut, [Piratvisuth T] NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand. [Tanwandee T] Division of Gastroenterology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. [Thongsawat S] Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand. [Sukeepaisarnjaroen W] Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand. Centro de Investigación Biomédica en red de Enfermedades Hepáticas y Digestivas, Insituto de Salud Carlos III, Madrid, Spain. [Esteban JI] Unitat del Fetge, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en red de Enfermedades Hepáticas y Digestivas, Insituto de Salud Carlos III, Madrid, Spain. [Bes M] Centro de Investigación Biomédica en red de Enfermedades Hepáticas y Digestivas, Insituto de Salud Carlos III, Madrid, Spain. Transfusion Safety Laboratory, Banc de Sang i Teixits, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, neoplasias::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias hepáticas::carcinoma hepatocelular [ENFERMEDADES], Population, Otros calificadores::/diagnóstico [Otros calificadores], Gastroenterology, Biological Factors::Biomarkers [CHEMICALS AND DRUGS], Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Epidemiologic Studies::Cohort Studies::Prospective Studies [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], factores biológicos::biomarcadores [COMPUESTOS QUÍMICOS Y DROGAS], Internal medicine, Other subheadings::/diagnosis [Other subheadings], Medicine, Humans, Prospective Studies, Protein Precursors, education, neoplasms, Survival rate, Univariate analysis, education.field_of_study, Hepatology, business.industry, Liver Neoplasms, Cancer, Hepatitis C, Hepatitis B, medicine.disease, digestive system diseases, técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios epidemiológicos::estudios de cohortes::estudios prospectivos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Neoplasms::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Liver Neoplasms::Carcinoma, Hepatocellular [DISEASES], Fetge - Càncer - Diagnòstic, Hepatocellular carcinoma, Case-Control Studies, Marcadors bioquímics, Matrix Metalloproteinase 3, Prothrombin, alpha-Fetoproteins, business, Biomarkers
Abstract

Early Stage; Hepatocellular Carcinoma Etapa temprana; Carcinoma hepatocelular Etapa primera; Carcinoma hepatocel·lular Hepatocellular carcinoma (HCC), the sixth most common cancer worldwide, has an incidence rate equal to mortality. Over 80% of HCC cases occur within a high-risk population, mainly patients with both cirrhosis and chronic hepatitis B or C. With a 5-year survival rate ranging from 90% for early stage HCC, there is a high medical need for the early detection of HCC. In this study, we systematically evaluated biomarkers mentioned in international guidelines and peer-reviewed literature for HCC surveillance and diagnosis with the aim of identifying combinations that display high sensitivity and specificity for early stage HCC. Fifty biomarkers were measured in the first sample panel, panel A (n = 110), and subjected to univariate analysis. Of these, 35 biomarkers (38 assays) from panel A and an additional 13 biomarkers from the literature were prioritized for subsequent multivariate evaluation with lasso regression and exhaustive search of two- to four-biomarker combinations (panel B). Panel B included 1,081 samples from patients with HCC (n = 308) or with chronic liver diseases (n = 740). Among all patients, 61.0% had hepatitis B, 32.9% had hepatitis C, and 60.5% had cirrhosis; 40.6% of patients with HCC had early stage cancer. Protein induced by vitamin K absence-II (PIVKA-II; also known as des-gamma-carboxy prothrombin [DCP]) and alpha-fetoprotein (AFP) demonstrated the best clinical performance, both individually and in combination, and the addition of a third biomarker (Lens culinaris agglutinin-reactive fraction of AFP [AFP-L3], cartilage oligomeric matrix protein [COMP], insulin-like growth factor-binding protein 3 [IGFBP3], or matrix metalloproteinase 3 [MMP3]) further increased sensitivity for the detection of both early stage and all-stage HCC. The addition of age and sex to the three-biomarker panel resulted in an improved diagnostic performance. Conclusion: The combination of AFP and PIVKA-II, with either IGFBP3, COMP or MMP3, plus age and sex, demonstrated the best performance for the detection of early- and all-stage HCC. These novel panels performed similar to that of the GALAD score (sex [gender], age, plus serum levels of AFP, AFP-L3 and DCP [PIVKA-II]), a promising screening tool developed for HCC detection. Supported by Roche Diagnostics GmbH.

Published
2021

38. Asian Pacific association for the study of liver (APASL) guidelines: hepatitis B virus in pregnancy

Author

Manoj Kumar, Zaigham Abbas, Milad Azami, Maria Belopolskaya, A. K. Dokmeci, Hasmik Ghazinyan, Jidong Jia, Ankur Jindal, Han Chu Lee, Wei Lei, Seng Gee Lim, Chun-Jen Liu, Qiang Li, Mamun Al Mahtab, David H. Muljono, Madunil Anuk Niriella, Masao Omata, Diana A. Payawal, Shiv K. Sarin, Olivier Ségéral, Tawesak Tanwandee, Nirupma Trehanpati, Kumar Visvanathan, Jin Mo Yang, Man‑Fung Yuen, Yingjie Zheng, and Y. H. Zhou

Subjects
Hepatitis B virus, Hepatitis B, Chronic, Hepatology, Pregnancy, Child, Preschool, Humans, Female, Hepatitis B e Antigens, Child, Hepatitis B
Abstract

Hepatitis B virus (HBV) infection still remains a major public health issue in the Asia-Pacific region. Most of the burden of HBV-related disease results from infections acquired in infancy through perinatal or early childhood exposure to HBV in Asia-Pacific. Hepatitis B during pregnancy presents unique management issues for both the mother and fetus. These APASL guidelines provide a comprehensive review and recommendations based on available evidence in the literature, for the management of females with HBV infection through every stage of pregnancy and postpartum. These also address the concerns, management challenges, and required follow-up of children born to hepatitis B-positive mothers.

Published
2021

39. Vitamin D-Binding protein Gene Polymorphism Predicts Pegylated Interferon-Related HBsAg Seroclearance in HBeAg-Negative Thai Chronic Hepatitis B Patients: A Multicentre Study

Author

Rattana Boonsirichan, Chalermrat Bunchorntavakul, Bubpha Pornthisarn, Supot Tuntipanichteerakul, Ekawee Sripariwuth, Kessarin Thanapirom, Satawat Thongsawat, Chaowalit Pattanasirigool, Teerha Piratvisuth, Theeranan Sanpajit, Wattana Sukeepaisarnjaroen, Yong Poovorawan, Tawesak Tanwandee, Piyawat Komolmit, Apinya Leerapun, Phunchai Charatcharoenwitthaya, Sirinporn Suksawatamnuay, Woramon Jeamsripong, and Sombat Treeprasertsuk

Subjects
Male, 0301 basic medicine, HBsAg, Vitamin D-binding protein, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Pegylated interferon, Genotype, Hepatitis B virus infection, Hepatitis B e Antigens, Vitamin D, response, Vitamin D-Binding Protein, General Medicine, Middle Aged, Prognosis, Recombinant Proteins, Seroconversion, 030220 oncology & carcinogenesis, Female, pegylated-interferon, Research Article, medicine.drug, Vitamin, Hepatitis B virus, medicine.medical_specialty, HBeAg-negative, Antiviral Agents, vitamin D deficiency, 03 medical and health sciences, Hepatitis B, Chronic, Internal medicine, Vitamin D and neurology, medicine, Humans, Retrospective Studies, Polymorphism, Genetic, business.industry, Interferon-alpha, medicine.disease, digestive system diseases, 030104 developmental biology, chemistry, polymorphisms, business, Follow-Up Studies
Abstract

Background: Vitamin D deficiency is related to poor clinical outcomes in patients with chronic hepatitis B virus (HBV) infection. Methods: We aimed to investigate the association between the genetic variants in the vitamin D metabolic pathway and the response to pegylated interferon (Peg-IFN) therapy in patients with HBeAg-negative chronic HBV infection. One hundred seven patients treated with Peg-IFN for 48 weeks were selected from 13 specialty hospitals. Eight genotypes of vitamin D cascade genes, including CYP27B1 (rs10877012), DHCR7 (rs12785878), CYP2R1 (rs2060793, rs12794714) and GC (rs4588, rs7041, rs222020, rs2282679), were found. Results: Eighty-two patients (83.7%) were infected with HBV genotype C. Eight patients had compensated liver cirrhosis (8.7%). At 24 weeks after treatment discontinuation, 41 patients (42.3%) achieved sustained treatment response, 53 (55.2%) obtained HBV DNA

Published
2019
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40. Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial

Author

Jin Lin Hou, Feng Lin, Lai Wei, Luisa M. Stamm, Yanhang Gao, Qin Ning, Seng Gee Lim, Sophia Lu, Peng Hu, Jidong Jia, Kinh Nguyen Van, Zhuangbo Mou, Abhasnee Sobhonslidsuk, Ming Xu, Teerha Piratvisuth, Minghua Su, Hoi Poh Tee, Guozhong Gong, Satawat Thongsawat, Guiqiang Wang, Lunli Zhang, Rosmawati Mohamed, Shanming Wu, Zhi Liang Gao, Jia Shang, Hongmei Mo, Hung Le Manh, Jun Cheng, Diana M. Brainard, Qing Xie, Yongfeng Yang, Long Dao, Xiaguang Dou, Hadas Dvory-Sobol, Zhongping Duan, Thi Tuyet Phuong Le, Pisit Tangkijvanich, Yan Huang, Hong Tang, Tawesak Tanwandee, Jun Li, Yuemin Nan, Yimin Mao, and Chee-Kiat Tan

Subjects
Adult, Liver Cirrhosis, Male, China, medicine.medical_specialty, Cirrhosis, Genotype, Sustained Virologic Response, Sofosbuvir, Hepatitis C virus, Hepacivirus, medicine.disease_cause, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, Sofosbuvir/velpatasvir, Internal medicine, medicine, Humans, Adverse effect, Respiratory Tract Infections, Singapore, Hepatology, business.industry, Headache, Gastroenterology, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Thailand, medicine.disease, Discontinuation, Drug Combinations, Treatment Outcome, Upper respiratory tract infection, Vietnam, RNA, Viral, Female, Carbamates, business, medicine.drug
Abstract

Summary Background Treatment with combined sofosbuvir and velpatasvir has resulted in high sustained virological response rates in patients chronically infected with hepatitis C virus (HCV) with genotypes 1–6 in clinical trials and real-world settings, but its efficacy and safety has not been assessed in Asia, a region with diverse HCV genotypes. Methods In this single-arm, open-label, phase 3 trial, we recruited patients from 38 sites across China, Thailand, Vietnam, Singapore, and Malaysia, who were chronically infected with HCV genotypes 1–6, and were HCV treatment-naive or treatment-experienced, either without cirrhosis or with compensated cirrhosis. Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks. The primary efficacy endpoint was sustained virological response, defined as HCV RNA less than 15 IU/mL at 12 weeks after completion of treatment (SVR12), assessed in all patients who received at least one dose of study drug. The primary safety endpoint was the proportion of adverse events leading to premature discontinuation of study drug. This trial is registered with ClinicalTrials.gov , number NCT02671500 , and is completed. Findings Between April 14, 2016, and June 30, 2017, 375 patients were enrolled in the study, of whom 374 completed the full treatment course and one discontinued treatment. Overall, 362 (97% [95% CI 94–98]) of 375 patients achieved SVR12. Among 42 patients with HCV genotype 3b, all of whom had baseline resistance-associated substitutions in NS5A, 25 (89% [95% CI 72–98]) of 28 patients without cirrhosis and seven (50% [23–77]) of 14 patients with cirrhosis achieved SVR12. The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients). There were no discontinuations due to adverse events. Serious adverse events were reported in three (1%) patients, none of which was judged to be related to sofosbuvir–velpatasvir treatment. Interpretation Consistent with data from other phase 3 studies, single-tablet sofosbuvir–velpatasvir for 12 weeks is an efficacious and safe treatment for Asian patients with chronic HCV infection, but might have lower efficacy in those infected with HCV genotype 3b and with cirrhosis. Funding Gilead Sciences.

Published
2019
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41. Knowledge, attitude, and behaviors toward liver health and viral hepatitis-related liver diseases in Thailand

Author

Pochamana Phisalprapa, Tawesak Tanwandee, Boon-Leong Neo, and Shikha Singh

Subjects
Adult, Health Knowledge, Attitudes, Practice, knowledge, attitudes, Hepatitis, Viral, Human, behaviors, liver diseases, Observational Study, General Medicine, Middle Aged, Hepatitis B, Thailand, Hepatitis C, Cross-Sectional Studies, Surveys and Questionnaires, Humans, Female, hepatitis, Aged, Research Article
Abstract

This study aimed to quantify and evaluate the knowledge and awareness toward liver health and diseases as well as explore the attitudes and knowledge toward screening, diagnosis, and treatment of liver disease among the Thai population. This is a cross-sectional, self-reported and web-based questionnaire study. Awareness, perceptions and attitudes toward liver-related health and diseases as well as screening, diagnosis and treatment of liver diseases were assessed among 500 Thai adults. Respondents were mostly ≥35 years (62.0%) and females (52.0%). While there was an overall awareness regarding viral hepatitis as the main etiology of liver failure/cancer, respondents expressed misperceptions that hint at social stigmatization or discrimination toward infected individuals. A significant proportion lacked knowledge of liver screening tests and relevant diagnostic tests for viral hepatitis-related liver diseases. Screening or treatment costs and perception of being healthy were among reasons for not seeking medical consultation when exposed to risk factors or diagnosed. Treatment practices of hepatitis included prescription medication (59.1%), functional foods (51.8%) and traditional treatment (28.2%). Multivariate analysis identified income, recent health screening status and being diagnosed with liver disease(s) as significant predictors of the knowledge, attitude, and behaviors of the Thai population toward liver diseases. This study highlighted a degree of misperception and lack of in-depth understanding toward hepatitis-related liver diseases including poor attitudes and knowledge toward screening, diagnosis, and treatment of liver diseases. Factors identified suggest an unmet need to encourage proactive health-seeking behaviors to reduce transmission risks of hepatitis-related liver diseases within the community.

Published
2021

42. Correction to: APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy

Author

George Lau, Ming-Lung Yu, Grace Wong, Alexander Thompson, Hasmik Ghazinian, Jin-Lin Hou, Teerha Piratvisuth, Ji-Dong Jia, Masashi Mizokami, Gregory Cheng, Guo-Feng Chen, Zhen-Wen Liu, Oidov Baatarkhuu, Ann Lii Cheng, Woon Leung Ng, Patrick Lau, Tony Mok, Jer-Ming Chang, Saeed Hamid, A. Kadir Dokmeci, Rino A. Gani, Diana A. Payawal, Pierce Chow, Joong-Won Park, Simone I. Strasser, Rosmawaiti Mohamed, Khin Maung Win, Tawesak Tanwandee, Shiv Kumar Sarin, and Masao Omata

Subjects
Hepatology
Published
2022
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43. APASL clinical practice guidance: the diagnosis and management of patients with primary biliary cholangitis

Author

Hong You, Xiong Ma, Cumali Efe, Guiqiang Wang, Sook-Hyang Jeong, Kazumichi Abe, Weijia Duan, Sha Chen, Yuanyuan Kong, Dong Zhang, Lai Wei, Fu-Sheng Wang, Han-Chieh Lin, Jin Mo Yang, Tawesak Tanwandee, Rino A. Gani, Diana A. Payawal, Barjesh C. Sharma, Jinlin Hou, Osamu Yokosuka, A. Kadir Dokmeci, Darrell Crawford, Jia-Horng Kao, Teerha Piratvisuth, Dong Jin Suh, Laurentius A. Lesmana, Jose Sollano, George Lau, Shiv K. Sarin, Masao Omata, Atsushi Tanaka, and Jidong Jia

Subjects
Hepatology, Cholangitis, Liver Cirrhosis, Biliary, Humans
Published
2021

44. Progression Rates by Age, Sex, Treatment, and Disease Activity by AASLD and EASL Criteria: Data for Precision Medicine

Author

Masaru Enomoto, Yong Kyun Cho, Teerapat Ungtrakul, Hidenori Toyoda, Yasuhito Tanaka, Jiayi Li, Ming-Lung Yu, Tai-Chung Tseng, Cheng Yuan Peng, Soung Won Jeong, Hirokazu Takahashi, Hyunwoo Oh, Ritsuzo Kozuka, Min Sun Kwak, Jae Yoon Jeong, Man-Fung Yuen, Eileen L. Yoon, Satoshi Yasuda, Cheng Hao Tseng, Clifford Wong, Pei-Chien Tsai, Ka Shing Cheung, Edward Gane, Rui Huang, Hwai I. Yang, An K. Le, Jia-Horng Kao, Chien-Hung Chen, Sang Bong Ahn, Jae-Jun Shim, Chao Wu, Dae Won Jun, Dong Hyun Lee, Chung Feng Huang, Eiichi Ogawa, Hyo Suk Lee, Ming Lun Yeh, Huy N. Trinh, Mindie H. Nguyen, Qing Xie, Tawesak Tanwandee, Chia-Yen Dai, Grace Lai-Hung Wong, Joseph Hoang, Sung Eun Kim, Ramsey Cheung, Jian Zhang, Christopher Wong, Yao-Chun Hsu, Yuichiro Eguchi, Changqing Zhao, Chris Cunningham, and Jiyoon Park

Subjects
Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, medicine.disease_cause, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Hepatitis B, Chronic, Median follow-up, Interquartile range, Internal medicine, Epidemiology, medicine, Humans, Precision Medicine, Retrospective Studies, Hepatitis B virus, Hepatology, business.industry, Incidence, Liver Neoplasms, Gastroenterology, Entecavir, Middle Aged, medicine.disease, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Cohort, 030211 gastroenterology & hepatology, Female, business, medicine.drug
Abstract

Background & AIMS Antiviral treatment criteria are based on disease progression risk, and hepatocellular carcinoma (HCC) surveillance recommendations for patients with chronic hepatitis B (CHB) without cirrhosis is based on an annual incidence threshold of 0.2%. However, accurate and precise disease progression estimate data are limited. Thus, we aimed to determine rates of cirrhosis and HCC development stratified by age, sex, treatment status, and disease activity based on the 2018 American Association for the Study of Liver Diseases and 2017 European Association for the Study of the Liver guidelines. Methods We analyzed 18,338 patients (8914 treated, 9424 untreated) from 6 centers from the United States and 27 centers from Asia-Pacific countries. The Kaplan-Meier method was used to estimate annual progression rates to cirrhosis or HCC in person-years. Results The cohort was 63% male, with a mean age of 46.19 years, with baseline cirrhosis of 14.3% and median follow up of 9.60 years. By American Association for the Study of Liver Diseases criteria, depending on age, sex, and disease activity, annual incidence rates ranged from 0.07% to 3.94% for cirrhosis, from 0.04% to 2.19% for HCC in patients without cirrhosis, and from 0.40% to 8.83% for HCC in patients with cirrhosis. Several subgroups of patients without cirrhosis including males younger than 40 years of age and females younger than 50 years of age had annual HCC risk near or exceeding 0.2%. Similar results were found using European Association for the Study of the Liver criteria. Conclusion There is great variability in CHB disease progression rates even among “lower-risk” populations. Future CHB modeling studies, public health planning, and HCC surveillance recommendation should be based on more precise disease progression rates based on sex, age, and disease activity, plus treatment status.

Published
2021

45. Safety, pharmacokinetics, and antiviral activity of RO7049389, a core protein allosteric modulator, in patients with chronic hepatitis B virus infection: a multicentre, randomised, placebo-controlled, phase 1 trial

Author

Rémi Kazma, Miriam Triyatni, Christian Schwabe, E.J. Gane, Zenghui Xue, Qingyan Bo, Annabelle Lemenuel-Diot, Yuyan Jin, Tawesak Tanwandee, Sheng Feng, Valerie Cosson, Xue Zhou, and Man-Fung Yuen

Subjects
Adult, Male, medicine.medical_specialty, Hepatitis B virus, Adolescent, Administration, Oral, medicine.disease_cause, Placebo, Antiviral Agents, Liver disease, Young Adult, Hepatitis B, Chronic, Pharmacokinetics, Internal medicine, medicine, Clinical endpoint, Humans, Adverse effect, Hepatology, Dose-Response Relationship, Drug, business.industry, Gastroenterology, Middle Aged, medicine.disease, Upper respiratory tract infection, Cohort, DNA, Viral, Female, business, Allosteric Site
Abstract

Summary Background RO7049389, a hepatitis B virus (HBV) core protein allosteric modulator being developed for the treatment of chronic HBV infection, was found to be safe and well tolerated in healthy participants (part 1 of this study). The objective of this proof-of-mechanism study (part 2) was to evaluate the safety, pharmacokinetics, and antiviral activity of RO7049389 in patients with chronic HBV infection. Methods This was a multicentre, randomised, placebo-controlled, phase 1 study. Patients with chronic HBV infection who were not currently on anti-HBV therapy were enrolled at 11 liver disease centres in Hong Kong, New Zealand, Singapore, Taiwan, and Thailand. Seven patients per dose cohort were randomly assigned (6:1) to receive oral administration of RO7049389 at 200 mg or 400 mg twice a day, or 200 mg, 600 mg, or 1000 mg once a day, for 4 weeks, or matching placebo. Randomisation was via interactive voice web response system-generated numbers, with study participants, investigators, and site personnel masked to treatment allocation. The primary endpoint of the study was safety of RO7049389 and its antiviral effect on HBV DNA concentration at the end of treatment, assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov , number NCT02952924 . Findings Between May 21, 2017, and April 3, 2019, 62 patients were screened for eligibility, and 37 eligible patients were enrolled in five dose cohorts sequentially. All adverse events were of mild or moderate intensity. Among the 31 patients who received RO7049389, the most common adverse events were headache (in five [16%] of 31 patients), increased alanine aminotransferase (ALT; five [16%]), increased aspartate aminotransferase (AST; four [13%]), upper respiratory tract infection (four [13%]), and diarrhoea (three [10%]). The most common moderate adverse events were ALT increase (three [10%]) and AST increase (two [6%]), and there were no serious adverse events. At the end of 4 weeks treatment, mean HBV DNA declines from baseline in RO7049389-treated patients were 2·44 log10 IU/mL (SD 0·98) in the 200 mg twice a day group, 3·33 log10 IU/mL (1·14) in the 400 mg twice a day group, 3·00 log10 IU/mL (0·54) in the 200 mg once a day group, 2·86 log10 IU/mL (0·79) in the 600 mg once a day group, and 3·19 log10 IU/mL (0·33) in the 1000 mg once a day group versus 0·34 log10 IU/mL (0·54) in the pooled placebo patients. Interpretation RO7049389 was safe and well tolerated and demonstrated antiviral activity over 4 weeks of treatment in patients with chronic HBV infection. These findings support further clinical development of RO7049389 as a component of novel combination treatment regimens for patients with chronic HBV infection. Funding F Hoffmann-La Roche.

Published
2021

46. The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease

Author

Jia-Horng Kao, Mohammed Eslam, Soek Siam Tan, Manoj Kumar, Diana A. Payawal, Yusuf Yilmaz, Saeed Hamid, Ming-Hua Zheng, Ian Homer Y. Cua, Sang Hoon Ahn, Tawesak Tanwandee, Shahinul Alam, Vincent Wai-Sun Wong, Yock Young Dan, Takumi Kawaguchi, Gamal Shiha, Jian-Gao Fan, Masao Omata, Jacob George, Rino Alvani Gani, Leon A. Adams, Shiv Kumar Sarin, Wah-Kheong Chan, Eslam, Mohammed, Sarin, Shiv K., Wong, Vincent Wai-Sun, Fan, Jian-Gao, Kawaguchi, Takumi, Ahn, Sang Hoon, Zheng, Ming-Hua, Shiha, Gamal, Yilmaz, Yusuf, Gani, Rino, Alam, Shahinul, Dan, Yock Young, Kao, Jia-Horng, Hamid, Saeed, Cua, Ian Homer, Chan, Wah-Kheong, Payawal, Diana, Tan, Soek-Siam, Tanwandee, Tawesak, Adams, Leon A., Kumar, Manoj, Omata, Masao, and George, Jacob

Subjects
medicine.medical_specialty, HEPATITIS-B-VIRUS, MEDLINE, Disease, PLACEBO-CONTROLLED TRIAL, 03 medical and health sciences, Liver disease, Liver clinical, 0302 clinical medicine, LONG-TERM OUTCOMES, Asian People, QUALITY-OF-LIFE, Internal medicine, Health care, Epidemiology, Medicine, SIMPLE NONINVASIVE INDEX, Humans, Intensive care medicine, Hepatology, business.industry, Fatty liver, medicine.disease, BODY-MASS INDEX, Fatty Liver, MAGNETIC-RESONANCE ELASTOGRAPHY, Liver, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, CORONARY-ARTERY-DISEASE, 030211 gastroenterology & hepatology, HEPATOCELLULAR-CARCINOMA PATIENTS, business, VISCERAL ADIPOSE-TISSUE
Abstract

Metabolic associated fatty liver disease (MAFLD) is the principal worldwide cause of liver disease and affects nearly a quarter of the global population. The objective of this work was to present the clinical practice guidelines of the Asian Pacific Association for the Study of the Liver (APASL) on MAFLD. The guidelines cover various aspects of MAFLD including its epidemiology, diagnosis, screening, assessment, and treatment. The document is intended for practical use and for setting the stage for advancing clinical practice, knowledge, and research of MAFLD in adults, with specific reference to special groups as necessary. The guidelines also seek to improve patient care and awareness of the disease and assist stakeholders in the decision-making process by providing evidence-based data. The guidelines take into consideration the burden of clinical management for the healthcare sector.

Published
2020

47. Transition rates to cirrhosis and liver cancer by age, gender, disease and treatment status in Asian chronic hepatitis B patients

Author

Matt, Liu, Tai-Chung, Tseng, Dae Won, Jun, Ming-Lun, Yeh, Huy, Trinh, Grace L H, Wong, Chien-Hung, Chen, Cheng-Yuan, Peng, Sung Eun, Kim, Hyunwoo, Oh, Min-Sun, Kwak, Michael, Cheung, Hidenori, Toyoda, Yao-Chun, Hsu, Jae Yoon, Jeong, Eileen L, Yoon, Teerapat, Ungtrakul, Jian, Zhang, Qing, Xie, Sang Bong, Ahn, Masaru, Enomoto, Jae-Jun, Shim, Chris, Cunningham, Soung Won, Jeong, Yong Kyun, Cho, Eiichi, Ogawa, Rui, Huang, Dong-Hyun, Lee, Hirokazu, Takahashi, Pei-Chien, Tsai, Chung-Feng, Huang, Chia-Yen, Dai, Cheng-Hao, Tseng, Satoshi, Yasuda, Ritsuzo, Kozuka, Jiayi, Li, Christopher, Wong, Clifford C, Wong, Changqing, Zhao, Joseph, Hoang, Yuichiro, Eguchi, Chao, Wu, Yasuhito, Tanaka, Ed, Gane, Tawesak, Tanwandee, Ramsey, Cheung, Man-Fung, Yuen, Hyo-Suk, Lee, Ming-Lung, Yu, Jia-Horng, Kao, Hwai-I, Yang, and Mindie H, Nguyen

Subjects
Liver Cirrhosis, Male, Carcinoma, Hepatocellular, Hepatitis B, Chronic, Asian People, Liver Neoplasms, Humans, Female, Antiviral Agents
Abstract

Increasing hepatitis-related mortality has reignited interest to fulfill the World Health Organization's goal of viral hepatitis elimination by 2030. However, economic barriers have enabled only 28% of countries to implement countermeasures. Given the high disease burden among Asians, we aimed to present age, sex, disease activity and treatment-specific annual progression rates among Asian chronic hepatitis B (CHB) patients to inform health economic modeling efforts and cost-effective public health interventions.We analyzed 18,056 CHB patients from 36 centers across the U.S. and seven countries/regions of Asia Pacific (9530 treated; 8526 untreated). We used Kaplan-Meier methods to estimate annual incidence of cirrhosis and hepatocellular carcinoma (HCC). Active disease was defined by meeting the APASL treatment guideline criteria.Over a median follow-up of 8.55 years, there were 1178 incidences of cirrhosis and 1212 incidences of HCC (297 without cirrhosis, 915 with cirrhosis). Among the 8526 untreated patients (7977 inactive, 549 active), the annual cirrhosis and HCC incidence ranged from 0.26% to 1.30% and 0.04% to 3.80% in inactive patients, and 0.55 to 4.05% and 0.19 to 6.03% in active patients, respectively. Of the 9530 treated patients, the annual HCC rates ranged 0.03-1.57% among noncirrhotic males and 2.57-6.93% among cirrhotic males, with lower rates for females. Generally, transition rates increased with age, male sex, the presence of fibrosis/cirrhosis, and active disease and/or antiviral treatment.Using data from a large and diverse real-world cohort of Asian CHB patients, the study provided detailed annual transition rates to inform practice, research and public health planning.

Published
2020

48. Comparison of viral control between two tenofovir dose reduction regimens (300 mg every 48 hours versus 300 mg every 72 hours) in chronic hepatitis B patients with moderate renal impairment from tenofovir-induced renal dysfunction

Author

Karn Poosanasuwansri, Kraiwiporn Kiattisunthorn, Siwaporn P. Chainuvati, Watcharasak Chotiyaputta, and Tawesak Tanwandee

Subjects
Drug, Male, medicine.medical_specialty, Cirrhosis, Tenofovir, media_common.quotation_subject, Renal function, Urine, Gastroenterology, Antiviral Agents, law.invention, 03 medical and health sciences, 0302 clinical medicine, Hepatitis B, Chronic, Randomized controlled trial, law, Virology, Internal medicine, Medicine, Humans, 030212 general & internal medicine, media_common, Hepatology, Drug Tapering, business.industry, Reabsorption, Infant, Newborn, medicine.disease, Thailand, Infectious Diseases, 030211 gastroenterology & hepatology, Dose reduction, Female, Kidney Diseases, business, medicine.drug
Abstract

Long-term use of tenofovir disoproxil fumarate (TDF) can induce renal dysfunction that requires TDF dose reduction. Previous studies showed that systemic drug use exerts a threefold higher risk of moderate renal impairment. This study aimed to compare viral control between two tenofovir dose reduction regimens in chronic hepatitis B (CHB) patients with moderate renal impairment from TDF-induced renal dysfunction. This noninferiority, randomized controlled study was conducted at the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Virologically suppressed CHB patients treated with TDF who had moderate renal impairment were randomly allocated to receive TDF 300 mg either every 48 or 72 hours. Forty-six patients (67.4% male) with a mean age of 62.8 ± 7.8 years were enrolled. Among all patients, 34.8% were HBeAg-positive, and 23.9% had cirrhosis. All included patients completed 12 months of follow-up. No patients had virological breakthrough. After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR > 60 mL/min/1.73 m2 in the TDF every 72 hours group. Other renal parameters, including serum phosphate, tubular maximal reabsorption for phosphate per GFR, urine protein-to-creatinine ratio, urine sugar and urine neutrophil gelatinase-associated lipocalin, were not significantly different between groups. Among TDF-treated CHB patients with TDF-induced moderate renal impairment, more aggressive dose reduction in TDF from every 48 hours to every 72 hours did not affect virological breakthrough. A higher proportion of patients in the TDF every 72 hours group had improvement in renal function.

Published
2020

50. Ten-day high-dose proton pump inhibitor triple therapy versus sequential therapy forHelicobacter pylorieradication

Author

Somchai Leelakusolwong, Monthira Maneerattanaporn, Tawesak Tanwandee, Chonticha Auesomwang, Pattarachai Kiratisin, and William D. Chey

Subjects
medicine.medical_specialty, Intention-to-treat analysis, Hepatology, biology, business.industry, medicine.drug_class, Gastroenterology, Lansoprazole, Proton-pump inhibitor, Amoxicillin, Helicobacter pylori, biology.organism_classification, 03 medical and health sciences, 0302 clinical medicine, Tolerability, 030220 oncology & carcinogenesis, Internal medicine, Clarithromycin, medicine, 030211 gastroenterology & hepatology, business, Adverse effect, medicine.drug
Abstract

Background and aim Eradication rates of Helicobacter pylori following standard triple therapy are declining worldwide, but high-dose proton pump inhibitor-based triple therapy (HD-PPI-TT) and sequential therapy (ST) have demonstrated higher cure rates. We aimed to compare the efficacy and tolerability of HD-PPI-TT and ST in H. pylori-associated functional dyspepsia (FD). Methods One hundred and twenty H. pylori-associated functional dyspepsia patients were randomized to receive 10-day HD-PPI-TT (60 mg lansoprazole/500 mg clarithromycin/1 g amoxicillin, each administered twice daily for 10 days) or 10-day ST (30 mg lansoprazole/1 g amoxicillin, each administered twice daily for 5 days followed by 30 mg lansoprazole/500 mg clarithromycin/400 mg metronidazole, each administered twice daily for 5 days). H. pylori status was determined in post-treatment week 4 by 14 C-urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared. Results Intention-to-treat eradication rates were similar in the ST and HD-PPI-TT groups (85% vs. 80%; P = 0.47). However, the eradication rate was significantly higher following ST compared with HD-PPI-TT in per protocol analysis (94.4% vs. 81.4%; P = 0.035). ST achieved higher cure rates than HD-PPI-TT in clarithromycin-resistant H. pylori strains (100% vs. 33.3%; P = 0.02). Treatment compliance was similar in the HD-PPI-TT and ST groups, although nausea and dizziness were more common in the ST group. Conclusions Sequential therapy achieved better H. pylori eradication than HD-PPI-TT in patients with FD. However, the eradication rate for ST fell from 94.4% in per protocol to 85% in intention-to-treat analysis. Adverse effects might result in poorer compliance and compromise actual ST efficacy (ClinicalTrials.gov: NCT01888237).

Published
2018
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