167 results on '"Chien-Yu Cheng"'
Search Results
2. Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan
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Chun-Chi Yang, Chung-Feng Huang, Te-Sheng Chang, Ching-Chu Lo, Chao-Hung Hung, Chien-Wei Huang, Lee-Won Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, Sheng-Shun Yang, Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, Chun-Jen Liu, Mei-Hsuan Lee, Hsing-Tao Kuo, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wang-Long Chuang, Kuo-Chih Tseng, Chi-Yi Chen, and Ming-Lung Yu
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Hepatitis C ,Direct-acting antivirals ,Glecaprevir ,Pibrentasvir ,Real world ,Taiwan ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Introduction Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR). Methods The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed. Results A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related. Conclusion Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.
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- 2024
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3. Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program
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Ming-Ying Lu, Chung-Feng Huang, Chao-Hung Hung, Chi‐Ming Tai, Lein-Ray Mo, Hsing-Tao Kuo, Kuo-Chih Tseng, Ching-Chu Lo, Ming-Jong Bair, Szu-Jen Wang, Jee-Fu Huang, Ming-Lun Yeh, Chun-Ting Chen, Ming-Chang Tsai, Chien-Wei Huang, Pei-Lun Lee, Tzeng-Hue Yang, Yi-Hsiang Huang, Lee-Won Chong, Chien-Lin Chen, Chi-Chieh Yang, Sheng‐Shun Yang, Pin-Nan Cheng, Tsai-Yuan Hsieh, Jui-Ting Hu, Wen-Chih Wu, Chien-Yu Cheng, Guei-Ying Chen, Guo-Xiong Zhou, Wei-Lun Tsai, Chien-Neng Kao, Chih-Lang Lin, Chia-Chi Wang, Ta-Ya Lin, Chih‐Lin Lin, Wei-Wen Su, Tzong-Hsi Lee, Te-Sheng Chang, Chun-Jen Liu, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wan-Long Chuang, Cheng-Yuan Peng, Chun-Wei- Tsai, Chi-Yi Chen, and Ming-Lung Yu
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hepatitis c virus ,antiviral agents ,artificial intelligence ,machine learning ,algorithms ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background/Aims Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy. Methods We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset. Conclusions Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.
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- 2024
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4. Respiratory virus coinfections during the COVID-19 pandemic: epidemiologic analysis and clinical outcomes from the Phase 2/3 molnupiravir trial (MOVe-OUT)
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Matthew G. Johnson, Julie M. Strizki, Erin Jensen, Jonathan Cohen, Christine Katlama, Roman Fishchuk, Alfredo Ponce-de-León, Nyda Fourie, Chien-Yu Cheng, Dorothy McCoy, Mary Vesnesky, Carmelle T. Norice, Ying Zhang, Angela Williams-Diaz, Michelle L. Brown, Patricia Carmelitano, Jay A. Grobler, Amanda Paschke, and Carisa De Anda
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COVID-19 ,molnupiravir ,epidemiology ,respiratory pathogens ,Microbiology ,QR1-502 - Abstract
ABSTRACTThis exploratory post hoc analysis assessed the incidence of respiratory viral coinfections and their impact on clinical outcomes in non-hospitalized adults with mild-to-moderate coronavirus disease-2019 (COVID-19) treated with molnupiravir versus placebo for 5 days in the Phase 2/3 MOVe-OUT trial (NCT04575597), which took place in October 2020 to January 2021 (Phase 2, n = 302) and May 2021 to October 2021 (Phase 3, n = 1,433). Among 1,735 total randomized participants, 1,674 had a baseline respiratory pathogen panel (NxTAG Respiratory Pathogen Panel for the Luminex MAGPIX instrument) performed and 69 (4.1%) were coinfected with at least one additional respiratory viral pathogen. Human rhinovirus/enterovirus (39/69, 56.5%) was the most common coinfection detected at baseline. In the modified intention-to-treat population, two participants with coinfecting respiratory RNA viruses were hospitalized and received respiratory interventions through Day 29, and none died; one participant in the molnupiravir group was coinfected with human rhinovirus/enterovirus, and one participant in the placebo group was coinfected with human metapneumovirus. Hospitalization or death occurred in 6.2% and 9.0% of non-coinfected participants in the molnupiravir versus placebo group, respectively, and over 90% did not require respiratory interventions. Most coinfecting respiratory RNA viruses detected at baseline were not detected at the end of therapy in both the molnupiravir and placebo groups. In summary, participants coinfected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and another respiratory RNA virus were not more likely to be hospitalized or die, or require respiratory interventions, compared to participants who were not coinfected with another respiratory RNA virus at baseline in both groups.IMPORTANCERespiratory viral coinfections are known to occur with coronavirus disease-2019 (COVID-19). In a cohort of non-hospitalized adults with mild-to-moderate COVID-19 treated with molnupiravir versus placebo in the MOVe-OUT trial during October 2020 to October 2021, 4.1% of participants had a documented viral coinfection; human rhinovirus/enterovirus was the most common pathogen detected with the NxTAG Respiratory Pathogen Panel assay. Participants who had a coinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and another respiratory RNA virus were not more likely to have worse clinical outcomes compared to those participants without a viral coinfection, and many coinfecting respiratory RNA viruses were no longer detected at the end of the 5-day treatment period in both groups.
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- 2024
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5. Longitudinal neutralizing antibody responses after SARS-CoV-2 infection: A convalescent cohort study in Taiwan
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Yen-Fang Huang, Fang-Chi Hsu, Jiunn-Jong Wu, Yi-Ling Lin, Ming-Tsan Liu, Chin-Hui Yang, Hsu-Sung Kuo, Yen-Ju Chen, Chien-Yu Cheng, His-Hsun Lin, Chun-Che Liao, Chih-Shin Chang, Jian-Jong Liang, Wen-Yueh Cheng, Jason C. Huang, Cheng-Pin Chen, Shu-Hsing Cheng, Yi-Chun Lin, Shung-Haur Yang, and Yiing-Jenq Chou
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SARS-CoV-2 ,COVID-19 ,Disease severity ,Neutralizing antibody titer ,Microbiology ,QR1-502 - Abstract
Background: Understanding the neutralizing antibody (NAb) titer against COVID-19 over time is important to provide information for vaccine implementation. The longitudinal NAb titer over one year after SARS-CoV-2 infection is still unclear. The purposes of this study are to evaluate the duration of the neutralizing NAb titers in COVID-19 convalescents and factors associated with the titer positive duration. Methods: A cohort study followed COVID-19 individuals diagnosed between 2020 and 2021 May 15th from the COVID-19 database from the Taiwan Centers for Disease Control. We analyzed NAb titers from convalescent SARS-CoV-2 individuals. We used generalized estimating equations (GEE) and a Cox regression model to summarize the factors associated with NAb titers against COVID-19 decaying in the vaccine-free population. Results: A total of 203 convalescent subjects with 297 analytic samples were followed for a period of up to 588 days. Our study suggests that convalescent COVID-19 in individuals after more than a year and four months pertains to only 25% of positive titers. The GEE model indicates that longer follow-up duration was associated with a significantly lower NAb titer. The Cox regression model indicated the disease severity with advanced condition was associated with maintaining NAb titers (adjusted hazard ratio: 2.01, 95% CI: 1.11–3.63) and that smoking was also associated with higher risk of negative NAb titers (adjusted hazard ratio: 0.55, 95% CI: 0.33–0.92). Conclusions: Neutralizing antibody titers diminished after more than a year. The antibody titer response against SARS-CoV-2 in naturally convalescent individuals provides a reference for vaccinations.
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- 2023
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6. Assessment of risk factors for virological nonsuppression following switch to dolutegravir and lamivudine, or bictegravir, emtricitabine, and tenofovir alafenamide fumarate in a real-world cohort of treatment-experienced adults living with HIV.
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Shu-Yuan Lee, Yi-Chun Lin, Cheng-Pin Chen, Shu-Hsing Cheng, Shu-Ying Chang, Shin-Yen Ku, and Chien-Yu Cheng
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Medicine ,Science - Abstract
Conflicting data exists regarding the baseline determinants of virological nonsuppression outcomes in treatment-experienced people living with human immunodeficiency virus (PWH) switching to antiretroviral treatment (ART) with bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) or dolutegravir/lamivudine (DTG/3TC) in Asia. This retrospective observational study, conducted at a designated HIV-care hospital from October 2019 to January 2023, aimed to address this gap. We assessed the odds of virological nonsuppression (VNS) at weeks 48 using logistic regression. A total of 988 patients were included, 35 patients (3.5%) with VNS at week 48. Pre-existing primary resistance-associated mutations (RAM) to nucleoside reverse transcriptase inhibitor (NRTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) were identified in 11.0% (51/465) and 14.4% (67/465), respectively. The identified risk factor was a record of virological failure ≥2 times (AOR 5.32, 95% CI 2.04-13.85), while an HIV viral load
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- 2024
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7. Preventing and controlling intra-hospital spread of COVID-19 in Taiwan – Looking back and moving forward
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Kuan-Yin Lin, Sung-Ching Pan, Jann-Tay Wang, Chi-Tai Fang, Chun-Hsing Liao, Chien-Yu Cheng, Shu-Hui Tseng, Chin-Hui Yang, Yee-Chun Chen, and Shan-Chwen Chang
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Infection prevention and control ,Access control ,Isolation ,SARS-CoV-2 testing ,Case investigation ,Contact tracing ,Medicine (General) ,R5-920 - Abstract
COVID-19 has exposed major weaknesses in the healthcare settings. The surge in COVID-19 cases increases the demands of health care, endangers vulnerable patients, and threats occupational safety. In contrast to a hospital outbreak of SARS leading to a whole hospital quarantined, at least 54 hospital outbreaks following a COVID-19 surge in the community were controlled by strengthened infection prevention and control measures for preventing transmission from community to hospitals as well as within hospitals. Access control measures include establishing triage, epidemic clinics, and outdoor quarantine stations. Visitor access restriction is applied to inpatients to limit the number of visitors. Health monitoring and surveillance is applied to healthcare personnel, including self-reporting travel declaration, temperature, predefined symptoms, and test results. Isolation of the confirmed cases during the contagious period and quarantine of the close contacts during the incubation period are critical for containment. The target populations and frequency of SARS-CoV-2 PCR and rapid antigen testing depend on the level of transmission. Case investigation and contact tracing should be comprehensive to identify the close contacts to prevent further transmission. These facility-based infection prevention and control strategies help reduce hospital transmission of SARS-CoV-2 to a minimum in Taiwan.
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- 2024
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8. Correlation of adverse effects and antibody responses following homologous and heterologous COVID19 prime-boost vaccinations
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Aristine Cheng, Ming-Ju Hsieh, Sui-Yuan Chang, Si-Man Ieong, Chien-Yu Cheng, Wang-Huei Sheng, and Shan-Chwen Chang
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Reactogenicity ,Immunogenicity ,Adverse effects ,Anti-SARS-CoV-2 IgG ,COVID19 vaccines ,Medicine (General) ,R5-920 - Abstract
Background: Studies correlating reactogenicity and immunogenicity of COVID-19 vaccines are limited to BNT162b2, with inconsistent results. We investigated whether adverse reactions after other COVID-19 vaccines reliably predict humoral responses. Methods: Adult volunteers were recruited for homologous or heterologous prime-boost vaccinations with adenoviral (ChAdOx1, AstraZeneca) and/or mRNA (mRNA-1273, Moderna) vaccines administered either 4 or 8 weeks apart. Adverse effects were routinely solicited and recorded by subjects in a standard diary card for up to 84 days post booster vaccination. Anti-SARS-CoV-2 IgG titers were measured pre- (visit 1), and post-booster dose at days 14 (visit 2) and 28 (visit 3). Results: A total of 399 participants (75% women) with a median age of 41 (interquartile range, 33–48 IQR) years were included. Vaccine-induced antibody titers at days 14 and 28 were significantly higher among subjects who reported local erythema, swelling, pain, as well as systemic fever, chills, headache, myalgia, arthralgia, fatigue compared to those who did not experience local or systemic reactogenicity. Post-vaccination humoral responses did not correlate with the occurrence of skin rash and correlated weakly with gastrointestinal symptoms. A significant correlation between post-vaccination peak body temperature and anti-SARS-CoV-2 spike IgG at Day 14, independent of vaccine type and schedule, was found. Conclusion: Specific symptoms of reactogenicity such as post-vaccination injection site pain, swelling, erythema and fever, myalgia and fatigue are significantly predictive of the magnitude of the anti-SARS-CoV-2 antibody response.
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- 2023
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9. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
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Cathrine Axfors, Andreas M. Schmitt, Perrine Janiaud, Janneke van’t Hooft, Sherief Abd-Elsalam, Ehab F. Abdo, Benjamin S. Abella, Javed Akram, Ravi K. Amaravadi, Derek C. Angus, Yaseen M. Arabi, Shehnoor Azhar, Lindsey R. Baden, Arthur W. Baker, Leila Belkhir, Thomas Benfield, Marvin A. H. Berrevoets, Cheng-Pin Chen, Tsung-Chia Chen, Shu-Hsing Cheng, Chien-Yu Cheng, Wei-Sheng Chung, Yehuda Z. Cohen, Lisa N. Cowan, Olav Dalgard, Fernando F. de Almeida e Val, Marcus V. G. de Lacerda, Gisely C. de Melo, Lennie Derde, Vincent Dubee, Anissa Elfakir, Anthony C. Gordon, Carmen M. Hernandez-Cardenas, Thomas Hills, Andy I. M. Hoepelman, Yi-Wen Huang, Bruno Igau, Ronghua Jin, Felipe Jurado-Camacho, Khalid S. Khan, Peter G. Kremsner, Benno Kreuels, Cheng-Yu Kuo, Thuy Le, Yi-Chun Lin, Wu-Pu Lin, Tse-Hung Lin, Magnus Nakrem Lyngbakken, Colin McArthur, Bryan J. McVerry, Patricia Meza-Meneses, Wuelton M. Monteiro, Susan C. Morpeth, Ahmad Mourad, Mark J. Mulligan, Srinivas Murthy, Susanna Naggie, Shanti Narayanasamy, Alistair Nichol, Lewis A. Novack, Sean M. O’Brien, Nwora Lance Okeke, Léna Perez, Rogelio Perez-Padilla, Laurent Perrin, Arantxa Remigio-Luna, Norma E. Rivera-Martinez, Frank W. Rockhold, Sebastian Rodriguez-Llamazares, Robert Rolfe, Rossana Rosa, Helge Røsjø, Vanderson S. Sampaio, Todd B. Seto, Muhammad Shahzad, Shaimaa Soliman, Jason E. Stout, Ireri Thirion-Romero, Andrea B. Troxel, Ting-Yu Tseng, Nicholas A. Turner, Robert J. Ulrich, Stephen R. Walsh, Steve A. Webb, Jesper M. Weehuizen, Maria Velinova, Hon-Lai Wong, Rebekah Wrenn, Fernando G. Zampieri, Wu Zhong, David Moher, Steven N. Goodman, John P. A. Ioannidis, and Lars G. Hemkens
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Science - Published
- 2024
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10. Serological response after COVID-19 mRNA-1273 booster dose in immunocompromised patients, Taiwan, July to August 2021
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Kuan-Yin Lin, Ming-Ju Hsieh, Sui-Yuan Chang, Si-Man Ieong, Chien-Yu Cheng, Wang-Huei Sheng, and Shan-Chwen Chang
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Serologic response ,Immunocompromised ,Autoimmune disease ,Non-steroidal anti-inflammatory drug ,mRNA vaccine ,Medicine (General) ,R5-920 - Abstract
Background: Whether immunocompromising conditions affect the immunogenicity of COVID-19 booster vaccination remains a concern, which impedes the vaccination campaign in people most vulnerable to COVID-19-associated morbidity and mortality. We aimed to evaluate the effect of immune dysfunction on immunogenicity of homologous and heterologous prime-boost COVID-19 vaccination. Methods: Between July and August, 2021, 399 participants were randomized to receive ChAdOx1/ChAdOx1 8 weeks apart, ChAdOx1/mRNA-1273 8 weeks apart, ChAdOx1/mRNA-1273 4 weeks apart, and mRNA-1273/mRNA-1273 4 weeks apart. The anti-SARS-CoV-2 spike IgG antibody titers on the day before booster vaccination and 4 weeks after booster vaccination were compared between participants with and without immunocompromising conditions. Results: Among ChAdOx1-primed participants, a trend of lower anti-SARS-CoV-2 spike IgG titers before booster vaccination were found in participants with autoimmune diseases (geometric means, 34.76 vs. 84.25 binding antibody units [BAU]/mL, P = 0.173), compared to those without. Participants receiving immunosuppressants and/or immunomodulators had significant lower anti-SARS-CoV-2 spike IgG titers before booster vaccination than those without (geometric means, 36.39 vs. 83.84 BAU/mL; P = 0.001). Among mRNA-1273-boosted participants, anti-SARS-CoV-2 spike IgG titers 4 weeks after booster vaccination were similar across all the strata. Participants with autoimmune diseases and receiving immunosuppressants and/or immunomodulators, had numerically lower anti-SARS-CoV-2 spike IgG titers 4 weeks after booster vaccination compared to those without (geometric means, 1474.34 vs. 1923.23 and 1590.61 vs. 1918.38 BAU/mL; P > 0.05). Conclusion: The immunogenicity of prime vaccination with ChAdOx1 decreased by immune dysfunction, but enhanced after receiving boost vaccination with mRNA-1273. Our study results support the efficacy of mRNA-1273 booster dose among immunocompromised hosts.
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- 2022
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11. Care cascade of tuberculosis infection treatment for people living with HIV in the era of antiretroviral therapy scale-up
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Kuan-Yin Lin, Chia-Jui Yang, Hsin-Yun Sun, Yuan-Ti Lee, Bo-Huang Liou, Ing-Moi Hii, Tun-Chieh Chen, Sung-Hsi Huang, Chun-Yuan Lee, Chin-Shiang Tsai, Chi-Ying Lin, Chun-Eng Liu, Hsi-Yen Chang, Chien-Yu Cheng, Po-Liang Lu, Chien-Ching Hung, and Taiwan HIV Study Group
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Medicine ,Science - Abstract
Abstract Testing and treatment of tuberculosis infection (TBI) are recommended for people living with HIV (PLWH). We aimed to evaluate the care cascade of TBI treatment among PLWH in the era of antiretroviral therapy (ART) scale-up. This retrospective study included adult PLWH undergoing interferon-gamma release assay (IGRA)-based TBI screening during 2019–2021. PLWH testing IGRA-positive were advised to receive directly-observed therapy for TBI after active TB disease was excluded. The care cascade was evaluated to identify barriers to TBI management. Among 7951 PLWH with a median age of 38 years and CD4 count of 616 cells/mm3, 420 (5.3%) tested positive and 38 (0.5%) indeterminate for IGRA. The TBI treatment initiation rate was 73.6% (309/420) and the completion rate was 91.9% (284/309). More than 80% of PLWH concurrently received short-course rifapentine-based regimens and integrase strand transfer inhibitor (InSTI)-containing ART. The main barrier to treatment initiation was physicians’ concerns and patients’ refusal (85.6%). The factors associated with treatment non-completion were older age, female, anti-HCV positivity, and higher plasma HIV RNA. Our observation of a high TBI completion rate among PLWH is mainly related to the introduction of short-course rifapentine-based regimens in the InSTI era, which can be the strategy to improve TBI treatment uptake.
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- 2022
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12. Week 96 Results of Switching from Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide among HIV/Hepatitis B Virus-Coinfected Patients
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Yu-Shan Huang, Chien-Yu Cheng, Hsin-Yun Sun, Shu-Hsing Cheng, Po-Liang Lu, Chen-Hsiang Lee, Yuan-Ti Lee, Hung-Chin Tsai, Chia-Jui Yang, Chun-Eng Liu, Bo-Huang Liou, Shih-Ping Lin, Sung-Hsi Huang, Mao-Wang Ho, Hung-Jen Tang, and Chien-Ching Hung
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viral hepatitis ,antiretroviral therapy ,bone mineral density ,hepatitis D virus ,hyperlipidemia ,proximal renal tubulopathy ,Microbiology ,QR1-502 - Abstract
ABSTRACT Data regarding the durability of tenofovir alafenamide (TAF)-containing antiretroviral therapy (ART) in maintaining hepatitis B virus (HBV) viral suppression among HIV/HBV-coinfected patients are limited. Between February and October 2018, 274 HIV/HBV-coinfected participants who had achieved HIV RNA of
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- 2023
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13. Self-Reported Health-Related Quality of Life and Residual Symptoms among Virologically Suppressed People Living with HIV in the Era of Single-Tablet Regimens in Taiwan: A Cross-Sectional Study
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Chien-Yu Cheng, Hsiu-Yin Wang, and Chia-Jui Yang
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health-related quality of life ,symptom burden ,virological suppression ,single-tablet regimens ,the fourth 90 ,people living with HIV ,Science - Abstract
This study assessed the health-related quality of life (HRQoL) and residual symptom burden among virologically suppressed people living with human immunodeficiency virus (HIV) (PLWH) using a single-tablet regimen in Taiwan. This cross-sectional study administered a self-reported online survey between July and October 2021 to anonymised virologically suppressed PLWH aged ≥20 years. Demographic, HIV-related variables, EuroQol-5-dimensions (EQ-5D), visual analogue scale (VAS), and HIV Symptom Index were analysed. Bivariate analyses were performed to compare HRQoL differences between PLWH and non-PLWH. Among 120 PLWH, 80.9% had HIV diagnosis for
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- 2024
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14. Immune response and safety of heterologous ChAdOx1-nCoV-19/mRNA-1273 vaccination compared with homologous ChAdOx1-nCoV-19 or homologous mRNA-1273 vaccination
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Wang-Huei Sheng, Sui-Yuan Chang, Pin-Hung Lin, Ming-Ju Hsieh, Hao-Hsiang Chang, Chien-Yu Cheng, Hung-Chih Yang, Ching-Fu Pan, Si-Man Ieong, Tai-Ling Chao, Jang-Pin Chen, Shu-Hsing Cheng, and Shan-Chwen Chang
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Adenovirus-vector vaccine ,Messenger RNA vaccine ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) ,Immune response ,Medicine (General) ,R5-920 - Abstract
Background/Purpose: Efficacy and safety data of heterologous prime-boost vaccination against SARS-CoV-2 remains limited. Methods: We recruited adult volunteers for homologous or heterologous prime-boost vaccinations with adenoviral (ChAdOx1, AstraZeneca) and/or mRNA (mRNA-1273, Moderna) vaccines. Four groups of prime-boost vaccination schedules were designed: Group 1, ChAdOx1/ChAdOx1 8 weeks apart; Group 2, ChAdOx1/mRNA-1273 8 weeks apart; Group 3, ChAdOx1/mRNA-1273 4 weeks apart; and Group 4, mRNA-1273/mRNA-1273 4 weeks apart. The primary outcome was serum anti-SARS-CoV-2 IgG titers and neutralizing antibody titers against B.1.1.7 (alpha) and B.1.617.2 (delta) variants on day 28 after the second dose. Adverse events were recorded up until 84 days after the second dose. Results: We enrolled 399 participants with a median age of 41 years and 75% were female. On day 28 after the second dose, the anti-SARS-CoV-2 IgG titers of both heterologous vaccinations (Group 2 and Group 3) were significantly higher than that of homologous ChAdOx1 vaccination (Group 1), and comparable with homologous mRNA-1273 vaccination (Group 4). The heterologous vaccination group had better neutralizing antibody responses against the alpha and delta variant as compared to the homologous ChAdOx1 group. Most of the adverse events (AEs) were mild and transient. AEs were less frequent when heterologous boosting was done at 8 weeks rather than at 4 weeks. Conclusion: Heterologous ChAdOx1/mRNA-1273 vaccination provided higher immunogenicity than homologous ChAdOx1 vaccination and comparable immunogenicity with the homologous mRNA-1273 vaccination. Our results support the safety and efficacy of heterologous prime-boost vaccination using the ChAdOx1 and mRNA-1273 COVID-19 vaccines. (ClinicalTrials.gov number, NCT05074368).
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- 2022
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15. Clinical assessment of SARS-CoV-2 infectivity by rapid antigen test compared with virus isolation
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Tai-Ling Chao, Wen-Hau Lee, Hui-Chun Hu, Yi-Chun Lin, Shu-Yuan Ho, Hui-Hou Chen, Cheng-Pin Chen, Ya-Min Tsai, Jun-Tung Fang, Si-Man Leong, Yu-Chen Cheng, Mavis Peng, Shu-Hsing Cheng, Chien-Yu Cheng, and Sui-Yuan Chang
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SARS-COV-2 ,Real-time RT-PCR ,Rapid antigen test ,Infectivity ,Infectious and parasitic diseases ,RC109-216 - Abstract
Although real-time reverse transcriptase polymerase chain reaction (real-time RT-PCR) remains as a golden standard for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, it can not be easily expanded to large-scaled screening during outbreaks, and the positive results do not necessarily correlate with infectious status of the identified subjects. In this study, the performance of Vstrip® RV2 COVID-19 Antigen Rapid Test (RAT) and its correlation with virus infectivity was examined by virus culture using 163 sequential respiratory specimens collected from 26 SARS-CoV-2 infected patients. When the presence of cytopathic effects (CPE) in cell culture was used as a reference method for virus infectivity, the sensitivity, specificity and accuracy of Vstrip® RV2 COVID-19 Antigen Rapid Test was 96.43%, 89.63%, and 90.8%, respectively. The highest Ct value was 27.7 for RdRp gene and 25.79 for E gene within CPE-positive samples, and the highest Ct value was 31.9 for RdRp gene and 29.1 for E gene within RAT positive samples. When the Ct values of specimens were below 25, the CPE and RAT results had high degree of consistency. We concluded that the RAT could be a great alternative method for determining the infectious potential of individuals with high viral load.
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- 2023
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16. Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan
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Chung-Feng Huang, Hsing-Tao Kuo, Te-Sheng Chang, Ching-Chu Lo, Chao-Hung Hung, Chien-Wei Huang, Lee-Won Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, Sheng-Shun Yang, Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, Chun-Jen Liu, Mei-Hsuan Lee, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wang-Long Chuang, Chi-Yi Chen, Kuo-Chih Tseng, and Ming-Lung Yu
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Medicine ,Science - Abstract
Abstract The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA throughout 12 weeks of end-of-treatment). The overall SVR12 rate was 98.9% (3110/3144), with 98.8%, 99.4% and 100% in patients receiving 8 weeks, 12 weeks, and 16 weeks of GLE/PIB respectively. The SVR12 rate in the treatment-naïve cirrhotic patients receiving 8 weeks of GLE/PIB was 98.2% (108/110). The most common AEs were fatigue (7.5%), pruritus (6.7%) and dizziness (1.5%). The mean number of outpatient visits during the GLE/PIB was 5.94 visits for patients treated with 8 weeks, significantly different from the patients treated with 12 weeks of GLE/PIB (6.90 visits). The results support the effectiveness and safety of GLE/PIB treatment in real-world clinical practice, and provide further evidence that the shorter, 8-week GLE/PIB regimen is effective and cost-saving.
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- 2021
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17. Multicenter evaluation of four immunoassays for the performance of early diagnosis of COVID-19 and assessment of antibody responses of patients with pneumonia in Taiwan
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Yi-Chun Lin, Yu-Lin Lee, Chien-Yu Cheng, Wen-Pin Tseng, Jhong-Lin Wu, Chien-Hao Lin, Ming-Yi Chung, Chun-Min Kang, Ya-Fan Lee, Cheng-Pin Chen, Chien-Hua Huang, Chun-Eng Liu, Shu-Hsing Cheng, Shyr-Chyr Chen, Shey-Ying Chen, and Po-Ren Hsueh
- Subjects
COVID-19 ,Immunoassays ,Antibody responses ,False positive ,Pneumonia ,Microbiology ,QR1-502 - Abstract
Background/purpose: Our study goals were to evaluate the diagnostic performance of four anti-SARS-CoV-2 antibodies tests and the differences in dynamic immune responses between COVID-19 patients with and without pneumonia. Methods: We collected 184 serum samples from 70 consecutively qRT-PCR-confirmed COVID-19 patients at four participating hospitals from 23 January 2020 to 30 September 2020. COVID-19 pneumonia was defined as the presence of new pulmonary infiltration. Serum samples were grouped by the duration after symptom onset on a weekly basis for antibody testing and analysis. The four immunoassays: Beckman SARS-CoV-2 IgG/IgM (Beckman Test), Siemens (ADVIA Centaur®) SARS-CoV-2 Total (COV2T) (Siemens Test), SBC COVID-19 IgG ELISA (SBC Test) and EliA SARS-CoV-2-Sp1 IgG/IgM/IgA P2 Research (EliA Test) were used for detecting the SARS-CoV-2 specific antibodies. Results: The sensitivity of all tests reached 100% after 42 days of symptom onset. Siemens Test, the only test detecting total anti-SARS-CoV-2 antibodies, had the best performance in the early diagnosis of COVID-19 infection (day 0–7: 77%; day 8–14: 95%) compared to the other 3 serological tests. All tests showed 100% specificity except SBC Test (98%). COVID-19 patients with pneumonia had significantly higher testing signal values than patients without pneumonia (all p values
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- 2021
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18. Clinical validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe acute respiratory syndrome coronavirus 2
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Pai-Ling Chang, Chia-Yi Lin, Cheng-Pin Chen, Yi-Chun Lin, Hui-Chun Hu, Shu-Hsing Cheng, and Chien-Yu Cheng
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SARS-CoV-2 ,COVID-19 ,Insulated isothermal PCR ,Microbiology ,QR1-502 - Abstract
To determine clinical performance of the single-target SARS-CoV-2 orf 1 ab reverse transcription-insulated isothermal PCR (RT-iiPCR) assay, the positive percentage agreement between this assay and a laboratory real-time RT-PCR assay was 96.8% (30 of 31; 95% confidence interval [CI], 90.5%–100%) and the negative percentage agreement was 97.1% (67 of 69; 95% CI, 93.1%–100%).
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- 2021
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19. Anti-Spike Antibody Response to Natural Infection with SARS-CoV-2 and Its Activity against Emerging Variants
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Cheng-Pin Chen, Kuan-Ying A. Huang, Shin-Ru Shih, Yi-Chun Lin, Chien-Yu Cheng, Yhu-Chering Huang, Tzou-Yien Lin, and Shu-Hsing Cheng
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COVID-19 ,neutralization antibody ,memory B cell ,Omicron ,SARS-CoV-2 ,Microbiology ,QR1-502 - Abstract
ABSTRACT The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has substantially affected human health globally. Spike-specific antibody response plays a major role in protection against SARS-CoV-2 infection. Here, we examined serological anti-spike antibody and memory B cell responses in adults with acute SARS-CoV-2 infection. Twenty-five adult patients were enrolled between January and September 2020, and 21 (84%) had a detectable spike-binding antibody response in serum on day 21 ± 8 (6 to 33) after the onset of illness. Among those with positive spike-binding antibody response, 19 (90%) had a positive hemagglutination titer and 15 (71%) had angiotensin-converting enzyme 2 (ACE2)-blocking serological activities. Follow-up serum samples collected 11 ± 1 (7 to 15) months after infection exhibited an average of 2.6 ± 1.0 (1.0 to 3.5)-fold reduction in the spike-binding antibody response. Moreover, convalescent and follow-up serum samples showed 83 ± 82 (15 to 306)- and 165 ± 167 (12 to 456)-fold reductions in the neutralization activity against the Omicron variant, respectively. Upon acute infection, spike-specific memory B cell responses were elicited, with an average frequency of 1.3% ± 1.2% of peripheral B cells on day 19 ± 7 (6 to 33) after the onset of illness. IgM memory B cells were predominantly induced. Patients with fever and pneumonia showed significantly stronger spike-binding, ACE2-blocking antibody, and memory B cell responses. In conclusion, spike-specific antibody response elicited upon acute SARS-CoV-2 infection may wane over time and be compromised by the emergence of viral variants. IMPORTANCE As spike protein-specific antibody responses play a major role in protection against SARS-CoV-2, we examined spike-binding and ACE2-blocking antibody responses in SARS-CoV-2 infection at different time points. We found robust responses following acute infection, which waned approximately 11 months after infection. Patients with fever and pneumonia showed significantly stronger spike-binding, ACE2-blocking antibody, and memory B cell responses. In particular, spike-specific antibody response in the convalescent and follow-up serum samples was substantially affected by emerging variants, especially Beta and Omicron variants. These results warrant continued surveillance of spike-specific antibody responses to natural infections and highlight the importance of maintaining functional anti-spike antibodies through immunization.
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- 2022
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20. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
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Cathrine Axfors, Andreas M. Schmitt, Perrine Janiaud, Janneke van’t Hooft, Sherief Abd-Elsalam, Ehab F. Abdo, Benjamin S. Abella, Javed Akram, Ravi K. Amaravadi, Derek C. Angus, Yaseen M. Arabi, Shehnoor Azhar, Lindsey R. Baden, Arthur W. Baker, Leila Belkhir, Thomas Benfield, Marvin A. H. Berrevoets, Cheng-Pin Chen, Tsung-Chia Chen, Shu-Hsing Cheng, Chien-Yu Cheng, Wei-Sheng Chung, Yehuda Z. Cohen, Lisa N. Cowan, Olav Dalgard, Fernando F. de Almeida e Val, Marcus V. G. de Lacerda, Gisely C. de Melo, Lennie Derde, Vincent Dubee, Anissa Elfakir, Anthony C. Gordon, Carmen M. Hernandez-Cardenas, Thomas Hills, Andy I. M. Hoepelman, Yi-Wen Huang, Bruno Igau, Ronghua Jin, Felipe Jurado-Camacho, Khalid S. Khan, Peter G. Kremsner, Benno Kreuels, Cheng-Yu Kuo, Thuy Le, Yi-Chun Lin, Wu-Pu Lin, Tse-Hung Lin, Magnus Nakrem Lyngbakken, Colin McArthur, Bryan J. McVerry, Patricia Meza-Meneses, Wuelton M. Monteiro, Susan C. Morpeth, Ahmad Mourad, Mark J. Mulligan, Srinivas Murthy, Susanna Naggie, Shanti Narayanasamy, Alistair Nichol, Lewis A. Novack, Sean M. O’Brien, Nwora Lance Okeke, Léna Perez, Rogelio Perez-Padilla, Laurent Perrin, Arantxa Remigio-Luna, Norma E. Rivera-Martinez, Frank W. Rockhold, Sebastian Rodriguez-Llamazares, Robert Rolfe, Rossana Rosa, Helge Røsjø, Vanderson S. Sampaio, Todd B. Seto, Muhammad Shahzad, Shaimaa Soliman, Jason E. Stout, Ireri Thirion-Romero, Andrea B. Troxel, Ting-Yu Tseng, Nicholas A. Turner, Robert J. Ulrich, Stephen R. Walsh, Steve A. Webb, Jesper M. Weehuizen, Maria Velinova, Hon-Lai Wong, Rebekah Wrenn, Fernando G. Zampieri, Wu Zhong, David Moher, Steven N. Goodman, John P. A. Ioannidis, and Lars G. Hemkens
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Science - Abstract
Abstract Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.
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- 2021
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21. Rapid establishment of a COVID-19 biobank in NHRI by National Biobank Consortium of Taiwan
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Shiu-Feng Huang, Yhu-Chering Huang, Feng-Yee Chang, Jung-Chung Lin, Chun-Hsiang Chiu, Chien-Wen Chen, Fu-Der Wang, Yen-Ling Chiu, Shu-Hsing Cheng, Chien-Yu Cheng, Yi-Chun Lin, Cheng-Pin Chen, Chien-Hsien Huang, Po-Yu Liu, Yuan-Ti Lee, Chen-Hsiang Lee, Yao-Shen Chen, Cheng-Len Sy, Yu-Ting Tseng, Cheng-Ting Hsu, Chia-Chun Tseng, Yu-Lin Lee, Chun-Eng Liu, and Huey-Kang Sytwu
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COVID-19 ,Biobank ,Pneumonia ,Consortium ,Medicine (General) ,R5-920 ,Biology (General) ,QH301-705.5 - Abstract
By the request of the Minister of Health and Welfare, NHRI Biobank was assigned to establish a COVID-19 biobank in early Feb, 2020 to collect COVID-19 patients’ blood samples for Taiwan researchers and industries in an emergent way. It was set up in less than 3 weeks and quickly opened for application. By August 5, 2020, this COVID-19 biobank has collected 165 blood samples of 110 patients from more than 10 hospitals across north, middle and south part of Taiwan, including both COVID-19 (+) and (-) pneumonia patients. This biobank can provide applicants with biosamples, such as serum, DNA and RNA, and also the clinical and genomic data, so as to accelerate the COVID-19 treatment and prevention research in Taiwan. This COID-19 biobank already received 15 applications. It has become the most important research resource for the COVID-19 pandemic in Taiwan, including new screening reagents, disease mechanism, the variable human responses and epidemic preventions. Since it is publicly available for both academic and industrial applicants.
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- 2020
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22. Lopinavir/ritonavir did not shorten the duration of SARS CoV-2 shedding in patients with mild pneumonia in Taiwan
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Chien-Yu Cheng, Yu-Lin Lee, Cheng-Pin Chen, Yi-Chun Lin, Chun-Eng Liu, Chia-Hung Liao, and Shu-Hsing Cheng
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COVID-19 ,SARS CoV-2 ,Lopinavir/ritonavir (LPV/r) ,Shedding ,Microbiology ,QR1-502 - Abstract
An increase of Ct values was 0.9 per day in 2 cases of COVID-19 treated with lopinavir/ritonavir (LPV/r), an increase was 1.0 per day in 3 cases without LPV/r through illness day 1–10, indicating that LPV/r did not shorten the duration of SARS CoV-2 shedding.
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- 2020
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23. Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan
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Shey-Ying Chen, Yu-Lin Lee, Yi-Chun Lin, Nan-Yao Lee, Chia-Hung Liao, Yuan-Pin Hung, Min-Chi Lu, Jhong-Lin Wu, Wen-Pin Tseng, Chien-Hao Lin, Ming-Yi Chung, Chun-Min Kang, Ya-Fan Lee, Tai-Fen Lee, Chien-Yu Cheng, Cheng-Pin Chen, Chien-Hua Huang, Chun-Eng Liu, Shu-Hsing Cheng, Wen-Chien Ko, Po-Ren Hsueh, and Shyr-Chyr Chen
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COVID-19 ,antibody response ,lateral flow immunoassays ,chemiluminescence immunoassays ,cross-reactivity ,Infectious and parasitic diseases ,RC109-216 ,Microbiology ,QR1-502 - Abstract
ABSTRACTThis multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e. two chemiluminescence immunoassays (CLIAs): Roche Elecsys® Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4–99.0%), Abbott Test (94.0%, 89.1–96.8%), Wondfo Test (91.4%, 85.8–94.9%), ASK Test (97.4%, 93.4–99.0%), and Dynamiker Test (90.1%, 84.3–94.0%) after >21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3–99.7%) for the Roche Test, 97.9% (95% CI, 94.8–99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1–100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.
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- 2020
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24. TROCA PARA UM REGIME COM 2 MEDICAMENTOS DOLUTEGRAVIR / LAMIVUDINA (DTG / 3TC) EM DOSE FIXA COMBINADA É NÃO INFERIOR A CONTINUAR COM UM REGIME DE 3 MEDICAMENTOS POR 48 SEMANAS EM UM ENSAIO CLÍNICO RANDOMIZADO (SALSA)
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Josep M. Llibre, Carlos Brites, Chien-yu Cheng, Olayemi Osiyemi, Carlos Galera, Laurent Hocqueloux, Franco Maggiolo, Olaf Degen, Libby Blair, Brian Wynne, James Oyee, Mark Underwood, Lloyd Curtis, Gilda Bontempo, Jean van Wyk, and Jucival Fernandes
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Infectious and parasitic diseases ,RC109-216 ,Microbiology ,QR1-502 - Abstract
A eficácia não inferior a longo prazo do regime de 2 medicamentos foi demonstrada em estudos de 144 semanas em virgens de tratamento e pacientes experimentados com um bom perfil de segurança e uma alta barreira à resistência. Avaliamos a eficácia e segurança da mudança para combinação de dose fixa DTG/3TC em adultos com HIV-1 em uso de qualquer regime antirretroviral (CAR) atual. SALSA é um estudo randomizado, controlado e aberto. Os participantes com RNA de HIV-1 6 meses em um esquema de 3/4DR sem falha virológica anterior ou mutações associadas à resistência a inibidor da transcriptase reversa de nucleosídeo (NRTI) ou DTG foram randomizados 1:1 (estratificado pela classe de terceiro agente da linha de base ) para mudar para DTG/3TC ou continuar CAR por 52 semanas. O desfecho primário foi a proporção de participantes com RNA de HIV-1 plasmático ≥50 c/mL na semana 48 (população exposta por intenção de tratamento ; falha virológica instantânea). Estimativas e intervalos de confiança foram baseados em análise estratificada usando o teste Cochran-Mantel-Haenszel ajustados para a terceira classe de agente da linha de base. No geral, 493 participantes foram randomizados (59% brancos; 39% mulheres; 39% com idade ≥50 anos; 50%/40%/10% com não NRTI/inibidor da integrase/inibidor da protease no início do estudo). DTG/3TC não foi inferior ao CAR contínuo na semana 48 usando análise de falha virológica instantânea (DTG / 3TC, 1/246 [0,4%]; CAR, 3/247 [1,2%]; diferença de tratamento ajustada [IC de 95%], -0,8% [-2,4%, 0,8%]); os resultados foram consistentes com a análise de resposta virológica instantânea (DTG/3TC, 232/246 [94,3%]; CAR, 229/247 [92,7%]; diferença de tratamento ajustada [IC de 95%], 1,6% [-2,8%, 5,9% ]). Nenhuma retirada virológica confirmada ou resistência observada ocorreu em nenhum dos grupos. Os resultados gerais de segurança foram comparáveis entre os grupos DTG/3TC e CAR quanto à frequência de quaisquer eventos adversos (AEs; 73% vs 70%), AEs que levam à retirada (2% vs 1%) e AEs graves (3% vs 6% ), respectivamente. Conclusão: No SALSA, a mudança para DTG/3TC foi não inferior à continuação da CAR na manutenção da supressão virológica na semana 48, com um perfil de segurança consistente com as bulas de DTG e 3TC. Ao longo de 48 semanas, o esquema com 2DR (DTG/3TC) oferece uma opção de troca com menos drogas antirretrovirais em comparação com 3/4DRs tradicionais, sem aumento do risco de falha virológica ou resistência.
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- 2022
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25. Dual therapy with ritonavir-boosted protease inhibitor (PI) plus lamivudine versus triple therapy with ritonavir-boosted PI plus two nucleos(t)ide reverse-transcriptase inhibitor in HIV-infected patients with viral suppression
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Tung-Che Hung, Guan-Jhou Chen, Shu-Hsing Cheng, Jhen-Hong Chen, Jheng-Lun Wei, Chien-Yu Cheng, and Chien-Ching Hung
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Microbiology ,QR1-502 - Abstract
Background: Dual antiretroviral regimens are attractive options to optimize the combination antiretroviral therapy in light of potential toxicities with long-term cumulative exposure to nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). Methods: In this retrospective observational study, we included HIV-infected patients on suppressive antiretroviral therapy with plasma viral load (PVL)
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- 2019
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26. Correction: Breadth and function of antibody response to acute SARS-CoV-2 infection in humans
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Kuan-Ying A. Huang, Tiong Kit Tan, Ting-Hua Chen, Chung-Guei Huang, Ruth Harvey, Saira Hussain, Cheng-Pin Chen, Adam Harding, Javier Gilbert-Jaramillo, Xu Liu, Michael Knight, Lisa Schimanski, Shin-Ru Shih, Yi-Chun Lin, Chien-Yu Cheng, Shu-Hsing Cheng, Yhu-Chering Huang, Tzou-Yien Lin, Jia-Tsrong Jan, Che Ma, William James, Rodney S. Daniels, John W. McCauley, Pramila Rijal, and Alain R. Townsend
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Immunologic diseases. Allergy ,RC581-607 ,Biology (General) ,QH301-705.5 - Published
- 2021
27. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV
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Shu-Hsing Cheng, Chia En Lien, Szu-Min Hsieh, Chien-Yu Cheng, Wang-Da Liu, Ching-Lung Lo, Wen-Chien Ko, Yen-Hsu Chen, Ching-Tai Huang, Hsiao-Ting Chang, Shinn-Jang Hwang, Ning-Chi Wang, Ming-Che Liu, Yu-Lin Lee, I-Chen Tai, Josue Antonio Garcia Estrada, Tzou-Yien Lin, and Wen-Sen Lee
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COVID-19 vaccine ,CpG 1018 ,S-2P protein ,HIV ,CD4/CD8 ratio ,immunogenicity ,Medicine - Abstract
Background: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). Methods: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. Results: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5–4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. Conclusions: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).
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- 2022
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28. Safety and Immunogenicity of a Heterologous Booster of Protein Subunit Vaccine MVC-COV1901 after Two Doses of Adenoviral Vector Vaccine AZD1222
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Shu-Hsing Cheng, Yi-Chun Lin, Cheng-Pin Chen, and Chien-Yu Cheng
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COVID-19 vaccine ,SARS-CoV-2 ,heterologous booster ,protein subunit vaccine ,MVC-COV1901 ,AZD1222 ,Medicine - Abstract
We report the safety and immunogenicity results in participants administrated with a booster dose of protein subunit vaccine MVC-COV1901 at 12 (Group A) or 24 (Group B) weeks after two doses of AZD1222 (ChAdOx1 nCoV-19). The administration of the MVC-COV1901 vaccine as a booster dose in both groups was generally safe. There were no serious adverse events related to the intervention as adverse events reported were “mild” or “moderate” in nature. In subjects fully vaccinated with two doses of AZD1222, waning antibody immunity was apparent within six months of the second dose of AZD1222. At one month after the MVC-COV1901 booster dose, those who were vaccinated within 12 weeks after the last AZD1222 dose (Group A) had anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers which were 14- and 6.5-fold increased, respectively, when compared to the titer levels on the day of the booster dose. On the other hand, fold-increase a month post-booster in people who had a booster 24 weeks after the last AZD1222 dose (Group B) were 19.5 and 14.0 times for anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers, respectively. Among those who were vaccinated within 12 weeks after the last AZD1222 dose, we also observed 5.2- and 5.6-fold increases in neutralizing titer levels against ancestral strain and Omicron variant pseudovirus after the booster dose, respectively. These results support the use of MVC-COV1901 as a heterologous booster for individuals vaccinated with AZD1222. Furthermore, regardless of the dosing schedule, the combination of AZD1222 primary series and MVC-COV1901 booster can be cost-effective and suitably applied to low- and middle-income countries (LMIC).
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- 2022
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29. A case of transient existence of SARS-CoV-2 RNA in the respiratory tract with the absence of anti-SARS-CoV-2 antibody response
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Yi-Chun Lin, Chien-Yu Cheng, Cheng-Pin Chen, Shu-Hsing Cheng, Sui-Yuan Chang, and Po-Ren Hsueh
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COVID-19 ,SARS-CoV-2 ,Asymptomatic infection ,Colonization ,Contamination ,Infectious and parasitic diseases ,RC109-216 - Abstract
We report the case of a patient who had travelled to Japan and who presented mild respiratory symptoms during the COVID-19 outbreak period. There was transient existence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in his oropharynx. The RNA was absent in the six respiratory specimens that were subsequently tested. An anti-SARS-CoV-2 antibody response was absent in the acute and convalescent sera. The reported case indicates that transient colonization of SARS-CoV-2 in the upper respiratory tract is possible without inciting any antibody response against the virus.
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- 2020
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30. Clinical features of acute human immunodeficiency virus infection in Taiwan: A multicenter study
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Te-Yu Lin, Chia-Jui Yang, Chung-Eng Liu, Hung-Jen Tang, Tun-Chieh Chen, Guan-Jhou Chen, Tung-Che Hung, Kuan-Yin Lin, Chien-Yu Cheng, Yi-Chien Lee, Shih-Ping Lin, Mao-Song Tsai, Yu-Lin Lee, Shu-Hsing Cheng, Chien-Ching Hung, and Ning-Chi Wang
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Microbiology ,QR1-502 - Abstract
Background/purpose: Acute HIV infection is characterized by a high concentration of HIV RNA in the plasma and rapid depletion of the CD4 cell count. This multicenter, retrospective observational study aimed to characterize the manifestations of acuteHIV infection in Taiwan. Methods: Between 1 January 2012 and 31 December 2016, all patients aged 20 years or greater who presented with acute HIV infection were included. Demographic and clinical characteristics of the patients at diagnosis were collected. Baseline laboratory assessment included hemogram, CD4 count, plasma HIV RNA load (PVL), serologic markers of syphilis and hepatitis A, B, and C viruses, and serum biochemistry. Results: The proportion of acute HIV infection was 6.9% among the patients with newly diagnosed HIV infection during the study period. The most common presenting symptoms of acute HIV infection were fever, fatigue, and myalgia. The median PVL at diagnosis was 5.9 log10 copies/ml, and median CD4 count was 307 cells/mm3. A total of 68 patients (27%) had baseline CD4 count less than 200 cells/mm3. Multiple logistic regression analysis, showed that the baseline CD4 count (OR, 4.02; p = 0.013) and aspartate aminotransaminase levels (OR, 3.49; p = 0.002) were associated with high PVL (>5 log10 copies/ml); and high baseline PVL (OR, 2.64; p = 0.002) was associated with symptomatic acute HIV infection. Conclusions: Manifestations of acute HIV infection are nonspecific and of wide spectrum ranging from fever to severe illness. A higher proportion of patients with initial CD4 counts of 200 cells/mm3 or less during acute HIV infection warrants early, timely diagnosis and treatment to prevent rapid disease progression. Keywords: Acute HIV infection, Aseptic meningitis, Combination antiretroviral therapy, Fiebig stage, Infectious mononucleosis
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- 2019
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31. Evaluation of cost-effectiveness of peginterferon plus ribavirin for chronic hepatitis C treatment and direct-acting antiviral agents among HIV-infected patients in the prison and community settings
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Cheng-Pin Chen, Chien-Yu Cheng, Huachun Zou, Chun-Han Cheng, Shu-Hsing Cheng, Cheng-Kuo Chen, Ching-Hsiang Chen, and Ming-Jong Bair
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Microbiology ,QR1-502 - Abstract
Background: In Taiwan, the majority of chronic hepatitis C carriers with HIV co-infection are intravenous drug users and inmates in correctional facilities. Peginterferon and ribavirin (PegIFN/RBV) have been the standard-of-care for chronic hepatitis C virus (HCV) infection more than decades. We evaluated the estimated cost-effectiveness of PegIFN/RBV from the National Health Insurance Research Database, covering the population of Taiwan from 1998 to 2013. Materials and methods: This is an observational study, and study during was 2010–2016 and a total of 239 patients were treated with PegIFN/RBV. Of them, 156 patients were treated in the correctional facilities of Taipei, Taoyuan, Taichung and Taitung prisons, and 83 patients were treated in communities. The cost-effectiveness was analyzed in regimens of PegIFN/RBV and direct-acting antiviral agents. Results: By multivariate analysis, the patients completed PegIFN/RBV in prison (adjusted odds ratio [aOR]: 4.56, 95% confidence interval [CI]: 1.58–13.12, p = 0.005), HCV RNA level
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- 2019
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32. Nasal high flow cannula maybe prioritized in treating patients suffering from COVID-19?
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Yung-Chia Huang, Chien-Yu Cheng, Chou-Jui Lin, and Shih-Wei Lee
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Medicine (General) ,R5-920 - Published
- 2021
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33. Breadth and function of antibody response to acute SARS-CoV-2 infection in humans.
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Kuan-Ying A Huang, Tiong Kit Tan, Ting-Hua Chen, Chung-Guei Huang, Ruth Harvey, Saira Hussain, Cheng-Pin Chen, Adam Harding, Javier Gilbert-Jaramillo, Xu Liu, Michael Knight, Lisa Schimanski, Shin-Ru Shih, Yi-Chun Lin, Chien-Yu Cheng, Shu-Hsing Cheng, Yhu-Chering Huang, Tzou-Yien Lin, Jia-Tsrong Jan, Che Ma, William James, Rodney S Daniels, John W McCauley, Pramila Rijal, and Alain R Townsend
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Immunologic diseases. Allergy ,RC581-607 ,Biology (General) ,QH301-705.5 - Abstract
Serological and plasmablast responses and plasmablast-derived IgG monoclonal antibodies (MAbs) have been analysed in three COVID-19 patients with different clinical severities. Potent humoral responses were detected within 3 weeks of onset of illness in all patients and the serological titre was elicited soon after or concomitantly with peripheral plasmablast response. An average of 13.7% and 3.5% of plasmablast-derived MAbs were reactive with virus spike glycoprotein or nucleocapsid, respectively. A subset of anti-spike (10 of 32) antibodies cross-reacted with other betacoronaviruses tested and harboured extensive somatic mutations, indicative of an expansion of memory B cells upon SARS-CoV-2 infection. Fourteen of 32 anti-spike MAbs, including five anti-receptor-binding domain (RBD), three anti-non-RBD S1 and six anti-S2, neutralised wild-type SARS-CoV-2 in independent assays. Anti-RBD MAbs were further grouped into four cross-inhibiting clusters, of which six antibodies from three separate clusters blocked the binding of RBD to ACE2 and five were neutralising. All ACE2-blocking anti-RBD antibodies were isolated from two recovered patients with prolonged fever, which is compatible with substantial ACE2-blocking response in their sera. Finally, the identification of non-competing pairs of neutralising antibodies would offer potential templates for the development of prophylactic and therapeutic agents against SARS-CoV-2.
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- 2021
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34. An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901
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Josue Antonio Estrada, Chien-Yu Cheng, Shin-Yen Ku, Hui-Chun Hu, Hsiu-Wen Yeh, Yi-Chun Lin, Cheng-Pin Chen, Shu-Hsing Cheng, Robert Janssen, and I-Feng Lin
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immunobridging ,MVC-COV1901 ,ChAdOx nCOV-19 ,neutralizing antibodies ,Medicine - Abstract
Rapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the world, this has not always been feasible. Recently, the Taiwan Food and Drug Administration, following the consensus of the International Coalition of Medicines Regulatory Authorities (ICMRA), adopted the use of immunobridging studies as acceptable for authorizing COVID-19 vaccines in lieu of efficacy data. Here, we describe a study in which our candidate vaccine, MVC-COV1901, an adjuvanted protein subunit vaccine, has been granted emergency use authorization (EUA) in Taiwan based on a noninferiority immunobridging study. Immunogenicity results from the per protocol immunogenicity (PPI) subset (n = 903) from the MVC-COV1901 phase 2 trial were compared with results from 200 subjects who had received an adenovirus vector vaccine, AstraZeneca ChAdOx nCOV-19 (AZD1222), in a separate study. The lower bound of the 95% confidence interval (CI) of the geometric mean titer (GMT) ratio comparing MVC-COV1901 to AZD1222 was 3.4. The lower bound of the 95% CI of the sero-response rate was 95.5%. Both the GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan.
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- 2022
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35. A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19).
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Cheng-Pin Chen, Yi-Chun Lin, Tsung-Chia Chen, Ting-Yu Tseng, Hon-Lai Wong, Cheng-Yu Kuo, Wu-Pu Lin, Sz-Rung Huang, Wei-Yao Wang, Jia-Hung Liao, Chung-Shin Liao, Yuan-Pin Hung, Tse-Hung Lin, Tz-Yan Chang, Chin-Fu Hsiao, Yi-Wen Huang, Wei-Sheng Chung, Chien-Yu Cheng, Shu-Hsing Cheng, and Taiwan HCQ Study Group
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Medicine ,Science - Abstract
ObjectiveIn this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study.MethodsSubjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020.ResultsThere were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70).ConclusionsNeither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.
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- 2020
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36. Incidence and Risk Factors of Reinfection with HCV after Treatment in People Living with HIV
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Chien-Yu Cheng, Shin-Yen Ku, Yi-Chun Lin, Cheng-Pin Chen, Shu-Hsing Cheng, and I-Feng Lin
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people who inject drugs (PWID) ,reinfection with HCV ,people living with HIV (PLWH) ,heroin dependency ,amphetamine abuse ,men who have sex with men (MSM) ,Microbiology ,QR1-502 - Abstract
Infection with hepatitis C virus (HCV) does not induce protective immunity, and re-exposure to HCV can reinfect the population engaging in high-risk behavior. An increasing incidence of acute hepatitis C infection in people living with HIV (PLWH) has been described in recent years. This retrospective cohort study was conducted in PLWH who completed HCV therapy between June 2009 and June 2020 at an HIV care hospital, to analyze their basic characteristics and risky behavior. Of 2419 patients, 639 were diagnosed with HCV infection and 516 completed the HCV therapy with a sustained virologic response. In total, 59 patients (11.4%) were reinfected with acute hepatitis C, and the median time to reinfection was 85.3 weeks (IQR: 57–150). The incidence of reinfection was 6.7 cases/100 person-years. The factors associated with reinfection were being male (AHR, 8.02; 95% CI 1.08–59.49), DAA (direct-acting antiviral) treatment (AHR, 2.23; 95% CI 1.04–4.79), liver cirrhosis (AHR, 3.94; 95% CI 1.09–14.22), heroin dependency (AHR: 7.41; 95% CI 3.37–14.3), and HIV viral loads
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- 2022
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37. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
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Cathrine Axfors, Andreas M. Schmitt, Perrine Janiaud, Janneke van’t Hooft, Sherief Abd-Elsalam, Ehab F. Abdo, Benjamin S. Abella, Javed Akram, Ravi K. Amaravadi, Derek C. Angus, Yaseen M. Arabi, Shehnoor Azhar, Lindsey R. Baden, Arthur W. Baker, Leila Belkhir, Thomas Benfield, Marvin A. H. Berrevoets, Cheng-Pin Chen, Tsung-Chia Chen, Shu-Hsing Cheng, Chien-Yu Cheng, Wei-Sheng Chung, Yehuda Z. Cohen, Lisa N. Cowan, Olav Dalgard, Fernando F. de Almeida e Val, Marcus V. G. de Lacerda, Gisely C. de Melo, Lennie Derde, Vincent Dubee, Anissa Elfakir, Anthony C. Gordon, Carmen M. Hernandez-Cardenas, Thomas Hills, Andy I. M. Hoepelman, Yi-Wen Huang, Bruno Igau, Ronghua Jin, Felipe Jurado-Camacho, Khalid S. Khan, Peter G. Kremsner, Benno Kreuels, Cheng-Yu Kuo, Thuy Le, Yi-Chun Lin, Wu-Pu Lin, Tse-Hung Lin, Magnus Nakrem Lyngbakken, Colin McArthur, Bryan J. McVerry, Patricia Meza-Meneses, Wuelton M. Monteiro, Susan C. Morpeth, Ahmad Mourad, Mark J. Mulligan, Srinivas Murthy, Susanna Naggie, Shanti Narayanasamy, Alistair Nichol, Lewis A. Novack, Sean M. O’Brien, Nwora Lance Okeke, Léna Perez, Rogelio Perez-Padilla, Laurent Perrin, Arantxa Remigio-Luna, Norma E. Rivera-Martinez, Frank W. Rockhold, Sebastian Rodriguez-Llamazares, Robert Rolfe, Rossana Rosa, Helge Røsjø, Vanderson S. Sampaio, Todd B. Seto, Muhammad Shahzad, Shaimaa Soliman, Jason E. Stout, Ireri Thirion-Romero, Andrea B. Troxel, Ting-Yu Tseng, Nicholas A. Turner, Robert J. Ulrich, Stephen R. Walsh, Steve A. Webb, Jesper M. Weehuizen, Maria Velinova, Hon-Lai Wong, Rebekah Wrenn, Fernando G. Zampieri, Wu Zhong, David Moher, Steven N. Goodman, John P. A. Ioannidis, and Lars G. Hemkens
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Science - Published
- 2021
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38. Letter to the Editor: Update on the followed-up CT exam of the first CoVID-19 pneumonia in Taiwan
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Yung-Chia Huang, Chen-En Hsieh, Chien-Yu Cheng, Yu-Long Fan Chian, and Shih-Wei Lee
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Medicine (General) ,R5-920 - Published
- 2020
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39. Circumcision to prevent HIV and other sexually transmitted infections in men who have sex with men: a systematic review and meta-analysis of global data
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Tanwei Yuan, MD, Thomas Fitzpatrick, BA, Nai-Ying Ko, ProfPhD, Yong Cai, ProfPhD, Yingqing Chen, ProfPhD, Jin Zhao, PhD, Linghua Li, PhD, Junjie Xu, ProfPhD, Jing Gu, PhD, Jinghua Li, PhD, Chun Hao, PhD, Zhengrong Yang, PhD, Weiping Cai, MD, Chien-Yu Cheng, MD, Zhenzhou Luo, MD, Kechun Zhang, MD, Guohui Wu, MD, Xiaojun Meng, MD, Andrew E Grulich, ProfPhD, Yuantao Hao, ProfPhD, and Huachun Zou, ProfPhD
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Public aspects of medicine ,RA1-1270 - Abstract
Summary: Background: Men who have sex with men (MSM) are disproportionately affected by HIV and other sexually transmitted infections (STIs) worldwide. Previous reviews investigating the role of circumcision in preventing HIV and other STIs among MSM were inconclusive. Many new studies have emerged in the past decade. To inform global prevention strategies for HIV and other STIs among MSM, we reviewed all available evidence on the associations between circumcision and HIV and other STIs among MSM. Methods: In this systematic review and meta-analysis, we searched PubMed, Web of Science, BioMed Central, Scopus, ResearchGate, Cochrane Library, Embase, PsycINFO, Google Scholar, and websites of international HIV and STI conferences for studies published before March 8, 2018. Interventional or observational studies containing original quantitative data describing associations between circumcision and incident or prevalent infection of HIV and other STIs among MSM were included. Studies were excluded if MSM could not be distinguished from men who have sex with women only. We calculated pooled odds ratios (ORs) and their 95% CIs using random-effect models. We assessed risk of bias using the Newcastle-Ottawa scale. Findings: We identified 62 observational studies including 119 248 MSM. Circumcision was associated with 23% reduced odds of HIV infection among MSM overall (OR 0·77, 95% CI 0·67–0·89; number of estimates [k]=45; heterogeneity I2=77%). Circumcision was protective against HIV infection among MSM in countries of low and middle income (0·58, 0·41–0·83; k=23; I2=77%) but not among MSM in high-income countries (0·99, 0·90–1·09; k=20; I2=40%). Circumcision was associated with reduced odds of herpes simplex virus (HSV) infection among MSM overall (0·84, 0·75–0·95; k=5; I2=0%) and penile human papillomavirus (HPV) infection among HIV-infected MSM (0·71, 0·51–0·99; k=3; I2=0%). Interpretation: We found evidence that circumcision is likely to protect MSM from HIV infection, particularly in countries of low and middle income. Circumcision might also protect MSM from HSV and penile HPV infection. MSM should be included in campaigns promoting circumcision among men in countries of low and middle income. In view of the substantial proportion of MSM in countries of low and middle income who also have sex with women, well designed longitudinal studies differentiating MSM only and bisexual men are needed to clarify the effect of circumcision on male-to-male transmission of HIV and other STIs. Funding: National Natural Science Foundation of China, National Science and Technology Major Project of China, Australian National Health and Medical Research Council Early Career Fellowship, Sanming Project of Medicine in Shenzhen, National Institutes of Health, Mega Projects of National Science Research for the 13th Five-Year Plan, Doris Duke Charitable Foundation.
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- 2019
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40. Changing seroprevalence of hepatitis C virus infection among HIV-positive patients in Taiwan.
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Chia-Wen Li, Chia-Jui Yang, Hsin-Yun Sun, Mao-Song Tsai, Shih-Ping Lin, Te-Yu Lin, Chien-Yu Cheng, Yi-Chien Lee, Yu-Shan Huang, Chun-Eng Liu, Yuan-Ti Lee, Hung-Jen Tang, Ning-Chi Wang, Shu-Hsing Cheng, Wen-Chien Ko, Chien-Ching Hung, and Taiwan HIV Study Group
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Medicine ,Science - Abstract
The study aimed to describe the evolution of the seroprevalence of hepatitis C virus (HCV) among human immunodeficiency virus (HIV)-positive patients included in two cohorts in Taiwan.We retrospectively collected the information on demographic and clinical characteristics of 4,025 and 3,856 HIV-positive Taiwanese, who were aged 18 years or older at designated hospitals around Taiwan in 2004-2007, when an outbreak of HIV infection was occurring, and 2012-2016, when the outbreak was controlled with the implementation of harm reduction program, respectively. Comparisons of HCV seropositivity were made among different age and risk groups for HIV transmission between these two cohorts.The overall HCV seroprevalence of the 2004-2007 cohort and 2012-2016 cohort was 43.4% (1,288/2,974) and 18.6% (707/3,793), respectively (P
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- 2018
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41. Multicenter study of skin rashes and hepatotoxicity in antiretroviral-naïve HIV-positive patients receiving non-nucleoside reverse-transcriptase inhibitor plus nucleoside reverse-transcriptase inhibitors in Taiwan.
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Pei-Ying Wu, Chien-Yu Cheng, Chun-Eng Liu, Yi-Chien Lee, Chia-Jui Yang, Mao-Song Tsai, Shu-Hsing Cheng, Shih-Ping Lin, De-Yu Lin, Ning-Chi Wang, Yi-Chieh Lee, Hsin-Yun Sun, Hung-Jen Tang, and Chien-Ching Hung
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Medicine ,Science - Abstract
OBJECTIVES:Two nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) plus 1 non-NRTI (nNRTI) remain the preferred or alternative combination antiretroviral therapy (cART) for antiretroviral-naive HIV-positive patients in Taiwan. The three most commonly used nNRTIs are nevirapine (NVP), efavirenz (EFV) and rilpivirine (RPV). This study aimed to determine the incidences of hepatotoxicity and skin rashes within 4 weeks of initiation of cART containing 1 nNRTI plus 2 NRTIs. METHODS:Between June, 2012 and November, 2015, all antiretroviral-naive HIV-positive adult patients initiating nNRTI-containing cART at 8 designated hospitals for HIV care were included in this retrospective observational study. According to the national HIV treatment guidelines, patients were assessed at baseline, 2 and 4 weeks of cART initiation, and subsequently every 8 to 12 weeks. Plasma HIV RNA load, CD4 cell count and aminotransferases were determined. The toxicity grading scale of the Division of AIDS (DAIDS) 2014 was used for reporting clinical and laboratory adverse events. RESULTS:During the 3.5-year study period, 2,341 patients initiated nNRTI-containing cART: NVP in 629 patients, EFV 1,363 patients, and RPV 349 patients. Rash of any grade occurred in 14.1% (n = 331) of the patients. In multiple logistic regression analysis, baseline CD4 cell counts (per 100-cell/μl increase, adjusted odds ratio [AOR], 1.125; 95% confidence interval [95% CI], 1.031-1.228) and use of NVP (AOR, 2.443; 95% CI, 1.816-3.286) (compared with efavirenz) were independently associated with the development of skin rashes. Among the 1,455 patients (62.2%) with aminotransferase data both at baseline and week 4, 72 (4.9%) developed grade 2 or greater hepatotoxicity. In multiple logistic regression analysis, presence of antibody for hepatitis C virus (HCV) (AOR, 2.865; 95% CI, 1.439-5.704) or hepatitis B surface antigen (AOR, 2.397; 95% CI, 1.150-4.997), and development of skin rashes (AOR, 2.811; 95% CI, 1.051-7.521) were independently associated with the development of hepatotoxicity. CONCLUSIONS:The baseline CD4 cell counts and use of NVP were associated with increased risk of skin rashes, while hepatotoxicity was independently associated with HCV or hepatitis B virus coinfection, and development of skin rashes in antiretroviral-naïve HIV-positive Taiwanese patients within 4 weeks of initiation of nNRTI-containing regimens.
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- 2017
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42. Trends and outcomes of late initiation of combination antiretroviral therapy driven by late presentation among HIV-positive Taiwanese patients in the era of treatment scale-up.
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Kuan-Yin Lin, Chien-Yu Cheng, Chia-Wen Li, Chia-Jui Yang, Mao-Song Tsai, Chun-Eng Liu, Yuan-Ti Lee, Hung-Jen Tang, Ning-Chi Wang, Te-Yu Lin, Yi-Chien Lee, Shih-Ping Lin, Yu-Shan Huang, Jun-Yu Zhang, Wen-Chien Ko, Shu-Hsing Cheng, Chien-Ching Hung, and Taiwan HIV Study Group
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Medicine ,Science - Abstract
The international and national HIV treatment guidelines in 2016 have focused on scaling up access to combination antiretroviral therapy (cART). We aimed to assess the trends and treatment outcomes of late cART initiation in Taiwan.Between June 2012 and May 2016, we retrospectively included antiretroviral-naive HIV-positive adults who initiated cART. Late initiation was defined as when cART was initiated in patients with a CD4 count
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- 2017
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43. Evolution of hepatitis A virus seroprevalence among HIV-positive adults in Taiwan.
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Yu-Lin Lee, Kuan-Yin Lin, Chien-Yu Cheng, Chia-Wen Li, Chia-Jui Yang, Mao-Song Tsai, Hung-Jen Tang, Te-Yu Lin, Ning-Chi Wang, Yi-Chien Lee, Shih-Ping Lin, Yu-Shan Huang, Hsin-Yun Sun, Jun-Yu Zhang, Wen-Chien Ko, Shu-Hsing Cheng, Yuan-Ti Lee, Chun-Eng Liu, Chien-Ching Hung, and Taiwan HIV Study Group
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Medicine ,Science - Abstract
The study aimed to describe the seroprevalence of hepatitis A virus (HAV) in HIV-positive adult patients in Taiwan between 2012 and 2016 and to examine the evolution of HAV seroprevalence between 2004-2007 and 2012-2016.Clinical information and data of anti-HAV antibody results were collected from 2,860 antiretroviral-naïve HIV-positive Taiwanese aged 18 years or older who initiated combination antiretroviral therapy at 11 hospitals around Taiwan between 2012 and 2016 (2012-2016 cohort). A multivariate logistic regression model was applied to identify independent variables associated with HAV seropositivity. Comparisons of HAV seroprevalences and associated clinical characteristics were made between this 2012-2016 cohort and a previous cohort of 1580 HIV-positive patients in 2004-2007 (2004-2007 cohort).Of the 2,860 HIV-positive patients between 2012 and 2016, the overall HAV seropositivity rate was 21.2% (605/2860), which was independently associated with an older age (adjusted odds ratio [AOR], per 1-year increase, 1.13; 95% confidence interval [95% CI], 1.11-1.15) and co-infection with hepatitis B virus (AOR 1.44; 95% CI, 1.08-1.93). Residence in southern Taiwan (AOR 0.49; 95% CI, 0.34-0.72) was inversely associated with HAV seropositivity. The overall HAV seroprevalence in the 2012-2016 cohort was significantly lower than that in the 2004-2007 cohort (21.2% vs 60.9%, p
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- 2017
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44. Seroprevalence of hepatitis B virus among adults at high risk for HIV transmission two decades after implementation of nationwide hepatitis B virus vaccination program in Taiwan.
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Hsin-Yun Sun, Chien-Yu Cheng, Nan-Yao Lee, Chia-Jui Yang, Shiou-Haur Liang, Mao-Song Tsai, Wen-Chien Ko, Wen-Chun Liu, Pei-Ying Wu, Cheng-Hsin Wu, Hsi-Hsun Lin, and Chien-Ching Hung
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Medicine ,Science - Abstract
BACKGROUND: Seroprevalence of hepatitis B virus (HBV) after implementation of universal neonatal HBV vaccination and catch-up vaccination programs remains rarely investigated among the adults who were born in the vaccination era (in or after 1986) and engaged in high-risk sexual behaviors. MATERIALS AND METHODS: Between 2006 and 2012, we determined HBV surface antigen ([HBsAg), anti-HBs, and HBV core antibody (anti-HBc), hepatitis C virus antibody (anti-HCV) and rapid plasma reagin titers among HIV-infected men who have sex with men (MSM) born during 1984-1985 (Group I: 244 persons) and those born in or after 1986 (Group II: 523), and HIV-uninfected MSM (Group III: 377) and heterosexuals (Group IV: 217) born in or after 1986. Prevalence and incidence of HBV infection were estimated and multivariate analysis was performed to identify factors associated with HBsAg positivity. RESULTS: Compared with Group I, Groups II-IV had a significantly lower prevalence of HBsAg positivity (7.8% vs 3.7%, 2.4%, and 3.2%, respectively); and the prevalence of anti-HBc positivity was also lower for Groups III and IV (30.3% vs. 19.6%, and 18.0%, respectively), but no difference was observed between Groups I and II (30.3% vs. 26.3%). In multivariate analysis, HBsAg positivity was significantly associated with syphilis (adjusted odds ratio, 2.990; 95% confidence interval, 1.502-5.953) and anti-HCV positivity (adjusted odds ratio, 3.402; 95% confidence interval, 1.091-10.614). In subjects of Group II with all-negative HBV markers at baseline, the incidence rate of HBsAg seroconversion was 0.486 episodes per 100 person-years; and for those who received combination antiretroviral therapy containing lamivudine and/or tenofovir, none developed HBsAg seroconversion during the follow-up. CONCLUSIONS: Among the adults who were born in or after 1986 and engaged in high-risk sexual behaviors in Taiwan, neonatal HBV vaccination and catch-up vaccination programs conferred long-term protection against HBsAg seroconversion and HBsAg positivity was associated with syphilis and anti-HCV positivity.
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- 2014
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45. Exploring the Relationship Between Learning Achievement and Discussion Records in Remote Maker Activities
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Chien, Yu-Cheng, Cheng, Pei-Yu, Csui, Lin-Tao, Yang, Yeongwook, Hooshyar, Danial, Huang, Yueh-Min, Goos, Gerhard, Founding Editor, Hartmanis, Juris, Founding Editor, Bertino, Elisa, Editorial Board Member, Gao, Wen, Editorial Board Member, Steffen, Bernhard, Editorial Board Member, Yung, Moti, Editorial Board Member, Huang, Yueh-Min, editor, Cheng, Shu-Chen, editor, Barroso, João, editor, and Sandnes, Frode Eika, editor
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- 2022
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46. Use Object-Detection to Identify Materials and Tools for STEAM Hands-on Activity
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Lee, Hsin-Yu, Chien, Yu-Cheng, Chang, Pei-Yu, Hooshyar, Danial, Huang, Yueh-Min, Goos, Gerhard, Founding Editor, Hartmanis, Juris, Founding Editor, Bertino, Elisa, Editorial Board Member, Gao, Wen, Editorial Board Member, Steffen, Bernhard, Editorial Board Member, Woeginger, Gerhard, Editorial Board Member, Yung, Moti, Editorial Board Member, Huang, Yueh-Min, editor, Lai, Chin-Feng, editor, and Rocha, Tânia, editor
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- 2021
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47. Enhancing Comprehension of Lecture Content in a Foreign Language as the Medium of Instruction: Comparing Speech-to-Text Recognition with Speech-Enabled Language Translation
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Shadiev, Rustam, Chien, Yu-Cheng, and Huang, Yueh-Min
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Scholars suggest that not every student completely comprehends the content of a lecture in a foreign language as the medium of instruction, especially in the case of those with low language ability. To facilitate comprehension of lectures in a foreign language, learning content was presented to students in multiple modalities; that is, in addition to verbal (speech of the instructor) and visual (lecture slides) content, texts generated by speech-to-text recognition (STR) or speech-enabled language translation (SELT) were shown to the students. The goal was to compare how these two additional content modalities (i.e., STR-texts vs. SELT-texts) facilitate student comprehension of lecture content. Because processing multimodal content requires additional cognitive resources, another goal was to explore whether STR-texts versus SELT-texts impose any cognitive load on the students. To this end, two groups of students were recruited, where they attended two lectures at the intermediate and advanced levels. STR-texts were shown to a control group, and SELT-texts were shown to an experimental group. The posttest results and the cognitive load of the students in both groups after each lecture were compared. Four main findings were obtained: (a) The experimental group outperformed the control group on both posttests. However, when student language ability was considered, the difference was statistically significant for low ability students only; (b) there was not a significant between-group difference in cognitive load; however, if student language ability was considered, a significant between-group difference existed during the more difficult lecture; (c) between-group differences in self-efficacy were statistically insignificant; and (d) associations among some research variables were found. Based on these results, several implications were drawn for the teaching and research community.
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- 2020
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48. A LUPDA Assessment Model for Activities in STEAM Education
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Chien, Yu-Cheng, Chang, Pei-Yu, Lee, Hsin-Yu, Huang, Tai-Yi, Huang, Yueh-Min, Goos, Gerhard, Founding Editor, Hartmanis, Juris, Founding Editor, Bertino, Elisa, Editorial Board Member, Gao, Wen, Editorial Board Member, Steffen, Bernhard, Editorial Board Member, Woeginger, Gerhard, Editorial Board Member, Yung, Moti, Editorial Board Member, Huang, Tien-Chi, editor, Wu, Ting-Ting, editor, Barroso, João, editor, Sandnes, Frode Eika, editor, Martins, Paulo, editor, and Huang, Yueh-Min, editor
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- 2020
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49. Facilitating Vocabulary Note Taking on Computers through the Deep Processing Strategy
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Liu, Ming-Chi, Huang, Yueh-Min, and Chien, Yu-Cheng
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The recording of words in a vocabulary notebook is regarded as a plausible and efficient method for learners, since they can organize and manage the individual words they wish to acquire. The wide appeal of portable computers has resulted in a rapid increase in taking notes via computers across college campuses. Although computers can increase transcription speed when students take notes, they are also detrimental to learning, because students tend to mindlessly transcribe results, resulting in shallow processing. To resolve the issue, in this study, an association-based strategy is introduced to assist learners in compiling vocabulary notebooks. To assess the strategy, an experiment was conducted to investigate the effects of the proposed nonlinear associations note-taking method with respect to the traditional linear outline method. The results show that both strategies could increase vocabulary retention; however, the associations format was significantly better than the outline format. In addition, through a deep analysis of both types of note-taking processes, we also found that students using the associations note-taking method developed more meaningful word association styles (e.g., linking words that had similar contexts) in composing their notes than students using the outline note-taking method. When examining how learners with different cognitive styles took the notes, the results showed that learner performance depends on cognitive style, as well as the chosen organizational format. The findings suggest that a nonlinear association note-taking strategy may help students organize words in a meaningful way.
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- 2019
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50. Fabrication of metallic nanonetworks via templated electroless plating as hydrogenation catalyst
- Author
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Chien, Yu-Cheng, Huang, Liang-Yu, Yang, Kai-Chieh, Krishnan, Mohan Raj, Hung, Wei-Song, Tsai, Jing-Cherng, and Ho, Rong-Ming
- Published
- 2021
- Full Text
- View/download PDF
Catalog
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