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1. Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial

Author

Wedemeyer, Heiner, Aleman, Soo, Brunetto, Maurizia, Blank, Antje, Andreone, Pietro, Bogomolov, Pavel, Chulanov, Vladimir, Mamonova, Nina, Geyvandova, Natalia, Morozov, Viacheslav, Sagalova, Olga, Stepanova, Tatyana, Berger, Annemarie, Ciesek, Sandra, Manuilov, Dmitry, Mercier, Renee-Claude, Da, Ben L., Chee, Grace M., Li, Mingyang, Flaherty, John F., Lau, Audrey H., Osinusi, Anu, Schulze zur Wiesch, Julian, Cornberg, Markus, Zeuzem, Stefan, and Lampertico, Pietro

Published
2024
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3. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study

Author

Janssen, Harry L A, Lim, Young-Suk, Lampertico, Pietro, Heo, Jeong, Chen, Chi-Yi, Fournier, Claire, Tsang, Tak Yin Owen, Bae, Ho, Chen, Chien-Hung, Coffin, Carla S, Ahn, Sang Hoon, Trinh, Huy, Flaherty, John F, Abramov, Frida, Zhao, Yang, Liu, Yang, Lau, Audrey, German, Polina, Chuang, Wan-Long, Agarwal, Kosh, and Gane, Edward

Published
2024
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5. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B

Author

Lim, Young-Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting-Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia-Horng, Gane, Edward, Hou, Jinlin, and Buti, Maria

Published
2023
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6. Eight‐year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials.

Author

Buti, Maria, Lim, Young‐Suk, Chan, Henry Lik Yuen, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia R., Chuang, Wan‐Long, Janssen, Harry L. A., Fung, Scott K., Izumi, Namiki, Jablkowski, Maciej S., Abdurakhmanov, Dzhamal, Abramov, Frida, Wang, Hongyuan, Botros, Irina, Yee, Leland J., Mateo, Roberto, Flaherty, John F., Osinusi, Anu, and Pan, Calvin Q.

Subjects
HEPATITIS B, CHRONIC hepatitis B, HEPATITIS associated antigen, CLINICAL trials, REVERSE transcriptase
Abstract

Summary: Background: In two phase 3 studies, tenofovir alafenamide (TAF) showed non‐inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB). Aims: Here, we report the studies' final 8‐year results. Methods: CHB patients (hepatitis B e antigen [HBeAg]‐negative and HBeAg‐positive) were randomised (2:1) to double‐blind TAF 25 mg/day or TDF 300 mg/day for up to 3 years, followed by open‐label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase/reverse transcriptase and by phenotyping. Results: Among 1298 patients randomised to double‐blind TAF (n = 866) or double‐blind TDF (n = 432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y → TAF6y) or year 3 (TDF3y → TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y → TAF6y and TDF3y → TAF5y groups, 69%, 66% and 73% (missing‐equals‐failure analysis) and 95%, 94% and 97% (missing‐equals‐excluded) of patients, respectively, achieved HBV DNA <29 IU/mL. Estimated glomerular filtration rate (Cockcroft‐Gault method; eGFRCG) and hip/spine bone mineral density (BMD) remained stable in patients receiving double‐blind/OL TAF, with only small declines at year 8. Decreases in eGFRCG and hip/spine BMD observed during double‐blind TDF improved after switching to OL TAF. No patients developed resistance to TAF. Conclusion: Long‐term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance. ClinicalTrials.gov numbers NCT01940341 and NCT01940471. [ABSTRACT FROM AUTHOR]

Published
2024
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7. TOP-400 Impact of bulevirtide given with or without nucleos (t)ide analogues on 48-week virologic outcomes in patients with chronic hepatitis delta virus infection

Author

Lampertico, Pietro, primary, Brunetto, Maurizia, additional, Buti, Maria, additional, Aleman, Soo, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Flaherty, John F., additional, Li, Mingyang, additional, Manuilov, Dmitry, additional, Da, Ben L., additional, Mercier, Renee-Claude, additional, Chee, Grace M., additional, Cornberg, Markus, additional, Wedemeyer, Heiner, additional, and Asselah, Tarik, additional

Published
2024
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8. FRI-390 Off-treatment outcomes after discontinuing tenofovir-based treatment in hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with chronic hepatitis B virus

Author

Buti, Maria, primary, Chan, Henry L.Y., additional, Fung, Scott K., additional, Peng, Cheng-Yuan, additional, Abramov, Frida, additional, Tedesco, Dana, additional, Wang, Hongyuan, additional, Yee, Leland J., additional, Flaherty, John F., additional, Gane, Edward J., additional, Lim, Young-Suk, additional, Janssen, Harry L.A., additional, and Agarwal, Kosh, additional

Published
2024
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9. Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase 3 randomized trial

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Berger, Annemarie, additional, Ciesek, Sandra, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, Da, Ben L., additional, Chee, Grace M., additional, Li, Mingyang, additional, Flaherty, John F., additional, Lau, Audrey H., additional, Osinusi, Anu, additional, Schulze zur Wiesch, Julian, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2024
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10. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety

Author

Chan, Henry L.Y., Buti, Maria, Lim, Young Suk, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia, Chuang, Wan Long, Janssen, Harry L.A., Fung, Scott, Izumi, Namiki, Abdurakhmanov, Dzhamal, Jabłkowski, Maciej, Celen, Mustafa K., Ma, Xiaoli, Caruntu, Florin, Flaherty, John F., Abramov, Frida, Wang, Hongyuan, Camus, Gregory, Osinusi, Anu, Pan, Calvin Q., Shalimar, Seto, Wai Kay, Gane, Edward, Chan, Henry L.Y., Buti, Maria, Lim, Young Suk, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia, Chuang, Wan Long, Janssen, Harry L.A., Fung, Scott, Izumi, Namiki, Abdurakhmanov, Dzhamal, Jabłkowski, Maciej, Celen, Mustafa K., Ma, Xiaoli, Caruntu, Florin, Flaherty, John F., Abramov, Frida, Wang, Hongyuan, Camus, Gregory, Osinusi, Anu, Pan, Calvin Q., Shalimar, Seto, Wai Kay, and Gane, Edward

Abstract

INTRODUCTION: The results from 2 phase 3 studies, through 2 years, in chronic hepatitis B infection showed tenofovir alafenamide (TAF) had similar efficacy to tenofovir disoproxil fumarate (TDF) with superior renal and bone safety. We report updated results through 5 years. METHODS: Patients with HBeAg-negative or HBeAg-positive chronic hepatitis B infection with or without compensated cirrhosis were randomized (2:1) to TAF 25 mg or TDF 300 mg once daily in double-blind (DB) fashion for up to 3 years, followed by open-label (OL) TAF up to 8 years. Efficacy (antiviral, biochemical, and serologic), resistance (deep sequencing of polymerase/reverse transcriptase and phenotyping), and safety, including renal and bone parameters, were evaluated by pooled analyses. RESULTS: Of 1,298 randomized and treated patients, 866 receiving TAF (DB and OL) and 432 receiving TDF with rollover to OL TAF at year 2 (n = 180; TDF→TAF3y) or year 3 (n = 202; TDF→TAF2y) were included. Fifty (4%) TDF patients who discontinued during DB were excluded. At year 5, 85%, 83%, and 90% achieved HBV DNA <29 IU/mL (missing 5 failure) in the TAF, TDF→TAF3y, and TDF→TAF2y groups, respectively; no patient developed TAF or TDF resistance. Median estimated glomerular filtration rate (by using Cockcroft-Gault) declined <2.5 mL/min, and mean declines of <1% in hip and spine bone mineral density were seen at year 5 in the TAF group; patients in the TDF→TAF groups had improvements in these parameters at year 5 after switching to OL TAF. DISCUSSION: Long-term TAF treatment resulted in high rates of viral suppression, no resistance, and favorable renal and bone safety.

Published
2024

11. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study

Author

Lampertico, Pietro, Buti, Maria, Fung, Scott, Ahn, Sang Hoon, Chuang, Wan-Long, Tak, Won Young, Ramji, Alnoor, Chen, Chi-Yi, Tam, Edward, Bae, Ho, Ma, Xiaoli, Flaherty, John F, Gaggar, Anuj, Lau, Audrey, Liu, Yang, Wu, George, Suri, Vithika, Tan, Susanna K, Subramanian, G Mani, Trinh, Huy, Yoon, Seung-Kew, Agarwal, Kosh, Lim, Young-Suk, and Chan, Henry L Y

Published
2020
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13. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks

Author

Fung, Scott K., primary, Pan, Calvin Q., additional, Wong, Grace Lai‐Hung, additional, Seto, Wai‐Kay, additional, Ahn, Sang Hoon, additional, Chen, Chi‐Yi, additional, Hann, Hie‐Won L., additional, Jablkowski, Maciej S., additional, Kim, Yoon Jun, additional, Yurdaydin, Cihan, additional, Peng, Cheng‐Yuan, additional, Nguyen, Tuan, additional, Yatsuhashi, Hiroshi, additional, Flaherty, John F., additional, Yee, Leland J., additional, Abramov, Frida, additional, Wang, Hongyuan, additional, Abdurakhmanov, Dzhamal, additional, Lim, Young‐Suk, additional, and Buti, Maria, additional

Published
2023
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14. S1617 Elevations in Total Serum Bile Acids During Bulevirtide Treatment Show No Association With Adverse Events of Interest in Patients With Chronic Hepatitis Delta: An Integrated Safety Analysis of 48-Week Data

Author

Lampertico, Pietro, primary, Aleman, Soo, additional, Asselah, Tarik, additional, Streinu-Cercel, Adrian, additional, Bogomolov, Pavel, additional, Morozov, Vlacheslav, additional, Stepanova, Tatyana, additional, Lazar, Stefan, additional, Bacic, Ana, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, Flaherty, John F., additional, Suri, Vithika, additional, Ye, Lei, additional, Tseng, Steve, additional, Christian-Cox, Florence, additional, Brunetto, Maurizia, additional, and Wedemeyer, Heiner, additional

Published
2023
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15. Freedom and Innovation in California's Charter Schools.

Author

Far West Lab. for Educational Research and Development, San Francisco, CA., Southwest Regional Lab., Los Alamitos, CA., Corwin, Ronald G., and Flaherty, John F.

Abstract

The charter-schools movement provides the opportunity to observe whether granting schools freedom from most state regulations actually produces more freedom for school administrators and teachers, and whether this autonomy produces other distinctive outcomes. This report summarizes findings of Southwest Regional Laboratory's (SWRL's) statewide survey of California charter schools. During 1994-95, 54 administrators and 230 teachers returned questionnaires that had been mailed to the 66 charter schools operating in California at the time. Survey responses were also received from 46 principals of noncharter (comparison) schools in California and 63 charter schools across the United States. Data are presented on school characteristics, institutional autonomy, educational innovation, teacher characteristics and effectiveness, and access to education. High-autonomy schools more often reported greater freedom and less cooperative relationships with unions; fewer purchasing restrictions and more money for instruction; more parent participation; and more at-risk students. Compared to their counterparts in regular schools, charter-school teachers reported that they had more influence but heavier workloads. Teachers in new charters were the least secure about their jobs but were among the most satisfied with their jobs. The most common innovations were related to instructional strategies, site-based governance, and parental participation. The data indicate that, as a group, charter schools do not select the most able, privileged students, nor do they exclude those who have been traditionally underserved. However, some evidence suggests that, in comparison to other schools, charter schools tend to skim students who come from low-income families, have below-average test scores; and qualify for special education, and/or they tend to select students from privileged families. Certain types of charter schools are less accessible than others to underserved, at-risk children. A total of 43 figures and 15 tables are included. (Contains 45 references.) (LMI)

Published
1995

16. Report on Workstation Uses: Effects of Success for All on the Reading Achievement of First Graders in California Bilingual Programs.

Author

Southwest Regional Lab., Los Alamitos, CA., Dianda, Marcella R., and Flaherty, John F.

Abstract

A study assessed the effectiveness of the Success for All Program for grade-one English-as-a-Second-Language (ESL) learners in bilingual or ESL programs in three California elementary schools. The reading instruction program provides both native (in this case, Spanish) language support as well as English language instruction and materials. The three schools in question were matched with comparison schools in their districts, that were similar in level of student disadvantage and other factors. The 2-year evaluation measured student (n=313) progress from kindergarten entry (receptive vocabulary) to the end of first grade (phonetic synthesis skills, recognition of common sight words, and text comprehension). Analysis of the results indicates that the 2 years of instruction in the Success for All program were effective for both students taught in Spanish-English bilingual programs and in ESL programs. While the instruction raised the average student performance, it also raised the performance of the lowest-performing students, with some of the largest treatment effects occurring in this group. A suggested area for further research is the monitoring of achievement over time. (MSE)

Published
1995

17. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy

Author

Jacobson, Ira M., Washington, Mary K., Buti, Maria, Thompson, Alexander, Afdhal, Nezam, Flisiak, Robert, Akarca, Ulus Salih, Tchernev, Konstantin G., Flaherty, John F., Aguilar Schall, Raul, Myers, Robert P., Subramanian, G. Mani, McHutchison, John G., Younossi, Zobair, Marcellin, Patrick, and Patel, Keyur

Published
2017
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18. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks.

Author

Fung, Scott K., Pan, Calvin Q., Wong, Grace Lai‐Hung, Seto, Wai‐Kay, Ahn, Sang Hoon, Chen, Chi‐Yi, Hann, Hie‐Won L., Jablkowski, Maciej S., Kim, Yoon Jun, Yurdaydin, Cihan, Peng, Cheng‐Yuan, Nguyen, Tuan, Yatsuhashi, Hiroshi, Flaherty, John F., Yee, Leland J., Abramov, Frida, Wang, Hongyuan, Abdurakhmanov, Dzhamal, Lim, Young‐Suk, and Buti, Maria

Subjects
CHRONIC hepatitis B, CARDIOVASCULAR diseases risk factors, CARDIOVASCULAR diseases, TENOFOVIR, SYSTOLIC blood pressure
Abstract

Summary: Background: Patients with chronic hepatitis B (CHB) who switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) show changes in lipid profiles. Aim: To evaluate how these changes affect cardiovascular risk. Methods: This pooled analysis, based on two large prospective studies, evaluated fasting lipid profiles of patients with CHB who were treated with TAF 25 mg/day or TDF 300 mg/day for 96 weeks. Patients who fulfilled the American College of Cardiology criteria (age 40–79 years, high‐density lipoprotein [HDL] 20–100 mg/dL, total cholesterol [TC] 130–320 mg/dL and systolic blood pressure 90–200 mmHg) required to assess 10‐year atherosclerotic cardiovascular disease (ASCVD) risk with baseline lipid data and at least one post‐baseline measurement were included in the ASCVD‐risk population. The 10‐year ASCVD risk was calculated for patients in this population, and changes from baseline to Week 96 were assessed using intermediate‐ (≥7.5%) and high‐risk (≥20%) cut‐offs. Results: Among 1632 patients, 620 (38%) met the criteria for the ASCVD‐risk population. At Week 96, fasting levels of all lipids, except TC:HDL ratio, were lower with TDF than TAF. No significant increase was observed in overall ASCVD risk or in any ASCVD‐risk categories during the 96‐week treatment period compared with baseline. A similar proportion of patients in the TAF and TDF treatment groups (1.3% and 2.3%, respectively; p = 0.34) reported cardiovascular events. Conclusion: Despite on‐treatment differences in lipid profiles with TAF and TDF, predicted cardiovascular risk and clinical events were similar for both groups after 96 weeks. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Relationship of hepatitis D viral load, ALT levels, and liver stiffness in untreated patients with chronic hepatitis D

Author

Aleman, Soo, primary, Lampertico, Pietro, additional, Brunetto, Maurizia, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, An, Qi, additional, Da, Ben, additional, Flaherty, John F., additional, Mercier, Renee-Claude, additional, Lau, Audrey, additional, Zeuzem, Stefan, additional, Cornberg, Markus, additional, and Wedemeyer, Heiner, additional

Published
2023
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20. Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis D: results from an interim analysis of a phase 3 randomized study

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Viacheslav, Morozov, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, An, Qi, additional, Flaherty, John F., additional, Osinusi, Anu, additional, Lau, Audrey, additional, zur Wiesch, Julian Schulze, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2023
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21. Continued treatment of early non-responder or partial virologic responders with bulevirtide monotherapy in patients with chronic hepatitis D through week 96 leads to improvement in virologic and biochemical responses

Author

Lampertico, Pietro, primary, Wedemeyer, Heiner, additional, Brunetto, Maurizia, additional, Bogomolov, Pavel, additional, Stepanova, Tatyana, additional, Ciesek, Sandra, additional, Berger, Annemarie, additional, Manuilov, Dmitry, additional, An, Qi, additional, Lau, Audrey, additional, Da, Ben, additional, Flaherty, John F., additional, Mercier, Renee-Claude, additional, Zeuzem, Stefan, additional, Cornberg, Markus, additional, Buti, Maria, additional, and Aleman, Soo, additional

Published
2023
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22. HDV full genome sequencing and sensitive HBV genotyping from a large cohort of HBV/HDV co-infected patients

Author

Manhas, Savrina, primary, Xu, Simin, additional, Chang, Silvia, additional, Aeschbacher, Thomas, additional, Mateo, Roberto, additional, Martin, Ross, additional, Liu, Yang, additional, Narguet, Stephanie, additional, Abdurakhmanov, Dzhamal, additional, Lampertico, Pietro, additional, Manuilov, Dmitry, additional, Flaherty, John F., additional, Mo, Hongmei, additional, Svarovskaia, Evguenia S, additional, and Asselah, Tarik, additional

Published
2023
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24. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks

Author

Yurdaydın, Cihan (ORCID 0000-0002-5419-7158 & YÖK ID 189330), Fung, Scott K.; Pan, Calvin Q.; Wong, Grace Lai-Hung; Seto, Wai-Kay; Ahn, Sang Hoon; Chen, Chi-Yi; Hann, Hie-Won L.; Jablkowski, Maciej S.; Kim, Yoon Jun; Peng, Cheng-Yuan; Nguyen, Tuan; Yatsuhashi, Hiroshi; Flaherty, John F.; Yee, Leland J.; Abramov, Frida; Wang, Hongyuan; Abdurakhmanov, Dzhamal; Lim, Young-Suk; Buti, Maria, School of Medicine, Yurdaydın, Cihan (ORCID 0000-0002-5419-7158 & YÖK ID 189330), Fung, Scott K.; Pan, Calvin Q.; Wong, Grace Lai-Hung; Seto, Wai-Kay; Ahn, Sang Hoon; Chen, Chi-Yi; Hann, Hie-Won L.; Jablkowski, Maciej S.; Kim, Yoon Jun; Peng, Cheng-Yuan; Nguyen, Tuan; Yatsuhashi, Hiroshi; Flaherty, John F.; Yee, Leland J.; Abramov, Frida; Wang, Hongyuan; Abdurakhmanov, Dzhamal; Lim, Young-Suk; Buti, Maria, and School of Medicine

Abstract

Background: patients with chronic hepatitis B (CHB) who switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) show changes in lipid profiles. Aim: to evaluate how these changes affect cardiovascular risk. Methods :this pooled analysis, based on two large prospective studies, evaluated fasting lipid profiles of patients with CHB who were treated with TAF 25 mg/day or TDF 300 mg/day for 96 weeks. Patients who fulfilled the American College of Cardiology criteria (age 40-79 years, high-density lipoprotein [HDL] 20-100 mg/dL, total cholesterol [TC] 130-320 mg/dL and systolic blood pressure 90-200 mmHg) required to assess 10-year atherosclerotic cardiovascular disease (ASCVD) risk with baseline lipid data and at least one post-baseline measurement were included in the ASCVD-risk population. The 10-year ASCVD risk was calculated for patients in this population, and changes from baseline to Week 96 were assessed using intermediate- (>= 7.5%) and high-risk (>= 20%) cut-offs. Results: among 1632 patients, 620 (38%) met the criteria for the ASCVD-risk population. At Week 96, fasting levels of all lipids, except TC:HDL ratio, were lower with TDF than TAF. No significant increase was observed in overall ASCVD risk or in any ASCVD-risk categories during the 96-week treatment period compared with baseline. A similar proportion of patients in the TAF and TDF treatment groups (1.3% and 2.3%, respectively; p = 0.34) reported cardiovascular events. Conclusion: despite on-treatment differences in lipid profiles with TAF and TDF, predicted cardiovascular risk and clinical events were similar for both groups after 96 weeks., This work has been funded by Gilead Sciences Ltd.

Published
2023

25. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B

Author

Lim, Young Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia Horng, Gane, Edward, Hou, Jinlin, Buti, Maria, Lim, Young Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia Horng, Gane, Edward, Hou, Jinlin, and Buti, Maria

Abstract

Background & Aims: Antiviral therapy may attenuate the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). We aimed to explore how tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) affect HCC risk in patients with CHB. Methods: The REACH-B, aMAP, and mPAGE-B models were utilized to assess HCC risk in patients with CHB from two global randomized-controlled trials evaluating the impact of TAF vs. TDF treatment. Standard incidence ratios (SIRs) were calculated using data from the REACH-B model as a ratio of observed HCC cases in the TAF- or TDF-treated patients vs. predicted HCC cases for untreated historical controls. Proportions of treated patients shifting aMAP and mPAGE-B risk categories between baseline and Week 240 were calculated. Results: Of the 1,632 patients (TAF, n = 1,093; TDF, n = 539) followed for up to 300 weeks, 22 HCC cases developed. Those receiving TAF had an SIR that was lower compared to the SIR of individuals receiving TDF: 0.32 (p <0.001) vs. 0.56 (p = 0.06). In the general study population, individuals without cirrhosis at baseline had an SIR that was lower compared to the SIR of individuals with cirrhosis at baseline: 0.37 (p <0.001) vs. 0.58 (p = 0.15). Of the patients at low risk of HCC at baseline, the majority (97%) remained low risk by mPAGE-B and aMAP scoring at Week 240. Among those at medium or high risk at baseline, substantial portions shifted to a lower risk category by Week 240 (mPAGE-B: 22% and 42%; aMAP: 39% and 63%, respectively). Conclusions: This evaluation provides evidence that treatment with TAF or TDF can reduce HCC risk in patients with CHB, particularly in patients without cirrhosis. Impact and implications: Despite the substantial impact of HCC on long-term outcomes of patients with CHB, the differential risk of HCC development among those receiving treatment with

Published
2023

26. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial

Author

Buti, Maria, Gane, Edward, Seto, Wai Kay, Chan, Henry L Y, Chuang, Wan-Long, Stepanova, Tatjana, Hui, Aric-Josun, Lim, Young-Suk, Mehta, Rajiv, Janssen, Harry L A, Acharya, Subrat K, Flaherty, John F, Massetto, Benedetta, Cathcart, Andrea L, Kim, Kyungpil, Gaggar, Anuj, Subramanian, G Mani, McHutchison, John G, Pan, Calvin Q, Brunetto, Maurizia, Izumi, Namiki, and Marcellin, Patrick

Published
2016
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27. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial

Author

Chan, Henry L Y, Fung, Scott, Seto, Wai Kay, Chuang, Wan-Long, Chen, Chi-Yi, Kim, Hyung Joon, Hui, Aric Josun, Janssen, Harry L A, Chowdhury, Abhijit, Tsang, Tak Yin Owen, Mehta, Rajiv, Gane, Edward, Flaherty, John F, Massetto, Benedetta, Gaggar, Anuj, Kitrinos, Kathryn M, Lin, Lanjia, Subramanian, G Mani, McHutchison, John G, Lim, Young-Suk, Acharya, Subrat K, and Agarwal, Kosh

Published
2016
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28. P1- HIGH VIRAL SUPPRESSION AND IMPROVED SAFETY PROFILE OF TENOFOVIR ALAFENAMIDE RELATIVE TO TENOFOVIR DISOPROXIL FUMARATE IN CHRONIC HEPATITIS B PATIENTS TREATED FOR 5 YEARS

Author

Seto, Wai Kay, primary, Chang, Ting-Tsung, additional, Chowdhry, Abhijit, additional, Chen, Chi-Yi, additional, Celen, Mustafa Kemal, additional, Ma, Xiaoli, additional, Ma, Mang, additional, Duseja, Ajay, additional, Yoon, Ki Tae, additional, Chow, Wan Cheng, additional, Yee, Leland, additional, Weber, Gregor, additional, Youn, Ms Jin, additional, Flaherty, John F., additional, Gaggar, Anuj, additional, Gao, Bing, additional, Camus, Gregory, additional, Bassetti, Eric, additional, Hwang, Jae Seok, additional, Inokuma, Tetshuro, additional, Lin, Young- Suk, additional, and Gane, Edward J., additional

Published
2023
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32. S1179 Bulevirtide Monotherapy at Low and High Dose in Patients With Chronic Hepatitis Delta: 24-Week Interim Data of the Phase 3 MYR301 Study

Author

Lee, Stacey, primary, Wedemeyer, Heiner, additional, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Suri, Vithika, additional, An, Qi, additional, Flaherty, John F., additional, Osinusi, Anu, additional, Schulze zur Wiesch, Julian, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2022
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34. Integrated efficacy analysis of 24-week data from two phase 2 and one phase 3 clinical trials of bulevirtide monotherapy given at 2 mg or 10 mg dose level for treatment of chronic hepatitis delta

Author

Lampertico, Pietro, primary, Aleman, Soo, additional, Blank, Antje, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Viacheslav, Morozov, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Ye, Lei, additional, Flaherty, John F., additional, Osinusi, Anu, additional, Cornberg, Markus, additional, Brunetto, Maurizia, additional, and Wedemeyer, Heiner, additional

Published
2022
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35. Treatment with bulevirtide improves patient-reported outcomes in patients with chronic hepatitis delta: An exploratory analysis of a Phase 3 trial at 48 weeks

Author

Buti, Maria, primary, Wedemeyer, Heiner, additional, Aleman, Soo, additional, Chulanov, Vladimir, additional, Viacheslav, Morozov, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Gish, Robert G., additional, Lloyd, Andrew, additional, Kaushik, Ankita, additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Osinusi, Anu, additional, Flaherty, John F., additional, and Lampertico, Pietro, additional

Published
2022
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37. Efficacy and safety of bulevirtide monotherapy given at 2 mg or 10 mg dose level once daily for treatment of chronic hepatitis delta: week 48 primary end point results from a phase 3 randomized, multicenter, parallel design study

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Viacheslav, Morozov, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Suri, Vithika, additional, An, Qi, additional, Flaherty, John F., additional, Osinusi, Anu, additional, zur Wiesch, Julian Schulze, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2022
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38. Bulevirtide is broadly active against all HDV genotypes expressing envelopes from HBV genotypes A-H and a large panel of clinical isolates

Author

Manhas, Savrina, primary, Han, Bin, additional, Xu, Simin, additional, May, Lindsey, additional, Han, Dong, additional, Yazdi, Tahmineh, additional, Chang, Silvia, additional, Aeschbacher, Thomas, additional, Aryal, Rishi, additional, Martin, Ross, additional, Liu, Yang, additional, Mateo, Roberto, additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Flaherty, John F., additional, Hollnberger, Julius, additional, Urban, Stephan, additional, Cihlar, Tomas, additional, Svarovskaia, Evguenia S, additional, and Mo, Hongmei, additional

Published
2022
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39. Integrated safety analysis of 24-week data from three phase 2 and one phase 3 clinical trials of bulevirtide monotherapy given at 2 mg and 10 mg dose level for treatment of chronic hepatitis delta

Author

Lampertico, Pietro, primary, Aleman, Soo, additional, Asselah, Tarik, additional, Bourliere, Marc, additional, Streinu-Cercel, Adrian, additional, Bogomolov, Pavel, additional, Viacheslav, Morozov, additional, Stepanova, Tatyana, additional, Lazar, Stefan, additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Ye, Lei, additional, Flaherty, John F., additional, Osinusi, Anu, additional, Brunetto, Maurizia, additional, and Wedemeyer, Heiner, additional

Published
2022
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40. No detectable resistance to bulevirtide in participants with chronic hepatitis D (CHD) through 24 weeks of treatment

Author

Hollnberger, Julius, primary, Liu, Yang, additional, Martin, Ross, additional, Manhas, Savrina, additional, Aeschbacher, Thomas, additional, Chang, Silvia, additional, Xu, Simin, additional, Han, Bin, additional, Yazdi, Tahmineh, additional, May, Lindsey, additional, Han, Dong, additional, Schöneweis, Katrin, additional, Flaherty, John F., additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Mateo, Roberto, additional, Svarovskaia, Evguenia S, additional, Mo, Hongmei, additional, and Urban, Stephan, additional

Published
2022
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41. Randomized, double-blind, placebo-controlled trial of Tenofovir Alafenamide in children and adolescents with chronic hepatitis B

Author

Schwarz, Kathleen, primary, Bezerra, Jorge, additional, Choe, Byung-Ho, additional, Lin, Chuan-Hao, additional, Abramov, Frida, additional, Nguyen, Anh-Hoa, additional, Liu, Yang, additional, Leisegang, Rory, additional, Flaherty, John F., additional, Pacurar, Daniela, additional, Kim, Kyung Mo, additional, Khaertynova, Shalimar, Ilsiyar, additional, Wu, Jia-Feng, additional, Tandon, Manish, additional, Rosenthal, Philip, additional, Viacheslav, Morozov, additional, Sokal, Etienne, additional, and Chang, Mei-Hwei, additional

Published
2022
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45. WED-397 Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients

Author

Kim, W. Ray, Lim, Young-Suk, Janssen, Harry L.A., Ahn, Sang Hoon, Jacobson, Ira, Mizokami, Masashi, Wong, Grace, Abramov, Frida, Yee, Leland J., Wang, Hongyuan, Frenette, Catherine, Flaherty, John F., Fung, Scott K., Marcellin, Patrick, Seto, Wai-Kay, Agarwal, Kosh, Hou, Jinlin, Lim, Seng Gee, Kao, Jia-Horng, and Buti, Maria

Published
2024
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46. Sa1629 LONG-TERM EFFICACY OF TENOFOVIR ALAFENAMIDE IN HBEAG-POSITIVE AND -NEGATIVE CHRONIC HEPATITIS B PATIENTS TREATED FOR UP TO 8 YEAR IN 2 PHASE 3 STUDIES

Author

Buti, Maria, Agarwal, Kosh, Chan, Henry L., Seto, Wai-Kay, Lim, Young-Suk, Brunetto, Maurizia R., Chuang, Wan-Long, Janssen, Harry L., Fung, Scott, Izumi, Namiki, Jablkowski, Maciej, Abramov, Frida, Wang, Hongyuan, Yee, Leland J., Mateo, Roberto, Flaherty, John F., Pan, Calvin Q., Shalimar, Marcellin, Patrick, and Gane, Edward

Published
2024
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48. Sa1618 EFFICACY AND SAFETY AT 96 WEEKS OF BULEVIRTIDE 2 MG OR 10 MG MONOTHERAPY FOR CHRONIC HEPATITIS DELTA: RESULTS FROM AN INTERIM ANALYSIS OF A PHASE 3 RANDOMIZED STUDY

Author

Wedemeyer, Heiner, Aleman, Soo, Brunetto, Maurizia R., Blank, Antje, Andreone, Pietro, Bogomolov, Pavel, Chulanov, Vladimir, Mamonova, Nina, Geyvandova, Natalia, Morozov, Viacheslav, Sagalova, Olga, Stepanova, Tatyana V., Manuilov, Dmitry, Mercier, Renee-Claude, An, Qi, Flaherty, John F., Osinusi, Anu, Lau, Audrey H., Wiesch, Julian Schulze zur, Cornberg, Markus, Zeuzem, Stefan, and Lampertico, Pietro

Published
2024
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49. Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Author

Lim, Young‐Suk, primary, Seto, Wai‐Kay, additional, Kurosaki, Masayuki, additional, Fung, Scott, additional, Kao, Jia‐Horng, additional, Hou, Jinlin, additional, Gordon, Stuart C., additional, Flaherty, John F., additional, Yee, Leland J., additional, Zhao, Yang, additional, Agarwal, Kosh, additional, and Lampertico, Pietro, additional

Published
2022
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