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3. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses

Author

Yuen, Man-Fung, Fung, Scott, Ma, Xiaoli, Nguyen, Tuan T., Hassanein, Tarek, Hann, Hie-Won, Elkhashab, Magdy, Nahass, Ronald G., Park, James S., Jacobson, Ira M., Ayoub, Walid S., Han, Steven-Huy, Gane, Edward J., Zomorodi, Katie, Yan, Ran, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Weilert, Frank, Ramji, Alnoor, Bennett, Michael, Ravendhran, Natarajan, Chan, Sing, Dieterich, Douglas T., Kwo, Paul Yien, Schiff, Eugene R., Bae, Ho S., Lalezari, Jacob, Agarwal, Kosh, and Sulkowski, Mark S.

Published
2024
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4. Safety, pharmacodynamics, and antiviral activity of selgantolimod in viremic patients with chronic hepatitis B virus infection

Author

Janssen, Harry L., Lim, Young-Suk, Kim, Hyung Joon, Sowah, Leonard, Tseng, Cheng-Hao, Coffin, Carla S., Elkhashab, Magdy, Ahn, Sang Hoon, Nguyen, Anh-Hoa, Chen, Diana, Wallin, Jeffrey J., Fletcher, Simon P., McDonald, Circe, Yang, Jenny C., Gaggar, Anuj, Brainard, Diana M., Fung, Scott, Kim, Yoon Jun, Kao, Jia-Horng, Chuang, Wan-Long, Brooks, Anna E., and Dunbar, P. Rod

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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7. Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial

Author

Bourgeois, Stefan, Vanwolleghem, Thomas, Nevens, Frederik, Horsmans, Yves, Van Vlierberghe, Hans, Nastri, Ana Catharina, Lacerda, Marcus, Ramji, Alnoor, Conway, Brian, Coffin, Carla, Janssen, Harry, Fung, Scott, Shafran, Stephen, Hou, Jin Lin, Sperl, Jan, Urbanek, Petr, Plisek, Stanislav, Hejda, Vaclav, Samuel, Didier, Lacombe, Karine, Zoulim, Fabien, Guyader, Dominique, Raffi, Francois, Asselah, Tarik, Bourliere, Marc, Hilleret, Marie-Noelle, Wedemeyer, Heiner, Schulze zur Wiesch, Julian, Sprinzl, Kathrin, van Boemmel, Florian, Hilgard, Gudrun, Sabranski, Michael, Arasteh, Keikawus, Chan, Henry LY, Yuen, Man Fung, Wong, Vincent Ws, Brunetto, Maurizia Rossana, Taliani, Gloria, Andreone, Pietro, Lampertico, Pietro, Kurosaki, Masayuki, Yatsuhashi, Hiroshi, Fujiwara, Kei, Takehara, Tetsuo, Kawaoka, Tomokazu, Asahina, Yasuhiro, Enomoto, Hirayuki, Yabushita, Kazuhisa, Notsumata, Kazuo, Takaguchi, Koichi, Kawabe, Naoto, Kato, Naoya, Koji, Ogawa, Namisaki, Tadashi, Suzuki, Yoshiyuki, Yoon, Jung-Hwan, Ahn, SangHoon, Lim, Young-Suk, Paik, Seung Woon, Kiew, Kuang Kiat, Mohamed, Rosmawati, Tan, Soek Siam, Lee, Yeong Yeh, Hlebowicz, Maria, Berak, Hanna, Gasiorowski, Jacek, Halota, Waldemar, Janczewska, Ewa, Geyvandova, Natalia, Morozov, Viacheslav, Andreeva, Alla, Gusev, Denis, Bessonova, Elena, Osipenko, Marina, Romanova, Svetlana, Gankina, Natalia, Sagalova, Olga, Stepanova, Tatiana, Crespo Garcia, Javier, Diago, Moises, Inmaculada, Fernandez, Calleja, Jose Luis, Forns, Xavier, Buti, Maria, Tangkijvanich, Pisit, Tanwandee, Tawesak, Piratvisuth, Teerha, Leerapun, Apinya, Yilmaz, Gurdal, Tabak, Ömer Fehmi, Akarca, Ulus Salih, Akova, Murat, Idilman, Ramazan, Forton, Daniel, Bell, David, Agarwal, Kosh, Kennedy, Patrick, Felizarta, Franco, Sulkowski, Mark, Nahass, Ronald, Rojter, Sergio, Jacobson, Ira, Korenblat, Kevin, Gitlin, Norman, Yuen, Man-Fung, Jacobson, Ira M, Janssen, Harry L A, Kakuda, Thomas N, Lambrecht, Tom, Beumont, Maria, Kalmeijer, Ronald, Guinard-Azadian, Carine, Mayer, Cristiana, Jezorwski, John, Verbinnen, Thierry, Lenz, Oliver, Shukla, Umesh, and Biermer, Michael

Published
2023
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8. Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection

Author

Sulkowski, Mark S., Agarwal, Kosh, Ma, Xiaoli, Nguyen, Tuan T., Schiff, Eugene R., Hann, Hie-Won L., Dieterich, Douglas T., Nahass, Ronald G., Park, James S., Chan, Sing, Han, Steven-Huy B., Gane, Edward J., Bennett, Michael, Alves, Katia, Evanchik, Marc, Yan, Ran, Huang, Qi, Lopatin, Uri, Colonno, Richard, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Jacobson, Ira M., Ayoub, Walid S., Weilert, Frank, Ravendhran, Natarajan, Ramji, Alnoor, Kwo, Paul Yien, Elkhashab, Magdy, Hassanein, Tarek, Bae, Ho S., Lalezari, Jacob P., Fung, Scott K., and Yuen, Man-Fung

Published
2022
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9. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection

Author

Yuen, Man-Fung, Agarwal, Kosh, Ma, Xiaoli, Nguyen, Tuan T., Schiff, Eugene R., Hann, Hie-Won L., Dieterich, Douglas T., Nahass, Ronald G., Park, James S., Chan, Sing, Han, Steven-Huy B., Gane, Edward J., Bennett, Michael, Alves, Katia, Evanchik, Marc, Yan, Ran, Huang, Qi, Lopatin, Uri, Colonno, Richard, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Jacobson, Ira M., Ayoub, Walid S., Weilert, Frank, Ravendhran, Natarajan, Ramji, Alnoor, Kwo, Paul Yien, Elkhashab, Magdy, Hassanein, Tarek, Bae, Ho S., Lalezari, Jacob P., Fung, Scott K., and Sulkowski, Mark S.

Published
2022
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11. 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.

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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13. 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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14. OS-033 A phase 2 open-label study to evaluate safety, tolerability, efficacy, and pharmacodynamics of JNJ-73763989, nucleos (t)ide analogs, and a low-dose PD-1 inhibitor in patients with chronic hepatitis B-Interim results of the OCTOPUS-1 study

Author

Asselah, Tarik, primary, Fung, Scott K., additional, Akhan, Sila, additional, Chuang, Wan-Long, additional, Buti, Maria, additional, Brunetto, Maurizia, additional, Agarwal, Kosh, additional, Diba, Camellia, additional, Jerzorwski, John, additional, Kakuda, Thomas, additional, Nalpas, Catherine, additional, Guinard-Azadian, Carine, additional, Verbinnen, Thierry, additional, Lathouwers, Erkki, additional, De Creus, An, additional, Lenz, Oliver, additional, and Biermer, Michael, additional

Published
2024
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15. FRI-363-YI Association between metabolic dysfunction, severity of liver fibrosis and fibrosis progression in patients with chronic hepatitis B-an individual patient data meta-analysis

Author

van Velsen, Lisa M., primary, Patmore, Lesley A., additional, Feld, Jordan J., additional, Chan, Henry L.Y., additional, Piratvisuth, Teerha, additional, Chien, Rong-Nan, additional, Dongelmans, Edo J., additional, Pavlovic, Vedran, additional, Yee, Leland J., additional, Brouwer, Willem Pieter, additional, Lau, Audrey H., additional, Hansen, Bettina E., additional, Buti, Maria, additional, Xie, Qing, additional, Patel, Keyur, additional, Fung, Scott K., additional, Janssen, Harry L.A., additional, and Sonneveld, Milan J., additional

Published
2024
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16. WED-379 Intrahepatic changes in immunologic and virologic markers during siRNA JNJ-73763989 (JNJ-3989) based treatment of chronic hepatitis B (CHB) patients: imaging mass cytometry (IMC) analyses from the INSIGHT study

Author

Thys, Kim, primary, Crabbe, Marjolein, additional, Wils, Hans, additional, Goehlmann, Hinrich, additional, Verheijden, Simon, additional, Lampertico, Pietro, additional, Asselah, Tarik, additional, Gane, Edward J., additional, Fung, Scott K., additional, Kennedy, Patrick, additional, Vanwolleghem, Thomas, additional, Janczewska, Ewa, additional, Wiesch, Julian Schulze zur, additional, Sulkowski, Mark S., additional, Guinard-Azadian, Carine, additional, Biermer, Michael, additional, and Lenz, Oliver, additional

Published
2024
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18. Addition of PEG-interferon to long-term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg-negative chronic hepatitis B: Multicentre Randomized Trial (PAS Study)

Author

MS MDL 1, Cancer, Infection & Immunity, Farag, Mina S., van Campenhout, Margo J.H., Sonneveld, M. J., Fung, Scott, van Erpecum, Karel J., Wong, David K., Verhey, Elke, de Man, Robert, De Knegt, Robert J., Brouwer, Johannes T., Baak, Hubertus C., Feld, Jordan J., Liem, Kin Seng, Boonstra, André, Hansen, Bettina E., Janssen, Harry L.A., MS MDL 1, Cancer, Infection & Immunity, Farag, Mina S., van Campenhout, Margo J.H., Sonneveld, M. J., Fung, Scott, van Erpecum, Karel J., Wong, David K., Verhey, Elke, de Man, Robert, De Knegt, Robert J., Brouwer, Johannes T., Baak, Hubertus C., Feld, Jordan J., Liem, Kin Seng, Boonstra, André, Hansen, Bettina E., and Janssen, Harry L.A.

Published
2024

19. 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

20. Longitudinal liver sampling in patients with chronic hepatitis B starting antiviral therapy reveals hepatotoxic [CD8.sup.+] T cells

Author

Nkongolo, Shirin, Mahamed, Deeqa, Kuipery, Adrian, Vasquez, Juan D. Sanchez, Kim, Samuel C., Mehrotra, Aman, Patel, Anjali, Hu, Christine, McGilvray, Ian, Feld, Jordan J., Fung, Scott, Chen, Diana, Wallin, Jeffrey J., Gaggar, Anuj, Janssen, Harry L.A., and Gehring, Adam J.

Subjects
CD8 lymphocytes -- Health aspects, Cell death -- Health aspects, Antiviral agents -- Patient outcomes, Hepatitis B -- Drug therapy -- Development and progression -- Patient outcomes, Health care industry
Abstract

Accumulation of activated immune cells results in nonspecific hepatocyte killing in chronic hepatitis B (CHB), leading to fibrosis and cirrhosis. This study aims to understand the underlying mechanisms in humans and to define whether these are driven by widespread activation or a subpopulation of immune cells. We enrolled CHB patients with active liver damage to receive antiviral therapy and performed longitudinal liver sampling using fine-needle aspiration to investigate mechanisms of CHB pathogenesis in the human liver. Single-cell sequencing of total liver cells revealed a distinct liver-resident, polyclonal [CD8.sup.+] T cell population that was enriched at baseline and displayed a highly activated immune signature during liver damage. Cytokine combinations, identified by in silico prediction of ligand-receptor interaction, induced the activated phenotype in healthy liver [CD8.sup.+] T cells, resulting in nonspecific Fas ligand-mediated killing of target cells. These results define a [CD8.sup.+] T cell population in the human liver that can drive pathogenesis and a key pathway involved in their function in CHB patients., Introduction Nonspecific activation of memory [CD8.sup.+] T cells is a common feature of acute and chronic human viral diseases (1-7). Bystander-activated [CD8.sup.+] T cells respond in a TCR-independent manner and [...]

Published
2023
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22. 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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24. Virus-associated Inflammation Imprints an Inflammatory Profile on Long-lived Monocyte-derived Macrophages in the Human Liver

Author

Sanchez Vasquez, Juan Diego, primary, Nkongolo, Shirin, additional, Traum, Daniel, additional, Kim, Samuel C., additional, Mahamed, Deeqa, additional, Mehrotra, Aman, additional, Patel, Anjali, additional, Chen, Diana, additional, Fung, Scott, additional, Gaggar, Anuj, additional, Feld, Jordan J., additional, Chang, Kyong-Mi, additional, Wallin, Jeffrey J., additional, Janssen, Harry L.A., additional, and Gehring, Adam J., additional

Published
2024
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25. Addition of PEG‐interferon to long‐term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg‐negative chronic hepatitis B

Author

Farag, Mina S., primary, van Campenhout, Margo J. H., additional, Sonneveld, M. J., additional, Fung, Scott, additional, van Erpecum, Karel J., additional, Wong, David K., additional, Verhey, Elke, additional, de Man, Robert, additional, De Knegt, Robert J., additional, Brouwer, Johannes T., additional, Baak, Hubertus C., additional, Feld, Jordan J., additional, Liem, Kin Seng, additional, Boonstra, André, additional, Hansen, Bettina E., additional, and Janssen, Harry L. A., additional

Published
2024
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30. 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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34. 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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35. Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis

Author

Ahn, Sang Hoon, Marcellin, Patrick, Ma, Xiaoli, Caruntu, Florin A., Tak, Won Young, Elkhashab, Magdy, Chuang, Wan-Long, Tabak, Fehmi, Mehta, Rajiv, Petersen, Jörg, Guyer, William, Jump, Belinda, Chan, Alain, Subramanian, Mani, Crans, Gerald, Fung, Scott, Buti, Maria, Gaeta, Giovanni B., Hui, Aric J., Papatheodoridis, George, Flisiak, Robert, and Chan, Henry L. Y.

Published
2018
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37. Intrahepatic characterization of virological and immunological markers in two distinct populations of chronic hepatitis B: baseline assessment of core liver and fine needle aspiration biopsies from the investigational INSIGHT study

Author

Lampertico, Pietro, primary, Asselah, Tarik, additional, Gane, Edward J., additional, Fung, Scott K., additional, Kennedy, Patrick, additional, Vanwolleghem, Thomas, additional, Janczewska, Ewa, additional, zur Wiesch, Julian Schulze, additional, Sulkowski, Mark S., additional, Wils, Hans, additional, Colombo, Daniele Filippo, additional, Neto, Nadia, additional, de Troyer, Ewoud, additional, Van den Berge, Koen, additional, Göhlmann, Hinrich, additional, Aerssens, Jeroen, additional, Jerzorwski, John, additional, Anastasiou, Zacharias, additional, Lenz, Oliver, additional, Verbinnen, Thierry, additional, Kakuda, Thomas, additional, Guinard-Azadian, Carine, additional, Tuefferd, Marianne, additional, and Biermer, Michael, additional

Published
2023
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39. Assessment of clinical and patient reported outcome measures in individuals with chronic hepatitis B who clear HBsAg, followed by the Canadian hepatitis B network

Author

Coffin, Carla, primary, Elkhashab, Magdy, additional, Doucette, Karen, additional, Fung, Scott K, additional, Ramji, Alnoor, additional, Ko, Hin HIn, additional, Osiowy, Carla, additional, Crotty, Pamela, additional, Manko, Anna, additional, Saunders, Chad, additional, Chan, Eric, additional, Keever, Angelina Villasis, additional, Chen, TianYan, additional, Poulin, Sebastien, additional, Zhu, Julie, additional, M, Mang, additional, and Cooper, Curtis, additional

Published
2023
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40. 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

41. 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

43. 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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45. Evaluation of APRI and FIB-4 scoring systems for non-invasive assessment of hepatic fibrosis in chronic hepatitis B patients

Author

Kim, W. Ray, Berg, Thomas, Asselah, Tarik, Flisiak, Robert, Fung, Scott, Gordon, Stuart C., Janssen, Harry L.A., Lampertico, Pietro, Lau, Daryl, Bornstein, Jeffrey D., Aguilar Schall, Raul E., Dinh, Phillip, Yee, Leland J., Martins, Eduardo B., Lim, Seng Gee, Loomba, Rohit, Petersen, Jörg, Buti, Maria, and Marcellin, Patrick

Published
2016
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46. Large-scale viral genome analysis identifies novel clinical associations between hepatitis B virus and chronically infected patients

Author

Podlaha, Ondrej, Gane, Edward, Brunetto, Maurizia, Fung, Scott, Chuang, Wan-Long, Pan, Calvin Q., Jiang, Zhaoshi, Liu, Yang, Bhardwaj, Neeru, Mukherjee, Prasenjit, Flaherty, John, Gaggar, Anuj, Subramanian, Mani, Izumi, Namiki, Shalimar, Lim, Young-Suk, Marcellin, Patrick, Buti, Maria, Chan, Henry L. Y., and Agarwal, Kosh

Published
2019
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