Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection
| العنوان: | Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection |
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| المؤلفون: | Mark S. Sulkowski, Kosh Agarwal, Xiaoli Ma, Tuan T. Nguyen, Eugene R. Schiff, Hie-Won L. Hann, Douglas T. Dieterich, Ronald G. Nahass, James S. Park, Sing Chan, Steven-Huy B. Han, Edward J. Gane, Michael Bennett, Katia Alves, Marc Evanchik, Ran Yan, Qi Huang, Uri Lopatin, Richard Colonno, Julie Ma, Steven J. Knox, Luisa M. Stamm, Maurizio Bonacini, Ira M. Jacobson, Walid S. Ayoub, Frank Weilert, Natarajan Ravendhran, Alnoor Ramji, Paul Yien Kwo, Magdy Elkhashab, Tarek Hassanein, Ho S. Bae, Jacob P. Lalezari, Scott K. Fung, Man-Fung Yuen |
| المصدر: | Journal of hepatology. 77(5) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Hepatitis B virus, Guanine, Hepatitis B, Chronic, Treatment Outcome, Hepatology, Double-Blind Method, DNA, Viral, Humans, Reverse Transcriptase Inhibitors, RNA, Drug Therapy, Combination, Hepatitis B e Antigens, Antiviral Agents |
| الوصف: | Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress HBV DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor that interferes with multiple aspects of HBV replication. This phase II trial evaluated the safety and efficacy of VBR in combination with entecavir (ETV) in treatment-naïve patients with cHBV.HBeAg-positive, treatment-naïve patients without cirrhosis were randomised 1:1 in a double-blind manner to once-daily VBR 300 mg+ETV 0.5 mg or placebo (PBO)+ETV 0.5 mg for 24 weeks. The primary endpoint was change in mean logAll patients in both treatment groups (PBO+ETV: 12/12; VBR+ETV: 13/13) completed the study. At Week 12, VBR+ETV led to a greater mean (SD) reduction from Baseline in logIn this 24-week study, VBR+ETV provided additive antiviral activity over PBO+ETV in treatment-naïve patients with cHBV, with a favourable safety and tolerability profile.NCT03577171 LAY SUMMARY: Hepatitis B is a long-lasting viral infection of the liver. Current treatments can suppress hepatitis B virus but do not offer the opportunity of cure, hence, new treatment approaches are required. Herein, we show that the combination of the novel core inhibitor vebicorvir with an existing antiviral (entecavir) in treatment-naïve patients chronically infected with hepatitis B virus demonstrated greater antiviral activity than entecavir alone. Additionally, vebicorvir was safe and well tolerated. Thus, further studies evaluating its potential role in the treatment of chronic hepatitis B are warranted. |
| تدمد: | 1600-0641 0357-7171 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b1b1959f900369042b7add8624579b93 https://pubmed.ncbi.nlm.nih.gov/35697332 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b1b1959f900369042b7add8624579b93 |
| قاعدة البيانات: | OpenAIRE |
Full Text via ClinicalKey | تدمد: | 16000641 03577171 |
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