Trial reportLiver international : official journal of the International Association for the Study of the Liver2016
A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection.
Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02021643 (A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin), which is not on this map. Cited by 13 papers.
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The trial behind it
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A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Who cites it
13 citing papers in PubMed.
- A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection.Liver international : official journal of the International Association for the Study of the Liver · 2016Trial
- Long-Term Hepatic and Extrahepatic Outcomes of Chronic Hepatitis C Patients After Sofosbuvir-Based Treatment (LONGHEAD Study).Infectious diseases and therapy · 2025Article
- Efficacy and Safety of Sofosbuvir and Ribavirin in an Italian Cohort of HCV Genotype 2 Elderly Cirrhotic Patients.The Eurasian journal of medicine · 2022Article
- Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study.Journal of Korean medical science · 2021Article
- The predictors of sustained virological response with sofosbuvir and ribavirin in patients with chronic hepatitis C genotype 2.The Korean journal of internal medicine · 2021Article
- Sofosbuvir-based regimen for genotype 2 HCV infected patients in Taiwan: A real world experience.PloS one · 2020Article
- Comparison of the Clinical Characteristics and Outcomes between Leprosy-Affected Persons in Sorokdo and the General Population Affected by Chronic Hepatitis C in Korea.Gut and liver · 2019Article
- Direct-acting antivirals in East Asian hepatitis C patients: real-world experience from the REAL-C Consortium.Hepatology international · 2019Article
- Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study.Scientific reports · 2018Observational
- Does the old-fashioned sofosbuvir plus ribavirin treatment in genotype 2 chronic hepatitis C patients still works for Koreans?Clinical and molecular hepatology · 2018Article
- Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study.Clinical and molecular hepatology · 2018Article
- Real-world effectiveness of sofosbuvir plus ribavirin for chronic hepatitis C genotype 2 in Asia: a systematic review and meta-analysis.BMJ open gastroenterology · 2018Article
- Observational
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18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsIn Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon-alpha plus ribavirin, but interferon-based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for treating chronic HCV infection. This phase 3b study examined the efficacy and safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 HCV infection ± compensated cirrhosis.
methodsIn this multicentre, open-label, phase 3b (NCT02021643) study, 87 patients (n = 43, treatment-naive; n = 44, treatment-experienced) received 12 weeks of treatment with sofosbuvir plus weight-based ribavirin. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were also collected.
resultsAll 87 patients (100%; 95% confidence interval, 92-100%) achieved SVR12, including the 13 patients with compensated cirrhosis. The most common treatment-emergent adverse events (AEs) were insomnia (16%, 14/87) and upper respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. There was one serious AE (biliary colic), which was deemed unrelated to study treatment. Laboratory abnormalities other than ribavirin-related reductions in haemoglobin were uncommon.
conclusionsThe results from this phase 3b study demonstrate that 12 weeks of treatment with the interferon-free regimen sofosbuvir plus ribavirin is effective and well tolerated in both treatment-naive and treatment-experienced Taiwanese patients with chronic genotype 2 HCV infection.
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