Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities

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• 作者：Samuel B. Ho^&lowast ; ; ^{samuel.ho2@va.gov} ; Alexander Monto^&Dagger ; ; Adam Peyton^§ ; ; David E. Kaplan^‖ ; Sean Byrne^¶ ; ; Scott Moon^¶ ; ; Amanda Copans^¶ ; ; Lorenzo Rossaro^¶ ; ; Anupma Roy^¶ ; ; Hadley Le^¶ ; ; Hadas Dvory-Sobol^¶ ; ; Yanni Zhu^¶ ; ; Diana M. Brainard^¶ ; ; William Guyer^¶ ; ; Obaid Shaikh^# ; Michael Fuchs^&lowast ; &lowast ; ; Timothy R. Morgan^&Dagger ; &Dagger ; ; on behalf of the VALOR study teamGeri Brown ; Ramsey Cheung ; Michael Fuchs ; Bruce Gilliam ; Sam Ho ; Lennox Jeffers ; David Kaplan ; Joseph Lim ; Alexander Monto ; Timothy Morgan ; Susanna Naggie ; Prashant Pandya ; Adam Peyton ; David Rimland ; Obaid Shaikh ; Rohit Talwani ; Boris Yoffee ; Emily Cartwright
• 关键词：VA ; DAA ; NS5B Inhibitor ; Substance Abuse ; Clinical Trial
• 刊名：Clinical Gastroenterology and Hepatology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：15
• 期：2
• 页码：282-288
• 全文大小：600 K
• 卷排序：15

文摘

We conducted a phase 4, open-label study with limited exclusion criteria to evaluate the safety and efficacy of sofosbuvir and ribavirin in veterans with hepatitis C virus genotype 2 infection, and compensated cirrhosis. This population is often excluded from clinical studies.MethodsWe performed a prospective study of treatment-naive (n = 47) and treatment-experienced (n = 19) patients with chronic hepatitis C virus genotype 2 infection and compensated cirrhosis at 15 Department of Veterans Affairs sites. All subjects were given sofosbuvir (400 mg, once daily) plus ribavirin (1000–1200 mg/day) in divided doses for 12 weeks. Patients with major psychiatric diseases or alcohol or substance use disorders were not excluded. The primary endpoint was sustained virologic response 12 weeks after therapy.ResultsFifty-two patients achieved a sustained virologic response 12 weeks after therapy (79%; 95% confidence interval, 67%–88%); 16 of these patients were treatment experienced (84%; 95% confidence interval, 60%–97%) and 36 were treatment naive (77%; 95% confidence interval, 62%–88%). All patients had at least 1 comorbidity. Thirty-five percent had depression, 24% had posttraumatic stress disorder, and 30% had anxiety disorder. In addition, 29% had current substance use. Of the 7 patients (11%) who discontinued the study treatment prematurely, 3 did so because of adverse events. The most common adverse events were fatigue, anemia, nausea, and headache. Serious adverse events occurred in 8 patients. Only 2 of the serious adverse events (anemia and nausea) were considered to be related to study treatment.ConclusionsIn a phase 4 study, 12 weeks treatment with sofosbuvir and ribavirin led to a sustained virologic response 12 weeks after therapy in almost 80% of veterans with hepatitis C virus genotype 2 infection, compensated cirrhosis, and multiple comorbidities, regardless of their treatment history. ClinicalTrials.gov, Number: NCT02128542