Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry

• Published in: Journal of hepatology Vol. 62; no. 5; pp. 1040 - 1046
• Main Authors: Ruane, Peter J, Ain, Dani, Stryker, Richard, Meshrekey, Raymond, Soliman, Mina, Wolfe, Peter R, Riad, Joseph, Mikhail, Sameh, Kersey, Kathryn, Jiang, Deyuan, Massetto, Benedetta, Doehle, Brian, Kirby, Brian J, Knox, Steven J, McHutchison, John G, Symonds, William T
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.05.2015
• Subjects: Adult; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Direct-acting antiviral; Drug Therapy, Combination - methods; Egypt; Egyptian; Female; Gastroenterology and Hepatology; Genotype 4; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - ethnology; Hepatitis C, Chronic - virology; Humans; Interferon-free therapy; Male; Middle Aged; Ribavirin - administration & dosage; Ribavirin - adverse effects; RNA, Viral - analysis; RNA-Dependent RNA Polymerase - antagonists & inhibitors; Sofosbuvir; Sofosbuvir - administration & dosage; Sofosbuvir - adverse effects; Treatment Outcome; United States; Viral Load - drug effects; Viral Load - methods; Viral Nonstructural Proteins - antagonists & inhibitors; United States; Egypt; ABT-450/r; LLOQ; aminotransferase:platelet ratio index; Direct-acting antiviral; pegylated interferon; CIs; SVR; Genotype 4; DAAs; ABT-450 with ritonavir; ULN; Egyptian; hepatitis C virus; sustained virologic response; lower limit of quantitation; ribavirin; direct-acting antiviral agents; RBV; PegIFNα; nucleoside inhibitor; Interferon-free therapy; upper limit of normal; APRI; HCV; NI; confidence intervals; Sofosbuvir; Hepatitis C virus
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2014.10.044

Background & Aims We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV). Methods Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400 mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25 IU/ml) 12 weeks after cessation of therapy (SVR12). Results Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n = 31) or 24 weeks (n = 29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49–83%) in the 12-week group, and by 93% of patients (95% CI, 77–99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event. Conclusions The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.