A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus

摘要: In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated pegylated interferon-alpha plus ribavirin, but interferons contraindicated in many and often poorly tolerated, particularly by the elderly those advanced liver disease. No interferon-free treatment regimens approved Korea. Sofosbuvir is an oral nucleotide analog inhibitor of HCV nonstructural 5B RNA polymerase. It USA, European Union Japan for treating a number genotypes, including genotype 2. Genotype 2 has seroprevalence 38-46% This single-arm, phase 3b study (NCT02021643) examined efficacy safety sofosbuvir ribavirin (12-week duration) HCV-infected treatment-naive treatment-experienced Korean without cirrhosis. The proportion sustained virologic response 12 weeks after discontinuation (SVR12) was 97% (125/129), 96% (101/105) 100% (24/24) achieving SVR12. Two experienced failure (n = 1, on-treatment failure; n relapse). patient discontinued due to adverse event (AE). most common treatment-emergent AEs were headache (18%, 23/129) pruritus (15%, 19/129). Few had grade 3 (5%, 6/129) or laboratory abnormalities (12%, 15/129). 4 AE reported. These data suggest that all-oral, regimen effective well tolerated infection.