Efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus genotype 1, 4, or 6 infection from the Asia–Pacific region and Russia: Final results from the randomized C‐CORAL study

作者：Lai Wei, Ji Dong Jia, Fu Sheng Wang, Jun Niu, Xu Zhao, Shengmei Mu, Li Liang, Zaiqi Wang, Peggy Hwang, Michael Robertson, Paul Ingravallo, Ernest Asante‐Appiah, Bo Wei, Barbara J. Evans, George J. Hanna, Rohit Talwani, Zhong Ping Duan, К. В. Жданов, Pin‐Nan Cheng, Tawesak Tanwandee, Vān Kính Nguyễn, Jeong Heo, Isakov Va, Jacob George, on behalf of the C‐CORAL Investigators · 发表于：Journal of Gastroenterology and Hepatology · 年份：2018 · DOI：10.1111/jgh.14509 · 被引用次数：26 · 研究领域：Hepatitis C virus research、HIV/AIDS drug development and treatment、Drug-Induced Hepatotoxicity and Protection

BACKGROUND AND AIM: Although treatment with direct-acting antivirals has dramatically improved morbidity and mortality attributable to chronic hepatitis C virus infection, universal access to these medicines has been slow in the Asia-Pacific region and Russia. This study evaluated efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus infection from Asia-Pacific countries and Russia (C-CORAL). METHODS: C-CORAL was a phase 3, randomized, placebo-controlled study (NCT02251990). Treatment-naive, HIV-negative, cirrhotic and non-cirrhotic participants with chronic hepatitis C genotype 1, 4, or 6 infection were randomized to elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks (immediate-treatment group) or placebo followed by deferred treatment with elbasvir/grazoprevir (deferred-treatment group). The primary efficacy outcome was sustained virologic response at 12 weeks, and the primary safety outcome was a comparison between the immediate-treatment group and placebo phase of the deferred-treatment group. RESULTS: A total of 489 participants were randomized (immediate-treatment group, n = 366; deferred-treatment group, n = 123). Sustained virologic response at 12 weeks in the combined immediate/deferred-treatment groups was 94.4% (459/486; 95% confidence interval = 92.4-96.5%). Sustained virologic response at 12 weeks was 98.2% in participants with genotype 1b, 91.9% with genotype 1a, and 66.7% with genotype 6 infection. Similar rates of adverse ev...