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

医学 内科学 安慰剂 随机对照试验 不利影响 病理 替代医学
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,Vasily Isakov,Jacob George
出处
期刊:Journal of Gastroenterology and Hepatology [Wiley]
卷期号:34 (1): 12-21 被引量:21
标识
DOI:10.1111/jgh.14509
摘要

Abstract 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 events and drug‐related adverse events were seen in the immediate‐treatment group versus placebo phase of the deferred‐treatment group (51.0% vs 50.4% and 21.4% vs 21.1%). Conclusions Elbasvir/grazoprevir for 12 weeks represents an effective and well‐tolerated treatment option for treatment‐naive people with genotype 1 infection from Asia–Pacific countries and Russia.

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