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J Gastroenterol Hepatol. 2019 Feb 19. doi: 10.1111/jgh.14636. [Epub ahead of print]

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection.

Author information

1
Peking University People's Hospital, Beijing, China.
2
Toranomon Hospital, Tokyo, Japan.
3
Icahn School of Medicine at Mount Sinai, New York, New York, USA.
4
Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.
5
Royal Perth Hospital, Perth, Western Australia, Australia.
6
College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Korea.
7
Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
8
Merck & Co., Inc., Kenilworth, New Jersey, USA.
9
Merck, Sharp & Dohme, Beijing, China.

Abstract

BACKGROUND AND AIM:

Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials.

METHODS:

This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12).

RESULTS:

Seven hundred eighty Asian participants from 15 countries were included in this analysis. SVR12 was achieved by 756/780 (96.9%) of all participants, including 748/772 (96.9%) of those who received elbasvir/grazoprevir for 12 weeks and 8/8 (100%) of those who received elbasvir/grazoprevir plus ribavirin for 16 weeks. In the genotype 1b-infected population, the SVR12 rate was 691/709 (97.5%), and there was no impact of age, high baseline viral load, or presence of cirrhosis. The most frequently reported adverse events were nasopharyngitis (8.0%), upper respiratory tract infection (5.4%), and diarrhea (5.2%). Twenty participants receiving elbasvir/grazoprevir for 12 weeks reported a total of 25 serious adverse events, and 7 (0.9%) discontinued treatment because of an adverse event.

CONCLUSION:

Elbasvir/grazoprevir administered for 12 weeks is an effective and generally well-tolerated treatment option for Asian individuals with hepatitis C virus genotype 1b infection.

KEYWORDS:

HCV clinical trials; HCV treatment; Hepatitis C, clinical

PMID:
30779220
DOI:
10.1111/jgh.14636

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