Format

Send to

Choose Destination
Liver Int. 2018 Sep;38(9):1552-1561. doi: 10.1111/liv.13685. Epub 2018 Jun 29.

Ledipasvir-sofosbuvir for treating Japanese patients with chronic hepatitis C virus genotype 2 infection.

Author information

1
Tokyo Medical and Dental University, Tokyo, Japan.
2
Kyoto Prefectural University of Medicine, Kyoto, Japan.
3
Yamagata University, Yamagata, Japan.
4
Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan.
5
Iwate Medical University, Iwate, Japan.
6
National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
7
Juntendo University Shizuoka Hospital, Shizuoka, Japan.
8
Okayama University, Okayama, Japan.
9
Gilead Sciences K.K., Tokyo, Japan.
10
Gilead Sciences, Inc., Foster City, CA, USA.
11
Osaka City University, Osaka, Japan.
12
University of Yamanashi, Yamanashi, Japan.

Abstract

BACKGROUND & AIMS:

Japanese patients with chronic hepatitis C virus (HCV) genotype 2 infection have high rates of sustained virological response (SVR) following 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin, which was the standard of care at the time this study was undertaken. We assessed the efficacy of 12 weeks of treatment with a ribavirin-free regimen of ledipasvir-sofosbuvir.

METHODS:

In an open-label, Phase 3 trial we enrolled Japanese patients with chronic HCV genotype 2 infection, with or without compensated cirrhosis. In Cohort 1, participants were randomized 1:1 to receive ledipasvir-sofosbuvir (n = 106) or sofosbuvir + ribavirin (n = 108) for 12 weeks. In Cohort 2, 25 ribavirin-intolerant or -ineligible patients received ledipasvir-sofosbuvir for 12 weeks. The primary endpoint was SVR 12 weeks after therapy (SVR12). In Cohort 1 non-inferiority was assessed with a prespecified margin of 10%.

RESULTS:

One-third (33%) of patients were treatment experienced, and 14% had cirrhosis. In Cohort 1, SVR12 rates were 96% (95% CI, 91% to 99%) with ledipasvir-sofosbuvir and 95% (95% CI, 90% to 98%) with sofosbuvir plus ribavirin, thus achieving non-inferiority. Among ribavirin-intolerant/ineligible patients in Cohort 2, SVR12 was 96% (95% CI, 80% to 100%) with ledipasvir-sofosbuvir. Overall, the most common adverse events were nasopharyngitis, anaemia, and headache; anaemia was only observed in patients receiving ribavirin. The percentage of patients who discontinued treatment because of an adverse event was low (1%).

CONCLUSIONS:

Among Japanese patients with HCV genotype 2, 12 weeks of treatment with ledipasvir-sofosbuvir resulted in high rates of SVR12 that were non-inferior to sofosbuvir + ribavirin.

KEYWORDS:

Japan; anaemia; direct-acting antiviral; ribavirin-free

PMID:
29297980
DOI:
10.1111/liv.13685
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center