Journal
HEPATOLOGY RESEARCH
Volume 47, Issue 11, Pages 1127-1136Publisher
WILEY
DOI: 10.1111/hepr.12851
Keywords
asunaprevir; daclatasvir; direct-acting antiviral; hepatitis C virus
Categories
Funding
- Bristol-Myers Squibb
- Ministry of Education, Culture, Sports, Science and Technology of Japan
- Japan Agency for Medical Research and Development
- Grants-in-Aid for Scientific Research [15K08980, 16K09334, 16K15420, 26461021] Funding Source: KAKEN
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Aim: Hepatitis C virus (HCV) infection is a risk factor for end-stage renal disease, renal graft failure, and hemodialysis patient mortality. However, the efficacy of direct-acting antiviral therapy for HCV-infected patients with renal impairment is unclear. Additionally, the promising NS5B inhibitor sofosbuvir has not been recommended for patients with severe renal impairment. In this prospective, multicenter study, we evaluated the efficacy and safety of daclatasvir and asunaprevir combination therapy, with a focus on patients with renal impairment. Methods: The study included 322 genotype 1 HCV-infected patients who received daclatasvir and asunaprevir combination therapy. The safety and sustained virological response was examined at 12weeks after the end of treatment and safety was evaluated according to renal function. Results: Of 322 patients, 5% (16/322) and 2.5% (8/322) had chronic kidney disease stage G3b (estimated glomerular filtration rate [eGFR], 30-44mL/min/1.73m(2)) and stage G4/5 (eGFR, 15-29/<15mL/min/1.73m(2)), respectively. Baseline presence of the NS5A resistance-associated variant, previous simeprevir treatment, and HCV RNA titers, which were predictors of a sustained viral response, were similar between patients with eGFR <45mL/min/1.73m(2) and eGFR >45mL/min/1.73m(2). Notably, the 12-week sustained viral response rate was comparable in patients with eGFR <45mL/min/1.73m(2) (100%, 24/24) and those with eGFR >45mL/min/1.73m(2) (88.9%, 265/298; P=0.07). Treatment discontinuation rates and adverse events, including alanine aminotransferase elevation, anemia, and renal disorders, were similar between the two groups. Conclusion: Daclatasvir and asunaprevir combination therapy for patients with renal dysfunction was highly effective and safe.
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