Asunaprevir and daclatasvir in hemodialysis patients with chronic hepatitis C virus genotype 1b infection

Abstract

Background and aim: Patients requiring hemodialysis show high morbidity with hepatitis C virus (HCV) infection, but there are difficulties associated with interferon-based therapies. Asunaprevir and daclatasvir could help patients with HCV genotype 1b because the drugs have a nonrenal metabolism and show good viral eradication. We evaluated the efficacy and safety of combined asunaprevir and daclatasvir therapy.

Methods: This was a multicenter prospective trial of patients with chronic hepatitis or compensated cirrhosis from HCV genotype 1b who had end-stage renal disease requiring chronic hemodialysis. Asunaprevir and daclatasvir were administered orally (100 mg twice daily and 60 mg once daily, respectively) for 24 weeks. The primary end-point was the proportion of patients achieving sustained virological response 12, defined as HCV RNA <15 IU/mL undetectable at 12 weeks after completion of asunaprevir and daclatasvir treatment.

Results: Between December 2014 and December 2015, 23 dialysis patients were enrolled, and 22 patients completed the protocol therapy. Sustained virological response 12 rates were 91.3% (95% confidence interval: 72.0-98.9) in the intention-to-treat and 95.5% (95% confidence interval: 77.2-99.9) in the per-protocol populations. Serum aminotransferase significantly decreased after initiation of asunaprevir and daclatasvir (P < 0.01), although the level was low at baseline. Asunaprevir and daclatasvir were well tolerated; however, one patient could not continue because of infective endocarditis and cerebral infarction.

Conclusions: Asunaprevir and daclatasvir could help patients with chronic hepatitis C receiving hemodialysis. Close collaboration with dialysis physicians is important when treating these patients because hemodialysis carries life-threatening risks.

Keywords: asunaprevir; daclatasvir; direct‐acting antivirals; hemodialysis; hepatitis C virus.

Figure 1

The rates of serum hepatitis C virus (HCV) RNA undetectable from 2 weeks after initiation to 12 weeks after completion with combined asunaprevir and daclatasvir treatment. Rapid virological response and early virological response rates were 100%, and the rate of sustained virological response (SVR) 12 was 91.3% in the intention‐to‐treat population.

Figure 2

Changes in biochemical data during asunaprevir and daclatasvir treatment. (a) Median serum alanine aminotransferase (ALT), (b) γ‐glutamyl transpeptidase (γ‐GT), (c) alpha fetoprotein (AFP), and (d) aspartate aminotransferase to platelet ratio index (APRI) levels decreased after initiation of combined asunaprevir and daclatasvir treatment. Serum ALT and γ‐GT levels significantly decreased (P < 0.01).