Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis

Byung Seok Lee, Myeong Jun Song, Jung Hyun Kwon, Tae Hee Lee, Ji Woong Jang, Seok Hyun Kim, Sae Hwan Lee, Hong Soo Kim, Ji Hoon Kim, Seok Bae Kim, Soon Young Ko, Do Seon Song, Byung Seok Lee, Myeong Jun Song, Jung Hyun Kwon, Tae Hee Lee, Ji Woong Jang, Seok Hyun Kim, Sae Hwan Lee, Hong Soo Kim, Ji Hoon Kim, Seok Bae Kim, Soon Young Ko, Do Seon Song

Abstract

Background/aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis.

Methods;: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed.

Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment.

Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis. (ClinicalTrials.gov ID NCT02580474).

Keywords: Asunaprevir; Chronic hepatitis C virus; Daclatasvir; Hemodialysis; Sustained virologic response.

Conflict of interest statement

CONFLICTS OF INTEREST

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
Fig. 1
Flowchart of patients enrolled in this study. SVR12, sustained virologic response 12 weeks posttreatment.
Fig. 2
Fig. 2
SVR12 according to intention-to-treat (ITT) and by per-protocol (PP) analysis. The overall SVR12 rate was 76.1% in an ITT analysis and 100% in a PP analysis. SVR12, sustained virologic response 12 weeks posttreatment; EOT, end of treatment.

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