Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection

Abstract

Background: This international, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT01609933) was conducted to evaluate the safety and efficacy of an enhanced regimen consisting of the direct-acting antivirals (DAAs) ombitasvir, paritaprevir, and ritonavir administered for 24 weeks, combined with pegylated interferon-α2a plus ribavirin (pegIFN-α2a/RBV) for 48 weeks, in patients with chronic hepatitis C virus (HCV) genotype 1 infection who had experienced virologic failure with a prior DAA regimen. This study was undertaken at a time when options were limited for the retreatment of patients who had failed prior DAA therapy.

Methods and results: Thirty-two patients were enrolled; the majority were male (78%) and White (94%), and the median age was 54.5 years. Twelve weeks after the last dose of study drug, sustained virologic response was achieved in 81.3% of patients. Five patients prematurely discontinued the study drugs and one patient relapsed. Safety and tolerability were similar to prior studies of pegIFN-α2a/RBV alone.

Conclusion: Given the availability of highly efficacious DAA regimens that are both IFN- and RBV-free, this regimen is no longer relevant in today's HCV treatment landscape.

Keywords: direct-acting antiviral; retreatment; virologic failure.

Conflict of interest statement

Disclosure David Bernstein has acted as a consultant for and received research grants from AbbVie and Gilead. Daniel E Cohen and Rakesh Tripathi are employees of AbbVie and may hold stock or options. The authors report no other conflicts of interest in this work.

Figures

Figure 1

Patient flow chart. Notes:aPatients who were screen failures may have had more than one reason for screen failure. Abbreviations: AE, adverse event; OBV, ombitasvir; pegIFN-α2a, pegylated interferon-α2a; PTV, paritaprevir; RBV, ribavirin.