Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection

Abstract

Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8weeks. The primary endpoint was sustained virological response at 12weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n=23) were HIV-positive, 93% (n=28) had genotype 1a infection and 53% (n=16) had ever injected drugs. Median maximum ALT in the preceding 12months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT>10xULN was documented in 83% (n=25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log10 IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n=1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.