- Efficacy of ritonavir-boosted paritaprevir/ombitasvir+dasabuvir (PrOD) ± ribavirin (RBV) rivals that of ledipasvir/sofosbuvir (LDV/SOF) ± RBV in HCV-infected patients who have previously failed interferon (IFN)-based triple therapy with first-generation protease inhibitors.
Why this matters
- PrOD is not among the treatment options recommended by the American Association for the Study of Liver Disease in this population with or without cirrhosis.
- Real-world Polish nationwide study of 335 HCV-infected patients (HCV-1b, 93%) in the EpiTer-2 database who had previously failed IFN-based triple therapy with telaprevir (TVR; 62%) or boceprevir (BOC; 38%).
- Most had F3 (BOC, 28.4%; TVR, 18.8%) or F4 fibrosis (BOC, 61.4%; TVR, 64.4%).
- Participants were randomly assigned to receive PrOD±RBV (BOC, 50.4%; TVR, 49.5%) or LDV/SOF±RBV (BOC, 49.6%; TVR, 50.5%).
- Primary endpoint: sustained virologic response at ≥12 weeks posttherapy (SVR12).
- Funding: None.
- In intent-to-treat (ITT) analysis, SVR12 rates were similar with PrOD±RBV vs LDV/SOF±RBV in:
- TVR-experienced patients (97% vs 96%).
- BOC-experienced patients (100% vs 98%).
- Modified ITT analysis (excluding patients lost to follow-up) supported these findings in:
- TVR-experienced patients (99% vs 98%).
- BOC-experienced patients (100% vs 99%).
- Most adverse events were mild-moderate.
- Patients who stopped treatment for adverse events (PrOD±RBV, n=3; LDV/SOF±RBV, n=2) all achieved SVR12.
- Clinician-determined RBV use, treatment duration.