According to data from recent Phase 3 trials, the use of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) plus dasabuvir (DSV) (Viekira Pak; AbbVie) with ribavirin (RBV) in patients with hepatitis C virus (HCV) genotype 1 infection led to high SVR12 rates regardless of acid-reducing agents (ARAs) and proton-pump inhibitors (PPIs) use or PPI dose.
ARAs and PPIs increase gastric pH and can impact the bioavailability of antiviral drugs, especially in patients with advanced liver disease caused by HCV infection. Mitchell L Shiffman, MD, and colleagues, reviewed data from six Phase 3 studies to assess the safety and efficacy of the three direct-acting antiviral (DAA) regimen containing ombitasvir, ritonavir-boosted paritaprevir, and dasabuvir, with or without ribavirin for HCV genotype 1 patients taking concomitant ARAs and PPIs.
Included studies looked at treatment-naive or peginterferon/ribavirin treatment-experienced patients with or without compensated cirrhosis that received OBV/PTV/r and DSV with or without weight-based RBV. Rates of SVR were defined as HCV RNA below the lower limit of quantification at 12 weeks post-treatment (SVR12). Safety was also assessed in patients who were taking concomitant ARAs.
A total of 2,053 patients were enrolled, of which 20% were receiving concomitant ARAs, and of which 15% were taking concomitant PPIs. Rates of SVR12 were 95.9% (95% CI: 93.5-97.4%) among patients receiving an ARA vs. 96.3% (95% CI: 95.3-97.2%) in patients not receiving a concomitant ARA. Among patients receiving a PPI, SVR12 was achieved in 95.1% (95 CI: 92.1-97.0%) of patients vs. 96.4% (95% CI: 95.9-97.2%) of patients not receiving a PPI.
Study authors pointed out that response rates were high despite the use of ribavirin or not and among patients receiving a standard vs. high-dose PPIs.
Findings from the study support “that the co-administration of OBV/PTV/r plus DSV with ARAs and PPIs does not negatively affect the chance for viral eradication.”
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