Combination therapy with Boehringer Ingelheim’s faldaprevir and deleobuvir plus Presidio’s PPI-668 cured 92 percent of those with genotype 1a of hepatitis C virus (HCV) when given with ribavirin. Results from the Phase IIa study were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London.
The 36 study participants were randomly dived into three even cohorts of 12 each: The first received 600 milligrams of the non-nucleoside NS5B polymerase inhibitor deleobuvir twice a day as well as once-daily doses of the protease inhibitor faldaprevir (120 mg), the pan-genotypic NS5A inhibitor PPI-668 and ribavirin. The second group received the same regimen except the faldaprevir dose was 400 mg. The third group took the regimen with the higher dose of faldaprevir, but without ribavirin. All participants were treated for 12 weeks.
Ninety-two percent of the first and second cohorts (11 out of 12 in both cases) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). In the end, 14 participants were required for the third cohort, because one was incarcerated early on during treatment and another experienced viral rebound at week eight as a result of not adhering to the treatment regimen. Of the other 12 participants, eight, or two-thirds, have achieved an SVR12, while one more participant stopped taking the therapy at week eight but has since achieved an SVR8.
The most common adverse side effects, reported in more than 5 percent of the participants, were nausea, fatigue, diarrhea, rash and insomnia.
To read a summary of the study findings, click here.
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