Boehringer Ingelheim’s investigational hepatitis C virus (HCV) therapies faldaprevir and deleobuvir (BI 207127), plus ribavirin, cured 95 percent of the participants with genotype 1b of the virus in a Phase IIb study. However, the therapies cured only 17 percent of those study participants who had genotype 1a of hep C. Called the SOUND-C3 study, it was presented at the Asian Pacific Association for the Study of the Liver (APASL) Liver Week in Singapore. Included in the study were 20 genotype 1b participants and 12 genotype 1a participants who took the combination therapy for 16 weeks. Four of those with 1b had cirrhosis of the liver.
Nineteen out of 20 (95 percent) of those with genotype 1b achieved a sustained virologic response (SVR) 12 weeks after completing therapy, which is considered a cure. All of those with cirrhosis were cured. Just two out of 12 (17 percent) of the genotype 1b participants achieved an SVR.
“These promising results indicate the potential of our interferon-free combination treatment to address an unmet medical need, and confirm our decision to focus on [genotype] 1b patients in our pivotal Phase III interferon-free HCVerso trials,” said Klaus Dugi, MD, PhD, senior vice president of medicine at Boehringer Ingelheim.
Three participants (9 percent) in the trial discontinued treatment as a result of adverse effects. Mild rash and nausea were the most common side effects. Among the most-common moderate- or higher-intensity side effects were anemia (16 percent), fatigue (9 percent), vomiting (9 percent) and nausea (9 percent).
To read the Boehringer Ingelheim release, click here.
Faldaprevir and Deleobuvir Cure 95% of Hep C Genotype 1b
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