A new, interferon-free combination therapy with faldaprevir (BI 201335), a next-wave protease inhibitor, and BI 207127, a non-nucleoside polymerase inhibitor, is safe and effective among people with hepatitis C virus (HCV), including those with advanced liver disease. Representatives from Boehringer Ingelheim presented the Phase IIb results of their SOUND-C2 study at the annual meeting of the American Association for the Study of Liver Diseases in Boston. This is the first paper to report on interferon-free treatments among patients with compensated cirrhosis.
Researchers recruited 362 hep C patients, 33 of whom had liver cirrhosis, for the open-label study, dividing them into five treatment arms. Each of the arms took 120 milligrams of faldaprevir once a day with one of the following:
- 600 mg of BI 207127 three times a day, plus ribavirin for either 16, 28 or 40 weeks.
- 600 mg of BI 207127 twice a day, with or without ribavirin for 28 weeks.
Patients with cirrhosis experienced sustained virologic response (SVR, considered a cure) rates between 43 and 80 percent for those taking regimens containing ribavirin, depending on their HCV sub-genotype and IL28B host genotype.
Among the total patient population, between 52 and 69 percent achieved an SVR 24 weeks after completing therapies containing ribavirin and 39 percent in the arm without ribavirin. The regimens proved well-tolerated, with only 8 percent of patients stopping treatment because of serious side effects, most of which the researchers deduced were not related to the antivirals. Boehringer Ingelheim will soon begin a Phase III trial of these investigative agents.
To read the aidsmap report, click here.
To read the Boehringer Ingelheim release, click here.