Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported results from the phase III STARTVerso 4 trial in patients co-infected with hepatitis C virus (HCV) and HIV, showing that HCV cure 12 weeks (SVR12) after the conclusion of treatment was achieved by 72 percent of all patients in the study. Patients were enrolled in either 120-mg or 240-mg faldaprevir dose groups. Data also showed that 80 percent of all patients were eligible for randomization to a shortened duration of treatment (24 weeks vs. 48 weeks) because they achieved protocol-defined early treatment success, and 86 percent of those patients achieved SVR12. The study enrolled 308 patients and evaluated faldaprevir, an oral protease inhibitor, in combination with pegylated interferon and ribavirin. The drug is under FDA review, with a target action date in the fourth quarter.

Merck & Co. Inc., of Whitehouse Station, N.J., reported data from the ongoing phase II C-WORTHY study testing its all-oral, once-daily regimen containing MK-5172, an investigational hepatitis C virus (HCV) HS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, in patients co-infected with HCV and HIV. At 12 weeks, 100 percent (29/29) of co-infected patients receiving the Merck combo plus ribavirin and 90 percent (26/29) of co-infected patients receiving MK-5172/MK-8742 alone had HCV RNA levels of less than 25 IU/mL vs. 100 percent (13/13) in patients with HCV alone treated with MK-5172/MK-8742. Data, which were presented at the Conference on Retroviruses and Opportunistic Infections in Boston, also showed a safety profile consistent with that observed for patients infected with HCV genotype 1 alone.