Interim study results from STARTversoTM 4 presented today at CROI show that 80 percent of hepatitis C (HCV) patients also infected with HIV achieved early treatment success with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV). These patients have a high unmet medical need due to limited treatment options; up to 10 million people are co-infected with HIV and HCV worldwide and it is estimated that only around one-third of those diagnosed actually receive HCV treatment.
These interim results from STARTVersoTM 4, demonstrate early treatment success in a majority of patients regardless of whether they were treatment-naïve or relapsed after prior treatment for HCV. Patients who achieved early treatment success may be eligible for 24 weeks rather than the standard 48 weeks of treatment with PegIFN/RBV. Interim on-treatment data show that 84 percent of patients had undetectable levels of HCV at week 12 of treatment with this regimen.
"Several factors influence the likelihood of treatment success in HCV mono-infected patients, including personal genetic makeup, viral genotype and stage of liver disease. Co-infection with HIV contributes additional factors, including potential drug-drug interactions that influence treatment decisions and outcomes," said lead study Investigator Douglas Dieterich, MD, Professor of Medicine, Liver Diseases at Mount Sinai Medical Center, New York, NY. "The early virologic response data from STARTVersoTM 4 are encouraging, especially given the inclusion of patients with cirrhosis, and we look forward to the final trial outcomes."
A diverse range of patients, including the more challenging to cure, are being treated in this study; 17 percent have liver cirrhosis, an advanced form of liver disease, and 22 percent of patients had relapsed after previous treatment with PegIFN/RBV.
Additional data presented at this meeting examined the drug-drug interactions (DDI) of faldaprevir with commonly-prescribed HIV medications darunavir/ritonavir, efavirenz, and tenofovir. The three Phase I studies demonstrated that there was no clinically relevant effect of faldaprevir on these HIV medications.
"We are proud to present interim Phase III results from STARTVersoTM 4 in patients co-infected with HCV and HIV; the potential for a shorter treatment duration for these patients is important, particularly in reducing the length of time they are exposed to possible side effects associated with a year-long course of interferon," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "Patients with HCV/HIV co-infection have a high unmet clinical need. The encouraging efficacy results and manageable interactions with HIV medications suggest faldaprevir in combination with PegIFN/RBV could be a viable treatment option for this important patient population."
The most frequent adverse events (AEs) in STARTVersoTM 4 were nausea (37%), fatigue (33%), diarrhoea (27%), headache (23%), and weakness (22%). The safety results of this study were thus comparable to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.
Faldaprevir is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. Interferon-based therapy with faldaprevir is effective in a broad spectrum of genotype-1 patients. In addition to the results presented today, the ongoing Phase III trial programme, STARTVerso, evaluates faldaprevir combined with PegIFN/RBV in treatment-naïve and treatment-experienced genotype-1 HCV patients.
Mount Sinai Medical Center