March 4, 2013
Today Boehringer Ingelheim Pharmaceuticals, Inc. announced the first interim results in HCV/HIV co-infected patients from the company's ongoing hepatitis C (HCV) clinical trial program, HCVerso
. These results, from the Phase 3 trial STARTVerso
4, were presented today at the 20
annual Conference on Retroviruses and Opportunistic Infections (CROI) in
The interim results showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS)*, as defined by the study protocol, when given an investigational HCV regimen that included faldaprevir (BI 201335). Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment with pegylated interferon and ribavirin (PegIFN/RBV). Patients who achieved ETS were eligible for randomization to a shortened duration of treatment (24 weeks versus 48 weeks). Investigators also reported on-treatment virologic response at week 12, which showed that 84% of all study patients had undetectable levels of hepatitis C virus.
"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
, MD, Professor of Medicine, Liver Diseases at Mount Sinai Medical Center,
New York, NY
. "The early virologic response data from STARTVerso
4 are encouraging, especially given the inclusion of patients with cirrhosis, and we look forward to the final trial outcomes."
The most frequent adverse events (AEs) in STARTVerso
4 were nausea (37%), fatigue (33%), diarrhea (27%), headache (23%), and weakness (22%). Serious AEs were reported in 32 patients (10%), including three deaths. To date, 18 patients have discontinued study participation due to AEs. The safety results of this study were comparable to those observed in HCV mono-infected treatment-naive patients in prior faldaprevir clinical studies. No patient on ART experienced a loss of HIV viral suppression during the study period.
In a separate oral presentation at CROI, investigators described the results from three open-label Phase 1 studies in healthy volunteers that evaluated the drug-drug interactions of faldaprevir with the common HIV medications darunavir/ritonavir, efavirenz, or tenofovir. In each of these studies, there was no clinically relevant effect of faldaprevir on the pharmacokinetics of any of the HIV medications studied. However, the respective effects of darunavir/ritonavir and efavirenz on faldaprevir informed the study design of STARTVerso
4. Patients already taking darunavir/ritonavir or efavirenz were enrolled into the 120mg and 240mg faldaprevir groups in STARTVerso
These drug-drug interaction findings are part of a comprehensive program to evaluate potential drug interactions of faldaprevir with other medications commonly taken by the diverse patient populations infected with HCV. Most AEs in the drug-drug interaction studies were mild or moderate and all were resolved by the end of the trials. Four healthy volunteers discontinued trial participation due to AEs, including mild or moderate rash, mild elevation in hepatic enzyme levels, or moderate myalgia.