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Boehringer Ingelheim Announces Interim Results Evaluating Virologic Response Rates in HCV/HIV Co-Infected Patients Treated with Faldaprevir
Date:3/4/2013

requent 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™ 4, respectively.

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.

"The interim virologic response rates from STARTVerso™ 4 in HCV/HIV co-infected patients, combined with the drug-drug interaction results of faldaprevir with common HIV medications, are encouraging as we continue toward our goal of developing new HCV
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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