Interim study results from STARTverso 4 presented at CROI have shown that 80% of hepatitis C ( HCV ) patients also infected with HIV achieved early treatment success with Faldaprevir 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 STARTVerso 4 have demonstrated 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 PegInterferon and Ribavirin.
Interim on-treatment data have shown that 84% of patients had undetectable levels of HCV at week 12 of treatment with this regimen.

The most frequent adverse events in STARTVerso 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.

STARTVerso 4, an open-label, phase III study, includes 308 individuals co-infected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy, and were either HIV treatment-naïve or being treated with antiretroviral therapy. The trial includes patients with cirrhosis ( 17% had F4 cirrhosis or Fibroscan greater than 13 kPa ): Group 1: 12 or 24 weeks of Faldaprevir 240 mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV; Group 2: 24 weeks of Faldaprevir 120 mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV.

Source: Conference on Retroviruses and Opportunistic Infections ( CROI ), 2013

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