Hepatology Xagena

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STARTVerso trial: treatment-naive patients with genotype-1 hepatitis C treated with investigational Faldaprevir and Pegylated Interferon / Ribavirin

The results from the pivotal Phase 3 STARTVerso trial of Faldaprevir in combination with Pegylated Interferon and Ribavirin ( PegIFN/RBV ) were presented.
In previously untreated patients with genotype-1 hepatitis C virus ( HCV ) who received once-daily Faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed ( SVR12 ). This is compared with 52% of patients receiving PegIFN/RBV plus placebo ( p less than 0.0001 ).

In addition, protocol-defined early treatment success ( ETS ) was achieved by 87% and 89% of patients treated with the Faldaprevir-based regimen ( 120mg or 240mg, respectively ), meaning they were eligible for an overall shorter treatment duration of 12 weeks Faldaprevir/24 weeks PegIFN/RBV.
Of those patients who completed treatment early, 86% and 89% ( 120mg or 240mg, respectively ) went on to achieve viral cure ( SVR12 ). This demonstrates that an overall treatment regimen of 24 weeks was sufficient to achieve viral cure in most patients, cutting treatment duration in half when compared to treatment with PegIFN/RBV alone ( 48 weeks ). A goal in HCV treatment innovation is to reduce the amount of time patients are exposed to treatment with Interferon.

STARTVerso included a diverse range of genotype-1a and 1b patients, including patients with compensated cirrhosis who are challenging to treat and cure.

Serious adverse events were experienced by 6% ( n=8 ) of placebo patients, 7% ( n=17 ) of patients receiving 120mg Faldaprevir and 7% ( n=17 ) of patients receiving 240mg Faldaprevir. Anemia ( 11%, 13%, 12% ), rash ( 6%, 8%, 9% ) and gastrointestinal issues ( 3%, 7%, 12% ) were the most common grade 2-4 adverse events in the placebo, Faldaprevir 120mg and Faldaprevir 240mg arms, respectively. No rash events were life-threatening; 1% of patients discontinued treatment in each study arm due to rash. Adverse events led to discontinuation of study medications in 4% ( n=5 ), 4% ( n=10 ) and 5% ( n=14 ) in the placebo, Faldaprevir 120mg and Faldaprevir 240mg arms, respectively. ( Xagena )

Source: Boehringer Ingelheim, 2013