Hepatology Xagena

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SOUND-C3 study: all-oral Interferon-free combination achieved 95% viral cure rates in genotype-1b hepatitis C patients

New data from Interferon-free SOUND-C3 study were presented during the APASL Liver Week in Singapore. The Phase IIb study investigated the efficacy and safety of Faldaprevir and Deleobuvir plus Ribavirin in treatment-naïve patients with genotype-1b ( GT-1b ) hepatitis C virus ( HCV ), one of the most common types of HCV globally.

Results showed that 95% of genotype-1b ( GT-1b ) infected patients ( 19/20 ) who received Interferon-free combination therapy achieved viral cure after 16 weeks of treatment. 20% ( 4/20 ) of GT-1b patients in the study had liver cirrhosis, all of whom achieved viral cure. Viral cure was defined as a sustained viral response 12 weeks after completion of treatment ( SVR12 ).
In contrast, patients with genotype-1a ( GT-1a ) infection and host IL28b type CC ( n=12 ) had a lower viral response of 17% SVR12 ( 2/12 ), suggesting a need for treatment of greater intensity for this population.

Eliminating injectable Interferon from treatment regimens is a highly desirable goal in HCV management as it can be challenging for patients due to the long treatment duration and often severe side-effects. Up to 50% of patients may not be eligible for treatment with Interferon and many patients who are eligible cannot tolerate the side-effects.

In SOUND-C3, optimising treatment ( by removing a deleobuvir first day loading dose and reducing treatment duration to 16 weeks ) for GT-1b-infected patients resulting in higher efficacy compared with SOUND-C2.
The SOUND-C2 study, presented in November 2012 at the AASLD Congress, showed viral cure rates of up to 85% with different Interferon-free regimens of Faldaprevir, Deleobuvir and Ribavirin in HCV GT-1b infected patients.

Overall tolerability in the SOUND-C3 trial was good with three patients ( 9% ) discontinuing treatment due to intolerance, and mild rash or nausea being the most common side-effects.
Adverse events of a moderate or higher intensity were rare, with anaemia ( 16% ), fatigue ( 9% ), vomiting ( 9% ) and nausea ( 9% ) being the most frequent adverse events. ( Xagena )

Source: Boehringer Ingelheim, 2013