Up to 82% of patients with hepatitis C achieved viral cure after 28 weeks’ treatment with a combination of Boehringer Ingelheim’s investigational antiviral agents – the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, according to results from the largest phase II trial of interferon-free treatment to date reported at this week’s International Liver Congress 2012 (18-22 April; Barcelona, Spain).
The SOUND-C2 study randomised 362 treatment-naïve patients to treatment with once daily BI 201335 plus BI 207127, with or without ribavirin, for 16, 28 or 40 weeks. Results reported during a late-breaking session showed that up to 82% of patients with two of the commonest genotypes of HCV (genotypes-1a CC and -1b) achieved viral cure after 28 weeks of treatment. Of all the patients studied, including those with the hardest to cure type of hepatitis C (genotype-1a non-CC), 68% achieved a viral cure.
“These data support the further evaluation of BI 201335, BI 207127 and ribavirin as an interferon-free regimen for the treatment of chronic HCV infection,” said lead investigator Stephan Zeuzem, professor of medicine at the Johann Wolfgang Goethe University Hospital, Frankfurt, Germany.
Standard treatment for hepatitis C is currently based on pegylated interferon plus ribavirin, but is effective in only about half of patients with chronic disease and the contraindications and severe side-effects associated with interferon, including depression, anemia, leukopenia and sepsis, can make treatment intolerable.
“Eliminating interferon from HCV treatment is an urgent need. Releasing patients from the side-effects and lengthy treatment commitment with interferon would be a huge advance,” said Professor Zeuzem. “Such treatments would minimise the impact of patients’ lives and may encourage them to start and stay on treatment, to achieve the ultimate goal of a virologic cure.”
Commenting on results from several trials with interferon-free regimens reported at the meeting, Mark Thursz, professor of hepatology at Imperial College London, UK, and secretary general of the European Association for the Study of the Liver, said: “I see a very rosy picture for patients with hepatitis C. Over the last 20 years, treatment has evolved from plain interferon to pegylated interferon and then to interferon plus ribavirin. We are now entering a different era – a revolution of treatment – with interferon-free regimens. These provide oral treatments with high rates of SVR [sustained virologic response].” He added that the development of interferon-free regimens would mean that groups of patients not previously able to tolerate treatment could now be treated.
Written By Susan Mayor