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BI 201335 & BI 207127 and ribavirin shows good efficacy, including hepatitis C patients with cirrhosis
Liz Highleyman, 2012-05-15 08:40:00
An interferon-free regimen of the hepatitis C virus (HCV) protease inhibitor BI 201335, the non-nucleoside polymerase inhibitor BI 207127, and ribavirin produced sustained virological response in 68% of previously untreated genotype 1 hepatitis C patients, with favourable safety and efficacy among people with liver cirrhosis, researchers reported at the 47th International Liver Congress (EASL 2012) last month in Barcelona.
The advent of direct-acting antiviral agents for HCV has ushered in a new era of treatment, but many patients and providers continue to wait for interferon-free therapy.
In the Phase 2b SOUND-C2 trial, Stefan Zeuzem (JW Goethe University) and an international team of colleagues evaluated Boehringer Ingelheim's BI 201335 and BI 207127 without pegylated interferon. In a prior Phase 1b study (SOUND-C1), these two drugs plus ribavirin produced high rates of rapid virological response with no serious adverse events.
SOUND-C2 included 362 treatment-naive chronic hepatitis C patients. About half were men, almost all were white, and the average age was approximately 48 years. About 10% had cirrhosis and about one-quarter had the favourable IL28B CC gene pattern; approximately 40% had the more difficult-to-treat HCV subtype 1a, the rest 1b.
Participants were randomly allocated into five treatment arms. All received 120mg once-daily (QD) BI 201335, with varying dosing schedules of BI 207127, with or without 1000 to 1200mg/day weight-adjusted ribavirin:
- BI 201335 + 600mg three times daily (TID) BI 207127 + ribavirin for 16 weeks;
- BI 201335 + 600mg TID BI 207127 + ribavirin for 28 weeks;
- BI 201335 + 600mg TID BI 207127 + ribavirin for 40 weeks;
- BI 201335 + 600mg twice-daily (BID) BI 207127 + ribavirin for 28 weeks;
- BI 201335 + 600mg TID BI 207127 with no ribavirin for 28 weeks;
The primary endpoint was sustained virological response, or undetectable HCV RNA (< 15 IU/mL), 12 weeks after completion of therapy (SVR12), which is now regarded as a cure. (4-week SVR results were reported for the 40-week group, which was still being followed for SVR12.)
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