Protease inhibitor TMC435 administered with peginterferon/ribavirin may be an effective treatment for patients with chronic hepatitis C who had experienced little or no response to prior peginterferon/ribavirin treatment, according to results presented at the International Liver Congress in Barcelona, Spain.
In a phase 2b, double blind study, researchers randomly assigned 462 patients into seven groups receiving the following once-daily treatments:
- 100 mg TMC435 with peginterferon/ribavirin (P/R) for 12 weeks
- 100 mg TMC435 with P/R for 24 weeks
- 100 mg TMC435 with P/R for 48 weeks
- 150 mg TMC435 with P/R for 12 weeks
- 150 mg TMC435 with P/R for 24 weeks
- 150 mg TMC435 with P/R for 48 weeks
- P/R with a placebo for 48 weeks
All participants had chronic HCV) genotype 1 and had previously experienced relapse or null or partial response to one or more courses of P/R therapy. Evaluated factors included sustained virologic response (SVR) and the occurrence of adverse events.
SVR had occurred 24 weeks after treatment in 61% to 80% of participants among the six groups that received the drug, compared with 23% of patients in the control group (P<.001). Rapid response after four weeks was experienced by 53% to 68% of participants within individual groups, compared with 2% of placebo patients.
Viral relapse occurred in 6% to 18% of participants within the drug groups, compared with 44% in the control group. Discontinuation of treatment because of a lack of response or viral breakthrough occurred in 9% to 17% of patients in the drug groups, compared with 53% of the control group. Adverse events experienced by patients were similar across all groups. A mild, asymptomatic bilirubin increase was observed among patients receiving the treatment, with no difference in severity between the two dosages.
“Following treatment with TMC435 plus P/R, patients who failed previous P/R treatment exhibited significantly higher SVR24 rates compared with placebo, including difficult-to-treat prior null-responders with cirrhosis,” the researchers wrote. “TMC435 was well-tolerated in this population.”
For more information:
Zeuzem S. Abstract #2. Presented at: The International Liver Congress, April 18-22, Barcelona, Spain.