The purpose of this study is to assess the effect of boceprevir in combination with peg-IFN and ribavirin to treat HCV. This drug combination was approved by the FDA for use in people with HCV but not for people infected with both HCV and HIV. This study will enroll people with and without HIV to determine if this treatment combination helps coninfected people as well. The results of the two groups will be compared. This might help us determine other factors, besides genotype and coinfection, that help predict response to HCV treatment.
In May 2011, boceprevir was approved by the US Food and Drug Administration (FDA) for the treatment of HCV. Unlike the previous medicines, boceprevir works by stopping the growth of the hepatitis C virus itself. NIH has an agreement with Merck & Co., Inc., the manufacturer of boceprevir, to provide boceprevir for this study.
The study will enroll 100 patients, 50 with HCV alone and 50 with HCV and HIV. All patients will receive interferon and ribavirin for the first four weeks; boceprivir will be added at week 4. The duration of treatment will be guided by the individual’s response to the treatment. Patients will be monitored regularly for HCV viral load, HIV viral load and CD4 t-cell count (if patient has HCV and HIV) and safety labs.
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Last Updated October 26, 2011
Last Reviewed October 04, 2011