Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon
(PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients
infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed
treatment duration of 48 weeks is used.
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with
BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration
will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients
will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be
treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment
duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of
BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.