Safety of 3 study drug inhibitors for HCV

Full Name

Hepatitis C: A randomized, double-blind, controlled study to evaluate the efficacy and safety of the combination of ABT-450/ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naÃ¯ve adults with genotype 1a chronic hepatitis C virus (HCV) infection (PEARL-IV) (1_PRO00000737)

Description

Participants will be randomized to 1 of 2 study arms: Arm A will receive the study drugs ABT-450/r/267, ABT-333 and RBV for 12 weeks ; Arm B will receive the study drugs ABT-450/r/267 and ABT-333 plus a placebo in place of RBV for 12 weeks. There will be twice as many participants enrolled in Arm A as in Arm B. At each scheduled visit (approximately every 2 weeks), vital signs will be checked and blood and urine samples will be taken. Physical exams and ECGs will occur at the start and finish of the study, and questionnaires will be administered every 4 weeks. After 12 weeks, 2 more annual follow-up visits will be scheduled.

Eligibility

Inclusion Criteria

At least 18 years of age, but not older than 70
Confirmed chronic hepatitis C infection
Cannot have received prior antiviral treatment for hepatitis C infection
Must be able to sign and date informed consent, and adhere to study visit schedule
Cannot be pregnant or breastfeeding
Must agree to use 2 effective methods of birth control while on study and for 7 months after stopping study drug
Appropriate blood levels; no liver cirrhosis