A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of
 multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072
 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
This was a Phase 2a, randomized, blinded, placebo-controlled, dose-ranging study in
 chronically, hepatitis C virus (HCV) genotype 1-infected participants designed to explore the
 safety, tolerability, pharmacokinetics, antiviral activity, as well as the evolution and
 persistence to resistance of ABT-450/r, ABT-333, or ABT-072. Participants were treated with
 ABT-450/r, ABT-333, or ABT-072 monotherapy for 3 days, followed by 81 days (12 weeks minus 3
 days of monotherapy) of ABT-450/r, ABT-333, or ABT-072 combined with pegylated
 interferon/ribavirin (pegIFN/RBV), followed by 36 weeks of pegIFN/RBV alone. Participants
 randomized to an ABT-450/r treatment group who achieved rapid virologic response (RVR) and
 had HCV ribonucleic acid (RNA) levels < 25 IU/mL at all subsequent visits were eligible to
 stop pegIFN/RBV therapy on or after Week 24.
Inclusion Criteria:

 -  Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level
 greater than or equal to 100,000 IU/mL) at screening

 -  Liver biopsy within 3 years with histology consistent with HCV-induced liver damage,
 with no evidence of cirrhosis or liver pathology due to any cause other than chronic
 HCV

 -  Treatment naïve male or female between the ages of 18 and 65

 -  Females must be post-menopausal for more than 2 years or surgically sterile

 -  Negative screen for drugs and alcohol

 -  Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus
 antibodies (anti-HIV Ab)

 -  No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers
 or inhibitors within 1 month of dosing

 -  Be in a condition of general good health, as perceived by the investigator, other than
 HCV infection

 Exclusion Criteria:

 -  Significant sensitivity to any drug

 -  Use of herbal supplements within 2 weeks prior to study drug dosing

 -  History of major depression within 2 years

 -  Prior treatment with any investigational or commercially available anti-HCV agents

 -  Abnormal laboratory tests