Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring VIEKIRA PAK Read More

Key Inclusion Criteria

• Male or female at least 18 years of age at time of screening.
• Subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment
• Subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration
• Subject must have at least one of the following indicators of chronic hepatitis C virus infection prior to study enrollment: Positive anti-HCV antibody or HCV RNA > 10,000 IU/mL at least 6 months before screening, and positive for HCV RNA at the time of screening, or HCV RNA > 10,000 IU/mL at screening and liver biopsy consistent with chronic HCV infection
• Subject has a screening laboratory result indicating HCV genotype 1-infection

Key Exclusion Criteria

• Subject, if female is pregnant or is breastfeeding, of if male, with female partner who is currently pregnant
• Subject has positive test result for hepatitis B surface antigen or confirmed positive anti-HIV antibody test
• Subject received study contraindicated medications prior to study drug administration
• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug.
• Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
• Current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin including previous exposure to ABT450 (paritaprevir) , ABT-267 (ombitasvir) or ABT-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration
• Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
• History of solid organ transplant
• Evidence of cirrhosis
• History of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy
• Confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening
• HCV genotype performed during screening indicates infection with any genotype other than genotype 1
• Recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol