Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: ombitasvir, paritaprevir/r, dasabuvir + ribavirin; ombitasvir, paritaprevir/r, dasabuvir
Intervention description: VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks; VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)
Intervention MeSH terms: Ribavirin; Ritonavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VIEKIRA PAK

Summary:

      This is a Phase IV, open-label, multi-center study to evaluate the real world sustained
      virological response rate, subject adherence, and subject reported outcomes during and after
      treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,
      with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
    

Eligibility criteria:

        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