IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: Ribavirin (RBV); BI 201335 (Faldaprevir); Ribavirin (RBV); BI 207127; BI 201335 (Faldaprevir); Ribavirin (RBV); BI 207127; Faldaprevir (BI 201335); BI 207127
Intervention description: 24 weeks of active RBV; 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335; 24 weeks of active RBV; 24 weeks of BI 207127; 24 weeks of BI 201335; 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin; 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127; 24 weeks of 201335; 24 weeks of BI 207127
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 470.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at
             screening in addition to at least one of the following:

               1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or

               2. liver biopsy typical of chronic hepatitis C , or

               3. history of elevated ALT at least 6 months prior to screening.

          -  HCV infection of sub-GT1b confirmed by genotypic testing at screening

          -  Treatment naïve defined as:

               1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin
                  and

               2. no prior treatment with at least one dose of any other licensed or
                  investigational antiviral agent for acute or chronic hepatitis C infection

          -  Plasma HCV RNA > or = 1,000 IU/mL at screening

          -  Liver biopsy within three years or fibroscan within six months prior to randomization.
             Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.

          -  Age 18 to 75 years

          -  Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to
             randomization

               1. with documented hysterectomy, or

               2. who have had both ovaries removed, or

               3. with documented tubal ligation, or

               4. who are post-menopausal with last menstrual period at least 12 months prior to
                  screening, or

               5. of childbearing potential with a negative serum pregnancy test at screening and a
                  negative urine pregnancy test on Day 1 (Visit 2), that agree to use two
                  non-hormonal methods of birth control from the date of screening until months
                  after the last dose of ribavirin. They must not breast-feed at any time from the
                  date of screening until 7 months after the last dose of ribavirin. Medically
                  accepted methods of contraception for females in this trial are diaphragm with
                  spermicide substance, intrauterine devices, cervical caps and condoms.

        OR:

        Male patients

          1. who are documented to be sterile, or

          2. who consistently and correctly use a condom while their female partners (if of
             child-bearing potential) agree to use one of the appropriate medically accepted
             methods of birth control from the date of screening until 7 months after the last dose
             of ribavirin, and

          3. without pregnant female partners. It is in the responsibility of the male patient to
             ensure that his partner (or partners) is not pregnant prior to enrolment into the
             study or becomes pregnant during the treatment and follow-up phase. Female partners of
             childbearing potential must perform monthly pregnancy tests from the date of screening
             until 7 months after the last dose of ribavirin (tests will be provided by the
             sponsor).

        Exclusion criteria:

          -  HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at
             screening.

          -  HCV subtype 1a, mixed 1a/1b or GT1 undefined

          -  Evidence of liver disease mainly due to causes other than chronic HCV infection such
             as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's
             disease

          -  HIV-1 or HIV-2 infection

          -  Hepatitis B virus (HBV) infection based on presence of HBs-Ag

          -  Evidence of decompensated liver disease, or history of decompensated liver disease,
             defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,

          -  International Normalized Ratio (INR) > or =1.7

          -  Serum albumin < 3.3 g/dL

          -  Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect
             ratio >1, unless history of Gilbert's disease

          -  Active or suspected malignancy or history of malignancy within the last 5 years (with
             the exception of appropriately treated basal cell carcinoma of the skin or in situ
             carcinoma of the uterine cervix)

          -  Patients with ongoing or historical photosensitivity or recurrent rash