Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

Inclusion Criteria

• Willing and able to provide written informed consent
• Age ≥ 18 years
• Documented evidence of chronic HCV infection (HCV RNA positive)
• Participant is a resident of Bilaspur and can provide locator information that can be verified by one of the study staff
• If participant is co-infected with HIV, he/she must have a cluster of differentiation 4 (CD4) > 350 cells/mm3 and be either: 1) antiretroviral therapy (ART) naïve or 2) on ART be on a tenofovir-containing regimen. If a subject's CD4 drops below 350 cells/μl (current threshold for HIV treatment in India), he/she will be able to initiate ART but we will ensure that the subject starts on a tenofovir-containing regimen, which is currently the standard for persons newly initiating ART in India.
• Subjects must have the following laboratory parameters at screening:
• alanine aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)
• aspartate aminotransferase (AST) ≤ 10 x ULN
• Hemoglobin ≥ 10 g/dl for male and 9 g/dl for female subjects
• International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
• Albumin ≥ 3 g/dl
• Direct bilirubin ≤ 1.5 x ULN
• Creatinine clearance ≥ 30 ml/min as calculated by the Cockcroft-Gault Equation
• Alpha fetoprotein 3.25 indicated extensive fibrosis/cirrhosis.) Participants with a FIB-4 >3.25 will be referred to the medical gastroenterology department for further assessment for cirrhosis. If cirrhosis is ruled out by medical gastroenterology, participants can be rescreened for the study.
• A female subject is eligible to enroll in the study if it is confirmed that she is:
• Not pregnant or nursing
• Not of childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation (for ≥12 months) of previously occurring menses)
• Of childbearing potential (i.e., women who have not had a hysterectomy, both ovaries removed or medically documented ovarian failure). [NOTE: Women ≤50 years of age with amenorrhea will be considered to be of childbearing potential.] These women must have a negative urine pregnancy test at screening and a negative urine pregnancy test on the Baseline /Day 1 visit prior to randomization and agree to one of the following modes of contraception for the duration of treatment and 12 weeks thereafter.
• Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, sumptothermal, post-ovulation methods) is NOT permitted.

or

i. Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until the end of treatment. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.

• intrauterine device (IUD) with a documented failure rate of less than 1% per year
• female barrier method: cervical cap or diaphragm with spermicidal agent
• tubal sterilization
• vasectomy in male partner
• Subjects must be of generally good health as determined by the investigator.
• Subjects must be able to comply with the dosing instructions for study drug administration and be willing to complete the study schedule of assessments.

Exclusion Criteria

• Pregnant or nursing female
• Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, model for end-stage liver disease (MELD) 10 mg/day)
• Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit.
• Contraindications to PEG
• Known hypersensitivity to the metabolites or formulat