Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients

Inclusion Criteria

• Have voluntarily signed the informed consent form.
• 18 years of age or older.
• Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
• HCV RNA plasma ≥ 10, 000 IU/ml at screening.
• HCV genotype 1-6.
• HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
• Stage F0-3, based on: hepatic elastography 500 cells/mm3; OR
• On a stable ART regimen (containing only permissible ART - see protocol section 3.2) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
• Negative pregnancy test at screening and baseline (females of childbearing potential only).
• All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.

Exclusion Criteria

• History of any of the following:
• Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
• Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
• Solid organ transplant.
• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
• Any of the following lab parameters at screening:
• ALT > 10 x ULN
• AST > 10 x ULN
• Direct bilirubin > ULN
• Platelets 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
• Pregnant or breastfeeding female.
• HBV infection (HBsAg positive).
• Use of prohibited concomitant medications as described in protocol section 5.2.
• Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
• Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
• Any investigational drug ≤6 weeks prior to the first dose of study drug.
• Ongoing severe psychiatric disease as judged by the treating physician.
• Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, propoxyphene, or alcohol, with the exception of a positive result (including methadone) associated with documented short-term use or chronic stable use of a prescribed medication in that class.
• Injecting drug use within the previous six months.
• Inability or unwillingness to provide informed consent or abide by the requirements of the study.