HCV-HIV Co-infected Patient Cohort in Thailand
Condition: Hepatitis C Infection; HIV
MeSH terms: Infections; Hepatitis C
Intervention: Peg-interferon + ribavirin under HIV physician supervision
Intervention description: Peg-interferon + ribavirin under HIV physician supervision
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; HIV; Thailand; pegylated interferon; ribavirin

Summary:

      This is a study of HCV treatment using the standard regimen of pegylated-interferon plus
      ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment
      will be implemented in conjunction with gastro-enterologists/hepatologists by internists
      responsible for the participant's HIV treatment.

      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life
      threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected
      patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV
      replication is suppressed on antiretroviral treatment.

      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows
      fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured
      are no longer contagious to other individuals, therefore widespread access to HCV treatment
      may contribute to the control of the HCV epidemic.

      A combination of injectable pegylated-interferon with oral ribavirin is currently the
      recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They
      are administered for 24 weeks in HCV mono-infected patients but need to be administered for
      one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV
      protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in
      patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter
      treatment.

      PRIMARY OBJECTIVE

      1. To determine the percentage of patients according to genotypes with sustained virological
      response 6 months after treatment discontinuation (SVR).

      HCV TREATMENT

        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)

        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of
           anemia.

      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a
      first part (starting in August 2014) and 45 patients in a second part, depending on funding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of chronic HCV infection for at least 6 months before study entry (at least
             one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least
             6 months before the HCV RNA load result)

          -  Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar
             equipment). During the first part of the study, priority will be given to patients
             with Fibrosis Stage F2-3.

          -  Negative pregnancy test (on the day of inclusion).

        Exclusion Criteria:

          -  Anemia and thrombocytopenia

          -  Severe liver damage, advanced stage cirrhosis or cancer

          -  Uncontrolled diabetes, Uncontrolled thyroid dysfunction

          -  Retinopathy

          -  Creatinine clearance <50 mL/min (Cockcroft)

          -  Disease associated with the immune system

          -  Significant heart problems

          -  Severe neuropsychiatric conditions Contra-indication to study treatment (including
             pregnancy or lack of effective contraception in the participant or female partner)

          -  Other exclusion criteria related to the use of ribavirin and peg-interferon

          -  Any conditions that, in the investigator's judgment, may compromise the follow up.