DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TPV/PEG-IFN/RBV
Intervention description: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.
Intervention MeSH terms: Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Hepatitis C; Individualised therapy; Response-guided therapy; Telaprevir; PEG-IFN; Ribavirin; Hepatitis

Summary:

      To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin,
      Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of written, informed consent.

          2. HCV genotype 1 infection

          3. Quantifiable HCV RNA at screening and baseline (>10,000 IU/ml)

          4. Recent hepatitis C infection with an estimated duration of Infection >6 months and ≤
             18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the
             previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative
             within the 24 months prior to anti-HCV antibody positive result OR B) i) First
             anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute
             clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first
             positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable

          5. Compensated liver disease (Child-Pugh A)

          6. Negative pregnancy test at screening and 24 hours prior to the first dose of study
             drugs.

          7. If heterosexually active, a female subject of childbearing potential and a
             nonvasectomized male subject who has a female partner of childbearing potential must
             agree to use 2 effective contraceptives from screening onwards until 6 months (female
             subject) or 7 months (male subject) after RBV therapy has ended. Note: Hormonal
             contraceptives may be continued but may not be reliable during telaprevir dosing and
             for 2 months following cessation of telaprevir. Therefore, subjects should agree to
             use 2 effective non-hormonal methods of contraception during telaprevir combination
             therapy and for 2 months after the last intake of telaprevir. As of two months after
             completion of telaprevir hormonal contraceptives can again be used as one of the two
             required effective methods of birth control.

          8. Subject is judged to be medically stable on the basis of physical examination, medical
             history and vital signs.

          9. Adequate English to provide written, informed consent and to provide reliable
             responses to the study interview

        Additional inclusion criteria for HIV positive individuals

          -  Confirmed HIV infection > 6 months duration

          -  CD4 > 200 cells/mm3 and HIV < 50 c/ml on stable antiretroviral therapy (ART) at least
             3 months prior to treatment

          -  Or

          -  CD4 >= 500 cells/mm3 and HIV viral load (VL) < 100,000 not on ART

          -  If on ART must be taking a regimen containing an accepted* combination of the
             following drugs: tenofovir ( TDF), lamivudine ( 3TC), emtricitabine (FTC), efavirenz
             (EFV), abacavir (ABC), raltegravir (RAL), etravirine (ETV), rilpivirine (RIL),
             ritonavir boosted atazanavir (r/ATZ) * Combination must be supported by current HIV
             treatment guidelines

        Exclusion Criteria:

          -  Individuals considered by the study investigators to be unlikely to participate in
             intensive follow-up and/or unwilling to provide extra blood samples

          -  Current injecting drug use (any injecting within previous 4 weeks)

          -  Standard exclusions to Pegylated-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir
             (TPV) therapy