DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
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.
DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy
 of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of
 early chronic HCV genotype 1 infection in individuals with and without HIV infection.
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