DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)

Kirby Institute

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: TPV/PEG-IFN/RBV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01743521

VHCRP1102

VX-950HCP4010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Group A - 8 weeks total therapy

Experimental group

Description:

8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy

Treatment:

Drug: TPV/PEG-IFN/RBV

Group B - 12 weeks total therapy

Experimental group

Description:

12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy

Treatment:

Drug: TPV/PEG-IFN/RBV

Group C - 24 weeks total therapy

Experimental group

Description:

24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy

Treatment:

Drug: TPV/PEG-IFN/RBV