ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

Detailed Description
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In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments. However, recent studies show that it is possible to propose a new treatment optimized to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

Official Title
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ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

Conditions
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Hepatitis

Intervention / Treatment
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* Drug: Peg-interféron alpha 2a + ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Weight 85 kg below the pre-inclusion visit. Documented HIV infection (HIV positive) HCV infection documented by a positive PCR HCV Genotype 1 or 4 Compensated liver disease (Child-Pugh below/equal to 6) Lymphocytes CD4 above 200/mm3 Patient not answering a treatment for hepatitis C. Patient not covered by dual by Peg-IFN + riba for at least three months (wash out) Exclusion Criteria: Co-infection with HBV (HBsAg positive) Neutropenia below 1000/mm3 Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3. Hemoglobin below 11 g / dL (men and women) Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PegIFN- alpha 2a + RBV<br> | Drug: Peg-interféron alpha 2a + ribavirin<br>* Pilot study, multicenter, open label<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C. |  | W72 or W96 (depending of the end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze rapid virological response (W4) and early (W12). |  | W4 and W12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)