Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients

Study Overview
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Brief Summary
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Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Official Title
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Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment

Conditions
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HIV Infections, Hepatitis C, Chronic, Treatment Failure

Intervention / Treatment
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* Drug: Peginterferon alfa2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy Signed informed consent Exclusion Criteria: Chronic hepatitis B Alcohol consumption>40g/day Evidence of decompensated liver disease Hepatocellular carcinoma Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Peginterferon alfa2a|nan|
|Drug: Ribavirin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level |  | 24 weeks after the end of anti-HCV treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a virological response |  | at weeks 24 and 48 | 
| Safety of treatment |  |  | 
| Influence of anti-HCV treatment on CD4 count and HIV RNA |  |  | 
| Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use, Ribavirin/adverse effects, Drug Therapy, Combination, Treatment Experienced, Treatment Naive