Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

Study Overview
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Brief Summary
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This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

Detailed Description
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The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d. The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d. The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

Official Title
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Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens

Conditions
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Hepatitis C, HIV Infections

Intervention / Treatment
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* Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
* Drug: Ribavirin (Copegus®) 1600 mg/day
* Drug: Epoetin β (450 UI/kg/week)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected patients coinfected with HCV genotypes 1 or 4 Persistent transaminase elevation Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d. Exclusion Criteria: Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks Patients with Child-Pugh B or C cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week) | Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week<br>* Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week<br>Drug: Ribavirin (Copegus®) 1600 mg/day<br>* Ribavirin (Copegus®) 1600 mg/day<br>Drug: Epoetin β (450 UI/kg/week)<br>* Epoetin β (450 UI/kg/week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL |  | 24 weeks after finishing treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum HCV-RNA titers |  | between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment | 
| Percentage of patients with serum HCV-RNA loads of < 50 IU/mL |  | at weeks 4, 8, 12, 24, and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ribavirin, non-responders, HCV co-infected patients, sustained virological response, Treatment Experienced