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

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; HIV Infections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00470210

2006-005554-74

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Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: Ribavirin (Copegus®) 1600 mg/day

Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

Drug: Epoetin β (450 UI/kg/week)