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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
Ribavirin (Copegus®) 1600 mg/day
Epoetin β (450 UI/kg/week)
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
Time frame: 24 weeks after finishing treatment
Changes in serum HCV-RNA titers
Time frame: 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
Time frame: at weeks 4, 8, 12, 24, and 48
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