AEGiS-ATDN: Pegasys

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

Pegasys

Information Bulletin #15 - May 2002

Pegasys in Co-infected Patients - The second pegylated interferon alfa-2a (Pegasys) plus ribavirin is still in clinical trials. Half way into the 48-week study involving 133 HIV/HCV co-infected participants, the results are promising. When compared with conventional interferon alfa-2a (Roferon A) plus ribavirin, after 24 weeks in the study, 44% of the Pegasys-treated patients have no detectable HCV, compared with 15% in the conventional interferon group. When this response was combined with data obtained from liver biopsy, 53% of the Pegasys-treated patients compared with 37% of the Roferon-treated patients responded to treatment.

In the trial, total CD4 cell counts declined, but there were also no increases in HIV viral load. The Pegasys arm experienced toxicities, but discontinuation of treatment was not significantly different between the two groups. The outcome for co-infected people who are over 40 years old, CD4 count less than 200, with HCV genotype 1 (the harder to treat variety), and liver disease are less rosy. Only about 30% from this subgroup showed a significant response to Pegasys. The final 48-week result from this trial will give a more complete picture of this drug, as well as long-term effectiveness and side-effects associated with it.

PEG-Intron, the partially FDA approved HCV treatment showed similar effectiveness in non-HIV patients. One study (by Roche) shows that Pegasys plus ribavirin produced a sustained virological response (undetectable HCV viral load after 6 months) in 46% of patients with genotype 1 versus 42% for PEG-Intron plus ribavirin in a similar group of patients.

It is difficult to compare the two drugs when the data are drawn from different studies. A "head-to-head" trial that directly compares the two drugs is needed. Pegasys is expected to receive FDA approval this year, but the precise timing is unknown. See the update on PEG-Intron below. For ongoing news about HIV, HCV and co-infection with one or more hepatitis viruses we highly recommend the web site: www.hivandhepatitis.com .

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