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FDA has approved Pegasys and Copegus for the treatment of chronic hepatitis C in HIV patients


FDA ( Food and Drug Administration ) has approved Pegasys ( Peginterferon alfa-2a ) and Copegus ( Ribavirin ) for the treatment of chronic hepatitis C in patients co-infected with hepatitis C and HIV.

Hepatitis C has become the most frequent cause of liver disease in HIV patients, and may be a leading cause of death.

The FDA approval of Pegasys combination therapy for the treatment of HCV-HIV co-infected patients are based on results from the AIDS Pegasys Ribavirin International CO-infection Trial ( APRICOT ).

A total of 868 patients from 19 countries was randomized to receive either Pegasys 180 mcg once weekly plus Copegus 800 mg daily; Pegasys 180 mcg monotherapy once weekly ( plus placebo ), or conventional interferon alfa-2a ( Roferon A ) 3MIU three times a week in combination with Copegus 800 mg daily, all for 48 weeks.

Investigators have found:

- 40% of patients treated with Pegasys plus Ribavirin achieved a sustained virological response ( SVR ) compared with 20% of patients treated with Pegasys monotherapy and 12% of patients treated with conventional Interferon/Ribavirin.

- Genotype 1 patients treated with Pegasys plus Ribavirin achieved a four-fold increase in SVR compared with conventional Interferon/Ribavirin ( 29% vs 7% ).

- 62% of genotype 2/3 patients treated with Pegasys plus Ribavirin combination therapy achieved an SVR compared to 20% with conventional Interferon/Ribavirin.

- Treatment with Pegasys plus Ribavirin was associated with the greatest overall histological improvement, even in patients who do not achieve an SVR.

Source: Roche, 2005

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