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FDA Panel Unanimously Votes for the Approvability of Pegasys/ Copegus For the Treatment of Hepatitis C
Alan Franciscus

Today, the US Food and Drug Administration drug advisory panel voted unanimously by an 11 to 0 vote to recommend FDA approval of Pegasys (pegylated alpha 2a) and Copegus (Roche's ribavirin). Pegasys and ribavirin may be more effective than an older treatment, the U.S. Food and Drug Administration staff said. The FDA posted on its Web site the review of Roche's application (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3909b1.htm) to treat hepatitis C with its once-weekly Pegasys injections and the daily ribavirin tablet (Copegus) - Rebetol (Schering's ribavirin is in capsule form).

Pegasys study NV15801 was the study published recently in the NEJM (Fried) which showed that Pegasys/Copegus was significantly superior to Rebetron with an overall sustained virological response (SVR) of 53% versus 44% (p=0.001).

The predictors of response to treatment were genotype (genotype 1 was the poorest responding genotype), viral load (high viral load was defined as >2 million copies/ml and high viral load showed poorer outcome), age (older results in poorer response), advanced liver disease (cirrhosis - more difficult to treat) and body weight (obesity is linked to steatosis/diabetes and hyperinsulinemia - all of which contribute to poor treatment success). Patients with genotype 1 high viral load (HVL) had an overall SVR for Pegasys/Copegus versus Rebetron of 40% and 33% respectively, genotype 1 low viral load (LVL) 52% and 44% respectively, non genotype 1 HVL 70% versus 54% respectively and non genotype 1 LVL 70% versus 68% respectively.

Age has be known to be a poor predictor of response to treatment for hepatitis C and this was further demonstrated in the NV15801 data presented by Roche which showed that patients less than 45 yo had an overall SVR of 61% compared to an overall SVR of 41% for patients over 45 yo. The FDA further analyzed the Roche data and showed in this trial that patients less than 35 years had an overall SVR over 68%, patients between 35yo and 44yo had an overall SVR of 56%, patients between 45 and 54yo had an overall SVR of 43% and patients over 55yo had an overall SVR of 35%

Pegasys/Copegus in this trial was associated with a slightly higher incidence of overall serious adverse events (12% Pegasys/Copegus versus 9% for Rebetron). The incidence and degree of neutropenia and thrombocytopenia were higher in the Pegasys/Copegus group although the rates of resolution were very similar to Rebetron. Dose modifications were higher in the Pegasys/Copegus group versus Rebetron (32% versus 18%) however the incidence of treatment withdrawals was very similar.

Roche and the FDA also discussed the results of their second phase III combination trial referred to as the NV15942 which showed very similar SVR's to the NV15801. This trial demonstrated that for genotype 2/3, Pegasys/Copegus can be given for a shorter duration of 24 weeks with lower doses of ribavirin (800mg/day). The trial also demonstrated that genotype 1 patients require 48 weeks of treatment and ribavirin dosed 1000mg for patients <75kg and 1200mg for patients >75kg.

The combination of Pegasys and Copegus is expected to be FDA approved for marketing in early December 2002.

Copyright November 2002 - Hepatitis C Support Project - All Rights Reserved. Permission to reprint is granted and encouraged with credit to the Hepatitis C Support Project.

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