quarta-feira, fevereiro 09, 2005
Pegasys aprovado para co-infectados VIH/VHC
Pegylated interferon alfa-2a, Roche’s Pegasys has been granted marketing approval by the European Commission for the treatment of hepatitis C virus in HIV-positive individuals. This is an extension of the drug’s earlier marketing approval for use in individuals monoinfected with hepatitis C virus.
Pegasys has been approved for use in combination with ribavirin for clinically stable individuals coinfected with HIV and hepatitis C virus. The European Commission’s approval follows last month’s Positive Opinion granted by the European Medicines Agency.
Approval of Pegasys for use in Europe is based upon the results of the APRICOT study, which found that overall, 40% of HIV - hepatitis C virus coinfected patients treated with Pegasys in combination with ribavirin achieved a sustained virological response after the completion of therapy, compared to 20% of individuals who received Pegasys monotherapy and 12% of patients who received standard interferon and ribavirin.
The study also yielded encouraging results for HIV patients coinfected with hepatitis C genotype 1, the hardest of the hepatitis C virus genotypes to treat, with 29% of genotype 1 patients achieving a sustained virological response compared to 7% of genotype 1 patients randomised to receive standard interferon and ribavirin.