http://www.medicalnewstoday.com/medicalnews.php?newsid=19693Pegasys combination therapy approved for hepatitis C and HIV co-infection treatment in Europe
07 Feb 2005
Pegasys becomes the first and only hepatitis C treatment indicated for patients suffering from both HIV and HCV -
The European Commission has approved Pegasys (peginterferon alfa-2a (40KD)) in combination with ribavirin for the treatment of chronic hepatitis C (HCV) in clinically stable patients co-infected with HIV. This Commission Decision comes only one month after the Positive Opinion was granted by the European Medicines Agency (EMEA), and it is now the first hepatitis C treatment to be indicated in HIV-HCV co-infected patients in the European Union. Co-infection has emerged as a major public health concern with data suggesting that globally 30% of patients with HIV infection are also infected with HCV1,2,3.
“This new indication represents a major breakthrough in the treatment of patients infected with both HIV and HCV in Europe,” said William M. Burns, CEO of Roche's Pharmaceutical Division. “Roche has a strong heritage of developing anti-viral medications for hepatitis, and this new indication further reinforces our commitment to finding innovative solutions for patients with unmet medical needs.”
The approval of Pegasys combination therapy for the treatment of HIV-HCV co-infected patients follows the recent European Commission approval of Pegasys for the treatment of hepatitis C patients with persistently ‘normal' liver enzymes, as well as several approvals worldwide for Pegasys in the treatment of chronic hepatitis B with additional milestones expected for this leading hepatitis treatment throughout 2005.
The study on which the approval has been granted
The extension of the current label is based on the results of APRICOT (AIDS Pegasys Ribavirin International CO-infection Trial). APRICOT is the first and only international multi-centre prospective study evaluating the efficacy and safety of pegylated interferon combination therapy in HIV-HCV co-infected patients. Results from the trial were recently published in the peer-reviewed New England Journal of Medicine4.
According to Dr. Francesca Torriani, Associate Professor of Medicine, Antiviral Research Centre, University of California and the lead author of the APRICOT study, “It is clearly important that we treat these patients as we now know that the leading cause of death in HIV-HCV co-infected patients is liver disease as a result of hepatitis C. With great strides being made in potent antiretroviral therapy, allowing HIV-infected patients to live longer, we don't want to see those benefits disappear by the emergence of fatal liver disease.”
APRICOT Results
Investigators randomized 868 patients from 19 countries into APRICOT. Patients co-infected with HIV-HCV were randomized to receive either Pegasys 180 ěg once weekly plus ribavirin 800 mg daily; Pegasys 180 ěg monotherapy once weekly (plus placebo), or conventional interferon alfa-2a (Roferon® A) 3MIU three times a week in combination with ribavirin 800 mg daily, all for 48 weeks.
The key results of APRICOT were:
-- 40% of patients treated with Pegasys plus ribavirin achieved a sustained virological response (SVR, which is indicative of a cure) compared with 20% of patients treated with Pegasys monotherapy and 12% of patients treated with conventional interferon/ribavirin.
-- Genotype 1 patients, those with the most difficult to treat type of the virus, 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.
-- Pegasys plus ribavirin therapy effectively treated hepatitis C in patients with HIV-HCV co-infection being compatible with antiviral treatment and had a positive effect on the virological control of HIV infection.
-- In APRICOT, treatment with Pegasys plus ribavirin was associated with the greatest overall histological improvement, even in patients who do not achieve an SVR.
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there is more in the article, but to get it all in one post it was cut back. It is accessible thru the link provided above. Willy
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