Panel Backs Indication Extension For Retrovir

Wellcome has announced that its anti-HIV product Retrovir (zidovudine) may soon be available for use in reducing the risk of transmitting HIV from mother to infant, following a positive recommendation by the US Food and Drug Administration's Antiviral Drugs Advisory Committee.

Burroughs Wellcome, the US arm of the Wellcome group, said that under the protocol considered by the panel, the pregnant infected women would get Retrovir capsules during pregnancy (100mg/day) and intravenous injections of the drug during labor (2mg/kg loading dose followed by continuous infusion at 1mg/kg/hr until delivery). After delivery, the newborns would be dosed with Retrovir syrup.

The Committee based its recommendation on data from the ACTG 076 study, which involved 477 patients. Data from 364 patients were available for appraisal by the Committee. The trial concluded that the risk of transmission was 8.3% for the zidovudine-treated group, compared with 25.5% for those taking placebo. ACTG 076 was halted in February of this year following an interim review by an independent data safety and monitoring board due to its overwhelmingly positive findings, according to Wellcome.