MCC drug decision to be debated

South Africa's AIDS conference to debate Medicines Control Council rejection of AIDS prevention drug

Robert Walgate(walgate@scienceanalysed.com)
Aug 4, 2003

South Africa's first national AIDS conference, which ends August 6, is to call an emergency session to debate a surprise decision by scientists to raise doubts about nevirapine, the one-shot treatment that is said to halve transmission of HIV during childbirth from mothers to their offspring.

Some 800,000 infants become infected with HIV each year worldwide, and 80,000 mothers in South Africa have already received the treatment, given as one dose at onset of labor. But South Africa's independent Medicines Control Council (MCC), composed of 10 committees with 146 members, last week announced that the Ugandan HIVNET012 study, on which claims for the efficacy and safety of nevirapine are based, "no longer meets regulatory requirements."

MCC had given the treatment provisional registration, but it announced on July 30 that "it is no longer valid for the MCC to continue to approve the use of nevirapine as a single...

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