Medicines Control Council phases out Nevirapine monotherapy

South African activists are up in arms after an announcement by the Medicines Control Council (MCC) that the only drug used to prevent transmission of HIV from mother to child be phased out or used only in conjunction with other drugs.

Nevirapine has been used in the South African public health sector since 2001 when the MCC approved the drug as a monotherapy for prevention of mother-to-child transmission, conditional upon monitoring resistance and its impact on efficacy.

Studies have shown that a dose of Nevirapine given to infected pregnant women during labour, followed by a dose given to the newborn baby, can reduce transmission of HIV by up to 50 percent.

According to the MCC, Nevirapine is increasingly ineffective on its own, but is acceptable if used in combination with other antiretroviral drugs like Zidovudine (AZT).

"We will have to change in line with the recommendations of the MCC, and will have to have a meeting to see what the various options are and what is relevant in South Africa," health ministry spokesman Sibani Mngadi reportedly said.

Activists argue that it is wrong to blacklist a drug now available in cheap, generic form, which has been shown to help prevent mother-to-child HIV transmission.

Dr Ashraf Coovadia of the Paediatric AIDS unit at Coronation Hospital in Johannesburg told PlusNews that before Neviripine was available, 20 percent of children born to HIV positive mothers at the hospital were HIV positive.

"Providing Neviripine to HIV positive women has brought that number down to 9 percent," said Dr Coovadia.

According to Zachie Achmat, who heads the South African-based Treatment Action Campaign (TAC), "The government should not say 'Nevirapine is poison'", and thus spread "confusion among poor people".

The statement made by the MCC said "Council believes that the risk-benefit profile of Nevirapine monotherapy has changed and, therefore, no longer recommends its use for the use of mother-to-child transmission (PMTCT) of HIV", and added that the clinical significance of these findings required further investigation, "as efficacy of future treatment options in mothers or babies who had Nevirapine-resistant HIV might be compromised".

Coovadia warned: "While we look for other effective, safer options we mustn't remove the one thing that is protecting thousands of babies from contracting the virus. We must explore the long term implications of the resistance, but to simply take it away with nothing in its place is ludicrous and will surely double the transmission rate overnight."

Although the South African government announced the continent's biggest and most ambitious AIDS treatment programme last year, according to the health ministry only a fraction of those needing antiretroviral drugs are receiving them - about 5,000 people, or 0.09 percent of those infected.

South Africa has an estimated 5.3 million HIV-positive people - the highest number of infections in the world.