The South African Medicines Control Council (MCC) has changed its mind on the use of nevirapine alone to reduce the risk of transmission of HIV from mother to child.
It now recommends the medication being used as part of a combination of pharmaceuticals to prevent mothers infecting their children with HIV at birth.
”Council believes that the risk-benefit profile of nevirapine monotherapy has changed and therefore no longer recommends its use for the prevention of mother-to-child transmission [PMTCT] of HIV,” the medicines regulator said in a statement on Monday.
The announcement follows on the heels of Minister of Health Manto Tshabalala-Msimang saying at her arrival at the 15th World Aids conference in Bangkok, Thailand, that there is ”ever-growing resistance against the prescription of nevirapine” for pregnant women who are HIV-positive.
She also said there is a growing body of evidence that breast-feeding may be a better feeding option for HIV-positive women than the formula milk that the government provides as part of its programme to prevent mother-to-child transmission of the virus.
At a meeting on July 2, the MCC recommended that nevirapine and zidovudine (AZT), previously approved for monotherapy in PMTCT, only be used in combination therapy.
”The approval of nevirapine as monotherapy for this indication, in April 2001, was conditional upon monitoring of resistance and its impact on efficacy,” the MCC added.
The MCC said significant numbers of mothers and babies build up resistance to nevirapine when exposed to it as a monotherapy to reduce the risk of the child contracting HIV from its mother during birth.
Recent studies conducted in South Africa, using nevirapine as a monotherapy for this purpose, showed up to half of patients treated became resistant to the medication, the MCC said in a statement.
”The clinical significance of these findings needs further investigation as the efficacy of future treatment options in mothers or babies who have nevirapine-resistant HIV may be compromised,” the regulator added.
”Council’s decision applies to all monotherapy interventions when used to reduce the risk of transmission of HIV from mother to child during labour. Council is of the view that combination therapy should be considered for this indication.”
It was not immediately clear from the statement what impact the decision will have on the Department of Health’s Comprehensive Plan for the Management, Care and Treatment of HIV and Aids.
Treatment Action Campaign (TAC) spokesperson Mark Heywood said there is nothing startling in the report as it has been known for four or five years now that nevirapine by itself is not the most efficient medication for PMTCT.
”Monotherapy using nevirapine has always been the choice of [the] government and we’ve supported it as it was better than nothing at all,” he said.
He said the TAC cautions against the Department of Health moving from monotherapy based on nevirapine to combination therapy before making sure the latter is fully in place.
Despite its pitfalls nevirapine reduces the infection rate of newborns from 30% to about 10%, meaning a single dose of nevirapine or AZT is still better than nothing at all, Heywood said. — Sapa