Nevirapine: MCC changes tack
2004-07-12 19:17
Pretoria - The South African Medicines Control Council has changed its mind on the use of nevirapine to reduce the risk of transmission of HIV from mother to child.
The medicines regulator said in a statement on Monday: "The council believes 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 announcement follows on the heels of SA Health Minister Manto Tshabalala-Msimang saying at her arrival at the 15th World Aids conference in Bangkok, Thailand, that there was "ever-growing resistance against the prescription of nevirapine" for pregnant women who were HIV positive.
She also said there was a growing body of evidence that breast-feeding might be a better option for HIV-positive women than the formula milk the government provided 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, be used only in combination therapy.
Patients become resistant - MCC
"The approval of nevirapine as monotherapy for this indication, in April 2001, was conditional on monitoring of resistance and its impact on efficacy," the MCC added.
The MCC said significant numbers of mothers and babies built 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, said the MCC.
"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.
Combination therapy should be used
"The council's decision applies to all monotherapy interventions when used to reduce the risk of transmission of HIV from mother to child during labour.
" The council feels combination therapy should be considered for this indication."
It was not immediately clear from the statement what impact the decision would have on the health department's comprehensive plan for management, care and treatment of HIV/Aids.
- SAPA