The University of Cape Town’s health sciences faculty has expressed ”extreme concern” over the threatened partial deregistration of the anti-retroviral nevirapine.
The dean, Professor Nicky Padayachee, and the directors of all five schools in the faculty said in a statement on Thursday that there was enough evidence to show that the drug was safe and effective for preventing mother-to-child transmission (MTCT) of HIV.
The statement reportedly also has the support of the several thousand staff members in the faculty.
The Medicines Control Council (MCC) last month rejected data from Ugandan trials on which the anti-retroviral’s registration for this purpose was based, and has given manufacturers Boehringer-Ingelheim 90 days to provide new safety evidence.
The UCT statement said though the Ugandan trial was initially questioned by the United States’s National Institutes of Health, and the Food and Drug Administration, it had since been accepted as valid by both bodies.
As recently as last month the World Health Organisation had issued a statement of continued support for nevirapine in MTCT-prevention programmes.
”Even if the validity of the Ugandan trial is not accepted by the MCC, there exists published and unpublished evidence elsewhere that Nevirapine is both safe and efficacious for the indication of preventing mother to child transmission of HIV,” the doctors said.
”We include here the results of the Saint (a trial at Chris Hani Baragwanath Hospital) trial as well as some smaller research projects undertaken here in South Africa.
”We believe that in considering the matter of nevirapine, the MCC should ensure it takes full cognisance of all available data on the matter.”
The doctors said they understood that the MCC had a mandate to control registration of pharmaceutical products.
But in doing so it should consider all relevant clinical data, constitutional commitments to health care for the most marginalised South Africans, and the wider socio-political context of the debate around mother-to-child HIV transmission prevention.
Any decision to deregister nevirapine would have an ”immeasurable” impact on the morale of HIV-positive women who had no alternative means of preventing the infection of their unborn babies.
It would also impact on the morale of the health workers who care for them and their babies, 30% of whom would now be born HIV-positive.
”We urge the Medicines Control Council to consider very carefully the implications of its decision and hope that it will not lead to the deregistering of a safe, cost-effective drug for the prevention of mother-to-child-transmission of HIV,” they said.
A cabinet statement said on Wednesday that government was studying the implications for its current Aids programmes of partial deregistration.
It was also considering what effect this could have on a Constitutional Court ruling last year that the drug should be provided to HIV-positive pregnant women at state hospitals.
”Whatever approach is adopted by government will be guided by its concern for the health of both mothers and babies affected with HIV,” the statement said. – Sapa