On the final day of the South African AIDS Conference in Durban, a full plenary session discussed the use and licensing of nevirapine for the prevention of mother to child transmission (PMTCT) and brought some much-needed clarity to recent debates (as reported here and previously here)
The head of the South African Medicines Control Council (MCC), Precious Matsoso, assured the conference that nevirapine would not be banned and that the MCC did not have concerns about the safety of nevirapine, when given as a single dose to a pregnant woman and to a baby for PMTCT.
The MCC had a clear remit to consider the quality, efficacy and safety of drugs it registered, and not to consider whether or how they could be delivered or paid for. The MCC could never be expected to go gathering information about the drugs that it registers - of which there are literally many thousands - but had to operate on the basis of evidence provided to it by applicants. That evidence had to meet professional standards, broadly in line with those adopted by other agencies such as the FDA and EMEA, she said.
There continues to be a problem because, as previously reported, the MCC has concluded that there were serious deficiencies in the way the HIVNET 012 trial was carried out and documented by US NIH-funded researchers in Uganda. This means the MCC cannot accept HIVNET 012 for the purposes of registering nevirapine as proving the efficacy of the drug. and was continuing to seek further information from the applicant (Boehringer Ingelheim). If this is not provided, then wording which currently endorses the use of nevirapine for the prevention of mother to child transmission when the drug is sold in South Africa may have to be removed. [This drew the observation that more than 70 other countries do recognise the use of nevirapine in this way, on the basis of HIVNET 012, and none have so far considered changing this.]
The MCC is also not prepared to accept the South African SAINT study as proof of nevirapine's efficacy, because it used nevirapine in a slightly different way. [This drew the observation that it would have been helpful, had the MCC raised this objection when the SAINT protocols were submitted to them for review prior to the trial.]
On the other hand, as Prof Salim Abdool Karim observed, HIVNET 012 was so decisive, that no ethics committee could now allow it to be repeated with a placebo control group. This makes it very hard to see how the MCC's objections could be answered.
As Prof James McIntyre of the Chris Hani Bharagwanath Hospital in Soweto, Johannesburg, observed, experience from programmes which have now provided nevirapine to tens of thousands of women has shown that the drug may be even more effective than it appeared in HIVNET 012.
The speed at which nevirapine-based PMTCT programmes have now been rolled out across South Africa, and especially in KwaZulu Natal, could simply not have been achieved if the programmes had depended on other more dificult regimens. There is still some way to go before PMTCT programmes are universally provided in South Africa and neighbouring countries, even where that commitment has been made at a political level and is backed up by protocols and funding. There are some intensive evaluations of PMTCT programmes now under way, which might possibly help the MCC gain confidence in the strength of the HIVNET 012 findings, but routine record keeping by services is a relatively low priority, and would certainly not match even the levels achieved by HIVNET 012.
Later in the same session, Prof Salim Abdool Karim of the University of Natal in Durban observed that regardless of the MCC's rulings, nevirapine could continue to be used "off label" for PMTCT, in exactly the same way that ARVs are provided in South Africa to rape victims for post-exposure prophylaxis. [And, contrary to some recent local media reports, will continue to be provided with central government funding to cover the cost.]
Finally, speaking officially on behalf of all of the South African health ministers, the KwaZulu Natal Health Minister, Dr Zwele Mkhize, insisted that PMTCT programmes would continue to be rolled out across the nation.
If any researchers should happen to be in possession of further compelling evidence which could be presented in the next 90 days, they are invited to notify the Medicines Control Council of South Africa with a view to resolving this issue.