MCC Presentation on Nevirapine Concerns

Cheryllyn Dudley MP (ACDP)

Friday, 16 August 2002


The Health Portfolio Committee heard today in Parliament that Nevirapine is still registered for treatment of HIV/Aids, that it is not banned and that it is still approved for indication of “reduction of the risk of intrapartum transmission of HIV –1 from mother to child. ”Nevirapine like AZT is one of the 17 available options for the treatment of this indication, and that review of HIVNET012 is ongoing. The MCC also confirmed that if they did not approve Nevirapine due to data irregularities, they would not prevent “off label use” as is the situation with mysoprostal the abortion drug which is not registered but widely used.

HIVNET 012 was a Nevirapine study done in Uganda, which established the efficacy of Nevirapine. According to Dr Jonathan Levin of the MCC, studies indicated that, whereas other anti-retroviral treatment resulted in 6 to 9 out of 100 babies born to HIV positive mothers being HIV Positive, Nevirapine treatment resulted in 12 to 13 out 100 babies being HIV positive and where no anti-retrovirals were used 16 to 18 babies out of 100 were HIV positive. He also pointed out that 10 to 12 babies out of 100 were later infected if breastfed.

“The South African Study, SAINT, according to Dr Levin, was inconclusive and does not show Nevirapine to be effective or ineffective,” said Mrs Dudley MP for the African Christian Democratic Party and Health Portfolio Committee member. Dr Levin referred to the findings as disappointing, but said that investigators found “no undue safety concerns, ” said Mrs Dudley.

The MCC Registrar said that while the EU has now fully approved Nevirapine only 10% of HIV positive mothers in the USA use Nevirapine. Mrs Dudley asked the registrar whether the low cost of Nevirapine as opposed to the cost of other treatments was not an important issue for South Africa. Mrs Dudley said, “It was likely that women in the USA choose to use other anti-retroviral treatments above Nevirapine as cost was not a factor, whereas in South Africa the cost of providing treatment is very much a factor which the department and the Minister have referred to often.” The MCC said this was a political issue, which they were not concerned with.

The MCC said they have a responsibility to constantly monitor and review their decisions and that their renewed concerns about Nevirapine stem from evidence of questionable data integrity on the Ugandan study. Issues such as resistance, lack of reporting by doctors and nurses on adverse reactions, and standards when administering the treatment were also a concern.

“On the facts presented by the MCC we must commend the MCC on their vigilance and commitment to risk reduction and quality assurance. In spite of concerns previously expressed, that government policy appeared to be having undue influence on the MCC, this would be a good time to give them benefit of the doubt. I for one however, am pleased that media and public pressure are balancing the effect of political pressure in a situation where the registrar is appointed by the Minister who is particularly sensitive and defensive over this issue,” said Mrs Dudley.


--------------------------------------------------------------------------------
For further comments please call Cheryllyn Dudley MP at 082 890 6520 or ACDP Media Liaison Liza Bloemetje at 082 478 1037