Govt will continue to adapt WHO guides, says Xundu and minister
This is according to Dr Nomonde Xundu, head of the health department’s AIDS directorate.
The health department is facing growing criticism as activists, health workers, researchers and doctors question crucial omissions from South Africa’s revised PMTCT guidelines adding that it is out of step with international practice.
HIV Clinicians Society president Dr Francois Venter said it was impossible to understand why South Africa, which is well resourced compared to many other countries who had adopted the WHO guidelines, remained out of step with international practice.
‘We are a middle income country behaving like an economic basket case,’ said Venter.
However, Xundu has made it clear that South Africa does not see the need to implement all aspects of the 2006 WHO guidelines. Countries such as Rwanda, that are much poorer than South Africa, implemented the WHO guidelines two years ago. South Africa only adapted its outdated guidelines two weeks ago.
Xundu yesterday received backing from the health minister Dr Manto Tshababalala-Msimang who said ‘WHO guidelines are indeed guidelines and Governments develop their own protocols’.
‘The World Health Organisation guidelines are the minimum best practice for resource poor countries and we are definitely not resource poor,’ said Fatima Hassan, co-ordinator of the Joint Civil Society Monitoring Forum.
After many delays, the policy committee of the National Health Council, which includes the health minister and her provincial MECs, last month adopted a set of PMTCT guidelines.
Criticism centres around the failure to include any mention of the drug 3TC, which has shown to be a safe, effective and inexpensive addition to AZT as part of a ‘tail regimen’. The 2006 WHO guidelines recommend that a short course of 3TC be administered to the mother to reduce the risk of later nevirapine resistance.
Health minister Manto Tshabalala-Msimang has on many occasions expressed her concern about possible nevirapine resistance in women who have participated in PMTCT programmes.
In December South Africa’s top HIV paediatricians, some who served on a PMTCT expert committee appointed by Government, also wrote a letter to Xundu, setting out the overwhelming evidence for a tail regimen of 3TC to be included in the guidelines.
The doctors added that in light of the evidence around resistance, if the updated policy is released without adding in the tail cover, then the updated policy should acknowledge the fact that women starting High Active Antiretroviral Therapy (HAART) (within the first six months post-delivery following exposure to nevirapine) should be informed of the risk of failure of their HAART regimen and provisions should be made for an alternate regimen (drugs).
No mention has been made of this in the updated version.
Xundu acknowledged that an expert team had called for the addition of 3TC. ‘Even though this position is recommended by the WHO, there is no agreement among experts as to the risk/benefit analysis of this approach,’ Xundu claimed.
However, Hassan pointed out that medical schemes and community programmes have been using dual and triple therapy for some time ‘so it is unclear which experts are the ones who are not sure about the risks/benefits’.
Xundu said government’s National Essential Drug List Committee (NEDLC) was also not totally satisfied with the evidence presented and that the study sample presented was too small.
Hassan said it was unclear what the NEDLC was unsure of. ‘This is minimum best practice as already used in many countries,’ she said.
The new guidelines were also criticized for continuing to recommend that pregnant HIV positive women should not be referred for HAART until their CD4 count has dropped below 200.
Scientific evidence is showing that there are significant health advantages to placing women on HAART once their CD4 count reaches 350. Healthworkers report that if patients wait until their CD4 counts are 200 or below, they often present very ill and very little can be done to save them.
The health department’s expert committee had also recommended this higher cut-off and according to sources there was agreement that it would be 250 and reviewed soon. However, media statements indicated that it remained at 200.
Xundu said the ‘when to start’ debate around HAART had not been resolved internationally. ‘There are suggestions now that even the 350 threshold may be late,’ she said.
She said the WHO guidelines recommended commencement at 350 ‘where this can be done’.
She indicated that the national treatment guidelines were being reviewed to consider current evidence, but at this stage there was no specific biological reason to treat pregnant women differently regarding commencement of HAART.
Hassan said it was puzzling that the health department asked an expert committee to make recommendations, taking into consideration the WHO guidelines, only to ignore the outcome of their work.
Healthworkers have also expressed concern over a statement from the health department that the two drugs in the programme ‘ AZT and nevirapine ‘ are schedule 4 medicines and have to be prescribed by a medical officer after an appropriate assessment of the patient.
Up to now professional nurses and midwives are known to routinely administer nevirapine as many of Government’s PMTCT sites do not have permanent doctors. Xundu confirmed that only licensed (and HIV and AIDS trained in the case of the PMTCT programme) doctors, pharmacists and supervised pharmacy assistants can prescribe and/or dispense these drugs.
‘The health department is engaging the relevant statutory bodies to investigate ways of getting around this matter,’ Xundu said.
Xundu did not comment on claims that the National Strategic Plan targets for PMTCT had not been met last year and would not be reached in 2008.
The updated guidelines, supposed to be available in the first week of this month, were made available on the health department website yesterday. ‘ Health-e News Service.
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