MTCT programmes in South Africa: nevirapine and the minister
Jonathan Berger and Nathan Geffen for HIV i-Base
Never one for passing up the opportunity to score a few cheap points, South Africa’s Minister of Health used the opening of the South African Department of Health’s exhibition at the XV International AIDS Conference in Bangkok on Sunday, 11 July 2004 to launch yet another unjustified attack on her most vocal and organised critic, the Treatment Action Campaign (TAC).
Claiming that new scientific evidence “vindicated” her original position on the use of nevirapine for the prevention of mother-to-child transmission of HIV (MTCT), Dr Manto Tshabala-Msimang sneeringly referred to the “pressure from some civil society organisations” that had caused the South African Constitutional Court to force the extension of the MTCT prevention “research programme”.
The following day, South Africa’s drug regulatory authority, the Medicines Control Council (MCC), issued a confusing press statement that referred to a 2 July 2004 meeting at which the MCC had recommended that nevirapine no longer be used as monotherapy for the prevention of MTCT. Failing to distinguish clearly between issues of resistance and efficacy, the MCC statement presented an inaccurate view of the risk of nevirapine resistance following its use for the prevenntion of MTCT. Most disturbingly, the MCC statement was silent on the implications of its recommendations for the public sector MTCT prevention programme that centres on the use of nevirapine monotherapy.
Shortly thereafter, TAC, Médecins Sans Frontières (MSF) and the AIDS Law Project called a public meeting in Bangkok to discuss the issue “from a scientific and human rights perspective.” Attended by activists, scientists, researchers, government officials and representatives of UNAIDS and the World Health Organization, the meeting provided an important forum for constructive engagement. A day later, the Minister issued a press release confirming that the South African government’s policy on the prevention of MTCT remained unchanged, with her department continuing to provide nevirapine as monotherapy “until new agreed upon treatment regimens are available.”
A study presented in Bangkok shows how the use of AZT and lamivudine in combination, taken by the mother for at least four days after the single dose of nevirapine, significantly reduces levels of resistance (see below in this issue of HTB for report on this study). But the best combination of medicines for reducing MTCT and avoiding resistance is triple-drug combination antiretroviral therapy, taken where this is medically indicated for the treatment of the mother herself and not simply for preventing MTCT.
With the introduction of treatment for AIDS into the South African public health service, it makes sense to keep as many antiretroviral drug options as possible open for pregnant HIV-positive women when they later develop AIDS. Therefore switching the MTCT protocol, wherever possible, to one that is more effective and results in less resistance, is rational, reasonable and in the interests of both mothers and the broader public.
So where does this take us? TAC’s stance, as articulated in numerous media interviews as well as written statements, has consistently been that regimens other than the single-dose nevirapine can and should be introduced into the public sector wherever possible. Where there is a current lack of capacity in a clinic, the single-dose nevirapine regimen is the minimum acceptable regimen for the prevention of MTCT. At the same time, clinics must be given the resources they need to be able to provide better regimens. Also, where an HIV-positive woman presents late to an antenatal clinic (during labour, for example), single-dose nevirapine might be the only regimen available to her. We trust that the Minister will follow this sensible approach.
This leaves one question unanswered: does the evidence on resistance “vindicate” the South African government’s original position on the use of nevirapine for the prevention of MTCT? Contrary to what the Minister asserted in her speech in Bangkok, the limited MTCT prevention programme adopted by government in late 2000 (prior to TAC’s court action) did not seek “to interrogate the use of nevirapine as a monotherapy”. Rather it sought to address certain operational issues, making no commitment to the universal rollout of the programme. Most disturbingly, the programme prohibited the prescription and use of nevirapine (or any other antiretrovirals) for the prevention of MTCT at any public health facility other than the 18 “pilot sites” at which the programme operated, regardless of the facility’s ability to administer the drug safely and effectively. Indeed, by the time the TAC initiated court action, many of the pilot sites had still not begun the programme.
The Minister of Health suggested that the TAC forced government to adopt the single-dose nevirapine regimen. While it is true that the TAC forced government to implement a countrywide MTCT prevention programme by taking the Minister to court, it is incorrect for her to claim that the TAC forced government to adopt the single-dose nevirapine regimen. This regimen was the Department of Health’s choice for its programme, despite knowing at the time that more effective regimens existed, usually involving AZT. This was arguably a reasonable choice though; single-dose nevirapine is simple to administer and a good starting point for the rollout of a universal MTCT prevention programme.
In its judgment, the Constitutional Court found that “the Constitution require the government to devise and implement within its available resources a comprehensive and co-ordinated programme to realise progressively the rights of pregnant women and their newborn children to have access to health services to combat mother-to-child transmission of HIV.” In particular, government was ordered, “without delay”, to “remove the restrictions that prevent nevirapine from being made available for the purpose of reducing the risk of mother-to-child transmission of HIV at public hospitals and clinics that are not research and training sites.”
The court also made it clear that the order relating to nevirapine does “not preclude government from adapting its policy in a manner consistent with the Constitution if equally appropriate or better methods become available to it for the prevention of mother-to-child transmission of HIV.” In other words, the order is not restricted to nevirapine, but rather refers to a comprehensive programme to prevent MTCT.
Has the Minister been vindicated? Clearly not! Knowing what we know now, we would still have gone to court. Many lives have been saved as a result of the intervention. A comprehensive MTCT prevention programme is now in place. Government has adopted a comprehensive policy on antiretroviral treatment and has started to implement it in the public sector. None of this would have happened without the “pressure from some civil society organisations” that the Minister continues to deride.
Jonathan Berger is the Head of Law & Treatment Access Unit, AIDS Law Project
Nathan Geffen is the National Manager, Treatment Action Campaign