HIV in South Africa: from research to policy
Antiretroviral drugs have become much cheaper over the past few years because of lobbying by activist groups, including those in South Africa. The manufacturers of nevirapine have offered the drug free over the next five years to countries in Africa to reduce vertical transmission. The costs to be incurred would therefore be the costs of establishing voluntary counselling and testing at antenatal clinics, including staff training and extra counsellors. Such costs may be considerable but need to be weighed against those of not providing this intervention (lives lost and treatment of HIV-infected children). Widespread counselling and testing would have additional benefits such as informing individuals about their infection status, which may prevent further sexual or perinatal transmissions.7 Counselling and testing is cost effective.8 Costing studies9,10 in South Africa have shown that antiretroviral therapy to prevent vertical transmission is cost effective.
Short-course regimens used to prevent vertical transmission have been shown in several studies2-4,11 to be safe with minimum side-effects. Follow-up of mothers and children many years after receiving zidovudine showed an acceptable safety profile.12 A decision analysis model13 has shown that nevirapine is beneficial even if its toxicity was up to 42 times that observed in clinical trials, and concluded that implementation of nevirapine should not be delayed by toxicity concerns.
Drug-resistance mutations in some mothers after a single dose of nevirapine are usually variants present at low frequency before the use of antiretroviral drugs, which are then selected and expanded when nevirapine is introduced. However, resistance does not affect the efficacy of antiretroviral prophylaxis to prevent vertical transmission, since these variants are not transmitted to the child, and they wane over time with absence of drug pressure.14 Drug resistance is not unique to HIV. As with tuberculosis and other infectious diseases, there needs to be good surveillance and monitoring for drug resistance.
Breastfeeding is a route of HIV transmission, but several strategies can minimise this risk.15 One solution is to replace breastfeeding with formula feeding. However, in the settings where many HIV-infected women live, formula feeding is not a safe alternative and the risk of HIV transmission is exchanged for the risk of mortality from diarrhoea and pneumonia.16 Counsellors need to advise mothers to understand the risks and benefits of breastfeeding and formula feeding so that they can make an informed choice. Women who choose to breastfeed can be assisted to make breastfeeding safer.15
The argument that nevirapine can only be used if women are not breastfeeding is not valid. Nevirapine used according to the HIVNET 012 regimen17 has its effect intrapartum and the reduction in transmission is obtained regardless of whether the mother is breastfeeding or formula feeding. The HIVNET 012 trial in Uganda18 showed that the acquisition of new infections due to breastfeeding at age 6 weeks to 12 months was not increased in the babies of mothers receiving nevirapine, the rate being similar to that in those of mothers who did not receive nevirapine.
The operational capacity to implement use of nevirapine already exists in several health-care facilities. It is ethically and morally unacceptable for government policy to preclude them from providing nevirapine in the best interests of their patients or instructing them to hold back until research at pilot sites is completed, since these pilot studies merely add to the substantial South African data already available on the experience of implementing antiretroviral prophylaxis to reduce vertical transmission.5,6,19 In settings with less capacity, less resource-intensive alternatives could be considered while resources and training are provided to address operational inadequacies. For example, although not universally accepted, the option of nevirapine for all pregnant women without HIV testing has been suggested, especially in high-prevalence settings.
Screening all pregnant women for anaemia, weight gain, syphilis, and rhesus factor is routine in the public health service. This capability serves as a foundation for a national programme to prevent HIV vertical transmission. Short-course antiretroviral therapies to prevent vertical transmission are being used successfully in the Western Cape.19 We applaud the provinces of KwaZulu-Natal and Gauteng for announcing that nevirapine will be widely available within the next few months.
In a developing country such as South Africa the few opportunities for controlling HIV spread need to be maximised. Over 5 million of the 42 million people living in South Africa are HIV-infected, and with more than half of these infections occurring in women, vertical transmission will continue to increase. There is a moral and public-health imperative to provide cost-effective interventions of known efficacy. The South African Government has an exemplary record by providing free immunisations against major childhood infections to children under the age of 6. The lack of a similar policy to prevent the single most common perinatally transmitted cause of mortality in children is of concern. In a recent court case the judge stated that "prohibiting the use of nevirapine outside the pilot sites in the public health sector is not reasonable and that it is an unjustifiable barrier to the progressive realization of the right to health care". The court ordered the government to provide a comprehensive national roll-out plan against vertical transmission by March 31, 2002. The government is appealing against this judgment.
As scientists and clinicians, we share a deep commitment to our patients and the public health of our nation. We have conducted and/or supported research aimed at decreasing vertical transmission. We remain fully committed to the implementation, within the broader government programme for AIDS prevention and care, of a national programme against vertical transmission, and to do further research in support of this goal. There is strong evidence in support of the use of antiretrovirals to reduce vertical transmission. The challenge remains in translating these research findings into policy and practice in South Africa.
*Salim Abdool Karim, Quarraisha Abdool Karim, Miriam Adhikari, Sharon Cassol, Matthew Chersich, Peter Cooper, Ashraf Coovadia, Hoosen Coovadia, Mark Cotton, Anna Coutsoudis, Win Hide, Greg Hussey, Gary Maartens, Shabir Madhi, Des Martin, John M Pettifor, Nigel Rollins, Gayle Sherman, Stanley Thula, Michael Urban, Sithembiso Velaphi, Carolyn Williamson
*University of Natal, Durban 4041, South Africa; Chris Hani Baragwanath Hospital; Stellenbosch University; University of Witwatersrand; University of the Western Cape; University of Cape Town; Southern African HIV Clinicians Society (authors listed alphabetically)
Source: The Lancet 359, 992 (2002)
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