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Vertical (mother-to-child) transmission of HIV in South Africa ranges from 19 to 36 per cent, depending on whether the child is breastfed or not.1 In 2000, the prevalence of HIV infection in antenatal clinic attendees in public health services was 24.5 per cent, and the government estimated that about 75,000 infants were born with HIV-1 infection in South Africa. About half these infections could have been prevented if short-course antiretroviral treatment had been available.2-6 The South African Government has claimed these interventions cannot be universally implemented because of cost, toxicity, drug resistance, breastfeeding, and the capacity of the health service to implement programmes.

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)

This article was reproduced with the kind permission of The Lancet.

To access linked references to The Lancet articles in the bibliography, register free with The Lancet.

References:

1 Coutsoudis A, Pillay K, Kuhn L, et al. Method of feeding and transmission of HIV-1 from mothers to children by 15 months of age: prospective cohort study from Durban, South Africa. AIDS 2001; 15: 379-87.

2 Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial . Lancet 1999; 354: 795-802. [Text]

3 Shaffer N, Chuachoowong R, Mock P, et al. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial . Lancet 1999; 353: 773-80. [Text]

4 Wiktor S, Ekpini E, Karon J, et al. Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Cote d'Ivoire: a randomised trial . Lancet 1999; 353: 781-85. [Text]

5 Gray G, McIntyre J, Jivkov B, et al. Preliminary efficacy, safety, tolerability and pharmacokinetics of short course regimens of nucleoside analogues for the prevention of mother-to-child transmission (MTCT) of HIV. 13th International AIDS Conference, Durban, South Africa, 2000: abstr TuOrB355.

6 Moodley D, Team SI. The SAINT Trial: nevirapine (NVP) versus zidovudine (ZDV) + lamivudine (3TC) in prevention of peripartum HIV transmission. 13th International AIDS Conference, Durban, South Africa, 2000: abstr LbOr2.

7 Coates TJ, Aggleton P, Gutzwiller F, et al. HIV prevention in developed countries . Lancet 1996; 348: 1143-48. [Text]

8 Sweat M, Gregorich S, Sangiwa G, et al. Cost-effectiveness of voluntary HIV-1 counselling and testing in reducing sexual transmission of HIV-1 in Kenya and Tanzania . Lancet 2000; 356: 113-21. [Text]

9 Wilkinson D, Floyd K, Gilks CF. National and provincial estimated costs and cost effectiveness of a programme to reduce mother-to child HIV transmission in South Africa. S Afr Med J 2000; 90: 794-98. [PubMed]

10 Soderlund N, Zwi K, Kinghorn A, Gray G. Prevention of vertical transmission of HIV: analysis of cost effectiveness of options available in South Africa. BMJ 1999; 318: 1650-56. [PubMed]

11 Musoke P, Guay L, Bagenda D, et al. A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-1-infected pregnant Ugandan women and their neonates (HIVNET 006). AIDS 1999; 13: 479-86. [PubMed]

12 Culnane M, Fowler M, Lee SS, et al. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women: Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA 1999; 281: 151-57. [PubMed]

13 Stringer JSA, Sinkala M, Rouse DJ, Goldenberg RL, Vermund SH. Effect of nevirapine toxicity on choice of perinatal HIV prevention strategies. Am J Public Health 2002; 92: 365-66. [PubMed]

14 Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS 2001; 15: 1951-57. [PubMed]

15 Coovadia HM, Coutsoudis A. Problems and advances in reducing transmission of HIV-1 through breast-feeding in developing countries. AIDScience 2001; 1: 1-12. [PubMed]

16 WHO collaborative study team on the role of breastfeeding on the prevention of infant mortality. Effect of breastfeeding on infant and child mortality due to infectious diseases in less developed countries: a pooled analysis . Lancet 2000; 355: 451-55. [Text]

17 Coutsoudis A, Goga AE, Rollins N, et al. Free formula milk for infants of HIV-infected women: blessing or curse? Health Policy Plan 2002; 17: 154-160. [PubMed]

18 Owor M, Deseyve M, Duefield C, et al. The one year safety and efficacy data of the HIVNET 012 trial. 13th International AIDS Conference, Durban, South Africa, 2000: abstr LbOr1.

19 Abdullah MF, Young T, Bitalo L, Coetzee N, Myers JE. Public health lessons from a pilot programme to reduce mother-to-child transmission of HIV-1 in Khayelitsha. S Afr Med J 2001; 91: 579-83. [PubMed]
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