Mother-to-child HIV prevention – the science, the costs, & the pilot programme

TAC was officially formed in December 1998 with the explicit aim to ensure that government implement a MTCT programme nationally, that government treat HIV/AIDS and that drug companies lower the prices of anti-retroviral drugs.”Our attempts to persuade government to act urgently on this matter, have been rebuffed,” the organisation said this week.

In July, attorneys for the Treatment Action Campaign wrote to the Minister and MECs for Health, requesting reasons why nevirapine was not being made widely available to prevent mother-to-child-transmission of HIV, as well as a clear national policy on MTCT prevention.

According to TAC, the Minister’s response was “unsatisfactory”. “We are committed to asserting legal and constitutional rights, when government fails to act on behalf of poor and vulnerable people,” TAC said.

According to the health department’s annual ante-natal survey held at clinics across the country in October last year, there is a 24,5% national prevalence rate among women attending ante-natal clinics in the public health services in South Africa. Information from this survey projects that there are about 4,7 million people in South Africa living with HIV/AIDS. Approximately three out of every 10 women with HIV give birth to a child with the virus.

SCIENCE AND EPIDEMIOLOGY

Several studies in South Africa and internationally, have found that there are numerous ways to prevent or decrease the transmission of the HI-virus from the pregnant mother to her child. In South Africa the Medical Research Council has estimated that 11% of new infections are as a result of mother to child transmission of HIV. In 1994 the findings of the Paediatric AIDS Clinical Trials Group were published.

These findings established that the provision of AZT after the first 14 weeks in pregnancy reduced the rate or MTCT by 67,5%. Consensus between government and civil society was that the regimen was unaffordable in the South African context at then prevailing market prices.

In 1998, the results of the Bangkok Perinatal AZT study (Thai study) found that MTCT could be reduced by 50% by using only 300mg AZT twice daily from the 36th week of pregnancy and 300mg every two hours during labour.

The results of the HIVNET 012 study (Uganda study) on Nevirapine in 1999 showed that a single 200mg tablet given to mothers in labour, followed by a single 2mg oral suspension to the newborns within 72 hours of delivery demonstrated similar results to short-course AZT (Thai study).

In 1999/2000, 1 306 pregnant women with HIV/AIDS participated in the South African Intrapartum Nevirapine Trial (SAINT study). The women were assigned two arms comparing 200mg Nevirapine during labour and one dose to mother and infant 24 to 48 hours after delivery with AZT and 3TC during labour and for one week after birth to mother and newborn infant.

The SAINT study demonstrated that HIV transmission from mother to child during birth could be reduced by more than 50%. A follow-up to the Uganda study showed that there might be a problem with resistance in a minority of women who take single dose Nevirapine. However, in a letter to the Health minister in June, TAC said that this resistance did not undermine the efficacy or safety profile of nevirapine for reducing MTCT in the majority of women with HIV/AIDS. The SAINT study confirmed that the drug costs for Nevirapine would be less than R30 per woman and child. Since then nevirapine’s manufacturer, Boehringer Ingelheim has offered the drug free to all SADC countries for a period of five years.

COSTS OF IMPLEMENTING MTCT PROGRAMMES

Looking at the costs of implementing MTCT programmes, researchers and scientists have found it to be a cost-effective and cost saving intervention.

In 1999, Abt Associates wrote that evidence strongly suggested that these programmes, while involving substantial cost, represented good value for money in both the private and public healthcare sectors.

In 1998 Neil Soderlund and Glenda Gray prepared a paper which stated that short-course AZT and formula feed was not only cost effective, but potentially also cost saving. Critically, the authors argued that an intervention that included counselling, testing, anti-retroviral medication and formula feed would cost the government less than 1% of the health budget.

In 1999 the MRC released a costing study on preventing MTCT that was summarised as follows:

– An estimated 64 398 paediatric HIV infections occurred from MTCT in South Africa in 1997 (11% of new infections).

– This study suggested that about 37% of infections from mother to child might be prevented through a national programme which includes short course AZT, infant milk formula and counselling.

– The estimated total cost of the national programme would be R160,54 million and is less than 1% of the national health budget or R3,73 per capital.

A costing study commissioned by the health department and released last year showed that a country-wide programme of nevirapine provision for MTCT would potentially save 14 000 babies from acquiring HIV at a cost of R87,5 million per year.

GOVERNMENT’S PRESENT POSITION

The Medicines Control Council approved nevirapine for use in MTCT programmes on April 18. Provinces received the go-head in June to give HIV positive women the drug, nevirapine at 18 pilot sites (two per province), to prevent them from passing the virus on to their babies. The health minister unilaterally delayed the implementation of the 18 provincial mother-to-child pilot programmes due to start on April 1, 2001 when she decided that they needed Cabinet approval. The Western Cape and Gauteng started their nevirapine programmes without waiting for the minister’s go-ahead. The pilot sites have been tasked to carry out routine data collection, operational research and look at the issue of resistance.

The following sites are currently running government’s MTCT pilots:

– Eastern Cape: Cecilia Makiwane, Frere and Rietvlei;

– Free State: Frankfort and Virgina;

– Gauteng: J Dumane, Natalspruit, Pretoria West and Kalafong;

– KwaZulu-Natal: King Edward, Prince Mshiyeni, Greys/Northdale, Edendale and Church of Scotland;

– Mpumalanga: Evander and Nkomazi sub-district;

– Northern Cape: De Aar and Galashewe;

– NorthWest: Tlhabane and Lehurutshe;

– Western Cape: Paarl and Gugulethu

– Northern Province

These pilots are scheduled to run for two years before expansion is considered.

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