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WASN adds its voice to the nevirapine monotherapy debate
Margaret Chinowaita, Women and AIDS Support Network (WASN)
Extracted from WASN Newsletter - March 2005
March 2005

WASN has added its voice to the ensuing debate on the use of Nevirapine in the Prevention of Parent to Child Transmission of HIV, which was reopened by South Africans last year at the HIV and AIDS conference in Bangkok,Thailand.

 In a statement, which was also made available to the press, WASN director Mary Sandasi said;

 “In response to the debate going on, on the use of Nevirapine for the Prevention of Parent to Child Transmission (PPTCT) program, WASN is concerned about the inaccuracy of information by certain individuals and groups. This has resulted in confusion and lack of confidence in the use of Nevirapine by HIV positive pregnant women. It is important to note that the Nevirapine being used in the PPTCT is used in minimum quantities, only once per pregnancy. Pregnancies are normally spaced over periods of two years and the single dose effect of Nevirapine would have disappeared in many cases.”

The advantages of using Nevirapine in developing countries outweigh the disadvantages in comparison to other ARV drugs used in PPTCT programs.

Sandasi said the administering of the drug is simple as the pill is taken at the onset of labour and it requires minimum supervision by health workers. In Zimbabwe, the expectant mother is given the tablet at 28 weeks to keep, so that, at the onset of labour, she can swallow the tablet. This is an advantage for rural women who have difficulty in accessing transport or who may resort to the “ox-drawn” ambulance (scotch-cart), which takes long to get the woman to the health centre.

In a wide-ranging interview with the head of AIDS and TB unit in the Ministry of Health and Child Welfare, Dr Owen Mugurungi said he supports the use of Nevirapine in the Prevention of Parent to Child Transmission of HIV programme.

Dr Mugurungi said the use of Nevirapine is appropriate in the Zimbabwean setting and also in other developing nations because usually pregnant women book late at the antenatal clinic. To prevent the transmission of HIV to the baby using other Anti Retroviral Therapy, the mother needs to book at least three months to allow her to take the drugs until she gives birth. But in Zimbabwe women book late making Nevirapine the only sound option because it is administered during labour.

Dr Mugurungi said some people are arguing that if a mother is given Nevirapine she will develop resistance to the drug for six months so it should not be administered to them. “This is an unfounded argument because she will only develop resistance for six months and there are many other ARVs that health professionals can choose from to manage the mothers HIV status.”

At the 15th International HIV and AIDS conference held in Bangkok, Thailand last year, the debate over the use of single dose Nevirapine re-opened when the South African Minister of Health, Ms Manto Tshabalala Msimang said the recent studies did not support the use of single dose Nevirapine in prevention of parent to child transmission of HIV (PPTCT). A day later the South African MCC (Medical Control Council) issued a confusing statement saying that it will “no longer recommend the use of Nevirapine monotherapy for the prevention of mother-to-child-transmission”. Rumours that the drug might be “de-registered” caused confusion among many South African delegates.

An emergency session was called to bring together activists, health professionals and government officials alike to clarify the status of Nevirapine. At this session, it was made clear that Nevirapine would not be deregulated as it plays an important role in triple combination therapy for adults living with HIV yet there was still much debate about the role Nevirapine monotherapy should play in PPTCT programmes.

Nevirapine is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. It is regularly prescribed as part of combination therapy for people living with HIV and AIDS. In addition, single dose Nevirapine (sd NVP) represents one of several prevention of PPTCT regimens, which are considered safe and effective by the World Health Organisation.

In this regimen, a single dose of Nevirapine is given to the mother at the onset of labour. Nevirapine rapidly crosses the placenta into the foetus with its effects lasting through the first week of life. The timing of its delivery to the mother during labour is important as up to two thirds of infants born with HIV are infected in the birth canal. The infant is given a single dose of Nevirapine within 72 hours of birth. The regimen is simple and low-cost, which makes it particularly attractive to PPTCT programmes in resource-limited settings.

Studies have shown that the regimen of NVP reduces the risk of HIV transmission to 13%, almost two-fold lower than a short course of zidovudine started during labour (Guay, et al, 1999). The safety of Nevirapine used in this way, as well as a combination of zidovudine and lamivudine has been repeatedly demonstrated (Moodly, et al, 2003).

Nevirapine has been registered in the USA, countries of the European Union and numerous other countries for use in combination therapy and for PPTCT prevention recommends Nevirapine for use among women in labour who have had no prior therapy. Nevirapine is also included on the World Health Organisation’s model list of essential Medicines for treatment and PPTCT purposes. The WHO and its partner United Nations agencies recommend that PTCT prevention using anti-retroviral regimens such as Nevirapine should be included in the minimum standard package of care for HIV-positive women and their children.

 Although considered safe and effective in reducing maternal-infant HIV transmission, there have been recent concerns about development of maternal NNRTI resistance following sd NVP. Speaking at the recent International HIV/AIDS Conference, Dr James McIntyre of the University of Witwatersrand in Johannesburg, South Africa reported that 39% of women had signs of NNRT resistance 6 weeks after receiving a single dose of Nevirapine although this decreases to about 14% by 6 months. He confirmed that the significance of the resistance following single dose Nevirapine is unclear and that more research is needed.

Emergence of NVP-resistant HIV-1 is more common among women with high baseline viral loads and low baseline CD4 cell counts (Morris, et al, 2004, Elshleman, et al, 2001). Recent studies suggest that the selection of this resistant virus may result in a less successful virological response if the mother (or infant) is later started on treatment containing NVP or another MNRTI. However, clinical (weight change) and immunological (CD4 count) outcomes have not been affected in studies reported to date.

Dr McIntyre also presented preliminary results of new research that suggest that the addition of a short course of combivir (zidovudine/lamivudine) to a single dose of Nevirapine can significantly reduce the likelihood of subsequent detection of NNRTI resistant HIV in the mother. The data comes from the Treatment Options Preservation Study (TOPS), which is conducting a randomised trial which they plan to enrol 300 mother-infant pairs in South Africa. In his presentation, Dr McIntyre presented 6-week follow-up data for the first 61 mothers and 68 infants. The study compares the outcome of NVP; sd NVP plus 7 days of Combivir. In the 4 and 7-day Combivir arms, mothers were also given twice-daily Combivir during labour, and infants were given Combivir (zidovidine 12mg/ lamivudine 6mg) twice daily within 6 hours of birth. Mothers were followed up at two and six weeks with safety assessments, plasma HIV viral loads and population sequencing for recognised NNRTI resistance genotypes.

In the sd NVP group, NNRTI resistance was identified in 9 of 18 women (50%) at six weeks postpartum. In contrast NNRTI resistance in the sd NVP plus 4 day Combivir group and the NVP plus 7-day Combivir group was 1 in 20 (5%) and 3 in 23 (13%), respectively.

Of the 68 infants for whom data were available, four had intrauterine HIV transmission and one infant became infected in the peri/post-partum period. With no serious treatment side-effects, the study seemed to suggest that the addition of short course Combivir to Nevirapine can reduce the risk of maternal-infant transmission of HIV and the development of NNRTI resistance. It is unclear how long Combivir treatment should be given and the significance of these findings for subsequent treatment efficacy needs to be established.

The results from studies on Nevirapine resistance are a cause for concern and studies that explore the use of combination therapy may prove to be useful. However much more research and data is needed to recommend changes in the use of Nevirapine in PPTCT programmes. For the time being, Nevirapine is needed in many resource-limited settings to reduce the transmission of HIV from the mother to her baby.

* Extracts of the story obtained from SAFAIDS News volume no. 3 of September 2004.   

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