# \[e-drug\] PMTCT through ARV treatment of infants **URL:** https://talk.edrugplus.org/t/e-drug-pmtct-through-arv-treatment-of-infants/17395 **Category:** e-drug **Created:** [August 8, 2003, 4:17am UTC](https://talk.edrugplus.org/t/e-drug-pmtct-through-arv-treatment-of-infants/17395 "2003-08-08T04:17:18Z") **Posts on this page:** 1 **Page:** 1
### Author: ![E-drug](https://avatars.discourse-cdn.com/v4/letter/e/ecd19e/32.png) [@E-drug](https://talk.edrugplus.org/u/E-drug) #### Post date: [August 8, 2003, 4:17am UTC](https://talk.edrugplus.org/t/e-drug-pmtct-through-arv-treatment-of-infants/17395/1 "2003-08-08T04:17:18Z")
E-drug: PMTCT through ARV treatment of infants --------------------------------------------- [At a time when the safety of nevirapine for prevention of mother to child transmission (PMTCT) of HIV infection is being questioned in one part of Africa, a study in another part of Africa shows that it is possible to use nevirapine in infants for PMTCT. Wendy Holmes of the Burnet Institute has provided some thoughts on the implications of this study. BS] Some thoughts on the implications of the SIMBA study findings Wendy Holmes Womens' and Children's Health Specialist Centre for International Health Macfarlane Burnet Institute for Medical Research and Public Health P O Box 2284 Melbourne 3001 Australia holmes@burnet.edu.au Vyankandondera J, Luchters S, Hassink E, Pakker N, Mmiro F, Okong P, Kituuka P, Ndugwa C, Mukanka N, Beretta A, Imperiale M, Loeliger E, Giuliano M. Lange J. Reducing risk of HIV-1 transmission from mother to infant through breastfeeding using anti-retroviral prophylaxis in infants (Stopping Infection from Mother-to-child via Breastfeeding in Africa (SIMBA) study). Second International Aids Society Conference on HIV Pathogenesis and Treatment. Paris, 16 July 2003. The Simba study enrolled HIV positive pregnant women and followed up 397 infants in two hospitals in Kigali, Rwanda, and Kampala, Uganda. The pregnant women were given a short combined course of zidovudine (AZT) and didanosine (DDI) from 36 weeks to one week after delivery, and the infants were given, from birth, either lamivudine (3TC) or nevirapine during the full breastfeeding period plus an additional four weeks after weaning. Mothers were counselled to breastfeed exclusively and to stop breastfeeding between 3 and 6 months. Median duration of breastfeeding was 100 days. About 90% breastfed exclusively. At the end of the study, HIV transmission occurred in 1.1% of infants on 3TC and 0.6% of those on nevirapine. The researchers compared this to a background risk from breastfeeding of around 15%. This study uses different drugs for the mothers and the babies in order to prevent the risk of nevirapine resistance in the mothers after the first baby. Implications: It is important that we now have a study that shows it is possible for babies to receive prophylactic ARV drugs during lactation, and that these drugs are able, for some months, to protect against postnatal transmission of HIV. The study also demonstrated, as have other studies, that it is possible to achieve very high rates of exclusive breastfeeding through supportive counselling. However we should note that several factors may have contributed to the reduction in transmission of HIV in this study: � The mothers took a combination of ARVs for one week post-partum when we know the risk of postnatal transmission is greatest. � The babies were exclusively breastfed, which may reduce risk of postnatal transmission, (and possibly even 'mop up' some of the transmission that occurs at delivery). � Because the babies breastfed exclusively there is likely to have been a lower incidence of breast problems (engorgement, sub-clinical mastitis, cracked nipples) that we know contribute greatly to postnatal transmission . � The 3TC or nevirapine given to the babies during the period of lactation are also likely to have protected the babies against infection. Some questions we need to ask: � Why was median breastfeeding duration briefer than planned? � How difficult did the mothers find the prophylactic regimen? � How good was compliance with the regimen? � What were the characteristics of the mothers, especially in terms of viral load and immune status? (The "background risk" for comparison should not be assumed to be 15%. This is the additional risk of MTCT of HIV with mixed feeding for 24 months, when mothers have received no anti-retroviral prophylaxis. But these mothers received ARVP, and the babies were exclusively breastfed, for, on average, only 3 - 4 months. It is difficult to assess the additional benefit from the breastfeeding intervention since the 'background risk' depends on many variables, most importantly the maternal viral load. It is important to remember that in the Bangkok ZDV short course trial, and in the PETRA study, the placebo group had a transmission rate much lower than had been expected.) Even though the cost of the drugs may be relatively low, the services that need to be established to enable this intervention to be implemented successfully at scale are not cheap. This is a complex regimen, involving three different ARVs - there are significant logistical implications, in terms of ordering, storage and security. The complexity also raises potential problems in training health care workers in the necessary protocols, and giving them the ability to answer the different questions that will arise. Counsellors will also need careful training to enable them to communicate clearly with mothers, fathers and families. Care needs to be taken to ensure that the nevirapine syrup is given only to the baby and not taken by other members of the family who may have HIV-related illness. National policy makers will need to consider the implications for general resistance in future with an increased number of ARV drugs available in public hospital settings. At the same conference Dr. Charles Boucher presented worrying findings from the "Combined analysis of resistance transmission over time of chronically and acute infected HIV patients in Europe" study, which tested 1,633 patients from 17 European countries who had just been diagnosed with HIV and who had not yet been treated for it. About 9.6% of the patients were resistant to at least one of the three types of antiretroviral drugs that suppress the virus. Resistance to nucleoside reverse-transcriptase inhibitors was found in 6.9%; resistance to non-nucleoside reverse-transcriptase inhibitors in 2.6 %; and resistance to protease inhibitors in 2.2%. For those babies who become infected with HIV in utero or during labour, their HIV is likely to develop resistance to nevirapine, reducing their future treatment options. Establishing sound systems for the training, supervision and support of HIV and infant feeding counselors remains a priority. This is a rapidly changing field and there is a need for mechanisms to disseminate new findings and their implications to health care professionals, public health officials and counsellors. Changing drug regimens in existing PMTCT programs has considerable implications for staff, and for mothers and their families. Counsellors need to be consulted about their experiences. In general, mothers have been pleased when their babies have received medicine in the nevirapine regimen, in comparison with the short course zidovudine regimen in which the baby did not receive a drug. There is also potential for better post-natal follow-up of both mother and baby when mothers need to return for supplies of nevirapine for their baby. 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