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Comment on Ethics of PMTCT Research

Dear colleagues,

I was unable to attend the Entebbe meeting because of bad weather in Europe and late connecting flights. However, I would like to share some personal thoughts on some of the issues that I believe were discussed at the meeting. 

While there has been much progress to reduce the risk of HIV transmission in infants, and especially in the area of postnatal transmission, it is likely that a significant and relatively large number of infants will still become infected through breastfeeding or will die through inappropriate use of replacement feeds. Many factors will contribute to this situation including the ongoing failure to identify all HIV-infected pregnant women. However, among women who are known to be infected with HIV, there are knowledge gaps that if addressed could further reduce the risks of HIV transmission through breastfeeding and improve the survival of infants. These include:

  • How can health systems and community-based interventions support adherence to ARV drugs that reduce the risk of postnatal transmission and improve the health of mothers?
  • Which ‘medical’ interventions such as drug or other pharmacological approaches, or combination of interventions, can eliminate the risk of transmission through breastfeeding with the lowest adverse effect profile for the mother and infant and at reasonable cost?

Even with an increasing number of mothers receiving lifelong antiretroviral treatment, the rate of postnatal transmission in programs is likely to remain, at best, in the order of 2-3%. Uncertainty around the adherence of mothers to take or give ARVs, or whether women will remain in HIV care and treatment programs, or whether health systems will be able to consistently deliver ARVs for 12-18 months, mean that rates of postnatal transmission of 2-3% are probably best case scenarios. 

However, even if postnatal transmission among infants known to be HIV-exposed was consistently reduced to 1-2% this would arguably still represent a major public health problem and justify an effort to further reduce transmission and an ongoing research agenda to inform this. 

Consider other conditions of infancy that result in large scale screening programmes and public health interventions because they are viewed as significant public health problems. In the United States, Europe and private healthcare facilities in South Africa, screening of pregnant women is routinely offered for neural tube defect, Down’s syndrome and congenital hypothyroidism. In South Africa, the prevalence of these conditions is estimated to be between 1:1000–1:10 000, 1:600–1:1000 and 1:3000–1:3500 respectively. Yet HIV infection through breastfeeding even in the context of ARVs is likely to result in 1:100 or 1:50 infants being affected. Much more than NTDs, Down’s or hypothyroidism. 

Hence, while providing ARVs to mothers while breastfeeding dramatically reduces transmission and enables mothers to breastfeed much more safely and thereby protect the child from other infectious diseases, the research agenda is not over.

In December 2012, WHO convened a guideline review meeting to update current ARV recommendations for HIV-infected pregnant women, mothers and for their infants. Among the research priorities listed at the end of the meeting was to find more effective ARV interventions (and without adverse effects), or other interventions to prevent postnatal transmission of HIV. This would include the possibility of a vaccine that could protect infants and children while they breastfeed. 

WHO puts a high value on rigorous, robust and ethical research. Without this, the survival of mothers and infants will remain in jeopardy. Conducting research in children is frequently complicated but needs to be done - they should not be excluded from research. 

While recognising that HIV vaccine research raises some of the most complicated ethical questions, and especially among children, it is needed.  I sat on the Biomedical Research Ethics Committee of the University of KwaZulu Natal in Durban for 10 years before joining WHO 4 years ago, and I recall the angst with which these issues were debated in order to find good solutions.

Thank you for the opportunity to contribute to this discussion.

Please note that these are my personal views and do not represent an official WHO position.

Kind regards,

 

Nigel Rollins MD FRCPCh

Department of Maternal, Newborn, Child and Adolescent Health (MCA) 

World Health Organization

 

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