13/04/05

HIV/AIDS drug for newborns declared safe

Copyright: UNICEF

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An independent study has rejected claims that research on a drug commonly used to prevent mother-to-child transmission of HIV was flawed.


The original research, conducted in Uganda in 1997, had supported use of the drug nevirapine, but reports later suggested that poor record keeping put its conclusions into question.


Last week (8 April), the Institute of Medicine, Washington DC, United States, published an independent assessment of the Ugandan trial, declaring that it was “both scientifically sound and ethically implemented”.


The Ugandan drug trial was funded by the US National Institutes of Health (NIH) and conducted by researchers from the United Kingdom, the United States and Uganda, led by Laura Guay of Johns Hopkins University, United States.


In a paper published in The Lancet in 1999, the researchers had concluded that nevirapine reduced the risk of HIV transmission to babies by nearly 50 per cent during the first 14-16 weeks of their life.


Since then it has widely been used in developing countries to prevent the transmission of HIV from mothers to their children during pregnancy and childbirth, or through breastfeeding.


In 2003, however, reports emerged in the media suggesing that the validity of the study’s results was questionable.


The allegations stemmed from concerns expressed internally at the NIH about the way data was recorded during the trial. An NIH investigation into the trial later that year concluded that although it was “not perfect”, the trial’s results were valid.


Several international scientists and HIV/AIDS activists also stood by the trial’s finding, especially after independent studies in South Africa, Malawi and Thailand confirmed the results.


Yet doubts remained. In December 2004, Arthur Ammann, president of Global Strategies for HIV Prevention, a US-based non-profit organisation, told Nature that some mothers in Africa were refusing to take nevirapine because of the bad press it had received (see Scientists defend use of AIDS drug). 


In an effort to put these claims to rest, the NIH commissioned the Institute of Medicine to conduct an independent review of the trial’s design and methodology.


The institute’s review committee assessed information from the original researchers and the NIH, and from previous audits of the study.


To test the study’s results independently, the committee also examined medical records for 49 of the 496 babies involved in the trial.


The committee did find some discrepancies. Some side effects of the drug, such as pneumonia and fever, had not been reported, and some participants’ consent to take part in the study had not been fully documented.


But the committee found no evidence that any deaths had gone unreported and concluded that the researchers had accurately recorded data on the survival and infection rates of newborns.


It concluded that the research does indeed show that nevirapine safely and effectively prevents mother-to-child transmission of HIV.