A ground-breaking South African study has provided the first hard evidence that treating HIV-positive babies with antiretroviral (ARV) medicines from as early as six weeks dramatically improves their chances of survival.
The study, conducted in Cape Town and Soweto, Johannesburg's largest township, and published in this week's issue of the New England Journal of Medicine, found that infants started on ARV therapy immediately after diagnosis were 76 percent less likely to die than those who began treatment only after displaying clinical symptoms. Early treatment also greatly reduced the progression of disease.
Prof Glenda Gray, of the Perinatal HIV Research Unit (PHRU) at the University of Witwatersrand in Soweto, one of the study sites, predicted that the results would have a profound effect on treating HIV-infected infants in both the developed and developing world.
"Before this study, people weren't sure if it was appropriate to treat children under one year who weren't showing signs of being immune-compromised [having weakened immune systems]," she told IRIN/PlusNews. "This study demonstrated that waiting until these children reach a certain stage [of disease progression], severely impedes their survival."
The trial, carried out by the Comprehensive International Programme of Research on AIDS in South Africa (CIPRA-SA), and sponsored by the US National Institutes of Health, enrolled 377 babies aged between six weeks and 12 weeks, who had contracted HIV despite their mothers receiving medication to prevent mother-to-child transmission (PMTCT).
One group of infants received treatment in line with World Health Organisation (WHO) guidelines at the time, which recommended starting ARVs on the basis of a lowered CD4 count (which measures the strength of the immune system), high viral load (the amount of HI-virus in the blood) or the presence of other clinical symptoms.
Infants in two other arms of the trial were given treatment immediately after diagnosis, at around seven weeks, with half of them receiving it until the age of one, and the other half until the age of two.
|This study demonstrated that waiting until these children reach a certain stage severely impedes their survival|
Dr Avy Violari of PHRU, one of the lead researchers, explained that HIV progressed much more rapidly in children under the age of two, and that the usual methods for monitoring immune system strength, such as CD4 counts, were not reliable. The trial tested the theory that "a blast of ARVs" for a limited period would delay disease progression, and extend the time until continuous treatment would be needed.
"There are concerns around having children on ARV therapy for a lifetime," she said. "It's also very hard, with the currently available regimens, to keep a person on treatment for 40 or 60 years, and to motivate a person to be adherent every day for the rest of their life."
Whether and for how long the strategy will delay the time until the children need to recommence treatment, and what effect the interruption might have on future treatment options, is not yet known; the trial is expected to produce further results by 2011.
The WHO, the US and several European countries have already revised their guidelines for treating HIV-infected infants, partly based on the preliminary results from the study released in 2007.
The South African government is in the process of revising its paediatric treatment guidelines. According to Gray, the recommendation that children start ARV treatment immediately after an HIV-positive diagnosis has been included in a draft version to be discussed at a national meeting next week.
"Hopefully, the new minister of health [Barbara Hogan] understands the importance of this study, and will recommend the implementation of these findings," said Gray.
Major challenges ahead
Both Gray and Violari acknowledged that acting on the study's findings would be difficult in settings where healthcare resources were already stretched and HIV-related stigma still prevented many women and their babies from being tested.
Violari said treating babies with ARVs was no more difficult than treating older children. "The main challenge is actually identifying these babies; a lot more effort needs to be put into early diagnosis."
PCR tests, the only way to determine whether babies under 18 months have contracted the virus, have been available in South Africa's public health sector since 2004, but implementation has been patchy.
Referring HIV-positive mothers and their babies from antenatal to paediatric programmes without losing them in the system, and providing sufficient training and support to healthcare workers, who are often afraid to treat small babies, present considerable logistical hurdles.
Persuading HIV-positive mothers to bring their babies for early testing has also been difficult. Even at the relatively well-resourced PHRU clinic in Soweto, and the Tygerberg Children's Hospital in Cape Town - the other site used in the study - PCR testing is only carried out in about 60 percent of babies born to HIV-positive mothers, said Violari.
Some of the mothers were too afraid, or in denial about their own status, to have their babies tested, she said, while others moved away or succumbed to AIDS-related illnesses.
Gray insisted that with sufficient political will, awareness-raising and training, the obstacles were not insurmountable. "We have to rely on advocacy, and make sure women aren't cheated out of care for their baby. If countries care about their babies enough, it's possible."
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