Findings from a clinical trial in Haiti bring the first conclusive evidence that HIV-positive people in developing countries have a significantly better chance of survival if they start antiretroviral (ARV) treatment earlier.
Last week, an independent data and safety monitoring board recommended immediately ending a trial being carried out by the Haitian Group for the Study of Kaposi's Sarcoma and Immune Deficiency Disorders (GHESKIO) Centers, because the evidence in favour of earlier treatment was so overwhelming.
The study was being run in the capital, Port-au-Prince, with funding from the US National Institute of Allergy and Infectious Diseases (NIAID).
Recent studies in the developed world have found that starting HIV-infected patients on treatment when their CD4 cell count (a measure of immune system strength) drops below 350 greatly reduces AIDS-related mortality. Waiting until it fell below 200 was previously thought to be optimal.
However, some experts argued that these findings could not be extrapolated to resource-limited settings because they were based on patient records rather than a large, randomised trial in a poor country.
The trial in Haiti, known as CIPRA HT 001, started in 2005, when 816 HIV-positive participants with CD4 counts between 200 and 350 were recruited. Half of them were randomly assigned to begin ARV treatment immediately; the other half were to start treatment only when their CD4 counts dropped below 200, in line with national treatment guidelines in Haiti and many other developing countries.
By the time the trial was stopped, six participants in the group that began treatment earlier had died, compared to 23 in the group that started treatment later.
The number of patients who contracted tuberculosis (TB), a common and often deadly opportunistic infection in people living with HIV, was 18 in the early-treatment group, compared to 36 in the other group.
The monitoring board recommended that all the trial participants now be offered ARV treatment and followed for 12 months to ensure that they adhered to the timetable for taking their medication.
"The public health community now has evidence from a randomized, controlled clinical trial — the gold standard — that starting ART [antiretroviral treatment] at CD4 cell counts between 200 and 350 in resource-limited settings yields better health outcomes than deferring treatment until CD4 cell counts drop below 200," said NIAID Director Anthony S. Fauci in a statement.
Although some countries changed their ARV treatment protocols after evidence from earlier studies, many in the developing world still wait until patients have a CD4 count of 200 or less to begin treatment. The study investigators were confident that many more countries would revise their treatment guidelines.
Carl Dieffenbach, director of the NIAID Division of AIDS, noted that raising the threshold for starting ARV treatment would greatly increase the number of people needing medication, and the need for the global community to provide more support to buy ARVs.
See also: SOUTH AFRICA: Government urged to raise treatment standards
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