A study in 35 countries that involved 4685 people infected with HIV has ended early because the results showed that immediate treatment reduced the risk of disease and death in half. The data, released today on a conference held by the US National Institute of Allergy and Infectious Diseases (NIAID), ending a divisive issue. The United States and many other countries recommend already treating people diagnosed with HIV infection, but the UK Guidelines and elsewhere are calling the start of treatment only after damage to the immune system occurs, in part because of concerns about the long-term toxicity of drugs.
As explained NIAID Director Anthony Fauci, the evidence suggests that early treatment of people benefited but no randomized controlled trial has ever proven to date. "These results clearly demonstrate that early antiretroviral treatment sooner rather than later is significant health benefits to the individual infected with HIV," said Fauci. "These results are certain to impact the medical treatment guidelines." He said the new results also validate the push to use treatment as prevention, other studies have shown that people with HIV on antiretroviral (ARV) are much less likely to transmit the virus to other.
strategic moment antiretroviral treatment (START) trial began in March 09 at the time, the World Health Organization (WHO) has recommended to start ARVs only after the CD4 count a person had dropped to 0 or less per microliter of blood. CD4 cells are white that HIV targets and destroys; normal numbers range from 0 to 10. START registered people infected with HIV who had more than 500 CD4 and has never taken ARVs. He told random half of the participants to begin treatment immediately, while the other half were offered after ARV CD4 counts fell to 350 or they developed an AIDS-defining illness. The trial evaluated the development of "events" include: AIDS, serious non-AIDS-related ailments, and death. START scheduled to end in December 2016.
A data safety and monitoring board that intermittently examined data beginning were blinded to the researchers reported study leaders this month, after an average of 3 years of observation, early treatment group had a 53% reduction in the risk of suffering an event. Specifically, 41 people who received early treatment had an event against 86 in the delayed treatment group. No proof surface of the increased toxicity of drugs in the early treatment group. All participants are now offered treatment, and the trial will continue to follow the participants until 2016 as originally planned to determine whether other surface differences due to the backlog. NIAID, the main sponsor of the study, only spent $ 154 million on the trial to date.
Michael Saag, director of the AIDS Research Center at the University of Alabama, Birmingham, START initially thought was a waste of money: He was already convinced by both the biology and less rigorously designed, smaller trials that treatment earlier made eminent sense. "I do not think the juice was worth the squeeze," he said. But his first reaction to this data? "Wow," Saag said. "I guess this is what they would find, but I do not really expected that we would see him earlier today. Perhaps this effect is even deeper than what I thought before the trial. and it makes me want to redouble my efforts to identify those who are infected and get them on therapy as quickly as possible. "
Saag, who sits on the wHO committee that issues international guidelines for the treatment of HIV, said the new data will likely influence the next review. "I do not see how WHO can ignore these data," he said, noting that some poorer countries may still have to give priority treatment to the sickest patients.
HIV treatment guidelines The UK, now updated, seems certain to change, too, said Ian Williams, an epidemiologist at University College London, who chaired the committee that drafted the previous version. "The START results are clearly very important and impressive," he said, "and I fully expect will result in a review and changes in the guidelines for 2015."
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