You can't do better than a clinical trial in Haiti. The [him] moderator hopes that WHO changes its guidelines SOON.
Overnight there are many more people in Myanmar in need of treatment.
[him] moderator
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IAS WELCOMES TRIAL FINDINGS SHOWING BENEFITS OF EARLIER ANTIRETROVIRAL TREATMENT
19 June 2009 (Geneva, Switzerland) - The International AIDS Society (IAS) today welcomed news from a clinical trial conducted in Haiti which supports mounting global consensus that HIV-positive patients in resource-limited countries are more likely to survive and experience less HIV disease progression if they start antiretroviral treatment (ART) earlier than currently recommended by the World Health Organization (WHO).
IAS President Julio Montaner explained that in developing countries ART is traditionally started once the patient’s CD4 cell count – a strong indicator of immune system strength - falls below a measure of 200 cells/mm3. This is not the case in industrialized countries, where – at the end of 2008 –clinical guidance now suggests ART began no later than at a CD4 count of 350 cells/mm3.
“Though the HIV treatment landscape continues to evolve, WHO guidelines for low- and middle-income countries on when to initiate antiretroviral treatment have remained unchanged since 2006. While we recognize that the current economic environment is particularly challenging, our ethical obligation to improve and prolong life is far more urgent. Whilst people are needlessly dying of AIDS-related illnesses, guidelines must set out, in no uncertain terms, the quantifiable individual and public health advantages of starting many more people on HIV treatment earlier in order to help achieve universal access goals,” said Dr Montaner.
Dr Montaner also pointed to research presented at the International AIDS Conference in Mexico City in 2008, which supported the refinement of guidance to improve treatment delivery and standards.
“We are learning much more about when to start ART; when to substitute one treatment for another based on toxicity, virological or clinical failure; how to enable different levels of health-care workers to deliver care; how to improve patient monitoring and support services; and how to optimize the preventive benefits of ART. But ART is not a magic bullet that will alone curb the HIV pandemic. We must focus more on scaling up HIV testing, combining and tailoring prevention interventions to the specific needs of vulnerable populations with ART to keep people alive and well and prevent further infections. This can only be accomplished if laws and policies are put in place to protect and promote the rights of people living with HIV, women, children and the communities most vulnerable, particularly gay men and other men who have sex with men, people who inject drugs and sex workers. Treating and caring for more people earlier and more effectively needs to be our common global ambition,” said Dr Montaner.
The study in Haiti was a randomized, controlled clinical trial carried out by the Haitian Group for the Study of Kaposi’s Sarcoma and Immune Deficiency Disorders (GHESKIO) Centers in Port-au-Prince, Haiti. The principal investigator is Jean William Pape, M.D., the director of the GHESKIO Centers and a professor of medicine at Weill Medical College of Cornell University in New York. The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is the study sponsor. The results show starting ART at CD4+ T cell counts of between 200 and 350 cells/mm3 improves survival compared with deferring treatment until CD4+ T cells drop below 200 cells/mm3.
The IAS is the world’s leading independent association of HIV professionals, with over 13,000 members in 188 countries working at all levels of the global response to HIV/AIDS. IAS members represent scientists, clinicians, public health, policy experts and community practitioners on the frontlines of the epidemic. The IAS is the lead organizer of the International AIDS Conference and the IAS Conference on HIV Pathogenesis, Treatment and Prevention.
More information about the clinical trial in Haiti can be found at
http://www3.niaid.nih.gov/news/QA/CIPRA_HT01_qa.htm and http://www.aidsmap.com/en/news/B4BEE942-4347-4FBB-87AC-38C654774959.asp and more information about the preventive benefits of ART is available online at http://www.aids2008.org/admin/images/upload/785.pdf
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HIV treatment should be started earlier in resource-limited settings, shows trial
Michael Carter, Friday, June 12, 2009
A major clinical trial has shown that HIV-positive patients in resource limited countries are more likely to survive and experience less HIV disease progression if they start taking antiretroviral therapy when their CD4 cell count is between 350 and 200 cells/mm3, rather than waiting until their CD4 cell count falls to below 200 cells/mm3.
Interim analysis of the CIPRA HT 001 study, a randomised control trial being conducted in Haiti, showed that patients who started HIV treatment before their immune system had been severely damaged had better outcomes.
A total of 816 adults with CD4 cell counts between 300 and 250 were recruited to the study. Half were randomised to start HIV treatment immediately, the others waiting until their immune systems had weakened further or they developed an AIDS-defining illness. The combination of antiretroviral drugs used in the study was efavirenz, 3TC and AZT.
The study’s independent safety and monitoring board recommended that the trial should be stopped early after a planned interim analysis showed that only six patients who started antiretroviral therapy when their CD4 cell count was between 350 – 200 cells/mm3 died. (Patient recruitment began in 2005 but the median duration of follow-up is unspecified in the NIAID press release).
This compared to 23 deaths amongst individuals who started treatment later. Furthermore, twice as many individuals in the deferred treatment arm of the study developed tuberculosis, an AIDS-defining illness, than did patients who started HIV treatment before their immune systems were severely damaged by the virus.
In the light of these findings, the study’s monitoring board recommended that it should be terminated immediately and that all individuals in the deferred treatment arm should be offered anti-HIV drugs.
HIV treatment guidelines in industrialised countries, such as the UK, recommend that HIV treatment should be started when an individual’s CD4 cell count is around 350 cells/mm3. Starting treatment at this time has been shown to reduce the risk of developing both HIV-related and non-HIV-related illnesses.
However, in resource limited settings, where only 30% of eligible individuals are currently taking anti-HIV drugs, treatment is not started until a patient’s CD4 cell count falls below 200 cells/mm3 or they develop AIDS. HIV treatment is often started by individuals when their immune systems are severely weakened, meaning that in many cases they die before they have the opportunity to benefit from HIV treatment.
“The public health community now has evidence from a randomized, controlled clinical trial – the gold standard – that starting antiretroviral therapy between 200 and 350 cells/mm3 in resource-limited settings yields better health outcomes than deferring treatment”, said Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, who sponsored the study.
http://www.aidsmap.com/en/news/B4BEE942-4347-4FBB-87AC-38C654774959.asp?type=preview
