THE results of NIH-funded experimental studies are likely to have a global impact treatment guidelines
A large international randomized clinical trial has found that infected with HIV individuals have a significantly lower risk of developing AIDS or other serious illnesses if they started taking antiretroviral drugs earlier, when the number of T lymphocytes CD4 + - the main measure of health immune system is greater, instead of waiting until the T lymphocyte count CD4 + down to lower levels. Together with data from previous studies showing that antiretroviral treatment reduced the risk of HIV transmission to uninfected sexual partners, these findings support provide treatment for all HIV-positive.
The new finding is theStrategic Timing of Antiretroviral Treatment (START) study, first major randomized clinical trial to determine the benefits of earlier antiretroviral treatment in individuals infected with the HIV virus. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, provided initial funding for the study START. Although the study was set to expire at the end of 2016 year, a mid-term review of the study data by a data monitoring committee and independent security (DSMB) recommended that the results be released early.
"We now have clear proof that is much greater the health benefit of an infected person BY VIRUS HIV start antiretroviral therapy sooner than later," said NIAID Director Anthony Fauci SS, MD "In addition, early therapy transmits a double benefit, not only improves the health of people, but at the same time, reducing their viral load reduces the risk of transmissibility of HIV to others. These overall findings have implications for the treatment of HIV. "
"This is an important milestone in HIV research," said Jens Lundgren, MD, University of Copenhagen and one of the START study co-chairs. "We now have strong evidence that early treatment is beneficial for HIV-positive patients.
These results support treatment for all, regardless of the number of T CD4 + lymphocytes.
The START study, which began in March 2011, was conducted by the International Network for Strategic Initiatives in Global HIV testing (INSIGHT) in 215 35 in local countries. The study enrolled 4.685 men and women infected with HIV aged 18 years or older, with a median age of 36. The participants had never taken antiretroviral therapy and were inscribed with CD4 + cell counts within the normal range of up 500 cells per cubic millimeter (cells / mm3). About half of the study participants were randomized to initiate antiretroviral treatment immediately (early treatment), and the other half were randomized to treatment delay until the T lymphocyte counts decreased to 4 CD350 + cells / mm3. On average, participants in the study were followed for a period of three years.
The study measured the combination of results that include severe AIDS-related events (such as AIDS defining cancers), severe cases of AIDS (cardiovascular events, renal, liver disease or cancer) and death. Based on March 2015 data, the DSMB found 41 cases of AIDS, AIDS death or serious among those who sign up in the early treatment of the study compared to 86 events in the delayed treatment group. The interim analysis of the DSMB found that the risk of serious illness or death was reduced in 53 percent among those in the early-treatment group, compared with those in which it was before last treatment.
The AIDS rates related to serious events as well as events unrelated to AIDS were lower in the early treatment group compared with the delayed treatment group. The risk reduction was more pronounced in relation to AIDS and related events. The findings were consistent across all geographic regions and the benefits of early treatment were similar for participants from low and middle income countries as well as participants from high-income countries.
"The study was rigorous and the results are clear," he told INSIGHT, principal investigator James D. Neaton, phd, professor of biostatistics at the University of Minnesota, Minneapolis.
"The final results of a randomized trial as START are likely to influence the way care is delivered to millions of HIV-infected individuals worldwide."
The University of Minnesota served as the sponsor regulate the statistical evaluation and data management and center.
Before starting the test, there were no randomized controlled trial to serve as the guide to starting treatment for individuals with higher CD4 + counts. Previous evidence of early support of treatment for HIV-positive patients with CD4 + counts above 350 was limited to data from randomized clinical trials or observational cohort studies, on expert opinion.
Start is the first large randomized clinical trial to offer concrete scientific evidence to support the current 'Treatment Guide the US recommending that all asymptomatic HIV-infected individuals should take antiretroviral drugs, regardless of CD4 + T lymphocyte counts. The current guidelines of the World Health Organization recommend that individuals infected with HIV start antiretroviral therapy when CD4 + cell counts drop to 500 cells / mm3 or less.
In light of the DSMB findings, the study's researchers are reporting to all participants of the provisional results. Participants will be offered treatment if they no longer are on antiretroviral treatment, and they will continue to be followed by 2016 year.
The antiretroviral drugs used in the study are the drugs donated by Abbvie, Inc., Bristol-Myers Squibb, Gilead Sciences and GlaxoSmithKline / ViiV Healthcare Janssen Scientific Affairs, LLC and Merck Sharp & Dohme Corp.
Moreover, funding for the NIH START study came from other entities, including the National Cancer Institute; the National Heart, Lung and Blood Institute, the National Institute of Mental Health; the National Institute of Neurological disorders and stroke; Eunice Kennedy Shriver National Institute of Child Health and Human Development; the NIH Clinical Center; and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Funding was also provided by the National Research Agency on AIDS and viral hepatitis (ANRS) in France, the Federal Ministry of Education and Research in Germany, AIDS treatment European Network and government organizations based in Australia, Denmark and the UK .
The Medical Research Council Clinical Trials Unit at University College London; the fight against HIV program in Copenhagen, Rigshospitalet of Copenhagen University in Denmark, the Kirby Institute at the University of New South Wales, Sydney, Australia; and the Veterans Affairs Medical Center associated with the George Washington University in Washington, DC coordinated the work of 215 START study sites.
NIAID conducts and supports research and NIH, throughout the United States, and all over the world to study the causes of the infection and immune mediated diseases, and to develop better means of preventing, diagnosing and treating these diseases. News releases, newsletters and other related materials are available on the NIAID.NIAID website
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Translated from original Starting Antiretroviral Treatment Improves Outcomes Early is for Claudio Souza and Revised by Mara Macedo