The results of the NIH-funded experimental studies are likely to have a global impact on 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 Strategic Timing of AntiRetroviral Treatment (START) study, first large randomized clinical trial to determine the benefits of prior antiretroviral treatment in individuals infected with the HIV virus. The National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institute of Health, provided first funding for the START study. Although the study was scheduled to be completed by the end of the year 2016, a mid-term review of the study data by an independent data monitoring and security committee (DSMB) recommends that results be released earlier.
"We now have clear evidence that the health benefit of a person infected by HIV VIRUS on initiating antiretroviral therapy is sooner than later," said NIAID Director Anthony SS Fauci, MD "In addition, early therapy provides a double benefit not only improves people's health but, at the same time, decreases their viral load, reduces the risk of HIV transmission to others. These findings have global 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 of 2011, was conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) in 215 locations in 35 countries. The study enrolled 4.685 HIV-infected men and women aged 18 years or older, with median age of 36. Participants had never taken antiretroviral therapy and were enrolled with CD4 + cell counts within the normal range of above 500 cells per cubic millimeter (cells / mm3). About half of the study participants were randomized to initiate antiretroviral therapy immediately (early treatment), and the other half were randomized to postpone treatment until the CD4 + T cell count declined to 350 cells / mm3. On average, participants in the study were followed for a period of three years.
The study measured the combination of outcomes that included severe AIDS-related events (such as AIDS-defining cancers), severe AIDS (cardiovascular events, kidney, liver disease, or cancer), and death. Based on March data from 2015, the DSMB found 41 cases of AIDS, severe AIDS or death among those enrolling in the early treatment of the study in relation to 86 events in the treatment group postponed. The interim analysis of the DSMB found that the risk of developing severe illness or death was reduced by 53 percent among those in the early-treatment group compared to those in whom treatment was delayed.
Serious-event-related AIDS rates as well as non-AIDS events were lower in the early-treatment group than in the deferred treatment group. The reduction of risk was more pronounced in relation to AIDS and related events. Findings were consistent across 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," said INSIGHT, lead 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 who recommend that all HIV-infected asymptomatic individuals should take antiretrovirals regardless of CD4 + T lymphocyte counts. The current guidelines of the World Health Organization recommend that individuals infected with the HIV virus begin antiretroviral therapy when CD4 + cells count down to 500 cells / mm3 or lower.
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 drugs donated by AbbVie, Inc., Bristol-Myers Squibb, Gilead Sciences and GlaxoSmithKline / ViiV Healthcare Janssen Scientific Affairs, LLC and Merck Sharp & Dohme Corp.
In addition, 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; National Institute of Neurological Disorders and Stroke; the 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 Agency for Research on AIDS and Viral Hepatitis (ANRS) in France, the Federal Ministry of Education and Research in Germany, the European AIDS Treatment Network and government organizations based in Australia, Denmark and the United Kingdom .
The Medical Research Council of the Clinical Trials Unit at University College London; the HIV program in Copenhagen, Rigshospitalet University of Copenhagen in Denmark, the Kirby Institute of the University of New South Wales, Sydney, Australia; and the Veterans Affairs Medical Center associated with George Washington University in Washington, DC coordinated the work of the 215 START sites.
NIAID conducts and supports research and the NIH throughout the United States and in all parts of the world to study the causes of infectious disease and immune-mediated diseases as well as to develop better ways to prevent, diagnose and treat these diseases. News releases, newsletters and other materials related to NIAID are available at. NIAID website
About the National Institutes of Health (NIH): The NIH, the nation's medical research agency, includes 27 centers and institutes and is a component of the US Department of Health and Human Services. The NIH is the leading federal agency performing and supporting basic, clinical and translational medical research, and is investigating the causes, treatments and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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Translated from original Starting Antiretroviral Treatment Improves Outcomes Early is for Claudio Souza and Revised by Mara Macedo