According to research presented today at the IDWeek Conference in Washington, D.C., initiating antiretroviral therapy (ART) earlier in the course of HIV infection, when the immune system is stronger, produces better long-term health outcomes than postponing ART.
The findings are based on an extended follow-up of participants in the Strategic Timing of Antiretroviral Treatment (START) research, which was financed by the National Institutes of Health. In 2015, START demonstrated a 57% reduced risk of AIDS and serious non-AIDS health outcomes among participants who initiated ART when their CD4+ T-cell counts were greater than 500 cells per cubic millimeter (mm3) in comparison to those who did not initiate ART until either their CD4+ T-cell counts fell below 350 cells/mm3 or they developed AIDS. Following the publication of these results in 2015, patients in the delayed treatment group were encouraged to initiate ART.
According to the Centers for Disease Control and Prevention, around 13% of HIV-positive individuals in the United States are unaware of their status. When HIV diagnosis and therapy are delayed, viral replication persists. This can significantly damage the health of the sick individual and raise the likelihood of virus transmission.
The international START study demonstrated the benefits of early ART initiation; however, a longer-term follow-up of 4,446 participants was conducted to determine whether the health benefits of early ART relative to deferred ART increased, remained constant, or decreased after the participants in the deferred arm were advised to initiate ART. The primary study outcomes were the number of individuals who developed AIDS, the number of participants who had serious non-AIDS health disorders, such as cardiovascular disease, kidney failure, liver disease, and cancer, and the number of people who died.
For individuals who initiated ART before the end of 2015, the median CD4+ cell count was 648 cells/mm3 for the immediate arm and 460 cells/mm3 for the deferred arm at the time of ART initiation. The analysis presented today compared the key research endpoints before the end of 2015 with those from January 1, 2016 to December 31, 2021. In the latter period, the majority of participants in the delayed arm were using ART. During the second phase, those commencing ART in the postponed group experienced rapid and sustained decreases in HIV viral load (less than or equal to 200 copies/mL); but, their CD4+ cell counts remained, on average, 155 cells lower than those in the immediate ART group. While the risk of adverse health consequences was significantly reduced shortly after ART was began in the delayed treatment group, an extra risk maintained in comparison to the immediate treatment group. In comparison to the immediate treatment group, the deferred ART group continued to have a slightly higher risk (21%) of significant health outcomes or death. During the five-year follow-up period, 27 cases of AIDS occurred in the deferred therapy group compared to 15 instances in the early treatment group. Similarly, there were 88 incidences of significant non-AIDS health concerns in the delayed treatment arm, compared to 76 in the urgent treatment arm. In the deferred treatment group, there were 57 deaths compared to 47 in the urgent treatment group.
According to the presenters, these findings demonstrate that ART greatly improves the health of a person with HIV and reduces the person’s chance of getting AIDS and serious health problems, and that early identification and treatment are essential for optimizing these benefits and minimizing risk.
The START research and its prolonged follow-up were undertaken by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), which was supported in part by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). It was directed by James D. Neaton, Ph.D., of the University of Minnesota, Minneapolis, together with START study co-chairs Abdel Babiker, Ph.D., of University College London, and Jens Lundgren, M.D., of the University of Copenhagen.
When
IDWeek, hosted by the Infectious Disease Society of America in Washington, D.C. Long-term benefits of early antiretroviral medication beginning in HIV infection: results of the extended follow-up of the START trial. Saturday, October 22, 2022 at 1:20 p.m.
Who
Carl Dieffenbach, Ph.D., head of the NIAID’s Division of AIDS, and Beverly L. Alston-Smith, M.D., chief of the Division’s Complications and Co-Infections Research Branch, are available to comment on this presentation.
NIAID conducts and funds research at NIH, throughout the United States, and internationally to investigate the causes of infectious and immune-mediated disorders and to create better methods for preventing, detecting, and treating them. On the NIAID website, you can find press releases, fact sheets, and other relevant information.
NIH stands for the National Institutes of Health. The National Institutes of Health (NIH), the nation’s medical research organization, consists of 27 Institutes and Centers and is part of the U.S. Department of Health and Human Services. The NIH is the principal government organization that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures for both common and rare diseases. Visit www.nih.gov for more information on the NIH and its initiatives.
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