Early diagnosis and treatment of HIV is important for better long-term health outcomes

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Friday, October 21, 2022


Starting antiretroviral treatment (ART) early in the course of HIV infection, when the immune system is stronger, leads to better long-term health outcomes than delaying ART, according to findings presented today at the IDWeek conference in Washington, DC

The findings are based on extended follow-up of participants in the Strategic Timing of Antiretroviral Treatment (START) trial funded 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 started ART when their CD4+ T-cell count—a key indicator of immune system health—was above 500 cells per cubic millimeter (mm³). ) compared to those who did not start ART until their CD4+ count fell below 350 cells/mm³ or they developed AIDS. Following the 2015 report of these findings, participants in the delayed treatment group were advised to start ART.

An estimated 1.2 million people in the United States are living with HIV, and approximately 13 percent do not know they are infected, according to the Centers for Disease Control and Prevention. When HIV diagnosis and treatment are delayed, HIV continues to reproduce. This can negatively affect the health of the infected individual and increase the risk of transmitting the virus to others.

The international START trial demonstrated the benefit of early ART initiation, but longer-term follow-up of 4,446 participants was undertaken to determine whether the health benefits of early ART compared with delayed ART increased, remained constant, or declined after delayed participants arm were advised to start ART. Primary study endpoints included the number of participants who developed AIDS; those who have developed serious health conditions other than AIDS, such as serious cardiovascular disease, kidney failure, liver disease, and cancer; and those who died.

For participants who started ART before the end of 2015, the median CD4+ cell count at the time of ART initiation was 648 cells/mm³ for the immediate arm and 460 cells/mm³ for the delayed arm. The analysis presented today compared the study’s primary endpoints before the end of 2015 with those in the extended follow-up period, from January 1, 2016 to December 31, 2021. During the latter period, most participants in the delayed arm were taking ART. During the second period, ART initiates in the deferred group had rapid and sustained declines in HIV viral load (less than or equal to 200 copies/mL); however, the CD4+ cell count remained an average of 155 cells lower than that of individuals in the immediate ART group. Although the risk of serious health outcomes was significantly reduced soon after initiation of ART in the delayed treatment group, some increased risk remained compared with the immediate treatment group. The delayed ART group continued to have a slightly higher risk (21%) of serious health outcomes or death compared with the immediate treatment group. Twenty-seven cases of AIDS occurred during the five-year follow-up period in the delayed treatment group compared with 15 cases in the early treatment group. Similarly, 88 cases of serious health problems other than AIDS occurred in the delayed treatment group compared with 76 cases in the immediate treatment group. Finally, there were 57 deaths in the delayed treatment group compared with 47 in the immediate treatment group.

These findings confirm that ART significantly improves the health of an individual with HIV and reduces the risk of developing AIDS and serious health problems, and that early diagnosis and treatment are key to maximizing these benefits and reducing risk, according to the presenters.

The START study and its extended follow-up were conducted by the International Network for Strategic Initiatives in Global HIV Studies (INSIGHT), funded in part by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. It was led by principal investigator James D. Neaton, Ph.D., of the University of Minnesota, Minneapolis, and START study co-chairs Abdel Babiker, Ph.D., of University College London, and Jens Lundgren, Ph.D., of the University of Copenhagen .


IDWeek of the Infectious Diseases Society of America in Washington, DC Presentation title, “Long-term benefits of early initiation of antiretroviral therapy in HIV infection: findings from extended follow-up of the START trial.” Saturday, October 22, 2022, at 1:20 p.m. p.m. EDT.


Carl Diefenbach, Ph.D., director of NIAID’s Division of AIDS, and Beverly L. Alston-Smith, MD, chief of the Division of Complications and Co-infections Research in NIAID’s Division of AIDS, are available for comment. this presentation.

NIAID conducts and supports research—at NIH, in the United States, and around the world—to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing, and treating these diseases. News releases, fact sheets, and other materials related to NIAID are available on the NIAID website.

For the National Institutes of Health (NIH):NIH, the national agency for medical research, includes 27 institutes and centers and is part of the US Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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