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August 5, 2015
Early Initiation of Antiretroviral Therapy Has Wide Benefit for HIV Patients
Minneapolis—Early initiation of antiretroviral therapy for human immunodeficiency virus (HIV) patients does much more than just prevent life-threatening acquired immunodeficiency syndrome (AIDS)–related syndromes. It also reduces the risk of cancer, cardiovascular disease, and other conditions unrelated to the underlying disease, according to a major new analysis of data from the Strategic Timing of AntiRetroviral Treatment (START) study, the first large-scale randomized clinical trial to establish that earlier antiretroviral treatment benefits all HIV-infected individuals. The National Institute of Allergy and Infectious Diseases (NIAID)–funded study recently was published in the New England Journal of Medicine simultaneous to presentation at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, Canada. In May 2015, START trial investigators released results indicating that beginning antiretroviral therapy early when immune systems are healthier, without waiting for CD4+ cell counts to decline, prevented a composite of serious AIDS events, such as AIDS-related cancers, serious non–AIDS-related events, and death among HIV-infected individuals. The more recent findings, which include 2 additional months of data, indicate that early initiation significantly reduces the risk of both major components of this combined outcome: serious AIDS events by 72%, and serious non-AIDS events by 39%. Non–AIDS-related events tracked by the study included cardiovascular disease, end-stage renal disease, liver disease, non–AIDS-defining cancer, or causes of death not attributable to AIDS. The reduction was seen regardless of age, sex, baseline CD4+ cell counts, geographic region, or country income level in the study, which began in 2011 with 4,685 HIV-infected adults at 215 sites in 35 countries. “This study conclusively shows that the benefits of early therapy far outweigh any adverse outcomes, and reinforces recommendations to offer immediate antiretroviral therapy to all patients,” said NIAID Director Anthony S. Fauci, MD. “Today’s findings show that early antiretroviral treatment presents no additional risk of serious, non-AIDS-related disease to people taking treatment, but actually confers valuable protection against these illnesses, helping keep HIV-infected people healthier longer." Participants in the randomized START trial, who were followed for an average of about 3 years, had never taken antiretroviral therapy and were enrolled with CD4+ cell counts in the normal range--above 500 cells per cubic millimeter (cells/mm3). Approximately half of the study participants were randomized to initiate antiretroviral treatment immediately and the other half were randomized to defer treatment until their CD4+ cell count declined to 350 cells/mm3. On average, participants in the study were followed for 3 years. The median age of study participants was 36, yet the most common events observed in the study were serious non-AIDS events, including many that typically affect older patients. “The comprehensive evaluation of the risks and benefits of early treatment in START provides policy makers, clinicians and HIV-positive individuals a strong set of data to inform antiretroviral therapy initiation policies,” said principal investigator James D. Neaton, PhD, a professor of biostatistics at the University of Minnesota in Minneapolis. The HIV medicines used in the trial are approved medications donated by AbbVie, Inc., Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Janssen Scientific Affairs, LLC, and Merck & Co.
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