ACTG Presents Data Linking Abacavir Use and Higher Cardiovascular Risk in HIV Patients at AIDS 2024

ACTG, a global network dedicated to clinical trials on HIV and other infectious diseases, is set to present an insightful analysis from the REPRIEVE trial at AIDS 2024 in Munich, Germany on July 26, 2024. This analysis reveals a significant association between the use of abacavir, an antiretroviral drug, and a higher incidence of major adverse cardiovascular events. The presentation will be part of the session titled "Comorbidities: The Heart of the Matter" and will be held from 10:30-11:30 am CEST in Hall B0b/Channel 5 and online.

Judith Currier, M.D., M.Sc., Chair of ACTG from the University of California Los Angeles, emphasized that this analysis reinforces previous findings that link abacavir use to increased cardiovascular risk, such as heart attacks and strokes. These findings should be considered by clinicians when determining treatment plans for people living with HIV.

The REPRIEVE trial, the first large-scale clinical trial aiming to reduce cardiovascular disease risk among people living with HIV, discovered that pitavastatin calcium, a cholesterol-lowering statin, reduced the risk of major adverse cardiovascular events by 36% compared to a placebo over a median follow-up period of five years.

The analysis presented at AIDS 2024 focused on the impact of prior and current use of specific antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These drugs were selected based on their previous associations with cardiovascular risks and kidney issues. Among the 7,769 participants in the study, 31.3% were born female, and 65.2% were non-white. The median age was 50, LDL cholesterol levels were 108 mg/dL, CD4 counts were 621 cells/mm3, and 88% had a viral load below 400 copies/mL. Participants had been on HIV treatment for a median of 9.5 years. The analysis revealed that the current or past use of abacavir increased the risk of major adverse cardiovascular events by 42% and 50%, respectively, whereas other antiretroviral treatments showed no such increase.

Carl Fichtenbaum, M.D., from the University of Cincinnati, the lead author of the study, noted the importance of understanding the various factors contributing to cardiovascular risk in people living with HIV. While the association between abacavir and cardiovascular risk is disappointing but not surprising, it is reassuring that other HIV therapies like tenofovir did not show an increased risk.

The REPRIEVE trial had several unique attributes. Participants had no known history of cardiovascular disease and were from a global cohort spanning 12 countries with low-to-moderate cardiovascular risk. All study endpoints were independently validated by the national Thrombolysis in Myocardial Infarction (TIMI) study group.

Initiated in 2015, REPRIEVE was a collaborative effort between the NIH’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID). Additional funding came from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc., Gilead Sciences, Inc., and ViiV HealthCare. The trial was led by Steven Grinspoon, M.D., Pamela S. Douglas, M.D., Heather Ribaudo, Ph.D., and Michael Lu, M.D., M.P.H.

In addition to the REPRIEVE data, ACTG will present other findings at AIDS 2024. One presentation by Kristine Erlandson and colleagues will show that statins do not affect muscle density or area, which is promising for individuals using statins to lower cardiovascular risks. Another presentation by Kara Chew and colleagues will discuss the efficacy and safety of ensitrelvir in non-hospitalized adults with COVID-19.

ACTG, the world’s largest and longest-running clinical trials network focused on HIV and infectious diseases, was founded in 1987. It aims to improve HIV management, develop cures, and innovate treatments for various infectious diseases. The network comprises numerous researchers, staff, and community members working across 65 locations on four continents to advance science and positively impact lives.