ACTG
Additional ACTG presentations address muscle density and area in HIV-infected and COVID-19-treated patients
LOS ANGELES, July 23, 2024 (GLOBE NEWSWIRE) — ACTG, a global clinical trials network focused on HIV and other infectious diseases, will present an exploratory analysis from the REPRIEVE trial showing that past and current use of abacavir is associated with a higher incidence of major cardiovascular events at AIDS 2024 in Munich, Germany. The oral presentation will take place on July 26, 2024, as part of the session “Comorbidities: The Heart of the Problem,” from 10:30-11:30 a.m. CEST in Hall B0b/Channel 5 and virtually.
“This carefully constructed analysis adds to the growing body of evidence that abacavir use is associated with an increased risk of cardiovascular events such as heart attack and stroke,” said ACTG Chair Judith Currier, MD, MSc, of the University of California, Los Angeles. “These data are consistent with previous studies that were considered somewhat controversial because the exact mechanism was not clearly defined, and should be taken into consideration by clinicians when evaluating treatment options for people with HIV.”
These are the latest results from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease in people with HIV. The trial found that participants who took pitavastatin calcium (a daily cholesterol-lowering statin tablet) had a 36% reduced risk of major adverse cardiovascular events compared to participants who took a placebo over an average five-year follow-up period.
The analysis, to be published at AIDS 2024, assessed the impact of past and current use of certain antiretroviral treatments (e.g., abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based on their past associations with cardiovascular risk and renal dysfunction (future analyses will examine the role of other antiretrovirals). Of the 7,769 participants, 31.3% were born female and 65.2% were non-white. The median age was 50 years, LDL (low-density lipoprotein, a type of cholesterol) was 108 mg/dL, CD4 count was 621 cells/mm3, and 88% had a viral load less than 400 copies/mL. Participants had been receiving HIV treatment for an average of 9.5 years. The researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42% and 50%, respectively, whereas current or past use of other antiretroviral treatments did not result in such an increase.
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“This analysis is important because we are trying to elucidate different factors that may help reduce cardiovascular risk in people with HIV,” said lead study author Carl Fichtenbaum, M.D., of the University of Cincinnati. “The association between abacavir and cardiovascular risk is disappointing but not surprising. However, it is reassuring that other HIV medications included in the analysis, such as tenofovir, were not associated with higher risk.”
REPRIEVE is unique in several ways: Study participants had no history of cardiovascular disease and were at low to moderate risk for cardiovascular disease in a global cohort from 12 countries, and all study endpoints were independently validated by the nationwide Thrombolysis in Myocardial Infarction (TIMI) study.
REPRIEVE was initiated in 2015 as cooperative agreements (HL12339, HL123336, HL164284, HL164285) and was a collaboration between the two largest NIH institutes: the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health. The study received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (provider of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare.
The trial is led by the Clinical Coordinating Center, led by Steven Grinspon, MD (Chair) and Pamela S. Douglas, MD (Co-Chair), and the Data Coordinating Center, led by Heather Rivaldo, PhD (Chief Statistician) and Michael Lu, MD, MPH, Protocol Chair of the REPRIEVE Mechanism Substudy. For more information, please visit www.reprievetrial.org.
In addition to these data from REPRIEVE, ACTG will also make the following announcements at AIDS 2024:
No evidence of effect of pitavastatin on muscle density or area in people with HIV (REPRIEVE, Poster Presentation: Tuesday, July 23, 12:00-1:00 PM CEST, Poster Exhibit Hall) Kristine Erlandson et al. This analysis from the REPRIEVE mechanistic substudy found that statins do not reduce muscle density or area. In this 2-year study of middle-aged HIV-infected people at low-to-moderate risk for cardiovascular disease, imaging confirmed that statins are safe and do not cause significant muscle damage. This is reassuring information for people who want to use statins to lower their risk of cardiovascular events such as heart attack and stroke.
Efficacy and Safety of Encitrervir in Non-Hospitalized Adults at Standard and High Risk for Severe COVID-19 Disease: The SCORPIO-HR Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial (ACTG 5407, Poster Presentation: Tuesday, July 23, 12:00pm-1:00pm CEST, Poster Exhibit Hall) Kara Chew, et al. The oral protease inhibitor ensitreruvir demonstrated antiviral activity, safety, and a trend toward faster time to symptom resolution compared to placebo, but SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to sustained resolution of 15 COVID-19 symptoms over 2 days in outpatient participants at standard and high risk for severe disease.
About ACTG
ACTG is the world’s largest and longest-running clinical trials network focused on HIV and other infectious diseases and the people who suffer from them. The network is funded by NIAID and collaborating NIH institutes under grant numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve management of HIV and its complications, develop cures for HIV, and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. ACTG is made up of thousands of dedicated researchers, staff, and community members working in 65 sites across four continents researching new treatments and cures for infectious diseases, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.
Disclaimer: This content is the sole responsibility of ACTG and does not necessarily reflect the official views of the NIH.
Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net
