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Additional ACTG Presentations Address Muscle Density and Area among People Living with HIV and COVID-19 Treatment

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 demonstrating that former and current use of abacavir was associated with a higher incidence of major adverse 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 Matter, from 10:30-11:30 am CEST at Hall B0b/Channel 5 and virtually.

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“This carefully constructed analysis adds to the body of evidence that abacavir use is associated with a higher risk of cardiovascular events like heart attacks and strokes,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “These data align with prior studies that had been considered somewhat controversial because no exact mechanism was clearly demonstrated and should be taken into account by clinicians when they evaluate treatment options for people living with HIV.”

These are the latest findings from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 36 percent compared with those receiving a placebo over a median duration of five years of follow up.

The analysis being presented at AIDS 2024 evaluated the role of prior and current use of select antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based upon prior association with cardiovascular risk and kidney impairment (future analyses are planned to examine the role of other antiretrovirals). Among 7,769 participants, 31.3 percent were born female and 65.2 percent were not white. The median age was 50, LDL (low-density lipoprotein, a kind of cholesterol) was 108 mg/dL, CD4 count was 621 cell/mm³, and 88 percent had a viral load under 400 copies/mL. Participants had been taking HIV treatment for a median of 9.5 years. Researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42 and 50 percent, respectively, while current or past use of other antiretroviral treatments caused no such increase.

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“This analysis is important as we seek to tease out the various factors that may help reduce cardiovascular risk in people living with HIV,” said lead study author Carl Fichtenbaum, M.D., University of Cincinnati. “While the association between abacavir and cardiovascular risk is disappointing, it is not a surprise. It is, however, reassuring that the other HIV therapies included in the analysis like tenofovir were not associated with a higher risk.”

REPRIEVE had a number of unique aspects: study participants had no known prior history of cardiovascular disease, the global cohort from 12 countries had low-to-moderate risk for cardiovascular disease, and all study endpoints were independently vetted by the national study Thrombolysis in Myocardial Infarction (TIMI).

REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes. It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare.

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The trial is led by Steven Grinspoon, M.D. (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, please visit www.reprievetrial.org.

In addition to these data from REPRIEVE, ACTG will also make the following presentations at AIDS 2024:

No Evidence of Pitavastatin Effect on Muscle Density or Area Among People with HIV (REPRIEVE; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kristine Erlandson, et al. This analysis from the REPRIEVE mechanistic substudy found that statins did not reduce muscle density or area. This two-year study of middle-aged people living with HIV at low-to-moderate risk of cardiovascular disease, confirmed through imaging that statins were safe and did not cause significant muscle damage. This is reassuring to people who want to use statins to lower their risk of cardiovascular events like heart attacks and strokes.

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Efficacy and Safety of Ensitrelvir in Non-Hospitalized Adults at Standard or High-Risk of Progression to Severe COVID-19: the SCORPIO-HR Phase 3, Randomized, Double-Blind Placebo-Controlled Trial (ACTG 5407; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kara Chew, et al. While the oral protease inhibitor ensitrelvir demonstrated anti-viral activity, safety, and a trend toward shorter time to symptom resolution compared to placebo, SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to two or more days sustained resolution of 15 COVID-19 symptoms in outpatient participants at standard and higher 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 living with them. It is funded by NIAID and collaborating NIH Institutes under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.

Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net

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