A National Institutes of Health (NIH) clinical trial was stopped early because a every day statin medication was found to cut back the increased risk of heart problems amongst people living with HIV in the primary large-scale clinical study to check a primary cardiovascular prevention strategy on this population. A planned interim evaluation of knowledge from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study found that participants who took pitavastatin calcium, a every day statin, lowered their risk of major antagonistic cardiovascular events by 35% compared with those receiving a placebo. Antagonistic drug events observed within the study were like those in the overall population taking statin therapy. The interim evaluation was sufficiently compelling that the study’s independent Data Safety and Monitoring Board (DSMB) beneficial it’s stopped early given adequate evidence of efficacy. The NIH accepted the DSMB recommendations.
REPRIEVE began in 2015 and enrolled 7,769 volunteers who were 40 to 75 years of age, of whom greater than 30% were women. REPRIEVE volunteers were all taking antiretroviral therapy, with CD4+ cell counts greater than 100 cells/mm3 of blood at enrollment, and had low-to-moderate traditional heart problems risk that will not typically be considered for statin treatment. The trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa.
The REPRIEVE study is primarily supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI) with additional funding from the NIH Office of AIDS Research. The study was conducted by the AIDS Clinical Trials Group (ACTG).
Many years of research and advances in HIV treatment have drastically reduced AIDS-related complications and deaths. As individuals with HIV live longer, premature heart disease and other chronic conditions have emerged as leading causes of morbidity and mortality, contributing to persistent gaps in lifespan between individuals with HIV and the broader population.
The REPRIEVE study reflects the evolution of HIV science, and progress from focusing totally on approaches to treat and control the virus to finding ways to enhance the general health of individuals living with HIV. These latest data suggest that a typical cholesterol-lowering medicine could substantially improve cardiovascular outcomes in individuals with HIV.”
Hugh Auchincloss, M.D., Acting NIAID Director
Statins are a category of medicines routinely prescribed to lower cholesterol and are known to forestall heart problems in those in danger in the overall population. It was not clear if statins would have the identical effect in people living with HIV and who’ve premature heart problems despite having low-to-moderate traditional risk. Within the REPRIEVE trial, participants were randomly assigned to receive a every day dose of 4 mg of pitavastatin or placebo. They were monitored for major antagonistic cardiovascular events and antagonistic reactions to pitavastatin, which is taken into account protected to be used with all prescribed antiretroviral therapy regimens.
The study’s DSMB met at planned intervals throughout the study to review safety and efficacy data. In its most up-to-date meeting, the DSMB determined that the advantages of every day pitavastatin use outweighed any risks and beneficial that the study terminate early, and that a full data collection be conducted across sites for final evaluation. Study participants are being notified of the findings and can proceed to be monitored for several months. Study results from the DSMB review are expected to be published in the approaching weeks.
“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that will help clinicians higher support the unique cardiovascular health needs of individuals living with HIV,” said NHLBI Director Gary H. Gibbons, M.D. “REPRIEVE is vital because there are limited existing interventions to assist prevent antagonistic cardiovascular outcomes on this population.”
The REPRIEVE study was funded by a grant to the Massachusetts General Hospital and led by Steven Grinspoon, M.D, professor of drugs at Harvard University, endowed chair in Neuroendocrinology and Metabolism and chief of the metabolism unit at Massachusetts General Hospital, who directed the study’s Clinical Coordinating Center. Pamela Douglas, M.D., the Ursula Geller Professor of Research in Cardiovascular Diseases within the Duke University Department of Medicine, was co-principal investigator of the Clinical Coordinating Center. Michael T. Lu, M.D., co-director of the Massachusetts General Hospital Cardiovascular Imaging Research Center, and Heather Ribaudo, Ph.D., a principal research scientist on the Center for Biostatistics in AIDS Research and the Department of Biostatistics at Harvard University, served as leads of the REPRIEVE study’s Data Coordinating Center. The study was conducted by the NIAID-funded ACTG. Additional implementation support was provided by the London-based NEAT ID Foundation, Kowa Pharmaceuticals America, Inc., Gilead Sciences, Inc. and Viiv Healthcare.
Source:
National Institutes of Health