Trial stopped early due to success of statins for CVD prevention in people with HIV
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Key takeaways:
- A trial of statin therapy in people living with HIV was stopped early.
- The decision was made due to greatly reduced CVD risk in the statin group and no evidence of excess serious adverse drug events.
The NIH announced a trial it is funding has been stopped early because an interim analysis found daily statin use greatly prevented major adverse CV events in people living with HIV.
The REPRIEVE trial was stopped after the interim analysis revealed that participants assigned pitavastatin calcium 4 mg daily had 35% reduced risk for major adverse CV events compared with those assigned placebo, according to a press release issued by the NIH.
“The REPRIEVE study reflects the evolution of HIV science, and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” Hugh Auchincloss, MD, acting director of the NIH’s National Institute of Allergy and Infectious Diseases, said in the release. “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV.”
REPRIEVE included 7,769 people living with HIV (age range, 40-75 years; more than 30% women) who were taking antiretroviral therapy, had CD4+ cell counts greater than 100 cells/mm of blood at enrollment and had low to moderate traditional CVD risk not traditionally requiring statin treatment, according to the release.
Adverse drug events in the trial were similar to those seen in the general statin-treated population, according to the release.
The study was stopped after a meeting of its data safety and monitoring board, which after a planned interim review of safety and efficacy data determined that the benefits of pitavastatin calcium in this population outweighed the risks, according to the release.
“These latest findings represent the culmination of an unprecedented 8-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” Gary H. Gibbons, MD, director of the NHLBI, said in the release. “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”
The results from the data safety and monitoring board review are expected to be published soon, according to the release.
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