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Trial Update of Pitavastatin to Prevent Cardiovascular Events in HIV Infection
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Download the PDF
Download the PDF
Published May 1, 2024
N Engl J Med
To the Editor:
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (Aug. 24 issue)1 was a global trial that assessed pitavastatin calcium as compared with placebo to prevent major adverse cardiovascular events (MACE) among participants with HIV infection who were at low-to-moderate predicted cardiovascular risk. In this trial, MACE was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause. The trial was designed to detect a hazard ratio of 0.70 with 85% power in the intention-to-treat population on the basis of an estimated 288 primary-outcome events.
In March 2023, the trial was stopped early for efficacy by the data and safety monitoring board during a planned interim analysis that was performed after the occurrence of 225 events (78% of the estimated number) on the basis of follow-up data through December 2022. At that time, the participants in the pitavastatin group had a 35% reduction in MACE as compared with the placebo group, without any unanticipated safety effects. The participants were advised to continue to receive their assigned treatment until a final trial visit between April and August 2023; the trial data were unblinded in November 2023. At the final trial visit, 13 participants (4 in the pitavastatin group and 9 in the placebo group) had started to receive a nonstudy statin since the trial cutoff. This report updates the published analysis with final data regarding efficacy and safety outcomes, including all participant follow-up (Figure 1). Additional details are provided in Section 1 in the Supplementary Appendix and in the protocol, available with the full text of this letter at NEJM.org.
Steven K. Grinspoon, M.D.
Massachusetts General Hospital, Boston, MA
Heather J. Ribaudo, Ph.D.
Harvard T.H. Chan School of Public Health, Boston, MA
Pamela S. Douglas, M.D.
Duke Clinical Research Institute, Durham, NC
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