Journal Article

Effects of Pitavastatin on COVID-19 Incidence and Seriousness Among a Global Cohort of People With HIV

Malvestutto, Carlos D, Bloomfield, Gerald S, Zanni, Markella V, Wang, Gary P, Diggs, Marissa R, Martinez, Esteban, Currier, Judith S, Umbleja, Triin, McCallum, Sara, Ribaudo, Heather J, Schnittman, Samuel R, Fichtenbaum, Carl J, Fitch, Kathleen V, Somboonwit, Charurut, Overton, Edgar Turner, Grinspoon, Steven K, Lu, Michael T, Douglas, Pamela S, Mushatt, David, Connick, Elizabeth, Aberg, Judith A, Foldyna, Borek, Erlandson, Kristine M

2024

Overview

Abstract Background Among people with HIV (PWH), COVID-19 is common and potentially severe. We leveraged REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) to assess the effects of statin therapy for cardiovascular disease prevention on COVID-19 outcomes (incidence and serious cases) among a global cohort of PWH. Methods COVID-19 data collection was implemented April 2020 to capture events from January 2020. COVID-19 was defined by positive test result or clinical diagnosis and serious COVID-19 according to the International Conference on Harmonisation definition. Among participants in follow-up on 1 January 2020, Cox proportional hazards modeling was used to estimate the hazard ratio (HR) of COVID-19 (pitavastatin/placebo), stratified by Global Burden of Disease region. Modification of statin effect following COVID-19 vaccination was evaluated via interaction with time-updated vaccination status. Results Among 6905 PWH, 32% were natal female and 41% were Black or African American. The median age was 53 years and the 10-year atherosclerotic cardiovascular disease risk score 4.5%. Statin therapy did not reduce COVID-19 incidence (HR, 1.05; 95% CI, .95–1.15) but appeared to reduce incidence of serious COVID-19 (HR, 0.75; 95% CI, .52–1.09). Among 1701 PWH with COVID-19, the relative risk (pitavastatin/placebo) for serious COVID-19 was 0.73 (95% CI, .52–1.03). The treatment effect size for serious COVID-19 fell within the hypothesized range, but the 95% CI crossed 1 given fewer-than-anticipated cases (117 vs 200). Furthermore, 83% reported COVID-19 vaccination by end of study, with a strong protective effect on serious COVID-19 (HR, 0.27; 95% CI, .14–.53; P < .0001). A protective statin effect was observed prior to vaccination. Conclusions Among PWH, statin therapy had no effect on COVID-19 incidence but showed potential to reduce risk of serious COVID-19 prior to COVID-19 vaccination. Clinical Trials Registration NCT02344290 (ClinicalTrials.gov). In a global cohort of people with HIV with low to moderate traditional atherosclerotic cardiovascular disease risk, statin therapy had no effect on COVID-19 incidence but showed potential to reduce the risk of serious COVID-19 prior to COVID-19 vaccination.

• Publisher: Oxford University Press
• Subject: Atherosclerosis / Cardiovascular disease / Clinical Trials and Therapeutics / Cohort analysis / COVID-19 vaccines / Immunization