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

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

doi:10.1093/ofid/ofae574

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

Open Forum Infect Dis. 2024 Oct 10;11(10):ofae574. doi: 10.1093/ofid/ofae574. eCollection 2024 Oct.

Authors

Markella V Zanni¹, Triin Umbleja², Carl J Fichtenbaum³, Kathleen V Fitch¹, Sara McCallum¹, Judith A Aberg⁴, Edgar Turner Overton⁵, Carlos D Malvestutto⁶, Gerald S Bloomfield⁷, Judith S Currier⁸, Samuel R Schnittman^{1

9}, Kristine M Erlandson¹⁰, Marissa R Diggs¹, Borek Foldyna¹¹, Esteban Martinez¹², Charurut Somboonwit¹³, Gary P Wang¹⁴, David Mushatt¹⁵, Elizabeth Connick¹⁶, Michael T Lu¹¹, Pamela S Douglas¹⁷, Heather J Ribaudo², Steven K Grinspoon¹

Affiliations

¹ Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
² Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Heath, Boston, Massachusetts, USA.
³ Division of Infectious Diseases, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
⁴ Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵ Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁶ Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.
⁷ Department of Medicine, Duke Global Health Institute, and Duke Clinical Research Institute, School of Medicine, Duke University, Durham, North Carolina, USA.
⁸ Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
⁹ Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
¹⁰ Division of Infectious Diseases, Department of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
¹¹ Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
¹² Infectious Diseases Service, Hospital Clinic and University of Barcelona, Barcelona, Spain.
¹³ Division of Infectious Diseases, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.
¹⁴ Division of Infectious Diseases, School of Medicine, University of Florida, Gainesville, Florida, USA.
¹⁵ Division of Infectious Diseases, School of Medicine, Tulane University, New Orleans, Louisiana, USA.
¹⁶ Division of Infectious Diseases, College of Medicine, University of Arizona, Tucson, Arizona, USA.
¹⁷ Duke Clinical Research Institute, School of Medicine, Duke University, Durham, North Carolina, USA.

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).

Keywords: COVID-19; HIV; PWH; REPRIEVE; statin.

Publication types

Clinical Trial

Associated data

ClinicalTrials.gov/NCT02344290

Abstract

Publication types

Associated data

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