Abstract
Background: Among people with HIV (PWH), COVID-19 is common and potentially severe. We leveraged REPRIEVE to assess the effects of statin therapy for cardiovascular disease (CVD) 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 or clinical diagnosis; serious COVID-19 according to ICH definition. Among participants in follow-up on January 1, 2020, Cox proportional hazards modeling was used to estimate the hazard ratio (HR) of COVID-19 (pitavastatin/placebo), stratified by the 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 females and 41% were Black or African American. Median age was 53 years and 10-year ASCVD risk score 4.5%. Statin therapy did not reduce COVID-19 incidence (HR 1.05, 95% confidence interval (CI): 0.95-1.15) but appeared to reduce incidence of serious COVID-19 (HR 0.75, CI 0.52-1.09). Among 1701 PWH with COVID-19, the relative risk (pitavastatin/placebo) for serious COVID-19 was 0.73 (CI 0.52-1.03). Treatment effect size for serious COVID-19 fell within the hypothesized range, but CI crossed 1 given fewer-than-anticipated cases (117 vs. 200). 83% reported COVID-19 vaccination by end-of-study, with a strong protective effect on serious COVID-19 (HR 0.27, CI 0.14-0.53, p<0.0001). 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.