INCIDENCE, PREDICTORS, AND CLINICAL OUTCOMES OF SARS-CoV-2 INFECTION IN PERSONS WITH HIV

Clinical manifestations and severity of COVID-19, the disease caused by SARS-CoV-2, in persons with HIV (PWH) have not been described in the United States (US). It is of critical importance to understand the spectrum of manifestations of COVID-19 in PWH and population-specific risk factors. PWH have altered immune responses and may be at higher risk for complications and death from COVID-19. Nearly half of PWH in the US are aged 50 or older, and many of them are affected by multiple comorbidities including diabetes, hypertension, cardiovascular disease (CVD), and hepatitis B or C virus coinfection, each of which may also increase risk of severe COVID-19 disease and death. The proposed research will build on the robust infrastructure and research platform of prospectively-collected and validated data in the multi-site CFAR Network of Integrated Clinical Systems (CNICS) cohort to investigate risk factors and clinical manifestations of COVID-19 in a geographically and demographically diverse population of PWH in routine care across the US. This supplement will enable us to rapidly augment CNICS data collection (diagnoses, laboratory, medication and procedure data) and medical record review procedures to ensure that relevant clinical factors (e.g. concomitant use of angiotensin-converting enzyme inhibitors and direct-acting antiviral agents), baseline comorbidities, indicators of disease severity (e.g. in-hospital incident respiratory, cardiac, thrombotic, hematologic, inflammatory, and renal consequences), and outcomes of COVID-19 are captured and adjudicated to characterize laboratory-confirmed COVID-19 cases occurring in PWH. We will investigate the observed incidence, predictors of severe clinical outcomes (hospitalization, ICU admission, intubation), and mortality associated with PCR-positive SARS-CoV-2 infection among PWH. Using SARS-CoV-2 serologic testing data obtained through routine care, we will also estimate the proportion of PWH who had minimally symptomatic or asymptomatic seroconversion to SARS-CoV-2. Our overarching hypothesis is that the severity of COVID-19 disease will be higher among PWH than in the general population, particularly among those with detectable HIV viremia, low CD4 cell count, and higher comorbidity burden including obesity, diabetes, CVD, liver and lung disease. This supplement leverages the comprehensive data available in CNICS and takes advantage of the ability to rapidly incorporate new data elements and adjudicate novel clinical outcomes.