ABSTRACT
Background. Effectively interrupting the source of transmission is a critical step in ending the HIV epidemic. COMEBACK (NCT04519970) is a 48-week single-center study in Chicago implemented in September 2020, with its main objectives to reengage lost-to-care patients and rapidly reinitiate ART to promote VS and favorable PROs. Methods. Adults off ART >=2 weeks, without history of significant B/F/TAF resistance or renal impairment, were rapidly started on B/F/TAF upon reengagement after same day collection of baseline labs and PROs. A retention screening assessment was used to stratify participants into case management (CM) tiers: Minimal, Moderate, or Advanced. An acuity assessment tool was adapted to determine whether participants needed additional support based on retention and VS. Currently, 80 of the expected 100 subjects are enrolled and 55 have reached the 24-week timepoint. Baseline and 6-month endpoints were analyzed for these participants. Results. At baseline (N=55), median age was 34 years (range, 24-62), with 92.6% Black and 72.2% cisgender male. Median CD4+ was 338 cells/mm3, with a median viral load 7,402copies/mL, (range, < 40-333,350, 16.3% VS). Median time off ART was 2.6 months (range, 0.5-243). For CM, participants were stratified into Minimal (71%) and Moderate (29%) tiers;none were identified as Advanced. Table 1 reflects tier shifts through 24 weeks. Shifts inCMintensity differs from the HIV adherence self-efficacy PRO completed within 24 weeks, indicating that at least 50% underestimated their need to integrate and maintain adherence to ART treatment. Forty of 55 participants (72.7%) were retained-in-care at 6 months, with VS in 61.8% (N=34/55) by intention-to-treat and 85% (N=34/40) by observed analysis. No resistance to B/F/TAF was detected through 6 months. Note: The table reflects patients retained on study at their week 24 endpoint. Conclusion. VS was high for participants retained-in-care, but lapses in retention and shifts toward more intense CM were likely due to social determinants of health challenges, including incarceration, housing insecurity, and COVID-19-related disruptions in healthcare.
ABSTRACT
Background. Although studies show most COVID-19 survivors have post-infection immunity against SARS-CoV-2 that could prevent re-infection, there is still a need to identify the breadth of antibody (Ab) responses associated with clinical phenotypes. We characterized Ab profiles at the estimated peak of Ab diversity among adults with recovered SARS-CoV-2 infections and determined their relationships with clinical factors. Methods. From April-June 2020, 41 health system employees with PCRconfirmed symptomatic COVID-19 infection enrolled 8-10 weeks after symptom onset. Symptom questionnaires including baseline demographics, COVID-19 symptoms, disease severity, and disease duration were collected and plasma samples were assayed using a custom Luminex Multiplex platform (Figure 1) to measure the antibody response against 20 COVID-19 related antigens (Figure 2). Differences in Ab profile titers among different groups were tested using nonparametric t test and Benjamini-Hochberg adjustment for multiplicity. Associations were considered significant at FDR< 0.05. Figure 1: Description of the Luminex Serology Assay Figure 2: List of the COVID-19 Related Antigens and Controls Measured Results. Mean age was 48 years (range 27-68), with 51% female, 37% White, 32% Black, 29% Asian, and 17% LatinX. Ab profiles (Figure 3) showed 100% cross-reactivity with related alpha and beta coronavirus, and 95% with SARS-CoV-1. 78% had Abs against SARS-CoV-2 nucleocapsid protein (NCP). However, 29% of patients had no immune response against the four spike protein epitopes. These participants also reported fewer symptoms, including no cases of anosmia/ageusia, suggesting mild illness. Anosmia/ageusia, fever, and cough associated significantly with higher Ab titers (Figure 4). Conclusion. Broad immune responses to various SARS-CoV-2 and related antigens were found among a heterogeneous patient population. However, less than 3 months after symptom onset, protective Ab responses to SARS-CoV-2 spike proteins were not detected in nearly one-third of recovered patients, primarily with mild infection. Intact sense of smell and taste demonstrated the greatest association with loss of seroprotective SARS-CoV-2 Ab responses, which may be clinically useful to predict post-infection immunity. Next steps include comparing the magnitude of Ab responses following full series completion with mRNA vaccination among this cohort.