Hospital Protection Correlates in Outpatient Covid-19 Convalescent Plasma Recipients

Background: High titer COVID-19 convalescent plasma (CCP) reduces hospitalizations among immunocompetent outpatients. This study evaluated recipient post-transfusion S receptor binding domain (S-RBD) IgG antibody levels and the association of progressing to hospitalization among unvaccinated outpatients with COVID-19 treated with CCP or control plasma. Method(s): This analysis focused on participants from a multicenter doubleblind, randomized, controlled trial comparing treatment of outpatients with COVID-19 convalescent plasma (CCP) or control plasma without SARS-CoV-2 antibodies. Participants with confirmed SARS-CoV-2 infection were transfused within 9-days of symptom onset between June 2020 and October 2021 (n=110 vaccinated control;n=105 vaccinated CCP;n=464 unvaccinated control;n=472 unvaccinated CCP;total n=574 control and n=577 CCP recipients). All subjects had specimens collected the day prior to transfusion (D-1), within 30 minutes after transfusion (D0), 14 (D14), 28 (D28), and 90 (D90) days post-transfusion. Ancestral SARS-CoV-2 S-RBD was measured by an in-house validated ELISA. All 54 COVID-19-related hospitalizations occurred within 2 weeks of transfusion. Result(s): Post-transfusion anti-S-RBD IgG levels on D0 were significantly greater for CCP (median=4 titer,log3) compared to control (median=2 titer,log3;p< 0.001) recipients. Neither sex nor age impacted antibody levels following CCP treatment at D14, D28, and D90. Vaccinated recipients had greater titers than unvaccinated recipients prior to transfusion with little change in titers post-transfusion. Unvaccinated recipients had low antibody titers on D-1 with CCP recipients exhibiting a significant increase in titer from D-1 to D0 compared to controls (mean fold change=1.89;p< 0.001). Among unvaccinated recipients, those who received CCP transfusion late ( >5 days after symptom onset) and had low D0 antibody levels (< 4.24 titer, log3) had the greatest proportion of hospitalizations (5.5%). In contrast, those who received CCP transfusion early (< 5 days after symptom onset) with high D0 antibody levels ( >4.24 titer, log3) had no hospitalizations. Unvaccinated CCP recipient anti-S-RBD IgG antibody levels on D0 correlated with donor anti-S-RBD IgG antibody levels (r=0.30, p< 0.001). Conclusion(s): Among unvaccinated outpatients with COVID-19, CCP recipient antibody dilutional titers after transfusion over 540 titer correlated with protection against hospitalization when transfusion occurred within 5 days of symptom onset. (Figure Presented).

Time Between Viral Loads for People With HIV During the COVID-19 Pandemic

Background: During the COVID-19 pandemic, patients experienced significant care disruptions, including lab monitoring. We investigated changes in the time between viral load (VL) checks for people with HIV associated with the pandemic. Methods: This was an observational analysis of VLs of people with HIV in routine care at a large subspecialty clinic. At pandemic onset, the clinic temporarily closed its onsite laboratory. The exposure was time period (time-varying): pre-pandemic (January 1st 2019-March 15th, 2020);pandemic lab-closed (March 16th-July 12th, 2020);and pandemic lab-open (July 13th-December 31st, 2020). We estimated time from an index VL to a subsequent VL, stratified by whether the index VL was suppressed (<= 200 copies/mL). We also calculated cumulative incidence of a non-suppressed VL following a suppressed index VL, and of re-suppression following a loss of viral suppression. Results: Compared to pre-pandemic, hazard ratios for next VL check were: 0.34 (95% CI: 0.30, 0.37, lab-closed) and 0.73 (CI: 0.68, 0.78, lab-open) for suppressed patients;0.56 (CI: 0.42, 0.79, lab-closed) and 0.92 (95% CI: 0.76, 1.10, lab-open) for non-suppressed patients. The 12-month cumulative incidence of loss of suppression was the same in the pandemic lab-open (4%) and pre-pandemic period (4%). The hazard of re-suppression following loss of suppression was lower during the pandemic lab-open versus the pre-pandemic period (hazard ratio: 0.68, 95% CI: 0.50, 0.92). Conclusions: Early pandemic restrictions and lab closure significantly delayed VL monitoring. Once the lab re-opened, non-suppressed patients resumed normal monitoring. Suppressed patients still had a delay, but no significant loss of suppression.

Time between Viral Loads for Suppressed and Non-Suppressed People with HIV during the COVID-19 Pandemic Compared to Pre-Pandemic

Background. During the COVID-19 pandemic, patients at the John G. Bartlett Specialty practice experienced disruptions in viral load (VL) monitoring due to 1) conversion to telemedicine visits and 2) closure of the onsite lab from March 16-July 13, 2021. We described the impact of the pandemic on VL monitoring. Methods. We measured time from all index VLs collected during 3 periods: January 1, 2019 to March 15, 2020 (pre-pandemic);March 16 to July 12, 2020 (pandemic, closed onsite lab);and July 13 to December 31, 2020 (pandemic, open onsite lab) until a subsequent VL, 1 year after the index VL, or administrative censoring on December 31, 2020, whichever came first. We classified follow-up time according to these periods (treating period as a time-varying variable). We report hazard ratios (HRs) and 95% Confidence Intervals (CI) from a Cox proportional hazards model comparing the hazard of a VL during the pandemic periods to the pre-pandemic period, stratified by whether the index VL was suppressed (≤200 copies/mL). We tested for interactions between patient characteristics (age, sex at birth, race, ethnicity, and recent substance use) and period, to investigate differential effects of the pandemic on delayed VL. Results. After 7,760 suppressed VL measurements, median times to subsequent VL during the pre-pandemic, pandemic (closed lab) and pandemic (open lab) periods, were 4.6 (HR=1.0), 8.9 (HR=0.34, CI:0.30, 0.37), and 5.8 (HR=0.73, CI:0.68,0.78) months respectively. After 1,025 non-suppressed VL measurements, median times to subsequent VL were 2.0 (HR=1.0), 3.9 (HR=0.57, CI:0.42,0.79), and 2.1 (HR=0.92, CI:0.76,1.10) months respectively. Time to subsequent VL after an index suppressed VL was less affected by the pandemic for patients who are white;had private insurance;or had no recent cocaine or heroin use. The effect of the pandemic on time to subsequent VL after a non-suppressed index VL did not significantly differ across patient characteristics. Conclusion. Onsite lab closure disrupted VL collection for all groups. Once the onsite lab opened, the pandemic period was still associated with a delay among suppressed patients, but not non-suppressed patients. Further studies are needed to investigate if these delays are associated with lapses in viral suppression.

County-level COVID-19 Case Fatality Rate in Medicaid Expansion States Compared to Non-Expansion States

Background. Medicaid expansion has been adopted by 38 states and the District of Columbia,1,2 contributing to lower rates of uninsured individuals in the US.3 During the COVID-19 pandemic, Medicaid enrollment offset employer-based insurance losses precipitated by the recession.4 The aim of this study was to evaluate whether Medicaid expansion may have impacted COVID-19 mortality. Methods. We conducted an ecologic study that included all US counties in the 50 states and District of Columbia. County-specific Medicaid expansion status was based on whether expansion was adopted within the state. COVID-19 cases and deaths for each county were obtained from the Centers of Disease Control (CDC). Unadjusted and multivariable negative binomial regression with robust standard errors to account for clustering of counties within each state were used to evaluate the association of COVID-19 case fatality rate and Medicaid expansion status. Adjusted models included the addition of four sets of county-level covariates thought to influence the association of Medicaid status and COVID-19 fatality rate: demographics, comorbidities, economic indicators, and physician density. These analyses were then performed in subgroups of counties defined by urbanicity (metro, suburban or rural) and quartiles of poverty rates. Incidence Rate Ratios (IRR) and 95% confidence intervals (CI) are reported. Results. A total of 1,814 Medicaid expansion and 1,328 non-expansion counties were included in the analysis. Crude case fatality rates were 2.1% (non-expansion) and 1.8% (expansion). Medicaid expansion was not associated with a significantly lower COVID-19 case fatality rate in either the unadjusted (IRR: 0.86;95% CI: 0.74, 1.01) or fully adjusted (IRR: 1.02;95% CI: 0.90, 1.16) models. In adjusted models, Medicaid expansion status was also not associated with differences in COVID-19 case fatality rate when counties were stratified by either urbanicity or percent of individuals living below the poverty line. Conclusion. In this county-level analysis, Medicaid expansion status was not associated with a significant difference in county-level COVID-19-related case fatality rates among people of all ages. Future individual-level studies are needed to better characterize the effect of Medicaid on COVID-19 mortality.

Visit completion during the telemedicine transition in early months of the pandemic

Background: Prior to the COVID-19 pandemic, evidence on telemedicine use in people with HIV was limited. In response to the pandemic, telemedicine was widely adopted. On March 16th, 2020, the John G. Bartlett Specialty Practice converted from exclusively in-person visits to mostly telemedicine visits. We studied the impact of this transition on visit completion. Methods: We conducted separate analyses of patients in the Johns Hopkins HIV Clinical Cohort scheduled for visits in the 14 weeks before and in the 14 weeks after the transition. For each 14-week period, we calculated the percentage of people who completed at least one visit. We calculated odds ratios (OR) for having completed ≥1 visit, associated with demographic and clinical factors in each period. Results: Pre-transition and post-transition characteristics of the study sample were: 1,580 vs 1,598 patients, 61% vs. 63% male, 80% vs. 78% black, 56 vs. 57 median age, 92% vs. 92% viral suppression, and 25% vs. 24% people with a history of injection drug use (IDU) by chart review. Pre-transition, 79% of patients completed ≥1 visit. Post-transition, 1,315 patients (82%) were scheduled for telemedicine visits and 283 were scheduled for in-person visits. Visit completion in the post-transition period was 84%, overall. Visit completion for telemedicine visits was 98%. Telemedicine visits were conducted 70% by phone, 30% by video. A History of IDU was associated with lower odds of visit completion, pre-transition OR=0.84 [95% confidence interval (CI):0.64,1.11], post-transition OR=0.74 [CI:0.55,0.99]. Substance use in recent years was associated with lower odds of visit completion post-transition: heroin use OR=0.39 [CI:0.24,0.62] and cocaine use OR=0.57 [CI:0.37,0.86]. OR for visit completion associated with tobacco use pre-transition was 0.64 [CI:0.50,0.82] and post-transition was 0.86 [CI:0.66,1.14]. Age 60+ was associated with higher odds of visit completion pre-transition (OR=1.67 [CI:1.16,2.41]) but not posttransition (OR=0.87 [CI:0.57,1.35]). Conclusion: Moving to telemedicine visits during the pandemic provided access to services, with a higher proportion of patients completing ≥1 visit, but many patients were only able to complete a telemedicine visit by phone. The impact of expanding access to telemedicine on probability of visit completion and possibly differential access by subsets of the population should be explored more once data for longer time periods are available, as should the long-term impact on other clinical outcomes.