Increase in False Positive Fourth Generation HIV Tests in Patients with COVID-19 Disease.

BACKGROUND: We observed an increase in the frequency of false positive (FP) HIV test results correlating with SARS-CoV-2 prevalence, which led us to measure FP rates of a laboratory-based fourth generation HIV antigen/antibody test among those with polymerase-chain reaction (PCR)-confirmed infection with SARS-CoV-2 compared to the FP rate of those testing PCR-negative for SARS-CoV-2. METHODS: All those PCR tested for SARS-CoV-2 result within 2 weeks of a HIV fourth generation assay were selected. Positive HIV fourth generation assays were independently reviewed and divided into groups of FP, true positives (TP), and presumptive negatives (PN). Variables included age, race, ethnicity, gender, pregnancy, and COVID-19 immunization status. Associations with positive SARS-CoV-2 tests were assessed using linear logistic regression. A multivariate logistic regression was used to assess sets of variables. RESULTS: There were 31,910 medical records that met criteria. The frequency of SARS-CoV-2 positive tests was then calculated in groups of HIV TP, FP, and PN. In total, 31,575 patients had a PN HIV test result, 248 patients had a TP, and 87 patients had a FP. Those with HIV FP tests had the highest percentage of COVID-19 positive test results at 19.5%, which was significantly higher than HIV PN (11.3%; p = 0.016) and HIV TP (7.7%; p = 0.002). After adjustment for all covariates, only FP HIV was significantly associated with COVID-19 (odds ratio 4.22; p = 0.001). CONCLUSIONS: This study reveals those patients with positive SARS-CoV-2 PCR tests are significantly more likely to have a FP fourth generation HIV test than those with negative SARS-CoV-2 PCR tests.

Descriptive Analysis of Patients Living With HIV Affected by COVID-19.

BACKGROUND: COVID-19 disease has spread globally and was declared a pandemic on March 11, 2020, by the World Health Organization. On March 10, the State of Michigan confirmed its first 2 cases of COVID-19, and the number of confirmed cases has reached 47,182 as of May 11, 2020, with 4555 deaths. SETTING: Currently, little is known if patients living with HIV (PLWH) are at a higher risk of severe COVID-19 or if their antiretrovirals are protective. This study presents epidemiologic and clinical features of COVID-19 infected PLWH in Detroit, Michigan. METHODS: This is a case series that included 14 PLWH with laboratory-confirmed COVID-19 infection who were evaluated at Henry Ford Hospital in Detroit, Michigan, between March 20, 2020, and April 30, 2020. RESULTS: Fourteen PLWH were diagnosed with COVID-19. Twelve patients were men and 2 were women; 13 patients were virally suppressed. Eight patients were hospitalized, and 6 patients were told to self-quarantine at home after their diagnoses. Three patients who were admitted expired during their hospital stay. No patient required bilevel positive airway pressure or nebulizer use in the emergency department, and none developed acute respiratory distress syndrome, pulmonary embolism, deep venous thrombosis, or a cytokine storm while on therapy for COVID-19. CONCLUSION: Although the clinical spectrum of COVID-19 among PLWH cannot be fully ascertained by this report, it adds to the data that suggest that HIV-positive patients with SARS-CoV-2 infection are not at a greater risk of severe disease or death as compared to HIV-negative patients.

The seroprevalence of COVID-19 in patients living with HIV in metropolitan Detroit.

BACKGROUND: COVID-19, a novel respiratory illness caused by SARS-CoV-2, has become a global pandemic. As of December 2020, 4.8% of the 941 people living with HIV in our Ryan White clinic have tested polymerase chain reaction positive for SARS-CoV-2. The aim of our study was to estimate the seroprevalence of COVID-19 in our Ryan White people living with HIV, irrespective of known past infection. METHODS: We conducted a cross-sectional study that recruited people living with HIV in the Ryan White program at Henry Ford Hospital in Detroit, Michigan, from September 2020 through May 2021. All Ryan White patients were offered participation during clinic visits. After informed consent, patients completed a survey, and had blood sampled for SARS-CoV-2 antibody testing. RESULTS: Of the 529 individuals who completed the written survey, 504 participants were tested for SARS-CoV-2 antibody and 52 people living with HIV were COVID-19 immunoglobulin (Ig) G positive resulting in a seroprevalence of 10.3%. Among 36 persons with PCR-confirmed COVID-19, 52.8% were IgG negative. Inclusion of PCR positive but IgG-negative people living with HIV yields a COVID-19 infection prevalence of 14.1%. CONCLUSIONS: These findings suggest that passive public health-based antibody surveillance in people living with HIV significantly underestimates past infection.

Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.

BACKGROUND: In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment. OBJECTIVE: To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high. DESIGN: Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multicenter trial. PATIENTS: Hospitalized patients with COVID-19 without end-organ failure. INTERVENTION: Bamlanivimab (7000 mg) or placebo. MEASUREMENTS: Antibody, antigen, and viral RNA levels were centrally measured on stored specimens collected at baseline. Patients were followed for 90 days for sustained recovery (defined as discharge to home and remaining home for 14 consecutive days) and a composite safety outcome (death, serious adverse events, organ failure, or serious infections). RESULTS: Among 314 participants (163 receiving bamlanivimab and 151 placebo), the median time to sustained recovery was 19 days and did not differ between the bamlanivimab and placebo groups (subhazard ratio [sHR], 0.99 [95% CI, 0.79 to 1.22]; sHR > 1 favors bamlanivimab). At entry, 50% evidenced production of anti-spike nAbs; 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1000 ng/L. Among those without and with nAbs at study entry, the sHRs were 1.24 (CI, 0.90 to 1.70) and 0.74 (CI, 0.54 to 1.00), respectively (nominal P for interaction = 0.018). The sHR (bamlanivimab vs. placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 [CI, 0.99 to 2.23]) or viral RNA (sHR, 1.89 [CI, 1.23 to 2.91]). Hazard ratios for the composite safety outcome (<1 favors bamlanivimab) also differed by serostatus at entry: 0.67 (CI, 0.37 to 1.20) for those without and 1.79 (CI, 0.92 to 3.48) for those with nAbs. LIMITATION: Subgroup analysis of a trial prematurely stopped because of futility; small sample size; multiple subgroups analyzed. CONCLUSION: Efficacy and safety of bamlanivimab may differ depending on whether an endogenous nAb response has been mounted. The limited sample size of the study does not allow firm conclusions based on these findings, and further independent trials are required that assess other types of passive immune therapies in the same patient setting. PRIMARY FUNDING SOURCE: U.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.

Telehealth and HIV Care During the COVID-19 Pandemic

Background The COVID-19 Pandemic led to many restrictions in health care services, and as a consequence, an expansion of telehealth capabilities. In order to meet the needs of PLWH along the Care Continuum, we developed a process to promote the use of our MyChart app. This HIPAA-compliant app allows patients to view their medical records, communicate with their providers, make appointments, and have video visits on their smart devices. This report describes our preliminary findings. Methods PLWH enrolled in the Ryan White Program, in the Infectious Diseases Clinic at Henry Ford Hospital who had not used telehealth services were asked to sign up for our MyChart (electronic medical record software) initiative. A telehealth Navigator interviewed and taught PLWH how to download and use MyChart, and supplied pre-loaded phones, as needed, to make virtual visits accessible. We collected demographic and clinical information and reasons for not using telehealth services. Results From October 2020 to May 2021, 209 PLWH were enrolled into our pilot program (Table 1). Of these: 48% were 45-64 years old (yo), while 21% were >/+ 60 yo and 3% < 25 yo;75% were male, 85% Black;48% MSM, and 84% virally suppressed (HIV RNA < 200 copies/mm3). When asked why they were not using telehealth services, 29% reported a lack of technology or capability to install MyChart on their phones, 27% needed further education, and 18% and had not prioritized installation of the application. Conclusion The crises created by the COVID-19 pandemic revealed a new role for telehealth services. Although available to all PLWH in our RW program, many had never used telehealth services. Over half lacked compatible devices or needed help to download or use the app. Compared to younger PLWH, older individuals were more likely to need assistance. Further work is needed to understand and promote digital parity. Disclosures All Authors: No reported disclosures

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.

BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. METHODS: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. RESULTS: On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).