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Topics in Antiviral Medicine ; 31(2):88-89, 2023.
Artigo em Inglês | EMBASE | ID: covidwho-2319643


Background: Data on the effectiveness of the bivalent booster vaccine against COVID-19 breakthrough infection and severe outcomes is limited. Method(s): Using patient-level data from 54 sites in the U.S. National COVID Cohort Collaborative (N3C), we estimated bivalent booster effectiveness against breakthrough infection and outcomes between 09/01/2022 (bivalent vaccine approval date) to 12/15/2022 (most recent data release of N3C) among patients completed 2+ doses of mRNA vaccine. Bivalent booster effectiveness was evaluated among all patients and patients with and without immunosuppressed/compromised conditions (ISC;HIV infection, solid organ/ bone marrow transplant, autoimmune diseases, and cancer). We used logistic regression models to compare the odds of breakthrough infection (COVID-19 diagnosis after the last dose of vaccine) and outcomes (hospitalization, ventilation/ECMO use, or death <=28 days after infection) in the bivalent boosted vs. non-bivalent boosted groups. Models controlled for demographics, comorbidities, geographic region, prior SARS-CoV-2 infection, months since the last dose of non-bivalent vaccine, and prior non-bivalent booster. Result(s): By 12/15/2022, 2,414,904 patients had received 2+ doses of mRNA vaccination, 75,873 of them had received a bivalent booster vaccine, and 24,046 of them had a breakthrough infection. At baseline, the median age was 52 (IQR 36-67) years, 40% male, 63% white, 10% Black, 12% Latinx, 3.5% Asian American/Pacific Islander, and 14% were patients with ISC. Patients received a bivalent booster were more likely to be female and had comorbidities. Bivalent booster was significantly associated with reduced odds of breakthrough infection and hospitalization (Figure). The adjusted odds ratios comparing bivalent vs. non-bivalent group were 0.28 (95% CI 0.25, 0.32) for all patients and 0.33 (95% CI: 0.26, 0.41) for patients with ISC. Compared to the nonbivalent group, the bivalent group had a lower incidence of COVID-19-related hospitalization (151 vs. 41 per 100,000 persons), invasive ventilation/ECMO use (7.5 vs. 1.3 per 100,000 persons), or death (11 vs. 1.3 per 100,000 persons) in all patients during the study period;the incidence of severe outcomes after bivalent boosting was similar among patients with and without ISC. Conclusion(s): A bivalent booster vaccine was highly effective against COVID-19 breakthrough infection and severe outcomes among patients received 2+ doses of mRNA vaccine and offered similar protection in patients with and without ISC. (Figure Presented).

Journal of the American Society of Nephrology ; 33:318, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-2126191


Background: In the non-immunosuppressed (non-IS) population, female sex is protective against adverse COVID-19 (C19) outcomes, possibly due to estrogenrelated immunity. Sex-based risk is attenuated in IS kidney transplant recipients (KTRs). Exogenous estrogen is associated with reduced C19 mortality in non-IS postmenopausal females. Here, we aimed to study the impact of estrogen or testosterone hormone replacement therapy (HRT) on C19 outcomes in KTRs compared to the general population. Method(s): We studied adult (>45 yrs) KTRs from across the US with C19 from 05-01-20 to 05-12-22, using EHR data from the National COVID Cohort Collaborative. Female and male patients were classified as no HRT, or HRT use in the last 6 months (exogenous systemic estrogens for females;testosterone for males). Using MV cox proportional hazards models and logistic regression, we determined the risk of developing a major adverse renal or cardiac event (MARCE), mortality, and other 90-day post-C19 outcomes. We repeated this analysis in a non-IS control group for comparison. Result(s): Over the study period, 11,498 KTRs and >1.9M non-IS patients were diagnosed with C19. In non-IS, relative to no HRT use, HRT use in the last 6 months was associated with significantly lower risk of MARCE (Hazard Ratio [HR] 0.54, 95% Confidence Interval [CI] 0.51-0.59, for females;0.63, 0.56-0.70, for males), mortality (HR 0.45, CI 0.40-0.51, for females;0.55, 0.45-0.66, for males), and all secondary events for males and females (Figure 1). In KTRs, HRT was not associated with any post-C19 outcome in either males or females;there was a trend towards lower risk in males on HRT vs not on HRT, for most outcomes. Conclusion(s): HRT was protective against adverse C19 outcomes in older non-IS males and females, but not in KTRs. The modifying effects of IS on the benefits of HRT requires further investigation.

Topics in Antiviral Medicine ; 30(1 SUPPL):18-19, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-1880917


Background: Real-world evidence on effectiveness of booster or additional doses of COVID-19 vaccine is limited. Methods: Using patient-level data from 50 sites in the U.S. National COVID Cohort Collaborative (N3C), we estimated COVID-19 booster vaccine effectiveness compared to full vaccination alone (completed 2 doses mRNA or 1 dose Janssen vaccine). At each month following full vaccination, we created comparable cohorts of patients with boosters propensity-score matched to those without boosters by age, sex, race/ethnicity, comorbidities, geographic region, prior COVID-19 infection, and calendar month of full vaccination. Booster efficacy was evaluated among patients with and without immunosuppressed/compromised conditions (ISC;HIV infection, solid organ or bone marrow transplant, autoimmune diseases, and cancer). We used Cox regression models to estimate hazards of breakthrough infection (COVID-19 diagnosis after last dose of vaccine) and logistic regression models to compare the risk of death ≤45 days after a breakthrough infection in the boosted vs. matched non-boosted groups. Results: By 11/18/2021, 656390 patients had received full vaccination, and 125409 fully vaccinated had received an additional booster (median time from last vaccine to booster dose: 7.4 months, IQR:6.6, 8.2). At completion of full vaccination, median age was 50 (IQR 33-64) years, 43% male, 50% white, 11% Black, 18% Latinx, 4.8% Asian American/Pacific Islander, and 20% had ISC. People receiving a booster were more likely to be older, male, white, and have ISC. Booster vaccine was significantly associated with a reduced hazard of breakthrough infection (Table). Booster efficacy ranged from 46% (booster receipt 1-4 months after full vaccination) to 83% (receipt 7 months after full vaccination) in people without ISC. Vaccine efficacy was lower, ranging from 43%-65%, in ISC patients (Table). Compared to fully vaccinated patients without booster receipt, patients with booster had an 83% (OR: 0.17, 95% CI: 0.11, 0.28) reduced risk of COVID-19 related death, independent of demographics, geographic region, comorbidities, ISC, prior COVID-19 infection, and time of full vaccination. Conclusion: A booster dose of COVID-19 vaccine has high effectiveness in reducing breakthrough infection risk among all fully vaccinated individuals, though only with moderate effectiveness among ISC patients. Nonetheless, booster vaccination significantly reduced risk for COVID-19 related death regardless of ISC status.

Topics in Antiviral Medicine ; 30(1 SUPPL):250, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-1880741


Background: The World Health Organization (WHO) ordinal scale (OS) is used to evaluate participant outcomes in clinical trials. We modified the WHO OS to enable assessment of patient outcomes associated with various treatment agents using the National COVID Cohort Collaborative (N3C), a national database containing electronic Health Record (EHR) data from > 2.7 million persons with a COVID-19 diagnosis from > 55 U.S. sites. Methods: Modified OS severity scores (Table 1) were assigned in the first through fourth weeks following COVID-19 diagnosis for a sample of patients in N3C. To adjust for disease severity at patient hospitalization, we developed separate models to examine OS levels of 3, 5, 7, and 9. Elastic net penalized multinomial logistic regression was used to simultaneously identify risk factors and predict the probability of each level of the ordinal scale at week 4. We studied groups of anticoagulants (AC), steroids, antibiotics, antiviral agents (AA), monoclonal antibodies (MA), and a miscellaneous group that included all other treatments. Other factors considered were presence of comorbid conditions using the Charlson Comorbidity Index (CCI), ethnicity, age, gender, and time of diagnosis (by quarter). Results: We included 1,489,191 COVID-19 (161,385 outpatients were excluded) patients. Patient characteristics and treatment approaches applied to each OS level were analyzed (Table 1). For hospitalized patients with a Week 1 OS score of 3,5,7, or 9, we found that increased CCI values are associated with higher probabilities of a worsened OS score at Week 4. Given that MAs are a standard treatment for patients at OS levels 3 and 5, and that steroids are typically used at OS 7 and 9, we studied treatment combinations related to MA and steroids given during Week 1. Improved outcomes by Week 4 were demonstrated with AA+MA for OS 3 and for AC+MA for OS 5 (Table 1). Patients at OS 7 in Week 1 had improved Week 4 outcomes with steroids alone while OS 7 patients with CCI>10 had better outcomes with steroids+AC. OS 9 patients treated with steroids+MA had better outcomes compared with those not given that combination. Conclusion: Our analyses identify relationships between COVID-19 serverity, specific treatments and outcomes at 4 weeks after diagnosis. Use of MA at lower levels of severity, and steroids at higher severity levels were associated with survival to hospital discharge.