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Open Forum Infectious Diseases ; 8(SUPPL 1):S807-S808, 2021.
Article in English | EMBASE | ID: covidwho-1746276


Background. SARS-CoV-2 continues to spread and the development of safe and effective therapeutics for the prevention of severe disease remains a priority. BRII-196 and BRII-198 are non-competing anti-SARS-CoV-2 mAbs with YTE triple amino acid substitution in Fc to extend half-life and reduce receptor binding, that are being studied for treatment of COVID-19 in the ACTIV-2 Trial, sponsored by NIAID and led by ACTG. Methods. ACTIV-2 evaluates safety/efficacy of investigational agents for treatment of non-hospitalized adults with mild-moderate COVID-19 under a randomized, blinded, controlled adaptive platform. BRII-196/BRII-198 (1000 mg each) as a single dose given as sequential infusions, or placebo to those at high risk of clinical progression (i.e., age ≥ 60 years or presence of other medical conditions) within 10 days of symptom onset and positive test for SARS-CoV-2. The primary endpoint was hospitalization and/or death through day 28. We report Phase 3 BRII-196/BRII-198 trial results per DSMB recommendation following an interim analysis. Results. Between January and July 2021, 837 participants (418 active, 419 placebo) from sites in the US (66%), Brazil, South Africa, Mexico, Argentina and the Philippines were randomized and received study product at time of emerging variants. Median age 49 years (Q1, Q3: 39, 58), 51% female, 17% Black/African-American and 49% Hispanic/Latino, with median 6 days from symptom onset. At interim analysis 71% and 97% had a day 28 and 7 visit, respectively. For all available data at interim review, BRII-196/BRII-198 compared to placebo had fewer hospitalizations (12 vs. 45) and deaths (1 vs. 9). At day 28 of follow-up, there was an estimated 78% reduction in hospitalization and/or death (2.4 vs. 11.1%), relative risk 0.22 (95% CI: 0.05, 0.86), P=0.00001 (nominal one-sided). Grade 3 or higher adverse events (AEs) were observed less frequently among BRII-196/BRII-198 participants than placebo (3.8% vs. 13.4%) with no severe infusion reactions or drug related serious AEs. Conclusion. BRII-196/BRII-198 was safe, well-tolerated, and demonstrated significant reduction compared to placebo in the risk of hospitalization and/or death among adults with mild-moderate COVID-19 at high risk for progression to severe disease.

Topics in Antiviral Medicine ; 29(1):285, 2021.
Article in English | EMBASE | ID: covidwho-1250279


Background: On March 13, 2020 a national emergency was declared and protective measures were implemented in response to the COVID-19 pandemic. PrEP prescriptions had increased in the United States since 2014, but shutdown because of COVID-19 resulted in decreased use of health services. The objective of this study was to evaluate the impact of the COVID-19 on PrEP prescriptions in the United States. Methods: We analyzed data from the IQVIA Real World Data-Longitudinal Prescriptions Database from 2017 to the end of June 2020. Using a validated algorithm, we identified PrEP prescriptions and new PrEP users. We used a Bayesian structural time series model to predict the trajectory in PrEP prescriptions for the period of March 15-June 27, 2020 in the absence of the pandemic. The prediction was computed based on the pre-COVID-19 weekly PrEP data from January 1, 2017 to March 14, 2020 in the IQVIA database and adjusted for decreased PrEP prescriptions during holidays. The impact of COVID-19 was inferred by the differences between predicted and observed time series. We stratified the effect of COVID-19 on PrEP prescriptions by age group, insurance type, and among 10 states with most PrEP prescriptions prior to the national emergency declaration. Results: In the absence of the pandemic, our time series model predicted that there would have been 264,281 PrEP prescriptions during March 15-June 27, 2020 and we observed 222,589 PrEP prescriptions in the IQVIA database, a 15.8% reduction after the emergency declaration (Figure). The model predicted 43,636 new PrEP users during the same time period and we observed 29,971 new PrEP users, a 31.3% reduction after the emergency declaration. The impact of the pandemic on PrEP prescriptions was greater for those who paid for PrEP with cash (34.3% reduction in PrEP prescriptions;44.3% reduction in new PrEP users). The COVID-19 impact varied among the 10 states with the most PrEP prescriptions prior to the pandemic, ranging from 6.8% to 25.1% reductions in PrEP prescriptions and 19.8% to 48.1% reductions in new PrEP users. The number of new PrEP users began to increase towards the end of June 2020. Conclusion: Closures during the initial phase of the COVID-19 pandemic resulted in decreases in PrEP prescriptions and even more in new PrEP users. Ongoing monitoring is warranted to assess whether the impact has abated since June 2020. The reasons for decreased PrEP prescriptions could be lack of access to care or decreased risk behavior during the pandemic.

Topics in Antiviral Medicine ; 29(1):288-289, 2021.
Article in English | EMBASE | ID: covidwho-1250091


Background: On March 13, 2020, the United States declared a national emergency to combat coronavirus disease 2019 (COVID-19). Many states and localities issued shelter-in-place or stay-at-home orders to reduce the spread of COVID-19, limiting movement outside the home to essential activities. Since that time the pandemic has been associated with documented disruptions in routine preventive and other nonemergency care. Screening for HIV infection as well as HIV-1 viral load monitoring for persons living with HIV have likely been affected by the pandemic. Laboratory data from the National Syndromic Surveillance Program provide one way to assess the impact of the COVID-19 pandemic on HIV screening, HIV diagnoses and HIV-1 viral load monitoring. Methods: Using data reported daily to CDC from a large commercial laboratory, we identified lab test reports for HIV screening or HIV-1 viral load testing. For reports with HIV screening test results, we assessed how often the final HIV test algorithm result was confirmed positive. We plotted daily counts of each of the three HIV test types and 7-day moving averages. We also calculated the difference in the number of each type of test performed between March 13, 2019 and September 30, 2019 from those performed during the same time period in 2020. Results: Compared with number of tests performed in 2019, there were 669,847 fewer HIV screening tests, 4,910 fewer confirmed HIV-1 diagnoses, and 67,694 fewer HIV-1 viral load tests performed during March 13 to September 30, 2020. The 7-day average number of HIV tests performed dropped dramatically after March 13, 2020 and did not recover to 2019 levels by September 30, 2020 (Figure). Conclusion: During the national COVID-19 emergency, routine screening for HIV and HIV-1 viral load monitoring may have been delayed or foregone by many patients and clinicians. Undiagnosed HIV infection and higher viral loads could have led to increased morbidity and transmission. Although the number of tests being performed has partially recovered from a nadir this spring, testing at this commercial lab has not yet rebounded to make up what was lost. Healthcare system adaptations including home testing, home sample collection, and telemedicine visits for HIV care can help to address this shortfall as the COVID-19 pandemic persists in the US.