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2.
Topics in Antiviral Medicine ; 30(1 SUPPL):40-41, 2022.
Article in English | EMBASE | ID: covidwho-1880656

ABSTRACT

Background:A previous report showed that a single 1200 mg subcutaneous (SC) dose of casirivimab and imdevimab (cas/imd) prevented symptomatic COVID-19 by 81.4% and reduced all SARS-CoV-2 infections (symptomatic and asymptomatic) by 66.4% in household contacts living with recently infected individuals over a 28-day period. While highly effective vaccines now exist for the prevention of COVID-19, a significant unmet need remains in patients who are unable to mount or maintain an adequate immune response to vaccination. Here we present additional results from 7-month follow-up period of the aforementioned study. Methods: In this randomized, double-blind, placebo-controlled Phase III trial, asymptomatic participants exposed to a SARS-CoV-2-infected household member were randomized 1:1 to a single SC dose of placebo or 1200 mg cas/imd (600 mg of each monoclonal antibody). Efficacy analyses include participants who were RT-qPCR negative for SARS-CoV-2 (no current infection) and seronegative for SARS-CoV-2 (no prior infection) at baseline. The trial consisted of a primary efficacy assessment period of 28 days (Month 1) and a 7-month follow-up period (Months 2-8). Results: Results from 842 placebo and 841 cas/imd RT-qPCR negative/seronegative enrolled participants (data through 04Oct2021, prior to emergence of Omicron) are presented. During the entirety of the 8-month study, cas/imd reduced the risk of symptomatic SARS-CoV-2 infections by 81.2% versus placebo (nominal P<0.0001;Table) and all SARS-CoV-2 infections (symptomatic and asymptomatic) by 68.2% versus placebo (nominal P<0.0001;Table). During Months 2-5, the risk of symptomatic and all infections were reduced by 100% and 89.5%, respectively (nominal P<0.0001). During Months 6-8 there was a resumption of symptomatic and all SARS-CoV-2 infections in the cas/imd group (19.9%;nominal P=0.6411 and 30.7%;nominal P=0.3967 risk reduction, respectively). Fewer cas/imd participants had a medically-attended visit versus placebo during the 8-months (1/841 [0.1%] vs 16/842 [1.9%], respectively). No new safety signals were identified for cas/imd during the follow-up period. Conclusion: During the 8-month study period, a 1200 mg SC dose of cas/imd prevented SARS-CoV-2 infections, with maximal protection through Month 5. The prolonged protection supports the use of cas/imd for the long-term prevention of COVID-19 against susceptible variants, offering a pre-exposure prophylaxis strategy for individuals who are unlikely to respond or be protected by vaccination.

3.
Topics in Antiviral Medicine ; 29(1):33-34, 2021.
Article in English | EMBASE | ID: covidwho-1250547

ABSTRACT

Background: Passive immunization has a long history for infection prevention following exposure. We report results of a descriptive interim analysis from a study of an antibody “cocktail” of casirivimab with imdevimab (cas/imdev;formerly REGN-COV2) designed to bind non-competing epitopes of the viral spike protein, as a potential passive vaccine for the prevention of COVID-19 in people at risk of infection from household contact. Methods: In this ongoing Phase 3 study, asymptomatic participants exposed to a COVID-19-infected household member were randomized 1:1 to placebo or 1200 mg cas/imdev (600 mg of each antibody administered subcutaneously) within 96 hours of their household member testing positive. The analysis included participants who tested negative for SARS-CoV-2 by nasal, saliva, or nasopharyngeal swab and who were seronegative to SARS-CoV-2 antibodies at baseline. The proportion of participants who developed an RT-PCR-confirmed SARS-CoV-2 infection (asymptomatic or symptomatic) during the 1-month efficacy assessment period was summarized. Results: Initial results from the first evaluable 223 placebo and 186 cas/imdev participants who completed ≥29 days of the study are reported. Reduction in PCR-positive symptomatic disease was 100% (0/186 cas/imdev vs 8/223 placebo;OR 0.00 [CI 0.00, 0.69]). Reduction in any PCR-positive infection (symptomatic or asymptomatic) was 48% (10/186 vs 23/223;OR 0.49 [CI 0.20, 1.12]). Placebo-group participants had on average 100-fold higher peak viral load. In the cas/imdev group, viral RNA was not detected for longer than 1 week but was detected for 3-4 weeks in approximately 40% of placebo participants (Fig. 1). The proportions of infected participants with high viral loads (>10 4 copies/mL) were 13/21 placebo vs 0/9 cas/imdev. Total weeks of viral RNA detection and high viral load were 44 and 22 weeks in the placebo group vs 9 and 0 in the cas/imdev group. Total symptomatic weeks were 21 for placebo vs 0 for cas/imdev. A similar proportion of participants experienced at least 1 serious adverse event: placebo, 3/222 and cas/imdev, 1/186;none were deemed related to study treatment. Injection site reactions were similar: placebo, 1.4%;cas/ imdev, 2.6%. Conclusion: In this descriptive interim analysis of participants at risk of SARSCoV- 2 infection from household transmission, a subcutaneous dose of the cas/ imdev antibody cocktail prevented symptomatic infection, reduced overall infection, and decreased viral load and duration of viral RNA detection.

4.
Topics in Antiviral Medicine ; 29(1):28, 2021.
Article in English | EMBASE | ID: covidwho-1249933

ABSTRACT

Background: Home delivery and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistic barriers, and could increase ART adherence and viral suppression particularly among men who engage less in clinic-based HIV care than women. If clients pay for this service and the benefits are sufficient, it could be a scalable strategy. Methods: We conducted a randomized trial, the Deliver Health Study, of a fee for home delivery and monitoring of ART compared to clinic ART delivery in Pietermaritzburg, KwaZulu Natal, South Africa. People living with HIV on ART or willing to initiate ART in the community were recruited through communitybased testing or from facilities and randomized to: 1) fee for home delivery and monitoring of ART;or 2) clinic-based ART (standard of care). The one-time fee for home delivery was tiered based on participant income (ZAR 30, 60, and 90;equivalent to $2, 4, 6). The outcomes were payment of the fee for home delivery;acceptability of the delivery service;and viral suppression, assessed using loglinear regression adjusting for gender and age. Results: From October 2019-January 2020, 400 persons were screened;of the 180 persons living with HIV, 162 were enrolled - 82 randomized to the fee for home delivery group and 80 to the standard of care group. Overall, 87 participants (54%) were men, 22% were <30 years, 101 (62%) were on ART, and 98 (60%) were unemployed. Among participants in the fee for home delivery group, 40 (49%), 32 (40%), and 9 (11%) were in the ZAR 30, 60, and 90 fee groups, respectively. Median follow-up was 47 weeks (IQR 43-50 weeks) spanning COVID-19 restrictions. Retention at exit was 96%. In the fee payment group, 98% of participants paid the full user fee and acceptability was high with 100% reporting willingness to continue to pay a fee. Compared to standard clinic care, in the intent-to-treat analysis, fee for home delivery of ART significantly increased viral suppression from 74% to 88% (RR=1.21, 95% CI: 1.02-1.42) with a RR of 1.31 among men;fee group (84%, RR=1.31, 95% CI: 1.01-1.71) compared to standard of care (64%). Conclusion: Among South African adults living with HIV on ART or initiating ART, a fee for home delivery and monitoring of ART significantly increased viral suppression compared to clinic-based ART. Client payment of a fee for home delivery and monitoring of ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result.

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