Post-severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Treatment Hospitalizations as a Sentinel for Emergence of Viral Variants in New York City

Cowman, Kelsie; Guo, Yi; Pirofski, Liise-anne; Wong, David C. N.; Bao, Hongkai; Chen, Victor; Hopkins, Una; Andrews, Erin E.; Hamel, J.; Keller, Marla J.; Bellin, Eran; Thota, Raja; Davis, Patricia; Rodriguez, Edwin Torres; Suthar, Pooja; Allen, Lauren; Rossi, James; Haviland, Adam; Orner, Erika P.; Szymczak, Wendy; Shujauddin, Sadahf; McCarthy, James S.; Binder, Barbara; Pushparaj, Vanitha; Bard, Linda; Pierino, Vincent Frank; Alsina, Leslie; Esses, David; McCaskie, Alicia; Campbell, Caron; Madzura, Tabitha; Wollowitz, Andrew; Basset, Kelly; White, Deborah; Ruíz, Rafael; Sosnowski, Frank; Nori, Priya

doi:10.1093/ofid/ofab313

Cited by 8 publications

(12 citation statements)

References 5 publications

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“… 12 , 17 , 19 The mechanism of action of molnupiravir is independent of mutations in the spike protein, which can affect the efficacy of monoclonal antibody treatments. 8 , 37 , 38 …”

Section: Discussionmentioning

confidence: 99%

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Bernal¹,

Silva

Musungaie³

et al. 2022

N Engl J Med

1,556

1,583

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Background New treatments are needed to reduce the risk of progression of coronavirus disease 2019 (Covid-19). Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness. Participants in the trial were randomly assigned to receive 800 mg of molnupiravir or placebo twice daily for 5 days. The primary efficacy end point was the incidence hospitalization or death at day 29; the incidence of adverse events was the primary safety end point. A planned interim analysis was performed when 50% of 1550 participants (target enrollment) had been followed through day 29. Results A total of 1433 participants underwent randomization; 716 were assigned to receive molnupiravir and 717 to receive placebo. With the exception of an imbalance in sex, baseline characteristics were similar in the two groups. The superiority of molnupiravir was demonstrated at the interim analysis; the risk of hospitalization for any cause or death through day 29 was lower with molnupiravir (28 of 385 participants [7.3%]) than with placebo (53 of 377 [14.1%]) (difference, −6.8 percentage points; 95% confidence interval, −11.3 to −2.4; P=0.001). In the analysis of all participants who had undergone randomization, the percentage of participants who were hospitalized or died through day 29 was lower in the molnupiravir group than in the placebo group (6.8% [48 of 709] vs. 9.7% [68 of 699]; difference, −3.0 percentage points; 95% confidence interval, −5.9 to −0.1). Results of subgroup analyses were largely consistent with these overall results; in some subgroups, such as patients with evidence of previous SARS-CoV-2 infection, those with low baseline viral load, and those with diabetes, the point estimate for the difference favored placebo. One death was reported in the molnupiravir group and 9 were reported in the placebo group through day 29. Adverse events were reported in 216 of 710 participants (30.4%) in the molnupiravir group and 231 of 701 (33.0%) in the placebo group. Conclusions Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19. (Funded by Merck Sharp and Dohme; MOVe-OUT ClinicalTrials.gov number, NCT04575597 .)

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“… 12 , 17 , 19 The mechanism of action of molnupiravir is independent of mutations in the spike protein, which can affect the efficacy of monoclonal antibody treatments. 8 , 37 , 38 …”

Section: Discussionmentioning

confidence: 99%

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Bernal¹,

Silva

Musungaie³

et al. 2022

N Engl J Med

1,556

1,583

View full text Add to dashboard Cite

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“…The role of monoclonal antibody therapy may be especially important in mitigating poor outcomes in an outbreak setting as was done here. However, with the rise of SARS‐CoV‐2 variants, specific monoclonal antibody therapy may be significantly less effective at preventing severe COVID‐19 27,28 …”

Section: Discussionmentioning

confidence: 99%

“…However, with the rise of SARS-CoV-2 variants, specific monoclonal antibody therapy may be significantly less effective at preventing severe COVID-19. 27,28 To prevent healthcare-associated COVID-19 cases, it is vital to vaccinate hospital staff, particularly those caring for high-risk patient population who are at increased risk for severe COVID-19. 29 Despite the occurrence of this outbreak, vaccination rates of the staff on the transplant unit remained well below the hospital average.…”

Section: Discussionmentioning

confidence: 99%

An outbreak of SARS‐CoV‐2 on a transplant unit in the early vaccination era

Palacios

Grubaugh

Alpert

et al. 2022

Transplant Infectious Dis

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Background: Solid organ transplant recipients are at increased risk of COVID-19associated morbidity and mortality. Aims: We describe a nosocomial outbreak investigation on an immunocompromised inpatient unit. Methods: Patients positive for SARS-CoV-2 were identified. An epidemiologic investigation was assisted with whole genome sequencing of positive samples. Results: Two patients were identified as potential index cases; one presented with diarrhea and was initially not isolated, and the other developed hypoxemia on hospital day 18 before testing positive. Following identification of a SARS-CoV-2 cluster, the unit was closed and all patients and staff received surveillance testing revealing eight additional positive patients and staff members. Whole genome sequencing confirmed an outbreak. Enhanced infection prevention practices mitigated further spread. Asymptomatic patients with COVID-19 were successfully treated with bamlanivimab. Discussion: Preventing SARS-CoV-2 outbreaks in transplant units poses unique challenges as patients may have atypical presentations of COVID-19. Immunocompromised patients who test positive for SARS-CoV-2 while asymptomatic may benefit from monoclonal antibody therapy to prevent disease progression. All hospital staff members working with immunocompromised patients should be promptly encouraged to follow infection prevention behaviors and receive SARS-CoV-2 vaccination. Conclusion: SARS-CoV-2 outbreaks on immunocompromised units can be mitigated through prompt identification of cases and robust infection prevention practices.

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“…Constant adaptation to variants with shifting antiviral effectiveness requires frequent revision and dissemination of treatment protocols as well as maintenance of a complex and changing drug stock. 6 The burnout milieu is compounded by reactive federal responses to new surges and constant threats to pandemic funding.…”

Section: Staffingmentioning

confidence: 99%

Rising from the pandemic ashes: Reflections on burnout and resiliency from the infection prevention and antimicrobial stewardship workforce

Nori

Stevens

Patel

2022

ASHE

Self Cite

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Hospital epidemiologists, infection preventionists, and antimicrobial stewards are integral to the pandemic workforce. However, regardless of pandemic surge or postsurge conditions, their workload remains high due to constant vigilance for new variants, emerging data, and evolving public health guidance. We describe the factors that have led to burnout and suggest strategies to enhance resilience.

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Post-severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Treatment Hospitalizations as a Sentinel for Emergence of Viral Variants in New York City

Cited by 8 publications

References 5 publications

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

An outbreak of SARS‐CoV‐2 on a transplant unit in the early vaccination era

Rising from the pandemic ashes: Reflections on burnout and resiliency from the infection prevention and antimicrobial stewardship workforce

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