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All Studies   All Outcomes    Recent:   

Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge

Arbel et al., New England Journal of Medicine, doi:10.1056/NEJMoa2204919 (date from preprint)
Jun 2022  
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Mortality, both age groups.. 56% Improvement Relative Risk Mortality, age 65+ 79% Mortality, age 40-64 -32% Hospitalization, both age.. 57% Hospitalization, age 65+ 73% Hospitalization, age 40-64 26% Paxlovid for COVID-19  Arbel et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? Retrospective 109,213 patients in Israel Lower mortality (p=0.37) and hospitalization (p=0.098), not sig. c19early.org Arbel et al., New England J. Medicine, Jun 2022 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
Retrospective 109,254 patients in Israel, 3,902 treated with nirmatrelvir, showing lower mortality and hospitalization with treatment for the subgroup of patients >65. Authors only provide subgroup results.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid1. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid"2.
Kamo et al. show significantly increased risk of acute kidney injury. Resistant variants are likely4,5.
Study covers molnupiravir and paxlovid.
risk of death, 55.8% lower, HR 0.44, p = 0.37, treatment 3,902, control 105,352, adjusted per study, both age groups combined.
risk of death, 79.0% lower, HR 0.21, p = 0.03, treatment 2 of 2,484 (0.1%), control 158 of 40,337 (0.4%), NNT 321, adjusted per study, multivariable, Cox proportional hazards, age 65+.
risk of death, 32.0% higher, HR 1.32, p = 0.81, treatment 1 of 1,418 (0.1%), control 16 of 65,015 (0.0%), adjusted per study, multivariable, Cox proportional hazards, age 40-64.
risk of hospitalization, 56.5% lower, HR 0.43, p = 0.10, treatment 3,902, control 105,352, adjusted per study, both age groups combined.
risk of hospitalization, 73.0% lower, HR 0.27, p < 0.001, treatment 2 of 2,484 (0.1%), control 151 of 40,337 (0.4%), NNT 340, adjusted per study, multivariable, Cox proportional hazards, age 65+.
risk of hospitalization, 26.0% lower, HR 0.74, p = 0.44, treatment 1 of 1,418 (0.1%), control 13 of 65,015 (0.0%), adjusted per study, multivariable, Cox proportional hazards, age 40-64.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Arbel et al., 1 Jun 2022, retrospective, Israel, peer-reviewed, mean age 60.0, 16 authors. Contact: ronen.arbel@gmail.com.
This PaperPaxlovidAll
Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge
Ph.D Ronen Arbel, Yael Wolff Sagy, Ph.D Moshe Hoshen, Erez Battat, M.D Gil Lavie, Ruslan Sergienko, Ph.D Michael Friger, M.D Jacob G Waxman, M.D Noa Dagan, Ran Balicer, Yatir Ben-Shlomo, B.Sc Alon Peretz, M.D Shlomit Yaron, M.D Danielle Serby, M.Sc Ariel Hammerman, Ph.D Doron Netzer
New England Journal of Medicine, doi:10.1056/nejmoa2204919
BACKGROUND The oral protease inhibitor nirmatrelvir has shown substantial efficacy in highrisk, unvaccinated patients infected with the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Data regarding the effectiveness of nirmatrelvir in preventing severe coronavirus disease 2019 (Covid-19) outcomes from the B.1.1.529 (omicron) variant are limited. METHODS We obtained data for all members of Clalit Health Services who were 40 years of age or older at the start of the study period and were assessed as being eligible to receive nirmatrelvir therapy during the omicron surge. A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of nirmatrelvir treatment with hospitalization and death due to Covid-19, with adjustment for sociodemographic factors, coexisting conditions, and previous SARS-CoV-2 immunity status. RESULTS A total of 109,254 patients met the eligibility criteria, of whom 3902 (4%) received nirmatrelvir during the study period. Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.27; 95% confidence interval [CI], 0.15 to 0.49). The adjusted hazard ratio for death due to Covid-19 was 0.21 (95% CI, 0.05 to 0.82). Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.74; 95% CI, 0.35 to 1.58). The adjusted hazard ratio for death due to Covid-19 was 1.32 (95% CI, 0.16 to 10.75). CONCLUSIONS Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.
References
Arbel, Hammerman, Sergienko, BNT162b2 vaccine booster and mortality due to Covid-19, N Engl J Med
Arbel, Sergienko, Friger, Effectiveness of a second BNT162b2 booster vaccine against hospitalization and death from COVID-19 in adults aged over 60 years
Callaway, Ledford, How bad is omicron? What scientists know so far, Nature
Dagan, Barda, Kepten, BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting, N Engl J Med
Dryden-Peterson, Kim, Kim, Nirmatrelvir plus ritonavir for early COVID-19 and hospitalization in a large US health system, doi:10.1101/2022.06.14.22276393v2
Hammond, Leister-Tebbe, Gardner, Oral nirmatrelvir for highrisk, nonhospitalized adults with Covid-19, N Engl J Med
Li, Wang, Lavrijsen, SARS-CoV-2 omicron variant is highly sensitive to molnupiravir, nirmatrelvir, and the combination, Cell Res
Lévesque, Hanley, Kezouh, Suissa, Problem of immortal time bias in cohort studies: example using statins for preventing progression of diabetes, BMJ
Rubin, Baden, Morrissey, Audio interview: understanding the omicron variant of SARS-CoV-2, N Engl J Med
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Vangeel, Chiu, Jonghe, Remdesivir, molnupiravir and nirmatrelvir remain active against SARS-CoV-2 omicron and other variants of concern, Antiviral Res
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