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0 0.5 1 1.5 2+ Mortality 95% Improvement Relative Risk Progression 39% Progression (b) 33% Hospitalization 56% Paxlovid for COVID-19  Ganatra et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? PSM retrospective 2,260 patients in the USA (Dec 2021 - Apr 2022) Lower mortality (p=0.0019) and progression (p=0.00011) Ganatra et al., Clinical Infectious Di.., Aug 2022 Favors paxlovid Favors control

Oral Nirmatrelvir and Ritonavir in Non-hospitalized Vaccinated Patients with Covid-19

Ganatra et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac673
Aug 2022  
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TriNetX retrospective 1,131 vaccinated COVID-19 patients treated with paxlovid and matched controls, showing lower mortality and hospitalization with treatment.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid Hoertel. 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" FDA.
risk of death, 95.2% lower, RR 0.05, p = 0.002, treatment 0 of 1,130 (0.0%), control 10 of 1,130 (0.9%), NNT 113, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), propensity score matching, day 30.
risk of progression, 39.2% lower, RR 0.61, p < 0.001, treatment 89 of 1,130 (7.9%), control 163 of 1,130 (14.4%), NNT 15, odds ratio converted to relative risk, combined ER/hospitalization/death, propensity score matching, day 30.
risk of progression, 32.9% lower, HR 0.67, p = 0.003, treatment 89 of 1,130 (7.9%), control 163 of 1,130 (14.4%), combined ER/hospitalization/death, propensity score matching, Kaplan–Meier, day 30.
risk of hospitalization, 56.5% lower, RR 0.44, p = 0.02, treatment 10 of 1,130 (0.9%), control 23 of 1,130 (2.0%), NNT 87, odds ratio converted to relative risk, propensity score matching, day 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ganatra et al., 20 Aug 2022, retrospective, USA, peer-reviewed, mean age 57.6, 9 authors, study period 1 December, 2021 - 18 April, 2022.
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Oral Nirmatrelvir and Ritonavir in Non-hospitalized Vaccinated Patients with Covid-19
MD Sarju Ganatra, MD, MSc Sourbha S Dani, MD Javaria Ahmad, MD Ashish Kumar, MD Jui Shah, MD, MPH George M Abraham, MD Daniel P Mcquillen, MD Robert M Wachter, MD Paul E Sax
Background Treatment of coronavirus disease-2019 (Covid-19) with nirmatrelvir plus ritonavir (NMV-r) in high-risk non-hospitalized unvaccinated patients reduced the risk of progression to severe disease. However, the potential benefits of NMV-r among vaccinated patients are unclear. Methods We conducted a comparative retrospective cohort study using the TriNetX research network. Patients ≥18 years of age who were vaccinated and subsequently developed Covid-19 between December 1, 2021, and April 18, 2022, were included. Cohorts were developed based on the use of NMV-r within five days of diagnosis. The primary composite outcome was all-cause emergency room (ER) visit, hospitalization, or death at a 30-days follow-up. Secondary outcomes included individual components of primary outcomes, multisystem symptoms, Covid-19 associated complications, and diagnostic test utilization. Results After propensity score matching, 1,130 patients remained in each cohort. A primary composite outcome of all-cause ER visits, hospitalization, or death in 30 days occurred in 89 (7.87%) patients in the NMV-r cohort as compared to 163 (14.4%) patients in the non-NMV-r cohort (OR 0.5, CI 0.39-0.67; p<0.005) consistent with 45% relative risk reduction. A significant reduction in multisystem symptom burden and subsequent complications such as lower respiratory tract infection, cardiac arrhythmia, and diagnostic radiology testing were noted in NMV-r treated patients. There was no apparent increase serious complications between days 10 to 30. Conclusion Treatment with NMV-r in non-hospitalized vaccinated patients with Covid-19 was associated with a reduced likelihood of emergency room visits, hospitalization, or death. Complications and overall resource utilization were also decreased.
Bernal, Da Silva, Musungaie, Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients, N Engl J Med
Commissioner, The, Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Gottlieb, Vaca, Paredes, Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients, N Engl J Med
Hammond, Leister-Tebbe, Gardner, Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19, N Engl J Med
Mensah, Lacy, Stowe, Disease severity during SARS-COV-2 reinfection: a nationwide study, Journal of Infection
Paxlovid, added to PANORAMIC study -PANORAMIC
Pfizer, An Interventional Efficacy And Safety, Phase 2/3, Double-Blind, 2 Arm Study To Investigate Orally Administered Pf
Tenforde, Self, Adams, Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity, JAMA
Vanderweele, Ding, Sensitivity Analysis in Observational Research: Introducing the E-Value, Ann Intern Med
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