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0 0.5 1 1.5 2+ Mortality, day 180 58% Improvement Relative Risk Mortality, day 30 79% Ventilation 48% ICU admission 56% Hospitalization, day 180 7% Hospitalization, day 30 34% Paxlovid for COVID-19  Bajema et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? PSM retrospective 3,174 patients in the USA (Jan - Feb 2022) Lower mortality (p=0.00035) and ICU admission (p=0.034) c19early.org Bajema et al., medRxiv, December 2022 Favors paxlovid Favors control

Effectiveness of COVID-19 treatment with nirmatrelvir-ritonavir or molnupiravir among U.S. Veterans: target trial emulation studies with one-month and six-month outcomes

Bajema et al., medRxiv, doi:10.1101/2022.12.05.22283134
Dec 2022  
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Retrospective 112,380 high-risk patients in the USA, showing lower mortality with paxlovid treatment. The title and headers of Table S14 are conflicting but the data appears to match the title.
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.
Study covers paxlovid and molnupiravir.
risk of death, 58.0% lower, HR 0.42, p < 0.001, treatment 20 of 1,587 (1.3%), control 48.6 of 1,587 (3.1%), NNT 55, cumulative 0-180 days, propensity score matching, day 180, Table S14.
risk of death, 78.8% lower, RR 0.21, p < 0.001, treatment 5 of 1,587 (0.3%), control 23.6 of 1,587 (1.5%), NNT 85, propensity score matching, day 30.
risk of mechanical ventilation, 48.3% lower, RR 0.52, p = 0.51, treatment 3 of 1,587 (0.2%), control 5.8 of 1,587 (0.4%), NNT 567, propensity score matching, day 30.
risk of ICU admission, 56.1% lower, RR 0.44, p = 0.03, treatment 10 of 1,587 (0.6%), control 22.8 of 1,587 (1.4%), NNT 124, propensity score matching, day 30.
risk of hospitalization, 7.0% lower, HR 0.93, p = 0.53, treatment 180 of 1,587 (11.3%), control 194.2 of 1,587 (12.2%), NNT 112, cumulative 0-180 days, propensity score matching, day 180, Table S14.
risk of hospitalization, 34.0% lower, RR 0.66, p = 0.03, treatment 43 of 1,587 (2.7%), control 65.2 of 1,587 (4.1%), NNT 71, propensity score matching, day 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bajema et al., 6 Dec 2022, retrospective, USA, preprint, median age 67.0, 18 authors, study period 1 January, 2022 - 28 February, 2022.
This PaperPaxlovidAll
Effectiveness of COVID-19 treatment with nirmatrelvir-ritonavir or molnupiravir among U.S. Veterans: target trial emulation studies with one-month and six-month outcomes
MD, MSc Kristina L Bajema, PhD Kristin Berry, PhD Elani Streja, PhD Nallakkandi Rajeevan, MS Yuli Li, PhD Lei Yan, PharmD Francesca Cunningham, MPH Denise M Hynes, MPH Mazhgan Rowneki, PhD, MHS Amy Bohnert, Edward J Boyko, MD, PhD Theodore J Iwashyna, PhD Matthew L Maciejewski, Thomas F Osborne, MD, MPH, MSc Elizabeth M Viglianti, PhD Mihaela Aslan, MPH, PhD Grant D Huang, BMBCh George N Ioannou
doi:10.1101/2022.12.05.22283134
Background: Information about the effectiveness of oral antivirals in preventing short-and longterm COVID-19-related outcomes during the Omicron surge is limited. We sought to determine the effectiveness of nirmatrelvir-ritonavir and molnupiravir for the outpatient treatment of COVID-19. Methods: We conducted three retrospective target trial emulation studies comparing matched patient cohorts who received nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir in the Veterans Health Administration (VHA). Participants were Veterans in VHA care at risk for severe COVID-19 who tested positive for SARS-CoV-2 in the outpatient setting during January and February 2022. Primary outcomes included all-cause 30-day hospitalization or death and 31-180-day incidence of acute or longterm care admission, death, or post-COVID-19 conditions. For 30-day outcomes, we calculated unadjusted risk rates, risk differences, and risk ratios. For 31-180-day outcomes, we used unadjusted time-to-event analyses. Results: Participants were 90% male with median age 67 years and 26% unvaccinated. Compared to matched untreated controls, nirmatrelvir-ritonavir-treated participants (N=1,587) had a lower 30-day risk of hospitalization (27.10/1000 versus 41.06/1000, risk difference [RD] -13.97, 95% CI -23.85 to -4.09) and death (3.15/1000 versus 14.86/1000, ). Among persons who were alive at day 31, further significant reductions in 31-180-day incidence of hospitalization (sub-hazard ratio 1.07, 95% CI 0.83 to 1.37) or death (hazard ratio 0.61, 95% CI 0.35 to 1.08) were not observed. Molnupiravir-treated participants aged ≥65 years (n=543) had a lower combined 30-day risk of hospitalization or death (55.25/1000 versus 82.35/1000, . A statistically significant difference in 30-day or 31-180-day risk of hospitalization or death was not observed between matched nirmatrelvir-or molnupiravir-treated participants. Incidence of most post-COVID conditions was similar across comparison groups. Conclusions: Nirmatrelvir-ritonavir was highly effective in preventing 30-day hospitalization and death. Short-term benefit from molnupiravir was observed in older groups. Significant reductions in adverse outcomes from 31-180 days were not observed with either antiviral. for use under a CC0 license.
References
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Bajema, Wang, Hynes, Rowneki, Hickok et al., Early Adoption of Anti-SARS-CoV-2 Pharmacotherapies Among US Veterans With Mild to Moderate COVID-19, January and February, JAMA Network Open
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{ 'DOI': '10.1101/2022.12.05.22283134', 'URL': 'http://dx.doi.org/10.1101/2022.12.05.22283134', 'abstract': '<jats:p>Background: Information about the effectiveness of oral antivirals in preventing ' 'short- and long-term COVID-19-related outcomes during the Omicron surge is limited. We sought ' 'to determine the effectiveness of nirmatrelvir-ritonavir and molnupiravir for the outpatient ' 'treatment of COVID-19. Methods: We conducted three retrospective target trial emulation ' 'studies comparing matched patient cohorts who received nirmatrelvir-ritonavir versus no ' 'treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir ' 'in the Veterans Health Administration (VHA). Participants were Veterans in VHA care at risk ' 'for severe COVID-19 who tested positive for SARS-CoV-2 in the outpatient setting during ' 'January and February 2022. Primary outcomes included all-cause 30-day hospitalization or ' 'death and 31-180-day incidence of acute or long-term care admission, death, or post-COVID-19 ' 'conditions. For 30-day outcomes, we calculated unadjusted risk rates, risk differences, and ' 'risk ratios. For 31-180-day outcomes, we used unadjusted time-to-event analyses. Results: ' 'Participants were 90% male with median age 67 years and 26% unvaccinated. Compared to matched ' 'untreated controls, nirmatrelvir-ritonavir-treated participants (N=1,587) had a lower 30-day ' 'risk of hospitalization (27.10/1000 versus 41.06/1000, risk difference [RD] -13.97, 95% CI ' '-23.85 to -4.09) and death (3.15/1000 versus 14.86/1000, RD -11.71, 95% CI -16.07 to -7.35). ' 'Among persons who were alive at day 31, further significant reductions in 31-180-day ' 'incidence of hospitalization (sub-hazard ratio 1.07, 95% CI 0.83 to 1.37) or death (hazard ' 'ratio 0.61, 95% CI 0.35 to 1.08) were not observed. Molnupiravir-treated participants aged ' '≥65 years (n=543) had a lower combined 30-day risk of hospitalization or death (55.25/1000 ' 'versus 82.35/1000, RD -27.10, 95% CI -50.63 to -3.58). A statistically significant difference ' 'in 30-day or 31-180-day risk of hospitalization or death was not observed between matched ' 'nirmatrelvir- or molnupiravir-treated participants. Incidence of most post-COVID conditions ' 'was similar across comparison groups. Conclusions: Nirmatrelvir-ritonavir was highly ' 'effective in preventing 30-day hospitalization and death. Short-term benefit from ' 'molnupiravir was observed in older groups. 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