Retrospective 3,159 high risk COVID-19 patients in China showing no significant difference for viral clearance with multivariable Cox regression, but significantly faster viral clearance with logistic regression. Cox results account for the time to events and can handle censored data, and may be more clinically meaningful because they directly relate to the instantaneous risk of an event occurring. Authors do not discuss the large difference between the Cox and logistic regression results, which may bre related to increased rebound with paxlovid, time-dependent treatment effects, baseline differences, censored data, and unmeasured confounding.
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.
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risk of no viral clearance, 0.5% lower, HR 1.00, p = 0.96, treatment 362, control 724, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
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risk of no viral clearance, 59.0% lower, OR 0.41, p < 0.001, treatment 362, control 724, adjusted per study, inverted to make OR<1 favor treatment, logistic regression, multivariable, RR approximated with OR.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Yang et al., 29 Mar 2024, retrospective, China, peer-reviewed, 10 authors, study period March 2022 - April 2022.
Contact:
drkaijiang@163.com, mingyan1970@126.com.
Reduced Viral Shedding Time in High-Risk COVID-19 Patients Infected by Omicron and Treated with Paxlovid: A Real-World Study from China
Wei Yang, Yahui Peng, Changsong Wang, Hongliu Cai, Lina Zhang, Jun Xu, Yongjie Wang, Maonan Wang, Mingyan Zhao, Kaijiang Yu
Infection and Drug Resistance, doi:10.2147/idr.s443574
Introduction: The purpose of this study was to compare the viral shedding time in patients infected with the Omicron variant during Paxlovid therapy and conventional therapy and to analyze the effects of Paxlovid on patients infected with COVID-19. Methods: In this study, the demographic and clinical characteristics and laboratory data of 3159 patients infected with the SARS-CoV -2 Omicron variant treated at Jilin Province People's Hospital were collected and analyzed. A total of 362 patients received Paxlovid therapy, and 2797 patients received conventional therapy. After propensity score matching (PSM), 1086 patients were obtained.
Results: The difference in platelet (PLT) count between the two groups was statistically significant but within the normal range (P < 0.05). CT value revealed that the nucleic acid test results became negative more quickly in the Paxlovid therapy group. Analysis of the Paxlovid therapy group showed that IgG and IgM levels were increased after Paxlovid therapy administration.
Conclusion: The CT value of the Paxlovid therapy group became negative more quickly. This finding suggests that Paxlovid treatment after early diagnosis of the Omicron variant may achieve good therapeutic efficacy.
Conclusions Our data show that the CT value of the Paxlovid therapy group became negative faster than that of the control group, suggesting that the use of the Paxlovid in Omicron variant may achieve excellent therapeutic efficacy after early diagnosis. Moreover, Paxlovid should be used with caution and only in high-risk patients.
Author Contributions All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure The authors declare that they have no conflicts of interest in this work.
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