Who Needs Paxlovid in 2024? (2025)

Views 47,346

View Metrics

Comment

3 Comments for this article

EXPAND ALL

September 7, 2024

Par for the course

Nik MANASSIEV, MD | QGPSC

I read most, but not all of the 'real world' studies. Those which I read, including studies from Hong Kong and Israel are open to bias. Please note the following comment in the article:

“We remain very confident in Paxlovid’s clinical effectiveness at preventing severe outcomes, including hospitalization and death, from COVID-19 in patients at high risk of severe disease,” Pfizer spokesperson Kit Longley said in an early August email.

The statement is par for the course. I am yet to see an employee of a drug company stating that their treatment is ineffective. Even less so if

CONFLICT OF INTEREST: None Reported

READ MORE

September 6, 2024

Paxlovid shows weak to no benefit

Richard Foulkes, MD |

Pfizer took a 5.6 billion(!) write off on returned Paxlovid in 2023. Of course depite this they had a revenue growth of 6%. Here we see very weak evidence for the benefit of Paxlovid with the best argument of no long Covid likely only appearing because it is rare to begin with and falls below sample size.

CONFLICT OF INTEREST: None Reported

September 6, 2024

Unveiling a Systemic Bias in Paxlovid Research Reporting

Eric Widera, MD | Universirt of California San Francisco

The article “The Latest Research About Paxlovid: Effectiveness, Access, and Possible Long COVID Benefits” has a surprising but unfortunately very expected omission in the summary of the evidence for nirmatrelvir–ritonavir (Paxlovid) – the lack of any discussion of the Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR) study.(1) EPIC-SR is one of only two randomized control trials of nirmatrelvir-ritonavir to treat symptomatic patients with COVID-19, and the only study of standard-risk unvaccinated and high-risk vaccinated adult participants with COVID-19. Importantly, EPIC-SR failed to show a significant difference in the primary endpoint of the time to sustained alleviation of all COVID–19–related signs or symptoms between the nirmatrelvir–ritonavir group and the placebo group.

While one may attribute this as an oversight, the omission of the EPIC-SR study is commonly seen both in the lay press and in academic publications. For example, an updated rapid living practice point published by the American College of Physicians (ACP) aimed to summarize the latest evidence on the use of treatments for COVID-19 in the outpatient setting made no mention of EPIC-SR.(2) At first glance, the omission of EPIC-SR appears to be appropriate given that EPIC-SR was published in April of 2024, and the inclusion criteria of the latest update to the rapid living practice points include studies published up until 15 November 2023. However, the results of EPIC-SR were first reported in a company press release on December 14, 2021 and posted on clinical clinicaltrials.gov in August of 2023.

Selective publication and delayed reporting are important sources of bias in systematic literature reviews and are a well-known phenomenon seen in studies sponsored by pharmaceutical companies. Multiple studies have shown that studies with negative results, like EPIC-SR, are not only less likely to be published but also take longer than studies with positive results to be posted on ClinicalTrials.gov or published in a peer-reviewed medical journal.(3-5) It should be of no surprise that as opposed to the significant delay seen in the publication of EPIC-SR, the positive trial in high-risk patients (EPIC-HR) was complicated on September 9th, 2021 and was published 5 months later in February of 2022.

Delayed reporting of trial can skew the perceived effectiveness of treatments like Paxlovid, underscoring the need for timely dissemination of all clinical trial data.

References

1.    Hammond J, Fountaine RJ, Yunis C, et al. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med. 2024;390(13):1186-1195. doi:10.1056/NEJMoa2309003
2.    Qaseem A, Yost J, Abraham GM, et al. Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 2). Ann Intern Med. 2023;176(10):1396-1404. doi:10.7326/M23-1636
3.    Qunaj L, Jain RH, Atoria CL, Gennarelli RL, Miller JE, Bach PB. Delays in the publication of important clinical trial findings in oncology. JAMA Oncol. 2018;4(7):e180264. doi:10.1001/jamaoncol.2018.0264
4.    Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-260. doi:10.1056/NEJMsa065779
5.    Manzoli L, Flacco ME, D’Addario M, et al. Non-publication and delayed publication of randomized trials on vaccines: survey. BMJ. 2014;348:g3058. doi:10.1136/bmj.g3058

CONFLICT OF INTEREST: None Reported

READ MORE

Ris (Zotero) EndNote BibTex Medlars ProCite RefWorks Reference Manager Mendeley

Add or change institution

JAMA+ AI

Select Your Interests

Customize your JAMA Network experience by selecting one or more topics from the list below.