Covid-19: Pfizer’s paxlovid is 89% effective in patients at risk of serious illness, company reports

Mahase, Elisabeth

doi:10.1136/bmj.n2713

Cited by 364 publications

(320 citation statements)

References 1 publication

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“…In a recent study, the participants were randomized 1:1; half of which received paxlovid and the other half received placebo administered orally every 12 hours for five consecutive days. ( Mahase, 2021b ) The study revealed that patients who were treated within three days of symptom onset, 0.8% (3/389) of them who received paxlovid were admitted to hospital by day 28 after randomization, with no deaths. In comparison, 7% (27/385) of patients who received placebo were admitted to the hospital, with seven deaths.…”

Section: Recommended Therapeutic Agents/potential Treatmentmentioning

confidence: 97%

See 1 more Smart Citation

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Drożdżal

Rosik

Lechowicz

et al. 2021

Drug Resistance Updates

206

157

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The COVID-19 pandemic is one of the greatest threats to human health in the 21 st century with more than 257 million cases and over 5.17 million deaths reported worldwide (as of November 23, 2021. Various agents were initially proclaimed to be effective against SARS-CoV-2, the etiological agent of COVID-19. Hydroxychloroquine, lopinavir/ritonavir, and ribavirin are all examples of therapeutic agents, whose efficacy against COVID-19 was later disproved. Meanwhile, concentrated efforts of researchers and clinicians worldwide have led to the identification of novel therapeutic options to control the disease including PAXLOVID™ (PF-07321332). Although COVID-19 cases are currently treated using a comprehensive approach of anticoagulants, oxygen, and antibiotics, the novel Pfizer agent PAXLOVID™ (PF-07321332), an investigational COVID-19 oral antiviral candidate, significantly reduced hospitalization time and death rates, based on an interim analysis of the phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness. The scheduled interim analysis demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint). However, there still exists a great need for the development of additional treatments, as the recommended therapeutic options are insufficient in many cases. Thus far, mRNA and vector vaccines appear to be the most effective modalities to control the pandemic. In the current review, we provide an update on the progress that has been made since April 2020 in clinical trials concerning the effectiveness of therapies available to combat COVID-19. We focus on currently recommended therapeutic agents, including steroids, various monoclonal antibodies, remdesivir, baricitinib, anticoagulants and PAXLOVID™ summarizing the latest original studies and meta-analyses. Moreover, we aim to discuss other currently and previously studied agents targeting COVID-19 that either show no or only limited therapeutic activity. The results of recent studies report that hydroxychloroquine and convalescent plasma demonstrate no efficacy against SARS-CoV-2 infection. Lastly, we summarize the studies on various drugs with incoherent or insufficient data concerning their effectiveness, such as amantadine, ivermectin, or niclosamide.

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Section: Recommended Therapeutic Agents/potential Treatmentmentioning

confidence: 97%

“…Up to day 28, no deaths were reported in the paxlovid group as compared to 10 deaths (1.6%) in the placebo group. ( Mahase, 2021b ).…”

Section: Recommended Therapeutic Agents/potential Treatmentmentioning

confidence: 99%

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Drożdżal

Rosik

Lechowicz

et al. 2021

Drug Resistance Updates

206

157

View full text Add to dashboard Cite

show abstract

“…A recent international randomized controlled clinical trial showed that the SARS-CoV-2 3-chymotrypsin-like protease (3CL pro ) inhibitor PF-07321332 is orally bioavailable and highly effective in reducing the clinical severity of COVID-19. Patients who received oral treatment with this inhibitor within three days of symptom onset showed an 89% lower risk of COVID-19-related hospital admission/death from any cause as compared with patients who received placebo 1 . Regulatory agencies of various countries are ready to initiate review of PF-07321332 for pharmaceutical approval.…”

Section: Introductionmentioning

confidence: 94%

Pro108Ser mutation of SARS-CoV-2 3CLpro reduces the enzyme activity and ameliorates the clinical severity of COVID-19

Abe

Kabe

Uchiyama

et al. 2022

Sci Rep

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Recently, an international randomized controlled clinical trial showed that patients with SARS-CoV-2 infection treated orally with the 3-chymotrypsin-like protease (3CLpro) inhibitor PF-07321332 within three days of symptom onset showed an 89% lower risk of COVID-19-related hospital admission/ death from any cause as compared with the patients who received placebo. Lending support to this critically important result of the aforementioned trial, we demonstrated in our study that patients infected with a SARS-Cov-2 sub-lineage (B.1.1.284) carrying the Pro108Ser mutation in 3CLpro tended to have a comparatively milder clinical course (i.e., a smaller proportion of patients required oxygen supplementation during the clinical course) than patients infected with the same sub-lineage of virus not carrying the mutation. Characterization of the mutant 3CLpro revealed that the Kcat/Km of the 3CLpro enzyme containing Ser108 was 58% lower than that of Pro108 3CLpro. Hydrogen/deuterium-exchange mass spectrometry (HDX-MS) revealed that the reduced activity was associated with structural perturbation surrounding the substrate-binding region of the enzyme, which is positioned behind and distant from the 108th amino acid residue. Our findings of the attenuated clinical course of COVID-19 in patients infected with SARS-CoV-2 strains with reduced 3CLpro enzymatic activity greatly endorses the promising result of the aforementioned clinical trial of the 3CLpro inhibitor.

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“…Few had received therapies known to reduce risk of disease progression. 4,6 There were also continued reports of non-beneficial medication use, i.e., ivermectin and hydroxychloroquine.…”

Section: Main Textmentioning

confidence: 99%

A national survey of early treatment seeking behavior among those with incident SARS-CoV-2 infection

Kojima

Brobeck

Slepnev

et al. 2022

Preprint

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Background: Despite effective means to treat SARS-CoV-2 infection, the early treatment seeking behavior of those newly diagnosed with infection is not clear. Methods: We surveyed users of a national SARS-CoV-2 testing company to assess the frequency and correlates of early treatment seeking behavior for a positive test result. We recruited adults (18 years or older) who had tested positive for SARS-CoV-2 by PCR at a large clinical laboratory. To be eligible, individuals had to have a positive test result within 7 days of enrollment. Surveys were anonymous and voluntary. We collected data on demographic characteristics, general health care access and utilization, awareness of treatment for COVID-19, treatment seeking behavior, and treatments received. Descriptive statistics and odds ratios (OR) with 95% confidence intervals (95% CI) were calculated on StataSE. Results: Participants were surveyed from 3-7 January 2022: among the 15,991 who viewed a survey request, 7,647 individuals were eligible and provided responses. The median age of a respondent was 42 years (interquartile range: 32 to 54), 68.9% of respondents were women, and respondents represented 33 different states, districts, and territories. Among respondents, 23.1% reported they had sought treatment or medical advice for their current COVID-19 diagnosis. Of those who were very aware of treatment for COVID-19, 31.0% sought treatment versus 16.7% who were unaware (p-value< 0.001). The odds of treatment seeking behavior were higher for those that were contacted by a medical professional after their diagnosis (OR: 4.57 [95% CI: 3.89 to 5.37]), those with a primary doctor (OR: 2.94 [95% CI: 2.52 to 3.43]), those who self-measured their oxygen saturation (OR: 2.53 [95% CI: 2.25 to 2.84]), and those over 65 years of age (OR: 2.36 [95% CI: 2.02 to 2.76]). There was no difference in those seeking treatment based on heritage, ethnicity, prior COVID-19 diagnosis, state political affiliation, or vaccination status. The odds of seeking treatment were lower among men (OR: 0.88 [95% CI: 0.78 to 0.99]) and those without insurance (OR: 0.62 [95% CI: 0.52 to 0.72]). The most common treatment locations were clinics and most common treatments were Vitamin C, Vitamin D, Zinc, Tylenol, and NSAIDs. Conclusion: More public outreach is needed to raise awareness of the benefits of treatment for COVID-19. We found that people who were more aware about treatment for COVID-19 were more likely to seek medical advice or therapy. Efforts to increase awareness might increase early treatment for SARS-CoV-2 infection. Increased outreach with treatment facilitation from medical professionals and/or public health staff to those with newly detected SARS-CoV-2 infections, particularly among those at higher-risk of complications, might also be helpful.

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Covid-19: Pfizer’s paxlovid is 89% effective in patients at risk of serious illness, company reports

Cited by 364 publications

References 1 publication

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

Pro108Ser mutation of SARS-CoV-2 3CLpro reduces the enzyme activity and ameliorates the clinical severity of COVID-19

A national survey of early treatment seeking behavior among those with incident SARS-CoV-2 infection

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