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Journal of the American Medical Association, 21.02.2024
Tilføjet 21.02.2024
This Medical News story examines the latest information about rebound, treatment eligibility, optimal dosing, and other questions related to nirmatrelvir-ritonavir for treating COVID-19.
Læs mere Tjek på PubMedJournal of the American Medical Association, 12.01.2024
Tilføjet 12.01.2024
This Medical News article discusses 2 new observational studies that examined associations with SARS-CoV-2 antiviral medications and long COVID.
Læs mere Tjek på PubMedBMC Infectious Diseases, 4.01.2024
Tilføjet 4.01.2024
Abstract Purpose To explore the effect of azvudine as compared to paxlovid for oral treatment of hospitalized patients with SARS-CoV-2 infection. Methods We analyzed data from a cohort of patients with SARS-CoV-2 infection in Shandong provincial hospital between February 15 and March 15, 2023. The primary outcome was time to sustained clinical recovery through Day 28 and secondary outcomes included the percentage of participants who died from any cause by Day 28, the average hospitilization time and expenses, the changes in liver and kidney function and adverse events. The Kaplan–Meier method and Cox regression model was used for statistical analysis. Results There was no significant difference between azvudine and paxlovid in terms of time to sustained clinical recovery (p = 0.429) and death rates (p = 0.687). As for hospitalization time and fee, no significant differences were observed between azvudine group and paxlovid group (Hospitalization time: p = 0.633; Hospitalization fee: p = 0.820). In addition, there were no significant differences in the effects of the two drugs on liver and kidney function (p > 0.05). Conclusion Among adults who were hospitalised with SARS-CoV-2 infection, azvudine was noninferior to paxlovid in terms of time to sustained clinical recovery, death rates, hospitalization time and cost, with few safety concerns. Trial registration ChiCTR2300071309; Registered 11 May 2023. Level of evidence Level III; Retrospective cohort study.
Læs mere Tjek på PubMedChang‐tai Zhu; Jian‐Yun Yin; Xiao‐hua Chen; Ming Liu; Shi‐gui Yang;
Reviews in Medical Virology, 11.11.2023
Tilføjet 11.11.2023
This study aimed to clarify the beneficial effect and the clinical application value of Paxlovid in the treatment of coronavirus disease‐19 (COVID‐19) through a systematic review. Databases including PubMed, Cochrane Library, Chinese Clinical Trial Registry, and were systematically searched for interventional or observational studies on the efficacy and safety of Paxlovid in the treatment of SARS‐COV‐2. The relative and absolute effect sizes for the outcomes were calculated based on the data reported in the original intervention literature. The external applicability of the evidence was analysed in terms of clinical application scenarios, patient willingness, and cost utility. One interventional and three observational studies were conducted. Four studies published in 2022, had participation sample sizes ranging 1780–109,254. Based on the randomised controlled trial data, the risk of all‐cause mortality, all‐cause death, and hospitalisation was significantly reduced in the Paxlovid group. Serious adverse events were reduced during the study. Based on observational studies, Paxlovid can significantly reduce the risk of death and hospitalisation in older patients with COVID‐19 (moderate certainty) and improve in‐hospital disease progression, composite disease progression, and viral load (low certainty). Paxlovid did not improve the outcomes of death and hospitalisation (low certainty) in patients aged
Læs mere Tjek på PubMedHaokun Tian; Changsen Yang; Tiangang Song; Kechen Zhou; Lequan Wen; Ye Tian; Lirui Tang; Weikai Xu; Xinyuan Zhang;
Reviews in Medical Virology, 8.09.2023
Tilføjet 8.09.2023
Our study is aimed to access the efficacy and safety outcomes for coronavirus disease 2019 (COVID‐19) patients treated with Paxlovid. According to inclusion and exclusion criteria, databases were used to retrieve articles from 1 January 2020 to 1 January 2023. Article screening, quality evaluation and data extraction were completed and cross‐checked. The meta‐analysis and trial sequential analysis (TSA) were conducted using RevMan, StataMP, and TSA software. A total of 42 original articles were included. Overall meta‐analysis results showed that for death, hospitalisation, death or hospitalisation, emergency department (ED) visit, intensive care unit (ICU) admission, and extra oxygen requirement outcomes, every odds ratio (OR) was 0.05. For adverse events (AEs) outcome, the OR was >1 and
Læs mere Tjek på PubMedClinical & Experimental Immunology, 11.08.2023
Tilføjet 11.08.2023
AbstractSARS-CoV-2, the virus responsible for COVID-19, has caused havoc around the world. While several COVID-19 vaccines and drugs have been authorised for use, these antiviral drugs remain beyond the reach of most low- and middle-income countries. Rapid viral evolution is reducing the efficacy of vaccines and monoclonal antibodies and contributing to deaths of some fully vaccinated persons. Others with normal immunity may have chosen not be vaccinated and remain at risk if they contract the infection. Vaccines may not protect some immunodeficient patients from SARS-CoV-2, who are also at increased risk of chronic COVID-19 infection, a dangerous stalemate between the virus and a suboptimal immune response. Intra-host viral evolution could rapidly lead to the selection and dominance of vaccine and monoclonal antibody resistant clades of SARS-CoV-2.There is thus an urgent need to develop new treatments for COVID-19. The NZACE2-Pātari project, comprising modified soluble ACE2 molecules, seeks to intercept and block SARS-CoV-2 infection of the respiratory mucosa. In vitro data presented here shows that soluble wild-type ACE2 molecules retain the ability to effectively block the Spike (S) glycoprotein of SARS-CoV-2 variants including the ancestral Wuhan, delta (B.1.617.2) and omicron (B.1.1.529) strains. This therapeutic strategy may prove effective if implemented early during the nasal phase of the infection and may act synergistically with other antiviral drugs such as Paxlovid to further mitigate disease severity.
Læs mere Tjek på PubMedGbinigie, O., Ogburn, E., Allen, J., Dorward, J., Dobson, M., Madden, T.-A., Yu, L.-M., Lowe, D. M., Rahman, N., Petrou, S., Richards, D., Hood, K., Patel, M., Saville, B. R., Marion, J., Holmes, J., Png, M. E., Hayward, G., Lown, M., Harris, V., Jani, B., Hart, N., Khoo, S., Rutter, H., Chalk, J., Standing, J. F., Breuer, J., Lavallee, L., Hadley, E., Cureton, L., Benysek, M., Andersson, M. I., Francis, N., Thomas, N. P. B., Evans, P., van Hecke, O., Koshkouei, M., Coates, M., Barrett, S., Bateman, C., Davies, J., Raymundo-Wood, I., Ustianowski, A., Nguyen-Van-Tam, J., Carson-Stevens, A., Hobbs, R., Little, P., Butler, C. C.
BMJ Open, 8.08.2023
Tilføjet 8.08.2023
IntroductionThere is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. Methods and analysisPANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). Eligibility criteria: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18–49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial. Ethics and disseminationEthical approval granted by South Central–Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals. Trial registration numberISRCTN30448031; EudraCT number: 2021-005748-31.
Læs mere Tjek på PubMedYu Wang, Danyang Zhao, Wenying Xiao, Jun Shi, Wei Chen, Qin Jia, Ying Zhou, Rongyu Wang, Xubo Chen, Liuliu Feng
Journal of Medical Virology, 1.08.2023
Tilføjet 1.08.2023
Clinical Infectious Diseases, 2.07.2023
Tilføjet 2.07.2023
AbstractBackgroundThe effects of Nirmatrelvir/Ritonavir (NMV-r or Paxlovid) on Covid-19 outcomes in younger vaccinated adults are unclear.ObjectiveTo assess if NMV-r use in vaccinated adults aged ≤50 is associated with improved outcomes and identify beneficial and non-beneficial subgroups.Design/SettingCohort study, TriNetX database.ParticipantsWe generated two propensity-matched cohorts of 2,547 patients from an 86,119-person cohort assembled from the TriNetX database. Patients in one cohort received NMV-r, and patients in the matched control cohort did not.MeasurementsMain outcome: composite of all-cause emergency department visits, hospitalization, and mortality.ResultsThe composite outcome was detected in 4.9% of the NMV-r cohort and 7.0% of the non-NMV-r cohort (OR 0.683, CI 0.540-0.864; p=0.001), indicating a 30% relative risk reduction. The number needed to treat (NNT) for the primary outcome was 47. Subgroup analyses found significant associations for patients with cancer (NNT=45), cardiovascular disease (NNT=30), and both conditions (NNT=16). No benefit was found for patients with only chronic lower respiratory disorders (asthma/COPD) or without serious comorbidities. 32% of NMV-r prescriptions in the overall database were for 18-50-year-olds.ConclusionNMV-r use in vaccinated adults aged 18-50, especially with serious comorbidities, was associated with reduced all-cause hospital visits, hospitalization, and mortality in the first 30 days of Covid-19 illness. However, NMR-r in patients without significant comorbidities or with only asthma/COPD had no association of benefit. Therefore, identifying high-risk patients should be a priority and avoid over-prescription should be avoided.
Læs mere Tjek på PubMedJournal of the American Medical Association, 28.06.2023
Tilføjet 28.06.2023
A combination of oral nirmatrelvir and ritonavir tablets, marketed as Paxlovid, recently received full US Food and Drug Administration (FDA) approval for managing mild to moderate COVID-19 infections in adults who are at high risk of developing severe disease. Paxlovid was previously granted Emergency Use Authorization in December 2021.
Læs mere Tjek på PubMedBenjamin L. Ranard, Carson C. Chow, Murad Megjhani, Shadnaz Asgari, Soojin Park, Yoram Vodovotz
Journal of Medical Virology, 8.06.2023
Tilføjet 8.06.2023
Journal of the American Medical Association, 1.03.2023
Tilføjet 1.03.2023
Patients with mild to moderate COVID-19 who were treated for 5 days with VV116, an investigational oral antiviral drug that is active against SARS-CoV-2, recovered as quickly from infection as did those treated with nirmatrelvir-ritonavir (Paxlovid), according to the results of a randomized noninferiority trial published in the New England Journal of Medicine.
Læs mere Tjek på PubMedJournal of the American Medical Association, 11.01.2023
Tilføjet 11.01.2023
In this narrative medicine essay, a psychiatrist finds that the difficulties she had helping her parents obtain Paxlovid seemed a common experience among her colleagues, so she offers patients and the medical community suggestions on how to simplify the process.
Læs mere Tjek på PubMedJournal of Medical Virology, 29.12.2022
Tilføjet 30.12.2022
Journal of Medical Virology, 28.12.2022
Tilføjet 30.12.2022
Journal of the American Medical Association, 28.12.2022
Tilføjet 28.12.2022
The antiviral therapy nirmatrelvir, 1 of the medications used in Paxlovid, may mitigate the development of long COVID conditions, according to an observational study by the US Department of Veterans Affairs (VA). The study was posted to the preprint server medRxiv in early November and had not yet been peer-reviewed.
Læs mere Tjek på PubMedJournal of the American Medical Association, 13.12.2022
Tilføjet 13.12.2022
Patients from certain racial and ethnic groups who sought outpatient care for COVID-19 were about 20% to 36% less likely to be prescribed Paxlovid (nirmatrelvir-ritonavir), a multi-institution study found.
Læs mere Tjek på PubMedJournal of the American Medical Association, 4.10.2022
Tilføjet 4.10.2022
The FDA has updated a checklist designed to help evaluate potential drug interactions and other patient factors before prescribing Paxlovid (copackaged nirmatrelvir and ritonavir tablets) for COVID-19. It incorporates additional guidance on drugs that should not be taken with Paxlovid or may require dose or other treatment adjustments.
Læs mere Tjek på PubMedJournal of the American Medical Association, 6.09.2022
Tilføjet 6.09.2022
Expiration dates have been extended from 9 months after manufacture to 12 months for 4 lots of the COVID-19 antiviral therapy Paxlovid, which consists of copackaged nirmatrelvir tablets and ritonavir tablets.
Læs mere Tjek på PubMedClinical Infectious Diseases, 17.08.2022
Tilføjet 19.08.2022
Clinical Infectious Diseases, 17.08.2022
Tilføjet 19.08.2022
Journal of the American Medical Association, 16.08.2022
Tilføjet 16.08.2022
Pharmacists can now prescribe nirmatrelvir-ritonavir (Paxlovid) with certain limitations under a revised Emergency Use Authorization (EUA) for the COVID-19 antiviral treatment.
Læs mere Tjek på PubMedJournal of the American Medical Association, 26.07.2022
Tilføjet 26.07.2022
Hospitalizations and emergency department visits for rebounding COVID-19 symptoms are rare after treatment with the antiviral therapy nirmatrelvir-ritonavir, according to a CDC analysis of electronic medical records from a large health care system.
Læs mere Tjek på PubMedFangfang Sun, Yanwei Lin, Xiaodong Wang, Yuan Gao, Shuang Ye
Lancet Infectious Diseases, 15.07.2022
Tilføjet 15.07.2022
The omicron variant of SARS-CoV-2 has been reported in Shanghai, China, since March 2022. In two months, the emergence of the omicron variant has resulted in 600 000 infections and about 500 deaths, especially in older people with comorbidities.1
Læs mere Tjek på PubMedGuido Antonelli, Daniele Focosi, Ombretta Turriziani, Marco Tuccori, Rossella Brandi, Silvia Fillo, Camilla Ajassa, Florigio Lista, Claudio M. Mastroianni
Clinical Microbiology and Infection, 2.07.2022
Tilføjet 2.07.2022
We read with interest the recent commentary by Girardin et al on the pharmacokinetic interactions with nirmatrelvir/ritonavir published online in CMI on March 28, 2022. Oral small-chemical antivirals have been recently authorized around the world and come with the promise of simplifying the management and reducing hospitalization of COVID-19 outpatients at risk of disease progression. Nirmatrelvir tablets co-packaged with ritonavir tablets (Paxlovid®, Pfizer) (300/100 mg dose twice daily for 5 days) was granted a conditional marketing authorization by EMA on January 29, 2022 on the basis of a phase 2/3 randomized controlled trial (RCT) in 2246 unvaccinated outpatients (mostly during the wave driven by the Delta variant of concern (VOC) – July to December 2021) in which treatment at a median of 3 days since onset of symptoms led to a 88.9% reduction in the relative risk of hospitalization (-5.81%) [1].
Læs mere Tjek på PubMedTalha Burki
Lancet Respiratory Medicine, 25.05.2022
Tilføjet 29.06.2022
In comments to Bloomberg published on May 3, 2022, Pfizer chief executive officer Albert Bourla suggested that patients who experience a relapse of symptoms after finishing a course of the company's COVID-19 antiviral, Paxlovid, should take a second course of the drug. Yet the emergency use authorisation issued by the US Food and Drug Administration (FDA) stipulates that Paxlovid is “not authorized for use longer than five consecutive days”. On May 4, John Farley, director of the Office of Infectious Diseases at the FDA, reiterated this message.
Læs mere Tjek på PubMedRubin R.
Journal of the American Medical Association, 28.06.2022
Tilføjet 28.06.2022
This Medical News feature examines the unexpected phenomenon of symptoms and positive test results recurring in Paxlovid users who’d a few days earlier felt fine and tested negative.
Læs mere Tjek på PubMedNajjar-Debbiny R, Gronich N, Weber G, et al.
Clinical Infectious Diseases, 2.06.2022
Tilføjet 4.06.2022
AbstractBackgroundPaxlovid was granted emergency use authorization for the treatment of mild to moderate COVID-19, based on the interim analysis of EPIC-HR trial. Paxlovid effectiveness needs to be assessed in a noncontrolled setting. In this study we used population-based real world data to evaluate the effectiveness of Paxlovid.MethodsThe database of the largest healthcare provider in Israel was used to identify all adults aged 18 years or older with first ever positive test for SARS-CoV-2 between January and February 2022, who were at high risk for severe COVID-19 and had no contraindications for Paxlovid use. Patients were included irrespective of their COVID-19 vaccination status. Cox hazard regression was used to estimate the 28 day HR for severe COVID-19 or mortality with Paxlovid examined as time-dependent variable.ResultsOverall, 180,351 eligible were included, of them only 4,737 (2.6%) were treated with Paxlovid, and 135,482 (75.1%) had adequate COVID-19 vaccination status. Both Paxlovid and adequate COVID-19 vaccination status were associated with significant decrease in the rate of severe COVID-19 or mortality with adjusted HR 0.54 (95% CI, 0.39-0.75) and 0.20 (95% CI, 0.17-0.22), respectively. Paxlovid appears to be more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease (interaction p-value <0.05 for all). No significant interaction was detected between Paxlovid treatment and COVID-19 vaccination status.ConclusionsThis study suggests that in the era of omicron and in real life setting Paxlovid is highly effective in reducing the risk of severe COVID-19 or mortality.
Læs mere Tjek på PubMedLaura Waters, Fiona Marra, Anton Pozniak, James Cockburn, Marta Boffito
Lancet, 23.03.2022
Tilføjet 15.04.2022
We thank Joseph Heskin and colleagues1 for highlighting the crucial issue of drug–drug interactions (DDIs) with ritonavir, the pharmacoenhancer or booster co-formulated with the novel SARS-CoV-2 protease inhibitor, PF-07321332 (Paxlovid, Pfizer [New York, NY, USA]).2 Since Paxlovid will be primarily administered to non-hospitalised individuals and prescribed by clinicians who might not routinely manage complex interactions or have access to their full medication list, an awareness of the DDI potential and clear pathways to support safe decision making are essential, ideally led by pharmacists who have speciality knowledge in this area.
Læs mere Tjek på PubMedSaravolatz L, Depcinski S, Sharma M.
Clinical Infectious Diseases, 4.03.2022
Tilføjet 7.03.2022
AbstractAt a crucial time with rapid spread of Omicron SARS-CoV-2 virus variant globally, the United States Food and Drug Administration has issued an emergency use authorization for two oral antivirals molnupiravir (>18 years) and nirmatrelvir-ritonavir (Paxlovid) (≥12 years; >40kg ) for the outpatient treatment of mild to moderate COVID–19 patients who are at risk for progression. Molnupiravir is a nucleoside analogue, whereas nirmatrelvir is a SARS-CoV-2 main protease inhibitor, and ritonavir is an HIV-1 protease inhibitor. Drug interactions are a major concern for nirmatrelvir-ritonavir. Nirmatrelvir-ritonavir demonstrated a greater risk reduction in hospitalization and death than molnupiravir compared to placebo. Both drugs need to be started within five days of symptoms onset and given for five days duration. This article will review the two oral COVID-19 antiviral drugs including the mechanisms of action, antiviral activity, pharmacokinetics, drug interactions, clinical experience including trials, adverse events, recommended indications, and formulary considerations.
Læs mere Tjek på PubMedTalha Khan Burki
Lancet Respiratory Medicine, 14.01.2022
Tilføjet 2.02.2022
On Dec 22, 2021, the US Food and Drug Administration (FDA) issued an emergency use authorisation for Pfizer's COVID-19 antiviral, Paxlovid. Trial results released by the manufacturer indicate that the drug cuts the risk of hospitalisation or death for high-risk patients by 88%, compared with the placebo, if given within 5 days of symptom onset. A second oral antiviral, Merck Sharp & Dohme's (MSD) molnupiravir, received FDA authorisation on Dec 23. In a phase 3 study of 1433 patients with mild-to-moderate COVID-19 and at least one risk factor for severe illness, treatment with molnupiravir within 3 days of symptom onset reduced the chances of hospitalisation or death by 30%, compared with the placebo.
Læs mere Tjek på PubMedJoseph Heskin, Scott J C Pallett, Nabeela Mughal, Gary W Davies, Luke S P Moore, Michael Rayment, Rachael Jones
Lancet, 1.01.2022
Tilføjet 31.12.2021
We read with interest the news that the UK Government has announced deals to procure the oral antivirals for SARS-CoV-2, molnupiravir (Lagevrio, Merck [Branchburg, NJ, USA]) and ritonavir in combination with PF-07321332 (Paxlovid, Pfizer [New York, NY, USA]).1 Although we welcome further partnership between the government and pharmaceutical industry in the provision of effective agents to manage the COVID-19 pandemic, we urge caution with the widescale use of ritonavir, given its propensity for causing clinically significant drug–drug interactions with commonly prescribed and over-the-counter medications.
Læs mere Tjek på PubMedZhonglei Wang, Liyan Yang
Journal of Medical Virology, 22.12.2021
Tilføjet 23.12.2021