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  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Low prevalence of nirmatrelvir-ritonavir resistance-associated mutations in SARS-CoV-2 lineages from Botswana (2020-2023) (Poster board: 139) -  May 2, 2024 - Abstract #AIDS2024AIDS_1153;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  PF-07817883 / Pfizer, Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  A Second-Generation Oral SARS-CoV-2 Main Protease Inhibitor Clinical Candidate for the Treatment of COVID-19. (Pubmed Central) -  Apr 30, 2024   
    The preclinical in vivo pharmacokinetics and metabolism studies in human matrices are suggestive of improved oral pharmacokinetics for PF-07817883 in humans, relative to nirmatrelvir. In vitro inhibition/induction studies against major human drug metabolizing enzymes/transporters suggest a low potential for perpetrator drug-drug interactions upon single-agent use of PF-07817883.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Enrollment change:  A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. (clinicaltrials.gov) -  Apr 29, 2024   
    P=N/A,  N=4000, Active, not recruiting, 
    In vitro inhibition/induction studies against major human drug metabolizing enzymes/transporters suggest a low potential for perpetrator drug-drug interactions upon single-agent use of PF-07817883. N=3000 --> 4000
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Proof-of-concept studies with a computationally designed Mpro inhibitor as a synergistic combination regimen alternative to Paxlovid. (Pubmed Central) -  Apr 19, 2024   
    In vitro pharmacological profiling established a lack of off-target effects, particularly CYP450 3A4 inhibition, as well as potential for synergy with the currently approved alternate antiviral, molnupiravir. Development and subsequent testing of a capsule formulation for oral dosing of Mpro61 in B6-K18-hACE2 mice demonstrated favorable pharmacological properties, efficacy, and synergy with molnupiravir, and complete recovery from subsequent challenge by SARS-CoV-2, establishing Mpro61 as a promising potential preclinical candidate.
  • ||||||||||  ombitasvir (ABT-267) / AbbVie, Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  A combination of nirmatrelvir and ombitasvir boosts inhibition of SARS-CoV-2 replication. (Pubmed Central) -  Apr 19, 2024   
    The increased potency of the nirmatrelvir-ombitasvir combination, over nirmatrelvir alone afforded a greater than 3 log10 reduction in viral titre, which is sufficient to fully prevent the detection of progeny SARS-CoV-2 viral particles at 48?h post infection. The mechanism of this potentiated effect was shown to be, in-part, due to joint inhibition of the 3-chymotrypsin-like protease via a positive allosteric modulation mechanism.
  • ||||||||||  ivermectin oral / Generic mfg.
    Review, Journal:  COVID-19: An Update on Epidemiology, Prevention and Treatment, September-2023. (Pubmed Central) -  Apr 18, 2024   
    At the current phase of the pandemic, nirmatrelvir/ritonavir, remdesivir, molnupiravir, sotrovimab (for patients from XBB.1.5 variant dominant settings), and convalescent plasma can be considered for the treatment of high-risk early-stage outpatients with COVID-19, while hospitalized patients with more severe disease can be treated with dexamethasone, anti cytokines including tocilizumab, sarilumab, baricitinib, and tofacitinib and antithrombotic agents including enoxaparin. Remdesivir oral analogues and ensitrelvir fumarate are promising agents for treating acute COVID-19, which are in phase trials now; however, ivermectin, fluvoxamine, and metformin were shown to be ineffective.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    PK/PD data, Journal:  Physiologically-based pharmacokinetic modelling guided dose evaluations of nirmatrelvir/ritonavir in renal impairment for the management of COVID-19. (Pubmed Central) -  Apr 15, 2024   
    Other HLM CLint, the most sensitive parameter, was adjusted, and the simulated plasma concentration profiles of nirmatrelvir in severe RI subjects were within the therapeutic index of 292-10?000?ng/mL for dosing regimens of loading doses of 300/100?mg followed by 150/100?mg or 75/100?mg twice daily of nirmatrelvir/ritonavir. Considering that nirmatrelvir is available as a 150?mg tablet, we recommend 300/100?mg followed by 150/100?mg twice daily as the dosing regimen to be investigated in severe RI.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Contributions of Hyperactive Mutations in Mpro from SARS-CoV-2 to Drug Resistance. (Pubmed Central) -  Apr 15, 2024   
    Hyperactive mutations were also about three times more prevalent than nirmatrelvir binding mutations in sequenced isolates from circulating SARS-CoV-2. Our findings indicate that hyperactive mutations are likely to contribute to the natural evolution of drug resistance in Mpro and provide a comprehensive list for future surveillance efforts.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Nirmatrelvir and ritonavir. (Pubmed Central) -  Apr 15, 2024   
    Our findings indicate that hyperactive mutations are likely to contribute to the natural evolution of drug resistance in Mpro and provide a comprehensive list for future surveillance efforts. No abstract available
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    SAFETY OF NIRMATRELVIR-RITONAVIR ADMINISTRATION IN IMMUNOCOMPROMISED CHILDREN : KIDS STUDY GROUP. (STATION 2) -  Apr 14, 2024 - Abstract #ESPID2024ESPID_613;    
    No significant adverse reactions were noted.The median duration of COVID-19 was 8.0 days (IQR: 5.0, 10.3). When comparing the duration of SARS-CoV-2 infection and the time from SARS-CoV-2 positivity to N/R administration, a significant positive correlation was found (r = 0.78, p-value < 0.001), suggesting that the earlier N/R is administered, the shorter the duration of COVID-19 in the study sample Learning Points/Discussion The administration of safe and effective antiviral drugs in fragile children, such as N/R administration, is crucial to hinder replication fo the virus, thus favoring viral mutations and viral clearance and reducing the duration of the infection.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. (Pubmed Central) -  Apr 14, 2024   
    P2/3
    The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo. (Supported by Pfizer; EPIC-SR ClinicalTrials.gov number, NCT05011513.).
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Review, Journal:  Ritonavir: 25 Years' Experience of Concomitant Medication Management. A Narrative Review. (Pubmed Central) -  Apr 13, 2024   
    However, rates of DDIs with contraindicated medications are low, suggesting these risks are manageable by infectious disease specialists who have experience with the use of PK enhancers. In this review, we provide an overview of ritonavir's mechanisms of action and describe approaches and resources available to mitigate adverse events and manage concomitant medication in both chronic and short-term settings.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Discovery of First-in-Class PROTAC Degraders of SARS-CoV-2 Main Protease. (Pubmed Central) -  Apr 12, 2024   
    MPD2 also displayed potent antiviral activity against various SARS-CoV-2 strains and exhibited enhanced potency against nirmatrelvir-resistant viruses. Overall, this proof-of-concept study highlights the potential of targeted protein degradation of MPro as an innovative approach for developing antivirals that could fight against drug-resistant viral variants.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Observational data, Journal:  Nirmatrelvir and ritonavir combination against COVID-19 caused by omicron BA.2.2 in the elderly: A single-center large observational study. (Pubmed Central) -  Apr 9, 2024   
    Overall, this proof-of-concept study highlights the potential of targeted protein degradation of MPro as an innovative approach for developing antivirals that could fight against drug-resistant viral variants. These findings suggest that administering nirmatrelvir-ritonavir within 10 days of symptom onset could potentially reduce the time it takes for SARS-CoV-2-infected patients to negative RT-PCR results, thereby expanding the current usage guidelines for nirmatrelvir-ritonavir.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Enrollment closed:  A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. (clinicaltrials.gov) -  Apr 8, 2024   
    P=N/A,  N=3000, Active, not recruiting, 
    These findings suggest that administering nirmatrelvir-ritonavir within 10 days of symptom onset could potentially reduce the time it takes for SARS-CoV-2-infected patients to negative RT-PCR results, thereby expanding the current usage guidelines for nirmatrelvir-ritonavir. Not yet recruiting --> Active, not recruiting
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Predictors of nirmatrelvir-ritonavir receipt among COVID-19 patients in a large US health system. (Pubmed Central) -  Apr 3, 2024   
    A limited chart review (N?=?40) confirmed that in some cases a decision not to treat was appropriate and aligned with national guidelines to use clinical judgement on a case-by-case basis. There is a need to enhance patient and provider awareness on the availability and benefits of nirmatrelvir-ritonavir for the treatment of COVID-19 illness.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Preclinical, Journal:  Design of a SARS-CoV-2 papain-like protease inhibitor with antiviral efficacy in a mouse model. (Pubmed Central) -  Apr 1, 2024   
    The in vivo lead Jun12682 inhibited SARS-CoV-2 and its variants, including nirmatrelvir-resistant strains with EC50 from 0.44 to 2.02 micromolar. Oral treatment with Jun12682 improved survival and reduced lung viral loads and lesions in a SARS-CoV-2 infection mouse model, suggesting that PLpro inhibitors are promising oral SARS-CoV-2 antiviral candidates.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Journal:  Antivirals for the treatment of mild and moderate COVID-19 in South Africa. (Pubmed Central) -  Mar 29, 2024   
    COVID-19 antivirals such as remdesivir, nirmatrelvir/ ritonavir and molnupiravir are safe and cost-effective and have received either full approval or emergency use authorisation from regulators. Using a proposed test-and-treat strategy, judicious use of antivirals could be impactful.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Enrollment change, Trial initiation date, Trial withdrawal:  A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco (clinicaltrials.gov) -  Mar 28, 2024   
    P=N/A,  N=0, Withdrawn, 
    In high-risk COVID-19 outpatients, early antiviral treatment with nirmatrelvir/ritonavir or remdesivir was associated with lower 28-day all-cause hospitalization or death. N=150 --> 0 | Initiation date: Oct 2023 --> Mar 2024 | Not yet recruiting --> Withdrawn
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Review, Journal:  Paxlovid for nonhospitalized patients with COVID-19. (Pubmed Central) -  Mar 22, 2024   
    Our findings highlight the importance of promptly treating high-risk COVID-19 patients with Nirmatrelvir/Ritonavir, as it also contributes to achieving a faster time to negative SARS-CoV-2 nasal swabs. No abstract available
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Observational data, Journal:  Physician characteristics associated with antiviral prescriptions for older adults with COVID-19 in Japan: an observational study. (Pubmed Central) -  Mar 20, 2024   
    Documentation of more such reports is important to identify drug interactions between nirmatrelvir-ritonavir and other agents, with the aim of preventing severe adverse effects. Our findings suggest that provider-level factors, such as the clinical experience of treating the patients with COVID-19, play an important role in the appropriate prescription of antiviral medications for COVID-19 in the primary care setting.