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  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Discovery of Nirmatrelvir Resistance Mutations in SARS-CoV-2 3CLpro: A Computational-Experimental Approach. (Pubmed Central) -  Nov 28, 2023   
    Our findings suggest that FEP can be a valuable tool in proactively monitoring the emergence of resistant strains and guiding the design of future inhibitors with reduced susceptibility to drug resistance. As nirmatrelvir is currently widely used for treating COVID-19, this research has important implications for surveillance efforts and antiviral development.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, azvudine (FNC) / Granlen, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Retrospective data, Review, Journal:  Evaluation of oral small molecule drugs for the treatment of COVID-19 patients: a systematic review and network meta-analysis. (Pubmed Central) -  Nov 27, 2023   
    For prespecified safety outcomes, SUCRA values ranked VV116 (OR = 0.09, 95% CI: 0.00-2.07: SUCRA 0.86) as the most beneficial intervention for the prevention of serious adverse events. When compared to other antiviral medications, paxlovid can reduce the mortality and hospitalization of COVID-19 patients.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Review, Journal, HEOR, Real-world evidence, Real-world:  Oral Molnupiravir and Nirmatrelvir/Ritonavir for the Treatment of COVID-19: A Literature Review with a Focus on Real-World Evidence. (Pubmed Central) -  Nov 21, 2023   
    As per current recommendations, their use is suggested in patients with mild to moderate symptoms who are at high risk of developing severe disease. Nevertheless, limited data exist regarding their efficacy in specific subpopulations, such as immunocompromised patients, those with severe kidney disease, pregnant women, and children.
  • ||||||||||  Enrollment closed:  AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) -  Nov 18, 2023   
    P1/2,  N=600, Active, not recruiting, 
    The optimal dose and effectiveness evaluation must be further investigated in a largeer cohort. Recruiting --> Active, not recruiting
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Preclinical, Journal:  Activation of PXR causes drug interactions with Paxlovid in transgenic mice. (Pubmed Central) -  Nov 16, 2023   
    We found that PXR activation increased CYP3A4/5 expression, accelerated NMV metabolism, and reduced the systemic exposure of NMV. In summary, our work demonstrated that PXR activation can cause drug interactions with Paxlovid, suggesting that PXR-activating drugs and herbs should be used cautiously in COVID-19 patients receiving Paxlovid.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Paxlovid as a potential treatment for long COVID. (Pubmed Central) -  Nov 14, 2023   
    The first prospective, randomized study of the RECOVER research initiative, RECOVER-Vital, will evaluate the SARS-CoV-2 antiviral nirmatrelvir/ritonavir (Paxlovid) as a potential treatment for long COVID. This manuscript explores what is known about Paxlovid to treat and prevent long COVID and examines the rationale for addressing this condition with an antiviral agent.
  • ||||||||||  Evusheld (cilgavimab/tixagevimab) / AstraZeneca, Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Trial completion, Enrollment change, Head-to-Head:  MANTICO 2: Non-inferiority Trial on Treatments in Early COVID-19 (clinicaltrials.gov) -  Nov 7, 2023   
    P3,  N=536, Completed, 
    (PROSPERO: CRD42023406456). Recruiting --> Completed | N=1095 --> 536
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Review, Journal:  SARS-CoV-2: The Virus, Its Biology and COVID-19 Disease-Counteracting Possibilities. (Pubmed Central) -  Nov 5, 2023   
    Also, the possibility to fight this virus with recently available drugs (Veklury, Lagevrio and Paxlovid) will be discussed. All these data clearly argue that SARS-CoV-2 variants still exhibit a dangerous potential-although with a lower case fatality rate-and that vaccination in combination with drug intake upon infection may help to lower the risk of developing chronic or temporary autoimmune diseases.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Observational data, Journal:  COVID-19 early curative treatments in kidney transplant recipients: is it really reasonable at the Omicron era? (Pubmed Central) -  Nov 5, 2023   
    There was no difference in outcome according to early therapeutic management: n/r, sotrovimab or no specific treatment. Our study both underlines a decreased severity of Omicron COVID-19 in KTRs (probably related to vaccinal immunity and decreased virulence of Omicron) and a potential severe adverse effects with n/r.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Impact of COVID-19 in Patients with Chronic Lymphocytic Leukemia Treated with Venetoclax: A Possible Role of the Association to Anti-CD20 Antibody? a Multicentre Seifem Study (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4221;    
    The retrospective multicenter study included CLL patients treated since 2017 with venetoclax single agent until progression or toxicity or venetoclax plus anti-CD20 antibody (mainly rituximab as part of VR protocol for 24 months in relapsed/refractory patients or obinutuzumab as part of VO protocol for 12 months in untreated patients)...Prophylaxis with tixagevimab/cilgavimab was administered in less than 20% of the patients...Remdesivir was chosen as treatment in 48.9%, nirmatrelvir/ritonavir in 21.3%...The analysis found over a third of patients infected by SARS-CoV-2, in 57% of the cases the infection was grade 1-2 with a mortality rate of almost 10%, but higher if COVID-19 was of grade 3-4 (18.2%). We confirmed the association of anti-CD20 antibody to venetoclax as a risk factor for SARS-CoV-2 infection and mortality rate in patients with CLL and severe COVID-19.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Journal:  Paxlovid mouth likely is mediated by activation of the TAS2R1 bitter receptor by nirmatrelvir. (Pubmed Central) -  Nov 1, 2023   
    We also show that saccharin, a non-nutritive sweetener that may block the activity of TAS2R1, has little or no effect on nirmatrelvir-stimulated TAS2R1 activity. Such findings may help identify novel strategies to alleviate Paxlovid mouth and increase treatment compliance.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Enrollment change, Trial termination:  A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease (clinicaltrials.gov) -  Oct 30, 2023   
    P1,  N=15, Terminated, 
    However, further confirmation through additional clinical trials is necessary. N=24 --> 15 | Recruiting --> Terminated; Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer
    Trial completion date, Trial primary completion date:  OPTICOV: OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial (clinicaltrials.gov) -  Oct 30, 2023   
    P2,  N=256, Recruiting, 
    N=24 --> 15 | Recruiting --> Terminated; Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA). Trial completion date: Jan 2025 --> Jul 2024 | Trial primary completion date: Jan 2024 --> May 2024