4- Thursday Pharmacotherapy News – 4th November

1 – A Learning Health System Randomized Trial of Monoclonal Antibodies for Covid-19

• Neutralizing monoclonal antibodies (mAb) targeting SARS-CoV-2 decrease hospitalization and death in patients with mild to moderate Covid-19. Yet, their clinical use is limited, and comparative effectiveness is unknown.
• In non-hospitalized patients with mild to moderate Covid-19, bamlanivimab, compared to bamlanivimab-etesevimab and casirivimab-imdevimab, resulted in 91% and 94% probabilities of inferiority with regards to odds of improvement in hospital-free days within 28 days.
• There was an 86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab at an odds ratio bound of 0.25.

Source: MedRxiv

2 – An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2

• Repurposing approved drugs may rapidly establish effective interventions during a public health crisis.
• This has yielded immunomodulatory treatments for severe COVID-19, but repurposed antivirals have not been successful to date because of redundancy of the target in vivo or suboptimal exposures at studied doses.
• Nitazoxanide is an FDA approved antiparasitic medicine, that physiologically-based pharmacokinetic (PBPK) modelling has indicated may provide antiviral concentrations across the dosing interval, when repurposed at higher than approved doses.
• Within the AGILE trial platform (NCT04746183) an open label, adaptive, phase 1 trial in healthy adult participants was undertaken with high dose nitazoxanide.
• Participants received 1500mg nitazoxanide orally twice-daily with food for 7 days.
• Primary outcomes were safety, tolerability, optimum dose and schedule.

Source: MedRxiv

3 – Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A review of spontaneously reported data from the UK, Europe, and the US

• A signal of myocarditis and pericarditis following mRNA COVID-19 vaccines first emerged in May 2021.
• This study aims to bring together spontaneously reported data from around the world to estimate the reporting rate in different countries and better understand the risk factors for myocarditis and pericarditis following exposure to COVID-19 mRNA vaccines.
• This study provides evidence that younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees.
• These very rare events with mild clinical course followed by full recovery in most cases were more frequent following the second dose.
• Reporting rates of myocarditis and pericarditis were consistent between the data sources.

Source: MedRxiv

4- Metformin: We need to either put it in our drinking water or rethink how we study it

• This study aims to expose the potential impact of residual confounding in common observational study designs investigating metformin using a type 2 diabetes cohort; to propose a more robust study design for future observational studies of metformin.
• Common observational study designs examining metformin in a type 2 diabetes population are likely impacted by significant residual confounding.
• By additionally considering numerous negative control outcomes and a complementary prediabetes cohort, the study design proposed here demonstrates efficacy at exposing residual confounding related to overall health, nullifying the claim derived from a standard study design.

Source: MedRxiv

5 – Deleterious drugs in COVID-19: a rapid systematic review and meta-analysis

• Concerns have been expressed about a number of drugs that potentially worsen outcomes in patients with COVID-19.
• In this study they sought to identify all potentially deleterious drug groups in COVID-19 and critically assess the underpinning strength of evidence pertaining to the harmful effects of these drugs.
• They found minimal high quality or consistent evidence that any drug groups increase susceptibility, severity or mortality in COVID-19.
• Converse to initial hypotheses, we found some evidence that regular use of ACEIs and ARBs prior to infection may be effective in reducing the level of care required, such as requiring intensive care, in patients with COVID-19.

Source: MedRxiv

6 – Immunogenicity and reactogenicity of booster vaccinations after Ad26.COV2.S priming

• In face of the developing COVID-19 pandemic with a need for rapid and practical vaccination strategies, Ad26.COV2.S was approved as single shot immunization regimen.
• While effective against severe COVID-19, Ad26.COV2.S vaccination induces lower SARS-CoV-2-specific antibody levels compared to its mRNA-based counterparts.
• To support decision making on the need for booster vaccinations in Ad26.COV2.S-primed individuals, they assessed the immunogenicity and reactogenicity of homologous and heterologous booster vaccinations in Ad26.COV2.S-primed health care workers (HCWs).
• Boosting of Ad26.COV2.S-primed HCWs was well-tolerated and immunogenic.
• Strongest responses were detected after boosting with mRNA-based vaccines.
• Based on our data, efficacy on infection and transmission of boosters is expected.
• In addition to efficacy, decision making on boost vaccinations should include timing, target population, level of SARS CoV-2 circulation, and the global inequity in vaccine access.

Source: MedRxiv

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