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1.
Expert Opin Drug Discov ; : 1-16, 2022 Mar 31.
Article in English | MEDLINE | ID: covidwho-1774242

ABSTRACT

INTRODUCTION: The ongoing COVID19 pandemic represents an unprecedented opportunity to test the feasibility of monoclonal antibody (mAb) therapies against respiratory viruses. While many hurdles were easily predictable (e.g. time to develop, scalability, and economic sustainability), mAb cocktails (i.e. the combination of two mAbs) were finally deployed in 2021, one year after the beginning of the pandemic. Of them, the REGN-COV-2 cocktail was likely the most successful experience and contributed at saving lives at the time of the wave sustained by the Delta variant of concern (VOC). AREAS COVERED: Herein, the authors review the preclinical and clinical history of the casirivimab + imdevimab cocktail for the treatment of novel coronavirus infection. The authors furthermore provide the reader with their perspectives on this cocktail including its current place in the treatment armamentarium. EXPERT OPINION: Unfortunately, results from clinical trials highlighted a very limited efficacy in inpatients; furthermore, the current evidence with regards to its lack of effectiveness against the current dominant VOC (omicron) suggests a very limited use of these drugs in the future. In the authors' opinion, this story reminds us of the limitations of mAb therapies in pandemic settings, and of the inferiority of monoclonal versus polyclonal antibody-based therapeutics in such scenarios.

2.
Drug Saf ; 43(8): 699-709, 2020 08.
Article in English | MEDLINE | ID: covidwho-1482336

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an "infodemic") about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, favipiravir, and umifenovir) that could have led to inappropriate and therefore hazardous use. In this article, we analyze the rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people's behavior, and the responses of some influential regulatory authorities in an attempt to minimize the actual or potential risks arising from this behavior. Finally, we discuss the role of pharmacovigilance stakeholders in emergency management and possible strategies to deal with other similar crises in the future.


Subject(s)
Coronavirus Infections , Drug Utilization/trends , Information Dissemination , Pandemics , Pneumonia, Viral , Public Health , Attitude to Health , Betacoronavirus , COVID-19 , Coronavirus Infections/classification , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Coronavirus Infections/psychology , Humans , Information Dissemination/ethics , Information Dissemination/methods , Medication Therapy Management/ethics , Medication Therapy Management/standards , Pharmacovigilance , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/psychology , Public Health/methods , Public Health/standards , SARS-CoV-2 , Social Media/ethics , Social Media/standards , Social Medicine/ethics , Social Medicine/standards
3.
Expert Opin Drug Discov ; 16(12): 1403-1414, 2021 12.
Article in English | MEDLINE | ID: covidwho-1324534

ABSTRACT

Introduction: In the COVID-19 pandemic emergency, research has been oriented toward the development of therapies that could cure critically ill patients and treatments that can reduce the number of hospitalized patients, in order to ease the pressure on health-care systems. Bamlanivimab, developed from human convalescent plasma, was the first monoclonal antibody to become available for emergency use in several countries. Expectations related to its use in COVID-19 patients as a single agent have been largely disregarded, especially against E484K-carrying SARS-CoV-2 variants.Areas covered: In this drug discovery case history, the development of the drug is described starting from the identification and selection of the antibody, from the pre-clinical and clinical trials up to the post-authorization phase.Expert opinion: Bamlanivimab has shown some efficacy in patients with mild to moderate COVID-19. Initially approved as a monotherapy, due to poor efficacy it is currently only usable in combination with etesevimab. Pharmacokinetic limitations and mainly the onset of SARS-CoV-2 variants are the main reasons for this limited clinical use. The use in preventing hospitalization also has ethical limits related to the sustainability of care, especially if, considering similar effectiveness, bamlanivimab is compared with convalescent plasma.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Neutralizing/therapeutic use , COVID-19/drug therapy , Drug Development , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Neutralizing/administration & dosage , COVID-19/therapy , COVID-19/virology , Humans , Immunization, Passive , Pandemics , SARS-CoV-2/drug effects
4.
MAbs ; 12(1): 1854149, 2020.
Article in English | MEDLINE | ID: covidwho-977345

ABSTRACT

Monoclonal antibody (mAb) therapy has been previously exploited for viral infections, such as respiratory syncytial virus pneumonia and Ebolavirus disease. In the ongoing COVID-19 pandemic, early signals of efficacy from convalescent plasma therapy have encouraged research and development of anti-SARS-CoV-2 mAbs. While many candidates are in preclinical development, we focus here on anti-SARS-CoV-2 neutralizing mAbs (or mAb cocktails) that represent the late-stage clinical pipeline, i.e., those currently in Phase 2 or Phase 3 clinical trials. We describe the structure, mechanism of action, and ongoing trials for VIR-7831, LY-CoV555, LY-CoV016, BGB-DXP593, REGN-COV2, and CT-P59. We speculate also on the next generation of these mAbs.


Subject(s)
Antibodies, Monoclonal/metabolism , Antibodies, Neutralizing/metabolism , Antibodies, Viral/metabolism , COVID-19/immunology , COVID-19/therapy , SARS-CoV-2/physiology , Antibodies, Monoclonal/genetics , Antibodies, Neutralizing/genetics , Antibodies, Viral/genetics , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Humans , Immunization, Passive/methods
6.
Crit Care ; 24(1): 331, 2020 06 11.
Article in English | MEDLINE | ID: covidwho-593538

ABSTRACT

Sars-CoV-2 complications include pneumonia and acute respiratory distress syndrome (ARDS), which require intensive care unit admission. These conditions have rapidly overwhelmed healthcare systems, with detrimental effects on the quality of care and increased mortality. Social isolation strategies have been implemented worldwide with the aim of reducing hospital pressure. Among therapeutic strategies, the use of immunomodulating drugs, to improve prognosis, seems promising. Particularly, since pneumonia and ARDS are associated with a cytokine storm, drugs belonging to therapeutic classes as anti-IL-6, anti-TNF, and JAK inhibitors are currently studied. In this article, we discuss the potential advantages of the most promising pharmacological approaches.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Cytokines , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/therapy , COVID-19 , Critical Illness , Humans , Intensive Care Units , Pandemics , Respiratory Distress Syndrome/virology , SARS-CoV-2 , Treatment Outcome
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