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The government has announced the launch of a COVID-19 Antivirals Taskforce that will aim to identify treatments for patients who have been exposed to COVID-19 to stop the infection spreading and speed up recovery time.
Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:
“An investment in antiviral medications is welcome indeed to complement the huge resource that has been poured into vaccines, although is disappointingly at odds with recent cuts to other UKRI funding schemes.
“It would be useful to understand whether this initiative is primarily to repurpose existing medications for COVID treatment clinical trials, or to develop novel treatments through supporting fundamental and translational research. The timescale of the autumn would suggest the latter, yet both would be beneficial in terms of the long term control of SARS-CoV2 infections, especially for those unable to access, or respond to current vaccines.
“The proven benefits of dexamethasone, tocilizumab and sarilumab highlight the value of drug repurposing, and these modulators have considerable impact upon the immune-mediated pathology of severe COVID. However, this approach has been far less successful for identifying direct-acting antiviral drugs against SARS-CoV2. The development of such drugs has been long-neglected by pharmaceutical companies, and many of the antivirals in COVID trials were repurposed from bygone programmes targeting e.g. hepatitis C, HIV or influenza. Moreover, the search for effective antiviral treatments has also led to inappropriate off-label use of drugs such as hydroxychloroquine and, more recently, Ivermectin, without any convincing or supportive clinical evidence; these are often combined with other medicines such as antibiotics and vitamin supplements, seemingly at random.
“Thus, a concerted boost to the development of novel direct-acting antivirals would be of considerable clinical benefit alongside repurposing, and the timescale for this could be greatly accelerated by the level of resource and logistical support afforded to the vaccine programmes. UK researchers are already identifying novel treatments in the laboratory, making their rapid future development a huge opportunity to help control the pandemic.”
Dr Andrew Garrett, Executive VP, Scientific Operations, ICON Clinical Research, said:
“The announcement of the formation of a COVID-19 antivirals taskforce is to be welcomed and shows ambition for the UK to be at the forefront of research into the treatment of COVID-19. This is aligned with the concept of clinical trials as a treatment option whereby patients in the UK are given the opportunity to have early access to the potential benefits of new treatments. The RECOVERY trial and other UK studies have shown the willingness of the UK population to take part in SARS-CoV-2 related clinical trials, that may not only benefit themselves, but also lead to better treatment options for others. The antivirals taskforce follows on from the successful vaccine model which delivered well beyond expectations. In this respect it has set a high bar, but it is important to remember that drug development is an inherently risky business.
“The highly ambitious target of having at least two effective treatment this year points to the taskforce supporting the re-purposing of existing drugs, and/or the latter stages of development for new targeted drugs, that are already in development. Re-purposed drugs have the advantage of a well characterized safety profile, but are less targeted than new drugs. However it takes time to establish the safety profile of new drugs.
“Nonetheless, this government-led initiative is a clear sign that the UK is open for business and is becoming an increasingly attractive place to undertake drug development.”
Dr Janet Scott, Clinical Lecturer in Infectious Diseases, MRC-University of Glasgow Center for Virus Research (CVR), and previous Chief Investigator: Glasgow Early Treatment Arm: Favipiravir (GETAFIX), said:
What are plausible candidates? What stage of development/investigation are they?
“The drugs which are the fastest into use, are drugs which are already in use for other diseases. The only current candidate for an antiviral drug which is also oral is Favipriavir. I am leading a trial called GETAFIX in Glasgow “Glasgow Early Treatment arm FAVIPIRAVIR” already and there is also a sister trial ongoing in London.
“This drug was developed as an anti- influenza drug in Japan, but has had some early success in trials in China speeding up time to a person clearing the virus from the system and reducing lung damage.
“For the monoclonal antibodies, two contenders are : casirivimab or imdevimab.
Is it feasible to have an anti-viral treatment by the autumn? What does it mean to ‘supercharge the search for antiviral treatments’ in practical terms?
“We already have one drug in clinical trial, so yes in my view with concerted effort it is possible to have results by the autumn. We cannot promise a positive outcome of course, results will be what they will be. Efforts so far to trial oral drugs have been logistically challenging due to prioritising (rightly) vaccine clinical trials and also the hospital based RECOVERY study. So with political will it is certainly possible to have current trials finished and new trials set up. I would advocate however also for putting an effort in parallel, into earlier phase clinical trials to keep the pipeline of new drugs moving, rather than focusing all research money on end stage clinical trials – that is: everything from improving or creating new drugs, through toxicology testing and first in man trials right up to large scale trials to see if the treatments work. That way we can have the first drugs quickly, but then have better improved drugs coming through – in my view it is unwise to assume we will have THE magic bullet on the first go. Viruses can become resistant to drugs as well as vaccines, (especially to monoclonal antibody based drugs) so it is never wise to let the research sit still.
“Please see our recent paper on repurposing anti-covid drugs especially the last section on “the way forward”
https://www.biorxiv.org/content/10.1101/2021.03.25.436935v1
Do anti-virals for mild/moderate disease exist for other diseases?
“Yes -aciclovir cream for herpes simplex (cold sores) and oral or IV for chicken pox or varicella zoster. The oldest antiviral, but still a very effective drug, oseltamivir for influenza.
What about prophylactics?
“We use aciclovir in pregnancy if a woman is not already immune to chicken pox and has been exposed.
Any other comments?
“This new initiative is very welcome, useful though to fund research at all parts of the pipeline. We do need a well tolerated, oral antiviral that can be used quickly, when a person gets their first symptoms.”
Dr Penny Ward, Faculty of Pharmaceutical Medicine, Visiting Professor in Pharmaceutical Medicine, Kings College London, said:
“The announced support for a new taskforce focusing on antiviral treatment/prevention of COVID-19 is much welcomed. Antiviral treatment of influenza has been shown to reduce hospitalization and prevent death in epidemic and pandemic waves and a similar, preferably simple to use antiviral, suitable for use in the community can add to the range of interventions critical to enable us to remain on top of the COVID pandemic even in the event of the emergence of viral variants insensitive to vaccines.”
What are plausible candidates? What stage of development/investigation are they?
“There are currently ongoing early phase trials of orally available antivirals, of which the most advanced is molnupiravir. A protease inhibitor developed by Pfizer (PF-07321332) is in phase I trials in the USA. A number of effective combinations of monoclonal antibodies have completed phase III trials, and newer ones from a variety of companies are in phase II studies currently. Although more difficult to deploy, because of the long half life of an antibody treatment, it remains possible to administer these in care homes, or infusion centres close to individuals homes.
Is it feasible to have an anti-viral treatment by the autumn? What does it mean to ‘supercharge the search for antiviral treatments’ in practical terms?
“As noted above some potential treatments are already in clinical trials and with additional support could perhaps be manufactured and deployed in community based studies in the UK. The UK GP nationwide network has become more adept at managing patients remotely, and this country is an ideal setting in which to conduct such trials.
Do anti-virals for mild/moderate disease exist for other diseases? What about prophylactics?
“Yes oseltamivir and baloxivir are both approved for the treatment and prevention of influenza as is the inhaled product zanamivir. Anti influenza antivirals can reduce the duration of illness, reduce the rate of hospitalisation and deaths from influenza when given early enough after first onset of disease. COVID can be approached in exactly the same way.”
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Dr Andrew Garrett: “I am employed by ICON which is a Contract Research Organization. ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials. I am a member of the UK Statistical Authority’s (UKSA) Research Accreditation Panel.”
Dr Janet Scott: “I am leading a trial called GETAFIX in Glasgow “Glasgow Early Treatment arm FAVIPIRAVIR but no financial conflict of interest.”
Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Until July 2019 I was Chief Medical Officer of Virion Biotherapeutics, which was a company developing broad spectrum RNA therapy for the treatment/prevention of respiratory virus infections. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
None others received.