The UK government has announced deals for Covid-19 antivirals molnupiravir (from Merck) and PF-07321332 /ritonavir (from Pfizer).
Prof Penny Ward, Independent Pharmaceutical Physician, Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“At last some news from the antiviral taskforce confirming advance purchase of a supply of two oral antivirals for COVID. Molnupiravir has been shown to reduce hospitalisation and death from COVID in a late phase study in unvaccinated people in the USA, while the Pfizer protease inhibitor (which has to be given with a dose of ritonavir) started phase III trials in July. We also heard disappointing news yesterday from Roche/Atea, whose antiviral treatment did not meet the primary endpoint in a community study, the companies stating that this may have been due to the study design, which investigated impact on disease duration in low risk, predominantly vaccinated, subjects with mild disease rather than subjects at risk of hospitalisation, as investigated in the Merck-Ridgeback and Pfizer trials. The total number of courses ordered is relatively limited, given that we have 40,000+ subjects infected every day currently. If this is the entire supply, if offered to all it would run out within a month or two. For this reason, it is highly likely that these treatments will be reserved for subjects at significant risk of hospitalisation/death from COVID (notwithstanding vaccination) if they become unwell, but we have yet to see the detailed data or any specific advice from the clinicians on who will be eligible for treatment. In the meantime, the NHS/HSA will need to consider how they will roll these medicines out into community practice. We know that, despite advice to use antiviral treatment in high risk patients becoming unwell with influenza, most patients are not offered therapy. This is not entirely because patients do not present until it is too late to use these medicines, which must be given within 48-72 hours of illness onset, but also because clinicians are simply unused to instituting active treatment for influenza. Although less acute, the same is true for COVID – in the successful trials treatment began within 5 days of onset of symptoms and this does mean that community practitioners will need to be available to diagnose and treat the patients eligible for these medicines rapidly, unless they are to be provided by pharmacists under a patient group directive approach as adopted for oseltamivir during the 2009 influenza pandemic.
“In the meantime, we are still not deploying the antiviral monoclonal antibody therapies in the community, even though the trials that supported MHRA approval were community based studies in high risk patients. Although it is more challenging to give an IV preparation within a community setting, it is not impossible and deployment of these medicines could be making an impact on hospitalisation rates even now. Given the strain the NHS is under in areas with particularly high rates of transmission, it seems worth a try.
“Clearly the NHS is awaiting MHRA approval for these medicines prior to deploying them on a wide scale, however an urgent treatment protocol/ compassionate use program could also be considered. Indeed, remdesivir was first made available in the UK via the early access to medicines (EAMS) scheme, which makes earlier access under careful conditions including reporting of outcomes from treatment possible in the UK. Maybe something else to consider while waiting for MHRA to complete their review.”
Dr Ruth McKernan, Chair at BioIndustry Association, said:
“It is very good news if we can add a couple of antiviral drugs to the suite of therapeutics available.
“Prevention is still better than cure but for vulnerable patients who can’t be vaccinated or don’t respond well, post-infection treatment with an oral drug is important. These are the strongest candidates currently available for this winter.
“We have learned a lot from the vaccine task force. Approval by MHRA is the beginning in learning how best to deploy a new therapeutic.
“There is still more to understand such as how well antiviral drugs work in vaccinated people and indeed in preventing infection in vulnerable individuals when given prophylactically. The UK NHS has shown how well it collects valuable data on new medicines so deploying as part of national study makes good sense at this stage.
“These are very selective and specific drugs. For the Biotech and Pharma industries the next horizon will be to look at some of the newer technologies that might provide broad activity against multiple viruses.”
Richard Torbett, Chief Executive, the Association of the British Pharmaceutical Industry, said:
“Vaccines have already done so much to help break the link between infections and hospitalisations. Antivirals are another line of defence for the most clinically vulnerable and patients that are seriously ill with COVID-19.
“This is good news and another example of how the pharmaceutical industry and the government are working together to make sure we have as many effective tools as possible to tackle this pandemic.”
All our previous output on this subject can be seen at this weblink:
Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. 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).”
Dr Ruth McKernan: “Chair of the BIA, Venture partner at SV health investors and hold Board positions on several biotech companies.”
None others received.