Thousands of vulnerable NHS patients in hospital due to COVID-19 are set to benefit from a groundbreaking new antibody treatment, the government has announced today (17 September 2021).
Ronapreve, a combination of 2 monoclonal antibodies, will be targeted initially at those in hospital who have not mounted an antibody response against COVID-19.
This includes people who are immunocompromised, for example those with certain cancers or autoimmune diseases, and therefore have difficulty building up an antibody response to the virus, either through being exposed to COVID-19 or from vaccination.
The government has taken action to secure supply of the new therapeutic for NHS patients across the 4 nations, buying enough to treat eligible patients in hospital from next week. Guidance will shortly be going out to clinicians so they can begin prescribing the treatment as soon as possible.
Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.
It will be used to treat patients without antibodies to SARS CoV-2 who are either aged 50 and over, or are aged 12 to 49 and are considered to be immunocompromised.
Antibody testing will first be used to determine whether patients are seronegative, meaning those who do not have an adequate existing antibody response, and will therefore receive the treatment. The treatment antibodies – casirivimab and imdevimab – will then be administered to patients through a drip and work by binding to the virus’s spike protein, stopping it from being able to infect the body’s cells.
Very pleased to hear this. The leaflet says it may be given to prevent C19, would that be for CEV patients in hospital for any treatment do you think? It is very reassuring news - maybe getting C19 isn’t quite a death sentence waiting in the wings after all 🤞🙂
Thank you Jackie. Very reassuring news for all of us. I am assuming that this isn’t, but a similar treatment to AZD7442. So, perhaps, there are more MAB treatments on the horizon.
There could be a major draw back immunocompromised people are breeding grounds for variants. Now evidence is coming to light that monoclonal treatments increase the risk of virus mutations, thus could fuel the pandemic.
Thanks, I looked at this paper and wasn't convinced that the figures show the mutations to have been driven by administration of the monoclonals, mainly bamlanivimab. In April the FDA withdrew that drug's EUA as monotherapy because it was ineffective against variants of concern, including the SA variant in which the E484K mutation is an important feature. Perhaps the mutations seen in these immunocompromised patients would have occurred without the administration of bamlanivimab. Case studies have shown that protracted illness and evolution of mutations is a feature of severe Covid in immunocompromised patients irrespective of treatment.
Other monoclonals perform better against existing variants because they each combine two antibodies targeting different epitopes. In Ronapreve (Regn-Cov in the figure), widely used in the US and now approved in the UK, only one of the two antibodies works against the Delta variant. Sotrovimab (GSK-Vir) seems to be more resilient to variants. AZ7442 we will have to see.
I would say that with the threat of evasive variants always there, more science is needed in this area, as monoclonal antibodies are expensive to produce and difficult to modify compared with vaccines.
There are similar theories that the vaccines themselves have driven mutations, also that vaccinated Covid patients have more severe disease. Not to say it's impossible but I've seen no solid evidence of either. Sustenance for the antivax movement though.
I would be interested to see any more peer-reviewed articles along these lines especially wrt monoclonal antibodies.
Thank you for posting this, it makes it all much clearer. My GP hadn't a clue about it, and I haven't phoned cancer centre because their hotline is usually bombarded.
Thanks for posting Jackie. But I don't understand why this has appeared on the government website only a week ago when Ronapreve approval was announced 5 weeks ago gov.uk/government/news/firs... Does the more recent announcement give any new information?
Yes I think we all need to be aware that this drug is available now.
I'm going to find out from my haematology unit what they know: does the hospital have a plentiful stock of Ronapreve? Which patients qualify for it: low or no antibodies? At what stage of Covid are they giving it? Could I have a letter from the haematologist recommending I be Ab tested on diagnosis and if deficient be given Ronapreve immediately?
Great news, if we can get it? Can’t even get a flu jab from my practice and who knows when I will be getting 3rd vaccination, my practise don’t know when ,but fingers and toes crossed.
That’s great advice Jackie, I’ve been on line and booked both my wife and I for flu jab tomorrow at my local boots, think I waited for my Gp last year until December. Thanks again Dave.
Great news Jackie, thanks for sharing. Certainly a good step forward.
It puzzles me though, that it emphasises that Ronapreve is for people in hospital.
At first I thought that meant it was only given in hospitals (like most infusions). Now I'm thinking it probably means it's only for people who have already in hospital due to serious Covid symptoms.
That would fit with what my haematologist told me a few weeks ago, which did not impress me at as from what I've heard on this forum, Ronapreve is best given as soon as possible after symptoms appear. I thought it was too late for monoclonals to help if someone was ill enough to need hospital admission.
Has anyone else in the UK had advice from their haematologists about this?
Paula
P.S. bennevisplace , I'll be very interested to hear how your haematology unit answers your questions on this subject.
I think it is only available as an infusion at the moment (subcutaneous to follow at some point). So given in hospital. It could be outpatient but I guess a confirmed Covid case would either be told stay at home until you get sick or admitted to the Covid ward.
You are right, it's critical to have monoclonals asap after diagnosis to prevent severe illness. As Ronapreve is very new to UK hospitals I'm not sure this is fully appreciated by staff focused on treating sick patients.
The protocol says the drug is for patients without neutralising antibodies to Covid, implying a test first. Are they going to test every case of mild Covid on admission? Is it a rapid yes/ no test like the Abingdon, or a more time consuming semi-quantitative test like the Roche, or what? Do they need a heads-up that immunocompromised patients showing positive for antibodies may well have very low levels insufficient to prevent severe illness?
I'll try to get some answers from my haematology unit.
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