"Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.
This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the second monoclonal antibody therapeutic to be approved following Ronapreve".
Sotrovimab is already approved in the European Union and has Emergency Use Authorisation in the USA.
No drugs have been "real-world" tested against the new Omicron variant, but GSK-Vir the makers of Sotrovimab expressed confidence that their monoclonal would be effective reuters.com/business/health...
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bennevisplace
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Indeed this is good news and another weapon in our arsenal. When I spoke to my CNS he said monoclonal antibodies would only be made available after you were hospitalised and tested against a particular aspect of the spike protein (the detail was lost on me).
This evening I have just participated in the CLL society webinar on Covid and monoclonol antibodies (from USA) and it was stated that you need to get the antibodies as soon as you test positive and its too late once you are at the stage of being hospitalised.
Does anyone know what is fact in the UK NHS? This discrepancy with fellow Cllers on the other side of the pond has me worried.
With Ronapreve, and now I guess Xevudy too (who thought that was a good name?), the road to eligibility NHS style is a stepwise process. Some of the steps are in the public domain, but AFAIK there's no published detailed protocol to ensure that patients who need these potentially life-saving drugs receive them in good time.
So, drawing on selected personal experience, I'll make one up:
1, Report symptoms to GP (if you can get through, remember switchboard may be jammed by too many callers at this busy time)
2. Book a PCR test appointment (as above)
3. Drive to the test centre, take the test
4. Get a POSITIVE result (usually within 48 hours)
5. Arrange an appointment for an antibody test
6. Attend your appointment (hope for same day, no guarantees)
7. Get a NEGATIVE antibody result (usually within 72 hours but could be twice that)
8. Ask your GP to locate a local hospital where you can receive either Ronapreve or Xevudy (don't confuse the issue by mentioning monoclonal antibodies), to confirm to the hospital you are eligible for the drug based on the two test results and your at-risk medical status, and to make an appointment for you to attend the relevant department (presumably a Covid ward).
9. When they can accommodate you (Covid wards are set to become very busy again), get yourself to the hospital, check in, and wait for a doctor to examine you.
10. Wait until the mAb infusion is ready (hoping that the vacant pharmacist posts have now been filled).
11. Have the infusion, approx 30 minutes.
12. Lie back and relax, you're in good hands.
N.B. The time scales in steps 1 through 9 are likely to be accelerated when and if Covid symptoms progress from mild to moderate, or to severe. In the latter case you won't be needing a monoclonal antibody therapy; stand by for oxygen and dexamethasone.
Disclaimer. The above description is fictional and is not intended to depict any real-life situation.
The next big question is how can we get this drug? In October HM Gov reportedly purchased a measly 100,000 doses (having earlier acquired 480,000 of Ronapreve). When I asked my consultant he knew nothing about the availability of the latter in the University of Sussex group of hospitals, nor the protocol for treating immunocompromised Covid patients.
Has anyone managed to find a hospital with stocks of either monoclonal? I believe we have at least one member who was treated with Ronapreve.
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