The U.K.GOV website has today updated this guidance, perhaps in anticipation of the result of the NICE technical appraisal of COVID therapeutics and pre exposure treatment The results of the appraisal is expected to be shared with stakeholders the week commencing 6 February 2023 and will be published on the NICE website five working days later.
gov.uk/government/publicati...
Jackie
I will look forward to anything that will help me lead a normal life as we all will, thankyou, Anne uk
Thank you Jackie. I look forward to NICE outcomes especially around evusheld or other prophetic medications for the vulnerable.
Ann
Hi Jackie I am currently recovering from Covid, my first episode.It was a lengthy and very unpleasant experience, but one I survived, which is good news, giving me hope for myself and our community.
Having been admitted to hospital as the virus impacted another underlying health problem, albeit for only 12 hours, I fail to see how NICE have come to the conclusion evusheld is not cost effective. The cost to the NHS in my case, of testing for every possible problem and the administration of sotrovimab by infusion not to mention an isolation room must have been equivalent to the cost of evusheld or more.
I am aware not everyone in our community will experience what I have however the potential and more, remains a possibility, especially following reports of some antivirals becoming less effective.
I try to keep up with what is happening with prophylactics especially evusheld and have done my best to help our cause by visiting and writing to my MP. , signing and sharing petitions etc.
My MP had written to Steve Barclay Health Minister on several occasions and spoke at Westminster Hall on my behalf with no success. She repeatedly received standard government negative responses which are infuriating and designed to make us give up. I am not a quitter so will continue to do all I can to assist our community overcome these injustices.
In follow up to your post about NICE decisions being on the horizon I believe the outcome remains the same they don’t consider it to be cost effective? I believe that NICE have also said that the NICE route should not have been used by the government?
I wondered if you could update me about where we go from here if anywhere?
Thank you
Ann
I am currently writing a response to NICE's preliminary draft guidance in the hope of overturning this decision. There are grounds but I'n not hopeful. One of their statements said that Evusheld did not prevent infection. Well, no but neither do vaccinations and yet we are almost mandated to have them. Like vaccinations, it does reduce morbidity and mortality, importantly hospital a d ICU admissions. In my view, Evusheld should be seen as an extension of the vaccination programme for those that do not have antibodies.
Whatever we do/say will hopefully lay the ground for Evusheld 2 being given rapid approval even if this is unsuccessful
Jackie
We all thank you for your considerable efforts on our behalf Jackie 👍
Newdawn
Thank you so much for the update and the work you do on our behalf Jackie. I can understand why you are not hopeful given the way this government have behaved. You are correct it should lay the grounds for evusheld 2 or other prophylactics that may come about in the future.
In my opinion the fact NICE did not feel they were the body to carry out these decisions speaks volumes and may prevent them using this route for future prophylactics.
Thank you
Ann
NICE guidelines may also want to add to their recommendations for prevention of long covid within the section listed for people who do get COVID. More research is needed on use of metformin for preventing long covid. According to the drugs.com website, metformin is compatible with BTKi, BCL2, and obinutuzumab/rituximab therapies.
Yesterday Eric Topol MD wrote about a two-week course of low-dose metformin for those with COVID, in his Substack Blog at erictopol@substack.com :
"A Breakthrough for Prevention of Long Covid
Until now the only way we knew that Long Covid could be prevented was to not get Covid. That’s still the case. But a new randomized, placebo-controlled trial of metformin has yielded exciting results—the first drug to be shown to help prevent Long Covid. Over a thousand people with mild-to-moderate Covid were randomly assigned to 2 weeks of metformin (500 mg pills, 1 on day 1, twice a day for 4 days, then 500 mg in AM and 1000 mg in PM for 9 days) or placebo. There was a 42% reduction of subsequent Long Covid as you can see by the event curve below, which corresponds to an absolute decrease of 4.3%, from 10.6% reduced to 6.3%.
Of note, the participants in the trial were fairly representative of the people who most often go on to manifest Long Covid, outpatients with a median age of 45 years and 56% were female. The low risk subgroups of people age <30 years or with a normal BMI were excluded. There were no treatment by subgroup interactions—that is there were overlapping 95% confidence intervals for the direction of benefit for metformin for all subgroups; no clear evidence that metformin worked better or worse for each. That’s consistently, although the statistical power for an interaction term is limited with only ~1,000 patients and a larger trial would be needed to know whether any of this subgroups below had differential effects with metformin. The findings in the trial also reinforced the higher risk of unvaccinated vs vaccinated status to get Long Covid (14 vs 7% among placebo assignees). The diagnosis of Long Covid in the trial relied upon being documented by a medical provider. The mechanism of metformin’s apparent benefit is unknown, but perhaps is related to its impact on reducing oxidant stress and inflammation, or suppressing viral replication, as has been demonstrated in the lab and animal models with the SARS-CoV-2 virus.
There are no other adequately sized or rigorous trials that have evaluated metformin to date. So this question is, without an independent replication, whether this trial’s data should be consider enough to recommend metformin in clinical practice. My view is yes, since the risk of side effects for 2 weeks of metformin is near zero (from both the trial itself and huge experience with metformin over decades for chronic use) and the cost is remarkably low, in fact as low as $1-2 dollars. The only other drug to date with some promising data to prevent Long Covid is Paxlovid, but that is from a large observational database, not derived from a randomized trial. Ideally, a 2X 2 factorial design trial would be conducted to test metformin plus paxlovid, either drug alone, or placebo. And to emphasize, we still have no drug validated to treat Long Covid, only 1 that now appears likely to help prevent it.
As I’ve written in the past, I don’t use the term “breakthrough” lightly. Besides Paxlovid, that I initially wrote about in 2021 here, and the new anti-obesity drugs here, I’m reluctant to go there. But to see such a pronounced benefit in the current randomized trial of metformin, in the context of it being so safe and low cost, I’d give it a breakthrough categorization. Another way to put it, that unless or until there are data to the contrary, if I got Covid, I’d take metformin for 2 weeks at the doses used in this trial. "
There's a lot of work going on in the background looking at old drugs and seeing if they can be repurposed. It's a difficult area to get funding for as there is none or little profit in it for the pharma companies.
Jackie
That’s good to know Jackie at least the scientists and medics haven’t forgotten us.
I am wonder if we are unfortunate enough to get another no from NICE and the government on evusheld where do we go from there?
There has been no press coverage about the injustices we continue to face locally or nationally that I am aware of for a long time. Is that the next stage for us or do we just have to accept?
Ann
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