Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid nytimes.com/2021/11/05/heal...
The problem, as always is time and the complex access routes.
This pill needs to be administered in th first 3 days. When it can take a week to see a GP, or longer to see a specialist how will this work in the UK?
The US is already talking about it being available from your local pharmacists.
Pfizer antiviral pill reduced risk of covid hospitalization and death by 89 percent in high-risk people, company study shows
Washington Post Today at 6:45 a.m.
An experimental coronavirus pill reduced the risk of hospitalization and death by 89 percent in high-risk people infected with the virus, pharmaceutical giant Pfizer announced Friday.
The effect of the drug, a five-day regimen designed to block the virus from making copies of itself, was found to be so strong midway through the study that an independent committee monitoring the clinical trial recommended it be stopped early. The data has not yet been published or peer-reviewed, but Pfizer said in a news release that it would submit the data to regulators “as soon as possible.”
Easy-to-deliver antiviral pills that blunt infections could be a powerful addition to the medical tool kit to manage the pandemic and equip the world for a future in which the coronavirus continues to circulate. Such treatments would augment the medical armamentarium, not replace highly protective vaccines, similar to how people receive flu shots but may be prescribed Tamiflu if they do fall ill.
“This is amazing news. My overall feeling was relief — it’s been a long path,” said Annaliesa Anderson, the chief scientific officer of Pfizer’s bacterial vaccines and hospital medicine division, who leads the program to develop the drug. Anderson, who has been working on the medicine since January 2020, said it was a “heart-in-your-mouth moment” when she learned the news Wednesday night while driving to Massachusetts for college visits with her daughter.
“We’re looking at end-to-end protection and treatment,” Anderson said. “We have the vaccine for protection, and now we have an opportunity for treatment.”
Pfizer has already begun manufacturing the drug and projects producing more than 180,000 pill packs by the end of this year. The company is working to rapidly scale up manufacturing to at least 21 million packs in the first half of next year, with a total production of 50 million packs in 2022. The company did not disclose the price.
The results mean the world could soon have two antiviral pills to treat people early in their sickness in addition to highly effective vaccines, if regulators deem the drugs safe and effective.
Drug maker Merck announced a month ago that its antiviral pill, molnupiravir, cut the risk of hospitalization or death by half in high-risk patients. Regulators in Britain cleared molnupiravir for use this week in people who are diagnosed with covid-19, the disease caused by the virus, and have at least one risk factor for severe illness. In the United States, an expert advisory committee to the Food and Drug Administration is scheduled to meet to scrutinize Merck’s drug shortly after Thanksgiving — a crucial step before a drug is authorized for use. Merck has said it will produce 10 million treatment courses in 2021.
The work on Pfizer’s antiviral drug, called paxlovid, built off efforts by Pfizer scientists to develop treatments for the outbreak of severe acute respiratory syndrome (SARS) nearly two decades ago. Paxlovid combines a new molecule designed by Pfizer scientists in July 2020 and ritonavir, an antiviral drug used to treat HIV.
In a clinical trial, participants at high risk of developing severe illness were given the drug regimen — three pills a day, twice a day — within three days of their covid-19 symptoms beginning. Half received the experimental drug and half received a placebo. Paxlovid was 89 percent effective in reducing risk of hospitalization and death. Among 389 people who received the drug, three hospitalizations and no deaths were reported. Among 385 people who got a placebo, 27 hospitalizations were reported, with seven subsequent deaths.
The trial also included people who were given the drug within five days of symptom onset to test whether there was leeway on timing. The window of opportunity for giving antiviral drugs to thwart acute respiratory infections is short, so people must recognize their symptoms and get tested and receive results right away for drugs to be effective. Tamiflu, for example, is often given too late.
The drug also appeared to be effective even at five days after symptoms began. For about 600 people who received the drug within five days of symptoms, six people were hospitalized. Among the 600 who received a placebo, there were 41 hospitalizations and 10 subsequent deaths.
The company reported that side effects after treatment were similar between the group that received the drug and those that received the placebo, and were mostly mild.
Paxlovid blocks a coronavirus protease, an enzyme the virus needs to make copies of itself. It uses a different mechanism than the Merck drug, which disables the virus by garbling its genome and has raised concerns about its potential to cause mutations in people’s cells.
Public health experts have eagerly awaited the arrival of antiviral drugs — and some believe that in the long run, more than one will probably be necessary to create cocktails and combination therapies that ensure the coronavirus doesn’t find a way to escape.
Thanks for posting a longer and more detailed article than the one I read this morning. Interesting development, another arrow in the quiver once it’s available.
Hoping scientists can develop a pill that doesn’t have such a “short clock” timeframe of having to take it to be effective. That would be a super-game changer.
…and as the article notes, these new covid pills are meant not to replace getting vaccinated! Great reminder.
Yes this looks good for everybody except those 10 folks in the placebo arm of the study who died, so close.
Agree. Was a real shocker (and so very sad) to read that placebo group death stat.
Pin,
I agree and the stats were much like they have been telling the CLL crowd. 10 deaths out of 41 hospitalizations is slightly higher than 25%.
But no deaths on the treated side.
Sad but life ain’t fair as my Aunt used to tell me.
Jeff
The trial did show there's a bit of leeway in the timing. 85 pct effective against hospitalisation when given 5 days after onset of symptoms.I'd take that!
Yeah saw that Bennie, n your right 5 Days is better than 3. Probably it’s difficult to stretch that timeframe out much further given how quickly covid can do severe damage.
I’m glad for what they’ve done! Sounds like a great pill.
Question that may be next, which treatment is best and more effective for CLL folks? Would it be Pfizer’s antiviral pill, Paxlovid or Regeneron’s monoclonal infusion or both?
Should I have a breakthrough covid infection my treatment choice would be a monoclonal antibody infusion. If an infusion is not available I would ask for the Pfizer piIls because the study showed strong results with immune compromised people like me.
Thanks Slow, it’s good to hear your thoughts on this. Hopefully we don’t have to find out. Just wanted to be prepared.
Thanks for posting. This may explain why the FDA is going slow on Molnupiravir.
Move over Molnupiravir, here comes Paxlovid evaluate.com/vantage/articl...
All I can say is Wow!
healthunlocked.com/user/kat... pointed out that the FDA may also be concerned about potential gene toxicity with Molnupiravir.
With respect to mutagenicity concerns with Molnupiravir, this Science article notes with respect to the UK "approval, for people at high risk of severe disease, comes as a prominent virologist has suggested using molnupiravir could do far more harm than good, potentially unleashing new, deadlier variants of SARS-CoV-2. Other virologists say the concern is worth tracking but is largely hypothetical, for now. “I don’t think we are in the position of withholding a lifesaving drug for a risk that may or may not happen,” says Aris Katzourakis, a viral evolution expert at the University of Oxford."
From A prominent virologist warns COVID-19 pill could unleash dangerous mutants. Others see little cause for alarm
- Merck & Co.’s newly approved oral drug works by generating mutations, raising hypothetical fears
science.org/content/article...
Note the conclusion:-
"More likely, Denison and others say, is that use of molnupiravir will drive the emergence of virus that is no more deadly or transmissible but is resistant to the drug, a common outcome for anti-infectious agents. But the 5 November news that another antiviral drug, from Pfizer, is highly effective against SARS-CoV-2 suggests a way to forestall resistance: using both pills in combination, the same multiprong strategy used to treat HIV and other infections.
On 30 November, a Food and Drug Administration advisory committee will review possible emergency use authorization for molnupiravir in the United States."
Related COVID-19 antiviral posts:
healthunlocked.com/cllsuppo....
healthunlocked.com/cllsuppo...
healthunlocked.com/cllsuppo...
Neil
While the concerns raised are largely theoretical, the potential for gene toxicity seems too serious to ignore. I wonder if preclinical and phase 1 trials can really eliminate the risk of cancer and birth defects arising from mutagenesis. Molnupiravir is a nucleoside analogue ("Molnupiravir Coding for Catastrophe" nature.com/articles/s41594-... ) and some years ago catastrophe befell nearly half of the patients in a clinical trial of the same class of antiviral nejm.org/doi/full/10.1056/N...
The article seemed to downplay the possibility of repeated issues with these class of drugs in the conclusion.
It was a bit more nuanced as I read it. In the discussion the authors suggested that the extreme reaction was due to the particular chemistry of the drug, but they also noted similar adverse events with other nucleoside analogues and some evidence of "mitochondrial injury".
One would expect the MHRA to have looked pretty carefully at all this before giving Molnupiravir its conditional marketing authorisation. You can read what they had to say about mutagenesis in section 5.3 of gov.uk/government/publicati... i.e. they believe it's not mutagenic in vivo.
However, the patient leaflet says "Animal studies with molnupiravir have shown harmful effects to the unborn animal. Lagevrio is not recommended in pregnancy".
New Guy Hoping for some answers!
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