🚨💊HUGE news: @US_FDA has finally granted approval to @ShionogiUS’s Xocova (Ensitrelvir), a 2nd-generation antiviral targeting SARS-CoV-2.
The approval is for the indication of “post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19”. However, just like with any drug, it can obviously also be used off-label (e.g. treatment of both acute COVID or Long COVID).
In Japan, Xocova received Emergency Use Authorization for the treatment of acute COVID all the way back in November 2022, received full approval in March 2024, and an expansion to include post-exposure prophylaxis in March 2026.
The post-exposure prophylaxis indications are based on the SCORPIO-PEP trial (https://t.co/Dxv0lhS2CM), where Xocova reduced the incidence of COVID-19 after household exposure by 67%, from 9.0% down to 2.9%.
Mechanically, Xocova is the same class of drug as Paxlovid - a 3C-like protease inhibitor that inhibits viral replication. From our best understanding, Xocova is probably slightly more potent than Paxlovid, but the more definitive advantage is that it comes with less side effects and less drug interactions (which are caused by the Ritonavir component of Paxlovid, added to boost the concentration of the actual antiviral, Nirmatrelvir).
Xocova should be useful for lowering viral load during an acute infection, especially if taken within a couple or days of symptom onset, which may help shorten the duration of acute symptoms. Will it do anything to prevent long-term damage or the development of Long COVID? Almost certainly not, just like Paxlovid, but I’d be more inclined to tell people that it’s worth trying if we’re no longer dealing with the side effect profile of Paxlovid.
Where it makes the most sense to use Xocova, just like with Paxlovid, is as a component of polytherapy for Long COVID driven by viral persistence. The big issue there, however, is that you need a longer course of these antivirals than most physicians are willing to prescribe and/or most insurance companies are willing to cover. And they’re generally not very effective as a monotherapy, you need to pair these oral antivirals with other therapies for better coverage and tissue penetration (eg. monoclonal antibodies and Nuvaxovid, and potentially even a 2nd antiviral like Remdesivir).
All in all, this is a very important and long overdue approval. It’s not a game-changing silver bullet, and notably, nobody should really be expecting to use or rely on Xocova in a way that they wouldn’t be open to using or relying on Paxlovid in the present. But there are plenty of applications for it, and Xocova should absolutely be seen as another Swiss cheese layer / tool in the toolbox for COVID conscious community members and any allied medical providers.
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Fully agree. "Close contact" describes behavior, but it does not describe how the virus gets from one person to the other. It could be through touch, inhalation of small particles in the air, or spray of large droplets.
Clean water. Clean food. Clean air.
I'm leading one of four Performer teams for the @ARPA_H BREATHE program. We're building a system that ensures clean air in buildings. We're demonstrating this in child care centers to improve health for kids and their families.
It's widely accepted that hantavirus transmits from rodent excreta to humans via inhalation of aerosolized virus, so I don't understand why we're so reluctant to acknowledge the inhalation route for human-to-human transmission.
https://t.co/aGFDKS94Qk
I spoke about the potential for airborne transmission of hantavirus, and Josh Santarpia talked about the National Quarantine Unit. I visited it last year; it's a critical resource for the country. @virginia_tech@VTEngineering
@ABC So: Patient zero caught an airborne virus (w/ ~30% CFR, long incubation period & asymptomatic spread) outdoors birdwatching, spread it on a poorly ventilated cruise ship & @WHO provided... dust masks?! Now @CDCgov is bringing 17 people to NE quarantine facility to just...go home?
1/ With #Hantavirus in the news, it is worth re-visiting the most famous outbreak which was in Yosemite National Park in 2012. 10 people were infected; 5 were in the ICU and 3 died. How they got infected was the most striking part of the outbreak and can help us think about the cruise ship today.
Let me be clear: this SICKENS me. I spent YEARS writing letters to get my interpreters in America because they SAVED OUR LIVES. One of my interpreters was a 15 year old kid. One day, we were working with the Afghan police and he went stone quiet. After we left, I asked him what was wrong. He told me that the Afghan police had just threatened to cut his lips off for helping us. He was FIFTEEN. And he risked EVERYTHING for our soldiers.
@BrowardHealth@Raquel_Savage Note that the Canadian Standards Association is drafting an update to medical PPE that recommends respirators.
https://t.co/L0I6k4QIEz
A multimodal AI agentic model that integrates electronic medical records, lifestyle, layers of biologic omics data to predict health outcomes and, with perturbations, "what if" scenarios a person improved lifestyle or took a medication
@Cell_Metabolism
https://t.co/qgVomjkipS
Every week I read things Walz is doing for MN — and then I look at #VT. What has #Vermont Gov Scott done lately??
Recruit health care companies to Colchester BioLabs facility. Bring in cyber security companies. Fin Services.
Vermont Gov is sleepwalking us into a fiscal ditch.
Long term follow up of a phase 1
trial of an mRNA tumor vaccine shows that 7/8 patients with pancreatic cancer, who mounted an immune response to the vaccine, are still alive 6 years later. This is breathtaking data and shows the promise of mRNA vaccines. https://t.co/J1kDmMRZQY
The idea vaccines cause autism was invented by Andrew Wakefield in 1998 and was so thoroughly debunked he lost his license for gross malpractice
And here we are 27 years later RFK Jr and his fans dredging up the same nonsense
Such a tiresome waste of time
"Nothing worth doing comes easy." For Kristen Gallagher, that means navigating the challenges of running a small fiber mill in central Vermont, and working alongside her father.
Vermont Human is produced by David Littlefield.
@vermontpublic Phil Scott should look around and adopt other governors ideas. This lottery game idea is pitiful and harmful.
Tax on out-of-state luxury homeowners like NY. New employer initiatives like Walz. Free childcare like New Mexico.
Scott is devoid of any interesting ideas!