Nirmatrelvir/ritonavir

Long COVID symptoms can improve, but their resolution is slow and imperfect

Retrieved on: 
Sunday, September 3, 2023
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Shortness of breath, brain fog, lethargy and tiredness, loss of smell or taste are common features of long COVID, as is the development of new conditions such as diabetes, heart disease, stroke, depression and dementia.

Key Points: 
  • Shortness of breath, brain fog, lethargy and tiredness, loss of smell or taste are common features of long COVID, as is the development of new conditions such as diabetes, heart disease, stroke, depression and dementia.
  • Read more:
    When does COVID become long COVID?
  • This and other recently published studies on long COVID show that while symptoms do resolve in many people, their resolution is slow and imperfect.

What did the study find?

    • The researchers followed 139,000 people with COVID and almost six million uninfected controls for two years, tracking deaths, hospitalisations and 80 long-term impacts of COVID, categorised into ten organ systems.
    • After two years, this “hospitalised” group remained at increased risk of 50 conditions.
    • This included a risk of clots and blood disorders, lung disease, fatigue, gut disorders, muscle and joint disorders and diabetes.

Findings from other recent research were similar

    • The risk of death was concentrated in the first six months after infection.
    • A third, not yet peer-reviewed and smaller cohort study of 341 people with long COVID from Spain, found only 7.6% of them recovered at two years.
    • An Australian (not yet peer-reviewed) study followed 31 people who developed long COVID and 31 matched controls who recovered from COVID for two years.
    • Finally, a recent whole-body positron emission tomography (PET) imaging and biopsy study showed prolonged tissue level immune-activation and viral persistence in the gut for up to a remarkable two years after COVID.

These studies have some limitations

    • It’s important to note the observational studies have some inherent limitations.
    • The US veterans cohort studied by Al-Aly is nearly 90% men, with an average age of 61 years, which is different to groups most at risk of long COVID.

We still don’t have treatments for long COVID

    • In July 2023, the White House established the Office of Long COVID Research and Practice.
    • Two randomised trials are testing whether the antiviral nirmatrelvir-ritonavir (Paxlovid) can treat long COVID are currently recruiting patients.

But it’s still important to prevent COVID (re)infections

    • Taken together, these studies on the longevity of long COVID add substantially to the case to fast-track the development of interventions and therapies to prevent and/or cure the condition.
    • In the meantime, it’s crucially important to prevent (re)infections in the first place to reduce the future burden of long COVID, already estimated to be greater than 65 million people globally.
    • If you suspect you have long COVID, discuss this with your GP, who may refer you to specialised services or multidisciplinary care.

SEC Charges Former Pfizer Statistician with Insider Trading Ahead of COVID-19 Announcement

Retrieved on: 
Thursday, June 29, 2023
COVID-19, Nirmatrelvir/ritonavir, Market abuse, Complaint, District court, Data analysis, United States district court, FBI, Security (finance), News, Pharmaceutical industry, Pfizer

On the day before the Paxlovid announcement, the complaint alleges, Dagar learned material, nonpublic information about the success of the trial.

Key Points: 
  • On the day before the Paxlovid announcement, the complaint alleges, Dagar learned material, nonpublic information about the success of the trial.
  • The case originated from the SEC’s Market Abuse Unit’s Analysis and Detection Center, which uses data analysis tools to detect suspicious trading patterns.
  • In a parallel action, the U.S. Attorney's Office for the Southern District of New York today announced criminal charges against Dagar and Bhiwapurkar.
  • The SEC appreciates the assistance of the U.S. Attorney’s Office for the Southern District of New York and the FBI.

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Retrieved on: 
Thursday, May 25, 2023
EUA, Taste, Post-exposure prophylaxis, Vaccine, Shenzhen Kangtai Biological Products, Office of Inspector General, U.S. Department of Health and Human Services, Diarrhea, Hospital, Center for Drug Evaluation and Research, Human services, Public, COVID-19, Clinical trial, Immunity, Food, Cosmetics, Multimedia, RNA, Animal, Federal Food, Drug, and Cosmetic Act, Dietary supplement, Patient, Risk, Diagnosis, Heated tobacco product, Research, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Disease, Pharmaceutical industry, SARS-CoV-2, Nirmatrelvir/ritonavir

Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

Key Points: 
  • Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
  • The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19."
  • EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
  • Based on the data currently available to the FDA, there is not a clear association between Paxlovid treatment and COVID-19 rebound.

Paxlovid associated with lower risk of hospital admission

Retrieved on: 
Thursday, March 16, 2023
Kaiser Permanente, Hospital, Regulation of tobacco by the U.S. Food and Drug Administration, Risk, Immunity, Coronavirus, Vaccination, Doctor of Philosophy, COVID-19, Food, Death, Nirmatrelvir/ritonavir, Pfizer, Patient, Pharmaceutical industry, Lancet

PASADENA, Calif., March 16, 2023 /PRNewswire/ -- A Kaiser Permanente study confirms the benefit of nirmatrelvir-ritonavir, also known as Paxlovid, as an early-stage treatment to prevent hospitalization for people with mild to moderate COVID-19, regardless of prior immunity or age. The study was published March 15, 2023, in Lancet ID.

Key Points: 
  • Paxlovid is an oral therapeutic drug aimed at reducing the risk for severe outcomes of coronavirus infection.
  • In the study population, 7,274 people had received Paxlovid, and 126,152 had not received Paxlovid.
  • Effectiveness in preventing hospital admission or death within 30 days after a positive test was 80% for people who were dispensed Paxlovid within 5 days after symptom onset.
  • Within the subgroup of patients who were dispensed Paxlovid on the day of their positive COVID-19 test, effectiveness was 90%.

Vir Biotechnology Announces Positive Final Draft Guidance on Sotrovimab from the UK’s National Institute for Health and Care Excellence (NICE)

Retrieved on: 
Wednesday, February 22, 2023
Marketing, Sotrovimab, Risk, Therapy, NICE, SAN, GSK, Nirmatrelvir/ritonavir, COVID-19, Patient, SARS-CoV-2, Pharmaceutical industry

Due to existing inventory, no meaningful additional sales of sotrovimab in the UK are anticipated in 2023.

Key Points: 
  • Due to existing inventory, no meaningful additional sales of sotrovimab in the UK are anticipated in 2023.
  • “We welcome the final draft guidance from NICE which we believe is particularly meaningful as the organization’s recommendations are informed by independent committees that aim to provide guidance to healthcare professionals on the best care options available to benefit their patients,” said George Scangos, Ph.D., Chief Executive Officer of Vir.
  • NICE expects to publish its final recommendations on medicines to treat COVID-19 in March 2023.
  • Sotrovimab has obtained emergency authorization, temporary authorization or marketing approval (under the brand name Xevudy®️) for early treatment of COVID-19, supplying more than 40 countries.