CategoryTreatment

UK strikes deals for two antiviral drugs to help combat coronavirus surge this winter

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Health Secretary Sajid Javid has hailed two new additions to the UK’s “armoury of life-saving measures” to tackle COVID-19 as he announced the purchase of 730,000 doses of possible coronavirus treatments.

The government’s antivirals taskforce has struck deals for two new coronavirus treatments, which – if they are approved by the medicines regulator – are expected to be given to those most vulnerable to COVID-19.

The agreements have seen the UK secure 480,000 courses of Molnupiravir – produced by Merck Sharp and Dohme (MSD) – which has been proven in clinical trials to reduce the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate COVID-19 symptoms by 50%.

The US has already struck a $1.2bn deal to purchase around 1.7m courses of Molnupiravir, should it be approved by the American regulator.

https://news.sky.com/story/covid-19-uk-strikes-deals-for-two-antiviral-drugs-to-help-combat-coronavirus-surge-this-winter-12439406

Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill

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The Bill & Melinda Gates Foundation said on Wednesday it would spend up to $120 million to kick-start development of generic versions of Merck & Co’s oral COVID-19 treatment to help ensure lower-income countries have equal access to the drug.

The aim is to reduce the gap between when wealthy countries have access to the antiviral medicine, molnupiravir, and when the rest of the world can benefit from it.

“To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to life-saving health products,” Melinda French Gates, co-chair of the Gates Foundation, said in a statement.

The Gates Foundation investment will be used to help drugmakers ramp up production of generic molnupiravir, as well as support regulatory filings and prepare local markets, Trevor Mundel, the foundation’s president of Global Health, said in an interview.

Initial data from a clinical trial on Merck’s experimental pill suggest it can halve the risk of serious disease and death from COVID-19 when given early in the illness.

Mundel said the funding would act as a bridge to get the manufacturing process started. Ultimately, he estimated the total cost to launch a generic version of Merck’s antiviral at up to $500 million dollars. “That’s where the global funders are going to have to come in,” he said.

https://www.reuters.com/business/healthcare-pharmaceuticals/gates-foundation-allots-120-mln-poor-nations-get-covid-19-drug-2021-10-20/

Aspirin lowers risk of COVID: New findings support preliminary Israeli trial

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“The number of weekly reported deaths from COVID-19 continues to decline, and is now at the lowest level in almost a year.” – WHO Director-General Tedros Adhanom Ghebreyesus. Still far too many people dying from COVID but signs again that things are slowly moving in a more positive direction.

Aspirin lowers risk of COVID: New findings support preliminary Israeli trial

Over-the-counter aspirin could protect the lungs of COVID-19 patients and minimize the need for mechanical ventilation, according to new research at the George Washington University.

The team investigated more than 400 COVID patients from hospitals across the United States who take aspirin unrelated to their COVID disease, and found that the treatment reduced the risk of several parameters by almost half: reaching mechanical ventilation by 44%, ICU admissions by 43%, and overall in-hospital mortality by 47%.

“As we learned about the connection between blood clots and COVID-19, we knew that aspirin – used to prevent stroke and heart attack – could be important for COVID-19 patients,” said Dr. Jonathan Chow of the study team. “Our research found an association between low-dose aspirin and decreased severity of COVID-19 and death.”

https://www.jpost.com/health-and-wellness/aspirin-lowers-risk-of-covid-new-findings-support-preliminary-israeli-trial-681127

Scientists discover highly potent antibody effective against SARS-CoV-2 variants

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Scientists at Lausanne University Hospital (CHUV) and EPFL have discovered a highly potent monoclonal antibody that targets the SARS-CoV-2 spike protein and is effective at neutralizing all variants of concern identified to date, including the delta variant. Their findings, published in the prestigious journal Cell Reports, pave the way to promising new therapeutic applications for protecting at-risk individuals, such as immunocompromised patients. The new antibody could also be used as a combination therapy in SARS-CoV-2-infected individuals.

In addition to its antiviral properties, the new antibody is designed to have a lasting effect in humans. A typical unaltered antibody provides protection for up to 3–4 weeks. But this new one can protect patients for 4–6 months. That makes it an interesting preventive-treatment option for unvaccinated at-risk individuals or for vaccinated individuals who are unable to produce an immune response. Immunocompromised patients, organ transplant recipients and those suffering from certain kinds of cancer could be protected against SARS-CoV-2 by receiving antibody injections two or three times a year.

The discovery of this new antibody marks a major step forward in the fight against COVID-19. It opens the door to improved treatments for severe forms of the disease and to enhanced prophylactic measures, especially for patients with weakened immune systems. However, this antibody is not intended to replace COVID-19 vaccines, which remain the most effective way to prevent infection.

https://www.chuv.ch/fr/chuv-home/espace-pro/journalistes/communiques-de-presse/detail/scientists-discover-highly-potent-antibody-effective-against-sars-cov-2-variants

AstraZeneca antibody cocktail study shows success treating COVID-19

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AstraZeneca’s antibody cocktail against COVID-19, which has proven to work as a preventative shot in the non-infected, was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms.

The drug, a combination of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50% in non-hospitalised patients who have had symptoms for seven days or less, the Anglo-Swedish drugmaker said on Monday.

The risk reduction was even better in patients who started therapy within just five days of initial symptoms, but AstraZeneca joins an already crowded field of medicines that were shown to prevent deterioration in patients with mild disease when given soon after diagnosis.

AstraZeneca executive Mene Pangalos said in a media call that the treatment results would mainly underscore the potential future use as a non-vaccine prevention.

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazenecas-covid-19-drug-cocktail-meets-main-goal-late-stage-trial-2021-10-11/

AstraZeneca seeks U.S. approval for drug cocktail to prevent COVID

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AstraZeneca has requested emergency approval from U.S. regulators for its antibody cocktail, the first protective shot other than vaccines against COVID-19, another potential major step in the global fight to combat the virus.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, Astra’s biotech compound known as AZD7442 contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.

COVID-19 therapies based on the same class of monoclonal antibodies are sold by rivals Regeneron (REGN.O), Eli Lilly and GlaxoSmithKline and its partner Vir to stop the disease from worsening during early, milder stages of the infection.

The AstraZeneca therapy, designed to last several months to a year, could protect people who do not have a strong enough immune response to COVID-19 vaccines due to, for instance, chemotherapy or anti-rejection drugs after organ transplants.

The drug, given in two sequential injections, could also supplement a vaccination course for those, such as military personnel, who need to booster their protection further, AstraZeneca has said.

https://www.reuters.com/world/us/astrazeneca-files-us-approval-drug-prevent-covid-19-2021-10-05/

Why Merck’s Covid-19 pill molnupiravir could be so important

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The pharmaceutical giant Merck on Friday reported good news for people sick with Covid-19: Its antiviral drug molnupiravir reduced the risk of hospitalization and death in at-risk patients by 50 percent, according to the company’s interim analysis.

A new and effective Covid-19 treatment — if approved by health regulators — could be a versatile tool for doctors to treat Covid-19 patients and could ultimately save lives. While there are a number of treatments for Covid-19 on the market, many of them are expensive, difficult to administer, not widely available, or only marginally effective.

Molnupiravir, originally developed to treat influenza, could solve many of these challenges. It’s administered as a twice-a-day pill for five days, compared to other Covid-19 treatments that require expensive intravenous transfusions, such as monoclonal antibodies and convalescent plasma. The antiviral drug remdesivir, currently the only drug with full Food and Drug Administration approval to treat Covid-19, also has to be delivered into the bloodstream.

A drug like molnupiravir (the name is a reference to Thor’s hammer, Mjölnir) could also help compensate for persistent gaps in Covid-19 vaccination coverage, both in the United States and abroad.

https://www.vox.com/22704265/merck-covid-19-antiviral-pill-molnupiravir-treatment-drug

Merck’s COVID-19 pill cuts risk of death, hospitaliSation by 50% in study

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Merck & Co Inc’s experimental oral drug for COVID-19, Molnupiravir, reduced by around 50% the chance of hospitalisation or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.

“This is going to change the dialogue around how to manage COVID-19,” Robert Davis, Merck’s chief executive officer, told Reuters.

If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

A planned interim analysis of 775 patients in Merck’s study found that 7.3% of those given molnupiravir were either hospitalized or had died by 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.

https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-covid-19-pill-cuts-risk-death-hospitalization-by-50-study-2021-10-01/

Drug Cocktail Significantly Reduced Severe COVID, Death in Outpatients

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A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly compared with placebo.

COVID-related hospitalization or death from any cause occurred in 18 of 1355 patients (1.3%) in the group getting 2400 mg infusions of the study drug compared with 62 (4.6%) of 1341 in the matching placebo group, indicating a relative risk reduction of 71.3%.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Florida, told Medscape Medical News that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”

https://www.medscape.com/viewarticle/960060

A pill to treat Covid-19: ‘We’re talking about a return to, maybe, normal life’

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Within a day of testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room.

When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought, ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?”

But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that’s part of an international effort to test an antiviral treatment that could halt covid early in its course.

By the next day, the couple were taking four pills, twice a day. Though they weren’t told whether they had received an active medication or placebo, within a week, they said, their symptoms were better. Within two weeks, they had recovered.

“I don’t know if we got the treatment, but I kind of feel like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt like the recovery was very quick.”

The Kellys have a role in developing what could be the world’s next chance to thwart covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and conceivably prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only curtail the duration of one’s covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill who has helped pioneer these therapies.

At least three promising antivirals for covid are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who is overseeing antiviral development.

“I think that we will have answers as to what these pills are capable of within the next several months,” Dieffenbach said.

https://edition.cnn.com/2021/09/27/health/covid-treatment-pill-khn-partner/index.html