I wonder what that drug costs compared to Ivermectin and HCQMerck pill breakthrough raises hopes of preventing COVID deaths
Author of the article:Reuters
Reuters
Deena Beasley and Carl O'Donnell
Publishing date:Oct 01, 2021 • 12 hours ago • 4 minute read • 6 Comments
An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc on May 17, 2021.
An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc on May 17, 2021. PHOTO BY MERCK & CO INC / HANDOUT /REUTERS
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An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.
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If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.
“An oral antiviral that can impact hospitalization risk to such a degree would be game-changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.
Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.
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“This is going to change the dialog around how to manage COVID-19,” Merck Chief Executive Robert Davis told Reuters.
Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that,” Adalja added.
The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.
Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up more than 21% on the news.
Shares of COVID-19 vaccine makers Moderna Inc were off more than 10%, while Pfizer was down less than 1%.
Jefferies analyst Michael Yee said investors believe “people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID.”
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Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.
White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is “a potential additional tool… to protect people from the worst outcomes of COVID,” but added that vaccination “remains far and away, our best tool against COVID-19.”
A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths among people at risk for severe disease. It found that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after treatment. That compared with a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.
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“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.
‘A HUGE ADVANCE’
Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world, 700,000 of them in the United States.
“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.
The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
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Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.
Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.
It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.
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The U.S. drugmaker said it expects to produce 10 million courses of the treatment by the end of 2021.
The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.
Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.
The U.S. government has the option to purchase up to an additional 3.5 million treatment courses if needed, a U.S. health official told Reuters. The official asked to remain anonymous because they were not authorized to comment publicly on the contract.
Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.
Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck’s research labs, said, “they are going to try to work with alacrity on this.”'
Merck pill breakthrough raises hopes of preventing COVID deaths
An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19,…torontosun.com
Watch: Dr. Campbell Reveals the Reason Behind India’s Ivermectin Blackout
By Jim HoftPublished October 3, 2021 at 7:45am
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Dr. John Campbell broke India’s Ivermectin Blackout wide open on YouTube by revealing the formula of the secret sauce, much to the dismay of Big Pharma, the WHO, and the CDC. Readers will want to watch this before it is taken down. See mark 2:22.
Each home kit contained the following: Paracetamol tablets [tylenol], Vitamin C, Multivitamin, Zinc, Vitamin D3, Ivermectin 12 mg [quantity #10 tablets], Doxycycline 100 mg [quantity #10 tablets]. Other non-medication components included face masks, sanitizer, gloves and alcohol wipes, a digital thermometer, and a pulse oximeter. See mark 2:33.
Campbell reports that the exciting things in the kit that grabbed his attention were: Zinc, Vitamin D3, Ivermectin, and secondary antibiotic treatment. “Interesting, that’s what the government decided to give.” See mark 3:40.
He has reviewed repurposed drugs for COVID before. He has interviewed both Dr. Tess Lawrie and Dr. Pierre Kory. Repurposed drugs hold the potential for benefitting many conditions, not the least of which include viruses and cancers.
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He attributes their success to many factors, including early detection and early treatment with kits costing a mere $ 2.65 per person. See mark 6:20.
Notice that Dr. Campbell does not mention a single person who had any toxicity from those ten 12 mg pills of Ivermectin – in the entire state of over 200 million. Not one poisoning was reported. No Indian poison control articles or telephone calls were reported. Out of millions of distributed medicine kits, each containing 120 mg of Ivermectin, not one person in Uttar Pradesh was reported to have had a problem with the drug.
Notice that Dr. Campbell at no time criticizes the medicine kit as “fringe” or ineffective. After all, it would be improper to accuse a WHO-sponsored program such as the Uttar Pradesh test and treat – coordinated by WHO – of being “fringe.”
Contrary to what little we receive – at great expense – from the government in the United States, these kits are efficient and contain gloves, a thermometer, and an oximeter. The last time I purchased an oximeter some ten years ago, it cost some $200.00. This entire kit – including the oximeter – costs only $2.65.