Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Saturday, October 02, 2021

Merck's New Antiviral COVID Treatment

"An oral antiviral that can impact  hospitalization risk to such a degree would be game-changing."
"[Existing treatments are] cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that."
Amesh Adaija, senior scholar, John Hopkins Center for Health Security 
 
"Most people have heard of Tamiflu, and they've heard of acyclovir,. Acyclovir is a type of antiviral used to treat chickenpox, herpes and shingles."
"We didn't develop a ton of other antivirals."
"Stop progression of disease, so you take them and you forget about it, right? The second thing we'd like the pill to do, if you're taking it for symptomatic disease, is stop long Covid, right? It's not just 'Don't let me get progressed and die -- don't let me have lingering cough, lingering headache.' "
"Treatment to serve as prevention], so someone with Covid-19 is less likely to transmit it to others. We'd like it to wipe out the SARS-CoV-2 replication in the nose so fast that your nose is no longer a danger to me."
Dr. Myron Cohen, professor of medicine, microbiology, immunology and epidemiology, University of North Carolina.
molnupiravir
This undated image provided by Merck & Co. shows their new antiviral medication. (Merck & Co. via AP)

"This is going to change the dialogue around how to manage COVID-19", chief executive Robert Davis of Merck & Co. pharmaceuticals stated. In collaboration with partner Ridgeback Biotherapeutics both plan to apply for U.S. emergency use authorization in the shortest possible time-frame along with plans to make regulatory applications worldwide. Their antiviral pill has the potential to significantly decrease death or hospitalization for people most at risk of contracting serious COVID-19.

Experts in the field view the antiviral, named molnupiravir, as a true breakthrough in treating the SARS-CoV-2 virus haunting the world community and strangling economic development. The treatments currently in use representing infused antiviral remdesivir from Gilead Sciences Inc., and generic steroid dexamethasone are administered once a patient with COVID has been hospitalized

Critical Phase III trial results were positive enough for the antiviral to convince outside monitors to recommend an early halt to the trials; they had given sufficient proof of the efficacy of the treatment. Both Swiss drugmaker Roche Holding AG and Pfizer are focusing on the development of an easy-to-administer antiviral pill. Only antibody cocktails which must be given intravenously have been approved to the present for non-hospitalized patients.

In Merck's study, a planned interim analysis of 775 patients studied hospitalizations or deaths, finding that 7.3 percent of people given molnupiravir were hospitalized with none dying, for 29 days following treatment, in comparison with hospitalization of 14.1 percent of placebo patients among whom there were eight deaths. The trial involved international patients representing a wide spectrum of study entrants with molnupiravir taken every 12 hours for a period of five days.
 
Viral sequencing performed to date indicates molnupiravir to be effective against all variants inclusive of the highly transmissible Delta strain. Adverse events rates were similar for both molnupiravir and placebo patients, according to Merck. With the expectation that the potential new treatment may aid in preventing serious illness from COVID, scientists have broadly welcomed the new antiviral.
 
The worldwide assault on the human body by the SARS-Cov-2 virus through COVID-19, has succeeded in causing the death of close to five million people around the world.
"This is the most impactful result that I remember seeing of an orally available drug in the treatment of a respiratory pathogen, perhaps ever."
"I think getting an oral pill that can inhibit viral replication -- that can inhibit this virus -- is going to be a real game changer."
Dr. Scott Gottlieb, former commissioner, US Food and Drug Administration

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