Merck just announced that molnupiravir, a nucleotide drug that inhibits the replication of viral RNA – a common strategy for antiviral drugs – works pretty well. (I've written about it before.) Molnupiravir, if approved would be the first orally active direct-acting antiviral drug for COVID – a significant advance in fighting the pandemic. In a trial of 775 patients with mild-to-moderate COVID-19 who were considered higher risk for severe disease molnupiravir reduced hospitalization by ...
What is molnupiravir and how does it work?
Molnupiravir offers the possibility of treating people in areas where monoclonal antibodies cannot be easily administered. Credit: Mariusz Burcz/Alamy
How many courses of molnupiravir does Merck supply to the US government?
Supply agreements: Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 3.1 million courses of molnupiravir to the U.S. Government, upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration.
Can I take molnupiravir If I am breastfeeding?
It is unknown whether molnupiravir has an effect on the breastfed infant or effects on milk production. Based on the potential for adverse reactions in the infant from molnupiravir, breastfeeding is not recommended during treatment with molnupiravir and for 4 days after the final dose.
Is molnupiravir at risk after move-out?
In anticipation of the results from MOVe-OUT, Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
What is the COVID-19 Molnupiravir medicine?
What is molnupiravir? Molnupiravir is an investigational medicine used to treat mild-to-moderate COVID-19 in adults: with positive results of direct SARS-CoV-2 viral testing, and • who are at high risk for progression to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
Does Paxlovid have side-effects?
“Paxlovid is usually very well-tolerated,” he says. Common side effects, which are usually mild, include: Altered or impaired sense of taste. Diarrhea.
What are the side effects of Remdesivir?
Remdesivir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:• nausea• constipation• pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected
How often can you take Paxlovid?
“With Paxlovid, you take three pills, twice a day, for a total of five days," says Rachel Kenney, a pharmacist at Henry Ford Health. "It helps your body fight off the virus, preventing it from replicating before it becomes serious.”
Does Paxlovid give you a bad taste in your mouth?
If you notice a nasty taste in your mouth after taking the antiviral pill Paxlovid for COVID-19, you're not imagining it. “About 5.6% of people who took Paxlovid in a study reported dysgeusia, which is a change in the taste in your mouth,” says Shivanjali Shankaran, MD, an infectious disease specialist at RUSH.
Is Paxlovid recommended for COVID-19?
Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease. Paxlovid treatment using the following online tool: Pfizer Safety Reporting and to FDA MedWatch.
Is Remdesivir approved for treatment of COVID-19?
Remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged ≥12 years and weighing ≥40 kg).
How does Remdesivir injection work to treat COVID-19?
Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body.
Can COVID-19 symptoms rebound after using Paxlovid?
A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causesCOVID-19) infection in some persons, independent of treatment with Paxlovid and regardless ofvaccination status.
Who can get Paxlovid?
The FDA has authorized Paxlovid for anyone age 12+ who is at high risk for developing a severe case of COVID-19.
What is the dosing interval for Pfizer-BioNTech COVID-19 vaccine?
The Pfizer-BioNTech COVID-19 vaccine is FDA-approved for use as a two-dose series administered 21 days apart to adolescents and adults 16 years and older and is authorized for emergency use in children ages 12-15 using the same schedule.
How many doses of the Pfizer-BioNTech COVID-19 vaccine are recommended?
Number of Shots: 2 doses in the primary series, given 3–8 weeks apart. People ages 5 years and older who are moderately or severely immunocompromised should get a third dose at least 4 weeks after their second dose.
How does molnupiravir work?
The coronavirus uses RNA as its genetic material. The structure of molnupiravir resembles the nucleosides (or chemical building blocks) used to make the virus’s RNA. The drug works by incorporating itself into the RNA as it’s being synthesized.
What antiviral drugs are used for HIV?
Dr. Shaw notes that several approved antiviral drugs already in wide clinical use—such as acyclovir and related drugs for herpesvirus infections, and reverse-transcriptase inhibitors for HIV infection —also work (via different mechanisms) in interfering with the replication of viral DNA or RNA.
What is the purpose of the Merck pill?
The goal of the Merck pill is to keep people out of the hospital, explains Dr. Meyer. “We want to prevent severe illness and death in people who are infected with mild-to-moderate COVID, but who are not yet hospitalized,” says Dr. Meyer. The Merck study suggested that molnupiravir would help patients who have at least one risk factor for severe COVID-19 to avoid hospitalization.
Does Molnupiravir affect DNA?
Because molnupiravir works by disrupting how the coronavirus replicates RNA, there could be a concern of a similar effect on human DNA or RNA. Merck reportedly has data from laboratory studies indicating that molnupiravir does not cause mutations in humans, but “the FDA will obviously need to see and evaluate this safety data in the approval process,” Dr. Shaw says.
Does Merck have an EUA?
Merck has applied to the Food and Drug Administration (FDA) for emergency use authorization (EUA) of the pill, called molnupiravir. While an authorization could become available in a matter of weeks, it’s not yet clear who would get it. But what we do know is that the company says it performed so well in a clinical trial that it halted the trial early, so it could move quickly to apply for the EUA. A company press release reports that the drug cut the risk of hospitalization and death by half in patients who had mild-to-moderate disease.
Can you take Remdesivir in the hospital?
Shaw says. Remdesivir, the only COVID-19 drug treatment fully approved by the FDA, can only be administered intravenously in the hospital . It’s also only for those ages 12 and older, regardless of how severe their symptoms are, and studies suggest it may provide only modest benefit.
What is molnupiravir?
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.
What are the eligibility criteria for Molnupiravir?
Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry. Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.
Does Merck supply Molnupiravir?
Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Is there an adverse event in Molnupiravir?
The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).
Is Merck a forward looking company?
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
What Is Molnupiravir?
Molnupiravir , which has already received authorization in the United Kingdom, is given as a pill. Its route of administration is an advantage over the currently available COVID-19 antiviral treatments, monoclonal antibodies, which must be given as an infusion at a doctor’s office, infusion center, or hospital.
Concerns
Members of a November advisory committee to the FDA posed several questions about the safety and effectiveness of the new drug. Among the concerns were that during the company’s presentation to the advisory committee, it reported that the effectiveness of the drug had fallen from earlier projections that were released.
What Experts Think
Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah, is not a member of the committee but he told Verywell that he thinks that “the data presented at the FDA advisory meeting and the discussion around it provide a complicated picture.”
Pfizer's COVID Pill
While Pfizer’s antiviral appears to be more effective than Merck’s (and potentially more helpful than monoclonal antibodies) it also has downsides: for one, the pill must be given with another medicine called ritonavir (an antiviral used to treat HIV) that interacts with many medications .
Testing and Vaccination Still Matter
Experts want the public to understand that even though treatments are now authorized to treat COVID-19, it does not mean that COVID vaccination is no longer needed.
Lowered expectations
Merck’s initial study group included 762 people who received 4 pills of either the antiviral or a placebo twice a day, for 5 consecutive days, between May and early August. A second group included 646 people who received the same treatment between August and early October.
Weighing up the risks
Although Merck reported similar rates of side effects for trial participants taking the antiviral as for those on the placebo, some researchers are worried that molnupiravir’s novel mechanism of action has the potential for long-term safety risks.
Hope remains
With the confirmed global death toll from the coronavirus standing at more than five million people, public-health officials have been hoping antivirals such as molnupiravir could be deployed quickly worldwide to save lives — especially with the Omicron variant spreading rapidly.
