On Friday, October 1, the multinational pharmaceutical company Merck and Ridgeback Biotherapeutics announced some welcome news about a promising at-home treatment for COVID-19. Merck shared the results of its 3rd phase trials for its recently acquired drug, Molnupiravir (a.k.a. MK-4482, EIDD-2801). According to the press release, “Molnupiravir reduced the risk of hospitalization or death by approximately 50%.” With these positive results, they explained that the phase 3 trial was ended early, and they were immediately seeking approval from the FDA under the Emergency Use Authorization provision, or EUA for short. [i]
If approved, this would make Molnupiravir the first COVID-19 antiviral medicine taken orally. It would also be the first COVID-19 medication with the potential for use from home as it is in pill form. According to Merck’s CEO, Robert M. Davis, “with these compelling results, we are optimistic that Molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
What is Molnupiravir?
Years ago, Emory University scientists identified Molnupiravir while screening compounds for use as antivirals against influenza. More recently, several virologists, including Timothy Sheahan and Ralph Baric of the University of North Carolina at Chapel Hill and Mark Denison of Vanderbilt University Medical Center, were able to show that Molnupiravir was effective against coronaviruses including SARS-CoV-2. [ii]
As a ribonucleoside analog, Molnupiravir embeds itself into a viral RNA strand, causing growth to stop or substantial mutations making replication impossible. [iii]
What did the 3rd Phase trial show?
The trial, named Phase 3 MOVe-OUT, stopped taking new patients after day 29 due to the overwhelmingly positive results. The trial focused on adult COVID-19 patients who had mild to moderate symptoms and were not hospitalized. 385 participants randomly received the drug, and 377 received only placebos. They found that through day 29, 14.1% of patients treated with placebos had been hospitalized, with 2.1% resulting in death. Whereas patients who were given Molnupiravir experienced 7.3% hospitalization and no deaths. So those who received Molnupiravir experience about 50% less hospitalization. [iv]
The results also showed that for all COVID-19 risk factor groups such as obesity, diabetes mellitus, heart disease, and age older than 60 years, the risk of hospitalization and death was reduced for those taking Molnupiravir. Drug efficacy was also consistent when facing the Delta, Gamma, and Mu variants.
Who should take Molnupiravir, and when?
Molnupiravir is only for use by those who have had COVID-19 for five days or less. Ideally, the patient would start taking the drug as soon as possible after experiencing symptoms. Immediately upon symptom detection is the best time to attack the virus as it’s replicating fast, and the immune system is trying to get up to speed with its defensive response.
In anticipation of approval, Merck already has Molnupiravir in production, and they expect ten million courses of treatments to be ready by the end of this year, 2021. The US government has 1.7 million courses on order, and it is expected that this is the first of many. If approved by the FDA for the EUA, it’s anticipated to happen toward the end of 2021, and those high at risk would get first access.
The course of treatment is comparable to Tamiflu. The prescription will supply a total of 40 pills to be taken over five days.
What will it cost?
The initial order is costing the US government about $700 per treatment course. However, it is expected that the treatment would be offered free in the US, just like the COVID-19 vaccines. Compared to a course of treatment using monoclonal antibodies, Molnupiravir represents a potential savings of about $1,400. [v]
What other “at home” COVID-19 treatments are under development?
When it comes to COVID-19 at-home treatments, it looks like Merck may have the market to itself at least until sometime next year, 2022. Atea Pharmaceuticals, Roche, and Pfizer are all working on similar antiviral drugs that are administered orally.
Are you ready for what’s next?
If there is one thing we have learned well from this pandemic, it will not be over quickly, and it will test the limits of every healthcare facility and public health agency. At AB Med, as healthcare clinicians, administrators, and public health consultants, we understand the unique pressures and environment you face now. Since the start, we have been very involved in the fight against COVID-19. We are ready to bring all our resources and personnel to help strengthen your initiatives for your community. So reach out to us today and discover how you can leverage our unique perspective as a trusted partner. We are in this together. Let’s Connect.
REFERENCES & RESOURCES
- Merck.com. (n.d.). Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study. [online] Available at: https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/ [Accessed 7 Oct. 2021].
- Schmidt, C. (n.d.). There Are Few Good COVID Antivirals, but That Could Be Changing. [online] Scientific American. Available at: https://www.scientificamerican.com/article/there-are-few-good-covid-antivirals-but-that-could-be-changing/ [Accessed 7 Oct. 2021].
- Merck.com. (n.d.). Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study. [online] Available at: https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/.
- Merck.com. (n.d.). Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study. [online] Available at: https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/.
- Robbins, R. (2021). What You Need to Know About Merck’s New Covid Treatment Pill. The New York Times. [online] 1 Oct. Available at: https://www.nytimes.com/2021/10/01/business/merck-covid-pill-molnupiravir.html [Accessed 7 Oct. 2021].
By: Erik McLaughlin MD, MPH and Aikaterini Papadopoulou, B.Arch
