Logo Medical Science Monitor

Call: +1.631.470.9640
Mon - Fri 10:00 am - 02:00 pm EST

Contact Us

Logo Medical Science Monitor Logo Medical Science Monitor Logo Medical Science Monitor

01 January 2022: Editorial  

Editorial: Current Status of Oral Antiviral Drug Treatments for SARS-CoV-2 Infection in Non-Hospitalized Patients

Dinah V. Parums

DOI: 10.12659/MSM.935952

Med Sci Monit 2022; 28:e935952

0 Comments

Abstract

ABSTRACT: On 4th November 2021, the first oral antiviral drug for COVID-19, molnupiravir (Lagevrio®), received full regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Molnupiravir is an orally bioavailable antiviral drug for use at home when a SARS-CoV-2 test is positive. On 22nd December 2022, the FDA granted emergency use authorization (EUA) for the oral antiviral drug, nirmatrelvir/ritonavir (Paxlovid®) for adults and children with mild and moderate COVID-19 at increased risk of progression to severe COVID-19. These regulatory drug approvals come at a crucial time when new variants of concern of the SARS-CoV-2 virus are spreading rapidly. Although the FDA approved remdesivir (Veklury®) on 22nd October 2020 for use in adults and children for the treatment of COVID-19 requiring hospitalization, its use has been limited by the requirement for intravenous administration in a healthcare facility. The four FDA-approved therapeutic neutralizing monoclonal antibodies, imdevimab, bamlanivimab, etesevimab, and casirivimab are costly and also require medically-supervised intravenous administration. The availability of effective, low-cost oral antiviral drugs available in a community setting that can be used at an early stage of SARS-CoV-2 infection is now a priority in controlling COVID-19. An increasing number of repurposed antiviral drugs are currently under investigation or in the early stages of regulatory approval. This Editorial aims to present an update on the current status of orally bioavailable antiviral drug treatments for SARS-CoV-2 infection.

Keywords: Editorial, molnupiravir, Ritonavir, severe acute respiratory syndrome coronavirus 2, COVID-19

Conclusions

Two years on from the start of the COVID-19 pandemic, it is clear that not only is the SARS-CoV-2 virus now an endemic pathogen, but it can rapidly mutate and develop new variants that may evade the immune response generated by current vaccines. The increasing burden on hospitals and healthcare systems is not sustainable and more control of SARS-CoV-2 infection is required at the community level, with early treatment from home. Full regulatory authorization of the orally bioavailable and repurposed oral antiviral drug, molnupiravir, and the recent FDA EUA of nirmatrelvir/ritonavir, herald the era of early treatment of SARS-CoV-2 infection to prevent severe COVID-19 and reduce hospital admissions.

References

1. Hu B, Guo H, Zhou P, Shi ZL: Characteristics of SARS-CoV-2 and COVID-19: Nat Rev Microbiol, 2021; 19(3); 141-54

2. Parums V: Editorial: Revised World Health Organization (WHO) terminology for variants of concern and variants of interest of SARS-CoV-2: Med Sci Monit, 2021; 27; e933622

3. Ferré VM, Peiffer-Smadja N, Visseaux B: Omicron SARS-CoV-2 variant: What we know and what we don’t: Anaesth Crit Care Pain Med, 2021; 100998; [Online ahead of print]

4. Talic S, Shah S, Wild H: Effectiveness of public health measures in reducing the incidence of COVID-19, SARS-CoV-2 transmission, and COVID-19 mortality: Systematic review and meta-analysis: BMJ, 2021; 375; e068302

5. Parums DV: Editorial: SARS-CoV-2 vaccine responses and breakthrough COVID-19: Med Sci Monit, 2021; 27; e935624

6. Noreen S, Maqbool I, Madni A: Dexamethasone: Therapeutic potential, risks, and future projection during COVID-19 pandemic: Eur J Pharmacol, 2021; 894; 173854

7. Khanna N, Pawar SV, Kumar A: A review on repurposed drugs and vaccine trials for combating SARS CoV-2: Curr Drug Res Rev, 2021; 13(3); 203-21

8. Khanna N, Pawar SV, Kumar A:: COVID-19 Treatment Guidelines Panel Coronavirus disease 2019 (COVID-19) treatment guidelines

9. Rubin D, Chan-Tack K, Farley J, Sherwat A: FDA approval of remdesivir – a step in the right direction: N Engl J Med, 2020; 383(27); 2598-600

10. Beigel JH, Tomashek KM, Dodd LE: Remdesivir for the treatment of COVID-19 – final report: N Engl J Med, 2020; 383; 1813-26

11. Beigel JH, Tomashek KM, Dodd LE:: First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA. The antiviral was found to be safe and effective following a stringent review of the available evidence, 2021

12. Kabinger F, Stiller C, Schmitzová J: Mechanism of molnupiravir-induced SARS-CoV-2 mutagenesis: Nat Struct Mol Biol, 2021; 28(9); 740-46

13. Malone B, Campbell EA: Molnupiravir: Coding for catastrophe: Nat Struct Mol Biol, 2021; 28(9); 706-8

14. Painter GR, Natchus MG, Cohen O: Developing a direct acting, orally available antiviral agent in a pandemic: The evolution of molnupiravir as a potential treatment for COVID-19: Curr Opin Virol, 2021; 50; 17-22

15. Sheahan TP, Sims AC, Zhou S: An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 in human airway epithelial cell cultures and multiple coronaviruses in mice: Sci Transl Med, 2020; 12(541); eabb5883

16. Cox RM, Wolf JD, Plemper RK: Therapeutically administered ribonucleoside analogue MK-4482/EIDD- 2801 blocks SARS-CoV-2 transmission in ferrets: Nat Microbiol, 2021; 6; 11-18

17. Painter WP, Holman W, Bush JA: Human safety, tolerability, and pharmacokinetics of molnupiravir, a novel broad-spectrum oral antiviral agent with activity against SARS-CoV-2: Antimicrob Agents Chemother, 2021; 65(5); e02428-20

18. Khoo SH, Fitzgerald R, Fletcher T: Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: A Phase I, open-label, dose-escalating, randomized controlled study: J Antimicrob Chemother, 2021; 76(12); 3286-95

19. Painter W, Sheahan T, Baric R: Reduction in infectious SARS-COV-2 in treatment study of covid-19 with molnupiravir: Top Antivir Med, 2021; 72; 304-5

20. Fischer W, Eron JJ, Holman W: Molnupiravir, an oral antiviral treatment for COVID-19: medRxiv, 2021; 2021; 21258639

21. Jayk Bernal A, Gomes da Silva MM, Musungaie DB: Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients: N Engl J Med, 2021; [Online ahead of print]

22. Jayk Bernal A, Gomes da Silva MM, Musungaie DB:: Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE)

23. Jayk Bernal A, Gomes da Silva MM, Musungaie DB: Pfizer Newsletter, November 5th, 2021: Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 EPIC-HR study

24. Jayk Bernal A, Gomes da Silva MM, Musungaie DB: Emergency use authorization 105: Paxlovid (nirmatrelvir co-packaged with ritonavir) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in certain adults and pediatric patients, 2021

25. Fan H, Lou F, Fan J: The emergence of powerful oral anti-COVID-19 drugs in the post-vaccine era: Lancet Microbe, 2021; [Online ahead of print]

SARS-CoV-2/COVID-19

25 January 2022 : Editorial  

Editorial: The 2022 World Health Organization (WHO) Priority Recommendations and Response to the Omicron Va...

Med Sci Monit In Press; DOI: 10.12659/MSM.936199  

25 January 2022 : Clinical Research  

Experience of the Polish Medical Air Rescue Service During the First Year of the COVID-19 Pandemic and Meas...

Med Sci Monit In Press; DOI: 10.12659/MSM.935474  

11 January 2022 : Clinical Research  

A Remote Questionnaire-Based Study to Compare Alcohol Use in 1030 Final-Year High School Students in Split-...

Med Sci Monit In Press; DOI: 10.12659/MSM.935567  

31 December 2021 : Clinical Research  

A Prospective Observational Study of 42 Patients with COVID-19 infection and a History of Hepatitis C Virus...

Med Sci Monit 2021; 27:e935075

In Press

28 Jan 2022 : Database Analysis  

Evaluation of Structural Neural Connectivity Between the Primary Auditory Cortex and Cognition-Related Brai...

Med Sci Monit In Press; DOI: 10.12659/MSM.936131  

27 Jan 2022 : Clinical Research  

Retrospective Study of the Association Between Platelet-to-Lymphocyte Ratio in Patients with Acute Coronary...

Med Sci Monit In Press; DOI: 10.12659/MSM.935002  

25 Jan 2022 : Editorial  

Editorial: The 2022 World Health Organization (WHO) Priority Recommendations and Response to the Omicron Va...

Med Sci Monit In Press; DOI: 10.12659/MSM.936199  

25 Jan 2022 : Clinical Research  

Experience of the Polish Medical Air Rescue Service During the First Year of the COVID-19 Pandemic and Meas...

Med Sci Monit In Press; DOI: 10.12659/MSM.935474  

Most Viewed Current Articles

30 Dec 2021 : Clinical Research  

Retrospective Study of Outcomes and Hospitalization Rates of Patients in Italy with a Confirmed Diagnosis o...

DOI :10.12659/MSM.935379

Med Sci Monit 2021; 27:e935379

01 Jan 2022 : Editorial  

Editorial: Current Status of Oral Antiviral Drug Treatments for SARS-CoV-2 Infection in Non-Hospitalized Pa...

DOI :10.12659/MSM.935952

Med Sci Monit 2022; 28:e935952

01 Nov 2020 : Review article  

Long-Term Respiratory and Neurological Sequelae of COVID-19

DOI :10.12659/MSM.928996

Med Sci Monit 2020; 26:e928996

05 Mar 2020 : Clinical Research  

The Effects of Social Support on Sleep Quality of Medical Staff Treating Patients with Coronavirus Disease ...

DOI :10.12659/MSM.923549

Med Sci Monit 2020; 26:e923549

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750