Medical Affairs professionals are familiar with the importance of corroborating clinical evidence regarding new drugs from Phase II and III trials with results obtained from real-world evidence (RWE) studies. The included publication references RWE data related to oral antivirals in the treatment of COVID-19.

“New orally bioavailable, direct-acting, antiviral therapeutics targeting RNA viruses including SARS-CoV-2 have arrived. Molnupiravir and nirmatrelvir plus ritonavir were granted an emergency use authorization by the US FDA in December 2021, for treating outpatients with first-ever SARS-CoV-2 infection confirmed by PCR (aged ≥18 years for molnupiravir and ≥12 years and children ≥40 kg for nirmatrelvir plus ritonavir), on the basis of the analysis of the pivotal randomized, placebo-controlled trials, MOVe-OUT and EPIC-HR. Both studies included unvaccinated outpatients receiving the antivirals within 5 days of symptom onset during the delta (B.1.617.2) surge. Participants were considered at risk for severe COVID-19, although fairly young (82·8% aged <60 years in MOVe-OUT and 87·2% aged <65 years in EPIC-HR), and their main risk factor for severity was overweight (73·7% participants had a BMI >30 kg/m2 in MOVe-OUT and 80·5% had a BMI >25 kg/m2 in EPIC-HR). In these populations, both antivirals were associated with a significant decrease in the relative risk of hospitalization or death: by 30% for molnupiravir and by 89% for nirmatrelvir plus ritonavir. Upon widespread use of these antivirals in 2022, further real-world data were needed to refine these results and to test their effectiveness under various conditions.”1

The final statement highlights the importance of confirmatory results obtained in RWE studies. “Further prospective studies are warranted in the setting of outpatients with breakthrough COVID-19 or in combination trials or when new oral therapeutics become available using these antivirals as comparators.”1

You can read more here.

References

  1. Burdet, C. (2022, October 8). Real-world effectiveness of oral antivirals for COVID-19. The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01929-8/fulltext

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred