Ensitrelvir Pill Shows Promise in Preventing COVID-19 After Exposure in Clinical Trial
On May 13, the New England Journal of Medicine published findings from a clinical trial indicating that the oral medication ensitrelvir significantly lowers the risk of contracting COVID-19 after exposure to the SARS-CoV-2 virus. Conducted between June 2023 and mid-September 2024, the study involved nearly 2,400 participants aged 12 and older across the United States, Argentina, Japan, South Africa, and Vietnam, all of whom had a household contact with confirmed COVID-19. Participants were divided into two groups: one received a five-day course of ensitrelvir within 72 hours of symptom onset in the household contact, while the other received a placebo. Within ten days, symptomatic COVID-19 developed in less than 3% of the ensitrelvir group, compared to around 9% in the placebo group. Lab-confirmed cases were 14% in the ensitrelvir group versus 21.5% in the placebo group. Developed by Shionogi, a Japanese pharmaceutical company, ensitrelvir inhibits an enzyme necessary for the virus's replication, akin to Pfizer's Paxlovid, which did not prevent post-exposure illness in a 2024 NEJM trial. Approved in Japan as Xocova for post-exposure protection, ensitrelvir is currently under FDA review in the U.S., with a decision anticipated in June. Experts stress that this drug should complement vaccination efforts rather than replace them.
Key facts
- Ensitrelvir reduced symptomatic COVID-19 risk from 9% to under 3% in a clinical trial.
- The trial included nearly 2,400 participants across the US, Argentina, Japan, South Africa, and Vietnam.
- The study was double-blinded and placebo-controlled, published in NEJM on May 13.
- Ensitrelvir blocks a viral enzyme, similar to Paxlovid but with post-exposure efficacy.
- The drug is approved in Japan as Xocova and under FDA review in the US.
- Participants had household exposure to COVID-19 and started treatment within 72 hours.
- Lab-confirmed COVID-19 occurred in 14% of the ensitrelvir group vs. 21.5% of placebo.
- Experts say the drug is most beneficial for older adults and immunocompromised individuals.
Entities
Institutions
- Shionogi
- Pfizer
- New England Journal of Medicine
- Vanderbilt University School of Medicine
- University of Virginia School of Medicine
- University of Minnesota Medical School
- Harvard Medical School
- Food and Drug Administration
Locations
- United States
- Argentina
- Japan
- South Africa
- Vietnam