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Antiviral Prevents Symptomatic COVID-19 in Post-Exposure Prophylactic Study


Image credit: Gustavo Fring, Pexels

Japan-based Shionogi announced today that its antiviral, ensitrelvir, demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. SCORPIO-PEP is the first phase 3 trial with Post-Exposure Prophylactic Use (PEP) of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 infection.

Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified. “COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” Simon Portsmouth, MD, FRCP, senior vice president, head of Clinical Development, said in a statement.

Trial Parameters

SCORPIO-PEP is a global study that included approximately 2,400 participants aged 12 years and older across the US and several countries in South America, Africa and Asia. Study participants with a negative screening test for SARS-CoV-2 infection and no symptoms, who were exposed to a person living in their household with symptomatic COVID-19, were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo once daily. Study participants began treatment within three days of when the household member with COVID-19 began showing symptoms. Participants then continued ensitrelvir or placebo for 5 days.

What You Need to Know

The phase 3 trial demonstrated that ensitrelvir significantly reduced the risk of symptomatic COVID-19 infection among household contacts exposed to the virus, compared to a placebo.

Ensitrelvir was well tolerated by participants, with no new safety concerns identified, highlighting its potential as a safe preventive option for COVID-19 exposure.

This study included around 2,400 participants across multiple continents, supporting the broader applicability of ensitrelvir.

“These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2,” Portsmouth said.

Detailed results from SCORPIO-PEP will be submitted for a presentation at a future scientific conference, according to the company.

Ensitrelvir is an investigational antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the FDA last year for COVID-19 treatment. In Japan, ensitrelvir, known as Xocova, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.

Reference
Shionogi Announces Global Phase 3 Trial Demonstrates Post-Exposure Prophylactic Use of Ensitrelvir Prevents Symptomatic COVID-19. Shionogi press release. October 29, 2024. Accessed October 29, 2024.
https://www.shionogi.com/global/en/news/2024/10/20241029.html



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