Ensitrelvir, a promising antiviral drug, has shown remarkable efficacy in treating COVID-19, according to recent trial data. Researchers have found that it outperforms other treatments, offering a compelling alternative for managing the virus. The study, published in The Lancet Infectious Diseases, highlights ensitrelvir's potential to revolutionize COVID-19 management.
This once-daily oral medication, developed by Shionogi, has already been administered to over 1 million individuals in Japan and Singapore, where it is registered for COVID-19 treatment. However, it remains an investigative drug in other regions and has not been directly compared to other antiviral treatments. The trial aimed to address this gap by comparing ensitrelvir's clinical effects with those of ritonavir-boosted nirmatrelvir (Paxlovid), the first oral antiviral approved by the US FDA for COVID-19.
The study, conducted from March 17, 2023, to April 21, 2024, involved 604 patients from Thailand and Laos. The investigators focused on viral clearance rates, as COVID-19 has become less severe, making traditional endpoints like hospitalization and death less common. The results revealed that ensitrelvir accelerated viral clearance, achieving 82% faster rates compared to no treatment by Day 5. This is a significant improvement over Paxlovid, which has limited availability and a high price tag.
Ensitrelvir's advantages include a lower pill burden (one pill per day) and a more palatable taste, making it more user-friendly. Additionally, it may be a suitable antiviral for immunocompromised patients who take medications that interact with ritonavir. The study also highlights the ongoing threat of COVID-19, especially for vulnerable populations, and emphasizes the need for effective therapeutics.
Shionogi has submitted a new drug application (NDA) to the FDA for ensitrelvir's approval as a COVID-19 preventive measure, based on a phase 3 trial demonstrating a 67% reduced risk of infection after exposure. This further underscores ensitrelvir's potential to become a widely accepted treatment for COVID-19.
