FDA to Review Ensitrelvir for COVID-19 Prevention

by Dr Natalie Singh - Health Editor
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New Guidelines Aim to Streamline Antibiotic Stewardship in Long-Term Care

September 02, 2025 | 3 min read

Updated guidelines released this week offer a extensive framework for antibiotic stewardship programs (ASPs) in long-term care facilities (ltcfs), addressing the unique challenges thes settings present in combating antimicrobial resistance. The guidelines, published in Infection Control & Hospital Epidemiology, emphasize a collaborative, multidisciplinary approach tailored to the specific needs of each facility.

“LTCFs are hotspots for antibiotic use and Clostridioides difficile infection, making robust ASPs crucial,” saeid lead author Dr. Jane smith, an infectious disease specialist.”However,implementing effective stewardship in these settings differs substantially from acute care hospitals. These guidelines aim to bridge that gap.”

key recommendations include:

Core Elements: The guidelines outline seven core elements for successful asps in LTCFs: leadership commitment, accountability, drug expertise, action, tracking, reporting, and education.
Team-Based Approach: ASPs should involve a multidisciplinary team including physicians, nurses, pharmacists, microbiologists, and administrators. Emphasis is placed on fostering open communication and shared decision-making.
Focus on Diagnosis & De-escalation: The guidelines advocate for improved diagnostic stewardship, including appropriate specimen collection and interpretation. Prompt de-escalation of broad-spectrum antibiotics to narrower-spectrum agents based on culture results is also prioritized.
Antimicrobial Formulary Management: Restricting antibiotic access and promoting the use of preferred agents can help optimize prescribing practices.
Education & Training: Ongoing education for all staff on antibiotic use, resistance, and infection prevention is essential. Addressing Unique Challenges: The guidelines acknowledge the complexities of LTCFs, such as high rates of colonization, polypharmacy, and limited diagnostic resources. Strategies for addressing these challenges are provided.
* Implementation Support: Recognizing that resources may be limited,the guidelines offer practical tools and resources to support ASP implementation,including templates for policies and procedures.

Experts believe these updated guidelines will be instrumental in improving antibiotic use and reducing the burden of antimicrobial resistance in LTCFs, ultimately protecting vulnerable residents. “This isn’t a one-size-fits-all approach,” Dr. Smith emphasized. “Facilities need to adapt these recommendations to their specific context and continuously monitor their progress.”## Oral Antiviral Shows Promise as COVID-19 post-Exposure Prophylaxis

The FDA is currently reviewing ensitrelvir, an oral antiviral developed by Shionogi, for potential use as post-exposure prophylaxis (PEP) against COVID-19, following changing approvals and recommendations.

William Schaffner, MD, professor of infectious diseases at Vanderbilt University Medical Center and a member of the Healio | Infectious Disease News Editorial Board, highlighted the potential benefits of an oral medication for COVID-19 prevention. “Should this become available, it would be wonderful. We would have an additional way to prevent severe COVID-19 in people, particularly those with high risk conditions, and [even] in people who do not, who have exposure and wish to take that extra step to prevent …hospitalization,” Schaffner told Healio, adding that the combination of vaccines and PEP could “work together to provide more safety for our population.”

Phase 3 data presented earlier this year at the Conference on Retroviruses and Opportunistic Infections demonstrated that the drug reduced SARS-CoV-2 transmission by 67% when administered to uninfected household contacts within 3 days of a household member developing symptoms.

Ensitrelvir is a once-daily oral antiviral that works by suppressing SARS-CoV-2 replication and is also being investigated as a treatment for those already infected. Currently approved for treating COVID-19 in Japan and Singapore, it is also under regulatory review in Taiwan. Shionogi has also applied for approval to use the drug in Japan for COVID-19 PEP and for treating specific cases of COVID-19 in children.

The FDA granted ensitrelvir fast-track designation as a COVID-19 therapeutic in 2023, and again earlier this year for its use as PEP.

The SCORPIO-PEP trial,a double-blind,placebo-controlled study,involved 2,389 household contacts of individuals with COVID-19 who tested negative for SARS-CoV-2 between June 2023 and August 2024. Participants were divided into two groups: those with confirmed negative RT-PCR tests and those without lab confirmation.

Within the group with negative lab tests, participants were randomly assigned to receive either ensitrelvir or a placebo within 72 hours of symptom onset in their COVID-19-positive housemates. Results showed a significantly lower proportion of participants developed COVID-19 in the ensitrelvir group compared to the placebo group.

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