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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
Patients on maintenance hemodialysis are highly vulnerable to severe COVID-19. Ensitrelvir, an oral SARS-CoV-2 3C-like protease inhibitor approved in Japan for COVID-19, has not been evaluated in patients on hemodialysis. Here we report real-world evidence on pharmacokinetics, antiviral activity and clinical effectiveness of ensitrelvir in patients on hemodialysis.
In this single-arm, open-label trial (December 2024–April 2025, jRCTs071240069), participants with mild COVID-19 received ensitrelvir 375 mg on Day 1, followed by 125 mg once daily on Days 2–5. Plasma ensitrelvir concentrations were measured before, during, and after hemodialysis on Visit 2 (Day 3) and after dialysis on Visit 3 (Day 5). Hemodialysis was performed before ensitrelvir daily administration. Clinical outcomes, SARS-CoV-2 RNA levels, and viral titers were monitored through Day 8. The primary endpoint was plasma ensitrelvir concentration relative to hemodialysis; secondary endpoints included clinical outcomes, and changes in SARS-CoV-2 RNA levels.
A total of eight participants were evaluated: mean age, 68.1 years; mean body weight, 58.0 kg; and mean body mass index (BMI), 24.05 kg/m2. Plasma ensitrelvir concentrations were similar geometric mean values before (18.0 μg/mL) and after (16.4 μg/mL) dialysis. These levels are consistent with the 24-hour mean trough levels reported in the prior studies. All participants were evaluated by investigators to have a clinical effectiveness by Day 8. SARS-CoV-2 RNA (mean±standard deviation) levels declined by 2.85±1.52 log₁₀ copies/mL from baseline to Day 8, along with viral titer reductions in majority of the participants. No treatment-emergent adverse events, hospitalizations, or severe COVID-19–related complications were observed.
Ensitrelvir exposure and pharmacokinetics were not affected by dialysis and was associated with favorable antiviral and clinical responses in participants on hemodialysis with mild COVID-19. These findings support that ensitrelvir can be used without any dose adjustments for patients on dialysis and be an important treatment option for this population.
This abstract was also submitted to the 95th Annual Meeting of the Japan Society for Infectious Diseases, Western Japan Regional Meeting.