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Introduction <p>EPIC-IC was a randomized, double-blind trial comparing the approved 5-day regimen of nirmatrelvir–ritonavir (NMV/r) vs. 10-day and 15-day NMV/r in immunocompromised individuals with mild-to-moderate COVID-19. We describe patient-reported global impressions of illness from EPIC-IC.</p> Methods <p>In EPIC-IC, 155 immunocompromised participants received 5-day, 10-day, or 15-day NMV/r (1:1:1). Participants completed the Global Impressions Questionnaire through week 24. Median times to first alleviation and resolution of symptoms and return to usual health and usual activities were estimated using Kaplan–Meier analyses for each treatment arm and post hoc subpopulations with severe vs. non-severe immunocompromise. Five-day arm times were compared vs. 10-day and 15-day arm times.</p> Results <p>Symptoms were alleviated after a median 6.0 (95% CI 4.0–9.0) days with 5-day NMV/r, similar to 9.0 (5.0–9.0) days with 10-day NMV/r (<i>p</i> = 0.627) and 10.0 (6.0–11.0) days with 15-day NMV/r (<i>p</i> = 0.528). Symptoms resolved after a median 16.0 (10.0–22.0) days with 5-day NMV/r, similar to 13.0 (9.0–14.0) days with 10-day (<i>p</i> = 0.140) and 13.0 (11.0–21.0) days with 15-day NMV/r (<i>p</i> = 0.471). In the severely immunocompromised subpopulation, symptoms resolved later with 5-day vs. 10-day NMV/r (<i>p</i> = 0.026). Participants returned to usual health after a median 11.0 (6.0–16.0) days with 5-day NMV/r, similar to 9.0 (6.0–13.0) days with 10-day (<i>p</i> = 0.319) and 10.0 (6.0–13.0) days with 15-day NMV/r (<i>p</i> = 0.218), and to usual activities after 10.0 (9.0–15.0) days with 5-day NMV/r, similar to 9.0 (6.0–10.0) days with 10-day (<i>p</i> = 0.102) and 9.0 (5.0–10.0) days with 15-day NMV/r (<i>p</i> = 0.190).</p> Conclusions <p>Times to symptom alleviation/resolution and returns to usual health/activities were similar with 5-day vs. extended NMV/r and comparable to those in the EPIC-HR trial. Five-day treatment may be adequate for most immunocompromised individuals, while extended treatment might improve symptom resolution in those with severe immunocompromise; larger studies are needed to confirm these findings.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT05438602.</p>

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Symptom Alleviation/Resolution and Returns to Usual Health/Activities in Immunocompromised Adults with COVID-19 Treated with Nirmatrelvir-Ritonavir: Results from the EPIC-IC Trial

  • 期刊论文

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  • 发表日期：

    2025年10月14日

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  • Ruth Mokgokong,
  • Paul Cislo,
  • Elena Tudone,
  • Edward Weinstein,
  • Joseph C. Cappelleri

摘要

Introduction

EPIC-IC was a randomized, double-blind trial comparing the approved 5-day regimen of nirmatrelvir–ritonavir (NMV/r) vs. 10-day and 15-day NMV/r in immunocompromised individuals with mild-to-moderate COVID-19. We describe patient-reported global impressions of illness from EPIC-IC.

Methods

In EPIC-IC, 155 immunocompromised participants received 5-day, 10-day, or 15-day NMV/r (1:1:1). Participants completed the Global Impressions Questionnaire through week 24. Median times to first alleviation and resolution of symptoms and return to usual health and usual activities were estimated using Kaplan–Meier analyses for each treatment arm and post hoc subpopulations with severe vs. non-severe immunocompromise. Five-day arm times were compared vs. 10-day and 15-day arm times.

Results

Symptoms were alleviated after a median 6.0 (95% CI 4.0–9.0) days with 5-day NMV/r, similar to 9.0 (5.0–9.0) days with 10-day NMV/r (p = 0.627) and 10.0 (6.0–11.0) days with 15-day NMV/r (p = 0.528). Symptoms resolved after a median 16.0 (10.0–22.0) days with 5-day NMV/r, similar to 13.0 (9.0–14.0) days with 10-day (p = 0.140) and 13.0 (11.0–21.0) days with 15-day NMV/r (p = 0.471). In the severely immunocompromised subpopulation, symptoms resolved later with 5-day vs. 10-day NMV/r (p = 0.026). Participants returned to usual health after a median 11.0 (6.0–16.0) days with 5-day NMV/r, similar to 9.0 (6.0–13.0) days with 10-day (p = 0.319) and 10.0 (6.0–13.0) days with 15-day NMV/r (p = 0.218), and to usual activities after 10.0 (9.0–15.0) days with 5-day NMV/r, similar to 9.0 (6.0–10.0) days with 10-day (p = 0.102) and 9.0 (5.0–10.0) days with 15-day NMV/r (p = 0.190).

Conclusions

Times to symptom alleviation/resolution and returns to usual health/activities were similar with 5-day vs. extended NMV/r and comparable to those in the EPIC-HR trial. Five-day treatment may be adequate for most immunocompromised individuals, while extended treatment might improve symptom resolution in those with severe immunocompromise; larger studies are needed to confirm these findings.

Trial Registration

ClinicalTrials.gov identifier, NCT05438602.