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
Year: 2025
Type: article
Abstract: 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. 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. 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). 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. ClinicalTrials.gov identifier, NCT05438602. When people with weakened immune systems get COVID-19, they usually get sicker than those with normal immune systems. A clinical trial tested how well the antiviral drug nirmatrelvir/ritonavir worked in people with weakened immune systems who had mild–moderate COVID-19 (having symptoms but not needing hospitalization). Participants were randomly chosen to take the drug for 5, 10, or 15 days. Everyone completed a 15-day ‘treatment’ period; after finishing drug treatment, the 5-day and 10-day groups took placebo pills for 10 days (5-day group) or 5 days (10-day group). Participants filled out a survey several times about their overall symptoms, health, and activities. Researchers checked when symptoms improved, when symptoms disappeared, and when participants returned to their normal health and activities. Symptoms improved after 6–10 days and went away after 13–16 days. In people with severe immune problems, symptoms went away more slowly in the group taking the drug for 5 days than in the group taking the drug for 10 days. People returned to normal activities after 9–10 days and to normal health after 9–11 days. This shows that most people with weakened immune systems felt better and returned to normal activities in similar amounts of time whether they took the drug for 5, 10, or 15 days. Five-day treatment is usually enough for people with weakened immune systems, but longer treatment might help people with severe immune problems.
Source: Infectious Diseases and Therapy
Institutions: Pfizer (United Kingdom), Pfizer (United States), Pfizer (Italy)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
Funder: Pfizer
OpenAlex ID: W4415146115