Burden of COVID-19 on Health-Related Quality of Life in Immunocompromised Adult Participants From the EPIC-IC Trial
Author(s)
Ruth Mokgokong, PhD, Paul Cislo, PhD, Elena Tudone, BSc, Edward Weinstein, MD, PhD, Joseph C. Cappelleri, MPH, MS, PhD;
Pfizer Inc, New York City, NY, USA
Pfizer Inc, New York City, NY, USA
OBJECTIVES: Immunocompromised (IC) patients may have reduced health-related quality of life (HRQoL), due to their condition, which could be worsened by COVID-19. This study assessed HRQoL in IC participants from the EPIC-IC trial.
METHODS: In EPIC-IC, participants received nirmatrelvir/ritonavir (NMV/r) twice daily over a 5,10, or 15-day (d) course (randomized 1:1:1). Participants completed the SF-36 v2® Health Survey at baseline through d44, weeks 12 and 24. Scores were converted to norm-based T-scores (Mean=50, SD=10). A mixed-effects model with repeated measures was implemented to assess the effect of treatment on physical and mental health component summary scores (PCS, MCS).
RESULTS: 150 participants assigned to NMV/r who received ≥1 dose were included. Median age was 58 years and 54% female. Mean (SD) PCS and MCS are reported in participants who received 5d NMV/r. At baseline, PCS and MCS was 36.87(8.28) and 43.878(10.77), indicating a severe impact on HRQoL. PCS and MCS scores increased up to d44 (47.18[9.02]; 50.55[9.91]), approaching or falling within the range of age-specific general population scores (PCS 47.55; MCS 53.87). In subgroups of severe and non-severe IC, similar improvements were observed over follow-up; however, participants with severe IC, compared with non-severe, had nominally lower scores (d44: severe IC PCS 42.94 [8.70]; MCS 46.99 [12.80]). In the overall population, no significant differences were observed between treatment arms over follow-up, but in severe IC participants, PCS at d10 was significantly higher in participants treated with NMV/r 10d vs 5d (35.82 [3.63] vs 43.00 [3.41]) and nominally higher at d21.
CONCLUSIONS: COVID-19 had a substantial impact on HRQoL in IC participants. In participants treated with NMV/r, HRQoL improved to general population values with no significant longer-term decrements observed. Severe IC participants trended towards worse HRQoL and may benefit from longer antiviral treatment duration. Larger studies are required to further evaluate optimal dosing in this population.
METHODS: In EPIC-IC, participants received nirmatrelvir/ritonavir (NMV/r) twice daily over a 5,10, or 15-day (d) course (randomized 1:1:1). Participants completed the SF-36 v2® Health Survey at baseline through d44, weeks 12 and 24. Scores were converted to norm-based T-scores (Mean=50, SD=10). A mixed-effects model with repeated measures was implemented to assess the effect of treatment on physical and mental health component summary scores (PCS, MCS).
RESULTS: 150 participants assigned to NMV/r who received ≥1 dose were included. Median age was 58 years and 54% female. Mean (SD) PCS and MCS are reported in participants who received 5d NMV/r. At baseline, PCS and MCS was 36.87(8.28) and 43.878(10.77), indicating a severe impact on HRQoL. PCS and MCS scores increased up to d44 (47.18[9.02]; 50.55[9.91]), approaching or falling within the range of age-specific general population scores (PCS 47.55; MCS 53.87). In subgroups of severe and non-severe IC, similar improvements were observed over follow-up; however, participants with severe IC, compared with non-severe, had nominally lower scores (d44: severe IC PCS 42.94 [8.70]; MCS 46.99 [12.80]). In the overall population, no significant differences were observed between treatment arms over follow-up, but in severe IC participants, PCS at d10 was significantly higher in participants treated with NMV/r 10d vs 5d (35.82 [3.63] vs 43.00 [3.41]) and nominally higher at d21.
CONCLUSIONS: COVID-19 had a substantial impact on HRQoL in IC participants. In participants treated with NMV/r, HRQoL improved to general population values with no significant longer-term decrements observed. Severe IC participants trended towards worse HRQoL and may benefit from longer antiviral treatment duration. Larger studies are required to further evaluate optimal dosing in this population.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR250
Topic
Patient-Centered Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine), SDC: Oncology