BASELINE (UNTREATED) RISK OF HOSPITALIZATION AND MORTALITY IN PATIENTS WITH SPECIFIC COMORBID HIGH-RISK CONDITIONS WHO ARE ELIGIBLE FOR NIRMATRELVIR/RITONAVIR TREATMENT: A SYSTEMATIC LITERATURE REVIEW EXPANSION STUDY
Author(s)
Tendai Mugwagwa, MSc1, David Campbell, PharmD, MS2, Athira Ajith, PharmD3, Nikolina Boskovic, MPH4, Sarah C. Katsandres, MPH4, Cynthia L. Gong, PharmD, PhD4, Tobias Bergroth, PhD5, Maria C. Pein, MSc6, Kristen Migliaccio-Walle, BS4;
1Pfizer Inc., Tadworth, United Kingdom, 2Curta Inc., Director, Seattle, WA, USA, 3Curta Inc., Bengaluru, India, 4Curta Inc., Seattle, WA, USA, 5Pfizer Inc., Stockholm, Sweden, 6Pfizer Inc., Buenos Aires, Argentina
1Pfizer Inc., Tadworth, United Kingdom, 2Curta Inc., Director, Seattle, WA, USA, 3Curta Inc., Bengaluru, India, 4Curta Inc., Seattle, WA, USA, 5Pfizer Inc., Stockholm, Sweden, 6Pfizer Inc., Buenos Aires, Argentina
OBJECTIVES: This systematic literature review (SLR) characterizes the real-world risk of hospitalization and mortality for untreated patients at high-risk for progression to severe COVID-19 during the Omicron variant era.
METHODS: A global SLR identified real-world studies (21/Dec/2021-21/Aug/2025) of patients (≥12 years) at high-risk for progression to severe COVID-19, untreated or treated with nirmatrelvir/ritonavir (NMV/r). Included studies had patients with at least one comorbid condition: advanced age, active cancer, cardiovascular disease (CVD), chronic cardiopulmonary disease (CPD), chronic kidney disease (CKD), chronic liver disease (CLD), dementia, diabetes (T1/T2), immunocompromised (IC), and overweight/obesity. Primary outcomes were risks of all-cause hospitalization, mortality, and combined outcome of hospitalization or mortality. Within-study adjusted risk was calculated based on relative risk using NMV/r.
RESULTS: Of 294 studies screened, 24 were included and outcomes extracted. For hospitalization, the observed range of untreated (and adjusted) risks are: age >50 years (n=2): 1.7-4.4% (1.7%); >65 years (n=3): 3.3-11.7% (3.2-4.4%); cancer (n=1): 4.7% (4.9%); CVD (n=1): 6.0% (6.3%); CPD (n=1): 4.6% (4.8%); CKD (n=1): 5.0% (5.3%); CLD (n=2): 6.4-6.7% (6.3-7.1%); dementia (n=1): 3.6% (3.2%); diabetes (n=1): 4.6% (5.0%); IC (n=2): 5.4-18.0% (5.5-21.3%); overweight/obese (n=2): 2.5-5.1% (2.4-5.3%). For mortality, the observed untreated (and adjusted) risks are: age >50 years (n=4): 0.0-0.6% (0.8%); >65 years (n=2): 0.7-5.8% (0.9%); >70 years (n=2): 3.4-4.5% (2.2-4.6%); cancer (n=1): 0.8% (0.9%); CVD (n=1): 1.0% (1.4%); CPD (n=3): 0.0-7.1% (0.4-5.2%); CKD (n=1): 1.0% (1.5%); CLD (n=2): 1.4-2.3% (4.6%); dementia (n=1): 4.3% (12.0%); diabetes (n=3): 0.0-2.3% (1.2-2.8%); IC (n=3): 0.4-8.0% (7.0%); overweight/obese (n=1): 0.3% (0.7%). For the combined outcome, the observed untreated (and adjusted) risks are: age >50 years (n=1): 0.8% (0.9%); >70 years (n=1): 5.0% (5.1%); CLD (n=1): 7.0% (7.0%); diabetes (n=2): 3.1-65.7% (2.8-71.5%); IC (n=1): 17.6% (16.3%).
CONCLUSIONS: High-risk COVID-19 patients remain at significant risk of hospitalization and death during the Omicron era, highlighting the importance of prioritizing their care.
METHODS: A global SLR identified real-world studies (21/Dec/2021-21/Aug/2025) of patients (≥12 years) at high-risk for progression to severe COVID-19, untreated or treated with nirmatrelvir/ritonavir (NMV/r). Included studies had patients with at least one comorbid condition: advanced age, active cancer, cardiovascular disease (CVD), chronic cardiopulmonary disease (CPD), chronic kidney disease (CKD), chronic liver disease (CLD), dementia, diabetes (T1/T2), immunocompromised (IC), and overweight/obesity. Primary outcomes were risks of all-cause hospitalization, mortality, and combined outcome of hospitalization or mortality. Within-study adjusted risk was calculated based on relative risk using NMV/r.
RESULTS: Of 294 studies screened, 24 were included and outcomes extracted. For hospitalization, the observed range of untreated (and adjusted) risks are: age >50 years (n=2): 1.7-4.4% (1.7%); >65 years (n=3): 3.3-11.7% (3.2-4.4%); cancer (n=1): 4.7% (4.9%); CVD (n=1): 6.0% (6.3%); CPD (n=1): 4.6% (4.8%); CKD (n=1): 5.0% (5.3%); CLD (n=2): 6.4-6.7% (6.3-7.1%); dementia (n=1): 3.6% (3.2%); diabetes (n=1): 4.6% (5.0%); IC (n=2): 5.4-18.0% (5.5-21.3%); overweight/obese (n=2): 2.5-5.1% (2.4-5.3%). For mortality, the observed untreated (and adjusted) risks are: age >50 years (n=4): 0.0-0.6% (0.8%); >65 years (n=2): 0.7-5.8% (0.9%); >70 years (n=2): 3.4-4.5% (2.2-4.6%); cancer (n=1): 0.8% (0.9%); CVD (n=1): 1.0% (1.4%); CPD (n=3): 0.0-7.1% (0.4-5.2%); CKD (n=1): 1.0% (1.5%); CLD (n=2): 1.4-2.3% (4.6%); dementia (n=1): 4.3% (12.0%); diabetes (n=3): 0.0-2.3% (1.2-2.8%); IC (n=3): 0.4-8.0% (7.0%); overweight/obese (n=1): 0.3% (0.7%). For the combined outcome, the observed untreated (and adjusted) risks are: age >50 years (n=1): 0.8% (0.9%); >70 years (n=1): 5.0% (5.1%); CLD (n=1): 7.0% (7.0%); diabetes (n=2): 3.1-65.7% (2.8-71.5%); IC (n=1): 17.6% (16.3%).
CONCLUSIONS: High-risk COVID-19 patients remain at significant risk of hospitalization and death during the Omicron era, highlighting the importance of prioritizing their care.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO56
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Infectious Disease (non-vaccine)