Baseline Risk of Hospitalization and Mortality in High-Risk Subgroups of a Nirmatrelvir/Ritonavir Treatment-Eligible Population With Mild-to-Moderate COVID-19 in the United States: A Systematic Literature Review
Author(s)
Kristen Migliaccio-Walle, BS1, Tendai Mugwagwa, MSc, PhD2, Ashley S. Cha-Silva, MS, PharmD3, Cynthia L. Gong, PharmD, PhD1, David Campbell, MS, PharmD1, Romina Quercia, MD, PhD, MGH4, Tobias Bergroth, BS5, David Veenstra, PharmD, PhD1, Mary M. Moran, MD3, Mendwas D. Dzingina, PhD, MSc, MBBS6;
1Curta, Seattle, WA, USA, 2Pfizer, Ltd, Tadworth, Surrey, United Kingdom, 3Pfizer, New York, NY, USA, 4Pfizer, London, United Kingdom, 5Pfizer, Stockholm, Sweden, 6Pfizer, GAV, Value & Evidence Strategy, United Kingdom
1Curta, Seattle, WA, USA, 2Pfizer, Ltd, Tadworth, Surrey, United Kingdom, 3Pfizer, New York, NY, USA, 4Pfizer, London, United Kingdom, 5Pfizer, Stockholm, Sweden, 6Pfizer, GAV, Value & Evidence Strategy, United Kingdom
Presentation Documents
OBJECTIVES: No study has systematically reviewed published real-world baseline (untreated) hospitalization and mortality risk among key subpopulations with COVID-19 infection at high-risk for progression to severe disease, which is essential to assessing the incremental value of antiviral treatment. To characterize the baseline risk of hospitalization and mortality for key high-risk subgroups in real-world US clinical practice for nirmatrelvir/ritonavir (NMV/r) eligible patients.
METHODS: A systematic literature review using PubMed, Embase, MedRxiv, SSRN and grey literature identified US RWE studies (December 2021 - January 2024) of patients ≥12 years with mild-to-moderate COVID-19, at high-risk treated with NMV/r or no antiviral. Subgroups included age, vaccination, and immunocompromised (IC) status. Study and patient characteristics, risks of hospitalization, mortality, and composite (hospitalization and mortality) at 1 month were extracted. To address inherent clinical and demographic differences between studies, baseline risks were calculated as the reported risk in the NMV/r group divided by the adjusted or matched treatment effect from each study.
RESULTS: Of 1023 studies screened, 24 met inclusion criteria and ≤25% provided sufficient data to calculate adjusted subgroup estimates. For all-cause hospitalization among people aged ≥50 (n=1) adjusted baseline risk of hospitalization was 3.9% (50-64 years) and 8.3% (>65 years). For vaccination status (n=1), hospitalization risk was 9.6%, 5.9%, and 3.6% for those with none, partial, and full vaccination respectively. Risk of hospitalization among IC was 14.9% (n=1). One study reported mortality by subgroup with a 90-day risk of 1.6% (age ≥65) and 0.3% (<65). Combined hospitalization/mortality risk by age group (n=3) ranged from 0.5% (age ≥50) to 7.8% (>60). By vaccination status, combined risk was 4.6% for none (n=1), 0.0-6.2% (partial, n=6), 0.0-5.8% (full, n=6), and 5.9% (boosted, n=2).
CONCLUSIONS: Understanding risks of hospitalization and mortality among key subpopulations of untreated patients with COVID-19 is important in valuing current and emerging antiviral treatments.
METHODS: A systematic literature review using PubMed, Embase, MedRxiv, SSRN and grey literature identified US RWE studies (December 2021 - January 2024) of patients ≥12 years with mild-to-moderate COVID-19, at high-risk treated with NMV/r or no antiviral. Subgroups included age, vaccination, and immunocompromised (IC) status. Study and patient characteristics, risks of hospitalization, mortality, and composite (hospitalization and mortality) at 1 month were extracted. To address inherent clinical and demographic differences between studies, baseline risks were calculated as the reported risk in the NMV/r group divided by the adjusted or matched treatment effect from each study.
RESULTS: Of 1023 studies screened, 24 met inclusion criteria and ≤25% provided sufficient data to calculate adjusted subgroup estimates. For all-cause hospitalization among people aged ≥50 (n=1) adjusted baseline risk of hospitalization was 3.9% (50-64 years) and 8.3% (>65 years). For vaccination status (n=1), hospitalization risk was 9.6%, 5.9%, and 3.6% for those with none, partial, and full vaccination respectively. Risk of hospitalization among IC was 14.9% (n=1). One study reported mortality by subgroup with a 90-day risk of 1.6% (age ≥65) and 0.3% (<65). Combined hospitalization/mortality risk by age group (n=3) ranged from 0.5% (age ≥50) to 7.8% (>60). By vaccination status, combined risk was 4.6% for none (n=1), 0.0-6.2% (partial, n=6), 0.0-5.8% (full, n=6), and 5.9% (boosted, n=2).
CONCLUSIONS: Understanding risks of hospitalization and mortality among key subpopulations of untreated patients with COVID-19 is important in valuing current and emerging antiviral treatments.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EPH173
Topic
Epidemiology & Public Health
Disease
SDC: Infectious Disease (non-vaccine)