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Abstract: TH-PO1095

Safety and Efficacy of Nirmatrelvir/Ritonavir in Patients with Moderate-Severe CKD with COVID-19: A Real-World Data Study

Session Information

  • COVID-19 - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Coronavirus (COVID-19)

  • 000 Coronavirus (COVID-19)

Authors

  • Ashruf, Omer S., Northeast Ohio Medical University, Rootstown, Ohio, United States
  • Orozco, Zara C., Northeast Ohio Medical University, Rootstown, Ohio, United States
  • Haq, Imad U., Northeast Ohio Medical University, Rootstown, Ohio, United States
  • Ashruf, Zaid, Northeast Ohio Medical University, Rootstown, Ohio, United States
  • Raina, Rupesh, Cleveland Clinic Akron General, Akron, Ohio, United States
Background

Chronic kidney disease (CKD) is a mortality risk factor for COVID-19, predisposing patients to poor clinical outcomes. Nirmatrelvir/ritonavir (Nm/r) is currently the most effective oral antiviral agent for COVID-19, with 89% reduction in hospitalization and mortality. The U.S. Food and Drug Administration advised against Nm/r in severe CKD patients due to lack of study. In this propensity-matched retrospective study, we assess side effects, efficacy, and severity of clinical outcomes in Nm/r-treated moderate-severe CKD patients with COVID-19.

Methods

Patient data was accessed from TriNetX, a platform that aggregates health record data of over 123 million patients. The experimental group consisted of Stage 3-5 CKD patients, with 2 separate eGFR measurements of <60 mL/min/1.73m2, prescribed Nm/r after COVID-19 infection. The control cohort was any non-CKD patient with COVID-19 prescribed Nm/r. Cohorts were 1:1 propensity matched for age, sex, race, and comorbidities: diabetes mellitus, hypertension, ischemic heart disease, heart failure, cerebrovascular disease, respiratory disease, smoking, and alcohol use. Outcomes assessed were COVID-19 rebound within 5-14 days, side effects within 5-35 days, and clinical outcomes (hospitalization, emergency department (ED) visit, intensive care unit (ICU) admit, and mortality) within 35 days. Odds ratio (OR) and hazard ratio (HR) with 95% confidence intervals (95%Cl) and Kaplan-Meier analysis were calculated.

Results

After matching, 2,491 patients were included in the analysis. Moderate-severe CKD patients were at greater risk of developing nausea/vomiting (OR 4.32, 95%CI 2.35-7.93), diarrhea (OR 2.78, 95%CI 1.64-4.72), and fatigue (OR 1.78, 95%CI 1.23-2.55). These side effects were associated with lower survival probability within 35 days, by 2.1%, 1.6%, and 1.5%, respectively. CKD patients were also at greater risk of COVID-19 rebound (OR 1.33, 95%CI 1.08-1.65), hospitalization (HR 5.75, 95%CI 4.06-8.15), and ED visit (HR 1.68 95%CI 1.29-2.17).

Conclusion

Our findings show that moderate-severe CKD patients fare greater risk of side effects, COVID-19 rebound, and severe outcomes compared to non-CKD high-risk groups even after Nm/r. Providers should counsel patients and monitor the side effect profile and risk of COVID-19 rebound in Nm/r treated CKD patients.

Funding

  • Other NIH Support