Affiliation:
1. Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong , Hong Kong Special Administrative Region (SAR) , China
2. The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong , Hong Kong SAR , China
3. Department of Microbiology, Prince of Wales Hospital, The Chinese University of Hong Kong , Hong Kong SAR , China
Abstract
Abstract
Background
Nirmatrelvir-ritonavir is currently not recommended in patients with an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2.
Methods
To determine the safety profile and clinical and virological outcomes of nirmatrelvir-ritonavir use at a modified dosage in adults with chronic kidney disease (CKD), a prospective, single-arm, interventional trial recruited patients with eGFR <30 mL/minute/1.73 m2 and on dialysis. Primary outcomes included safety profile, adverse/serious adverse events, and events leading to drug discontinuation. Disease symptoms, virological outcomes by serial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral polymerase chain reaction (PCR) tests, rapid antigen tests, and virological and symptomatic rebound were also recorded.
Results
Fifty-nine (69.4%) of the 85 participants had stage 5 CKD and were on dialysis. Eighty (94.1%) completed the full treatment course; 9.4% and 5.9% had adverse and serious adverse events, and these were comparable between those with eGFR < or >30 mL/minute/1.73 m2. The viral load significantly decreased on days 5, 15, and 30 (P < .001 for all), and the reduction was consistent in the subgroup with eGFR <30 mL/minute/1.73 m2. Ten patients had virological rebound, which was transient and asymptomatic.
Conclusions
Among patients with CKD, a modified dose of nirmatrelvir-ritonavir is a well-tolerated therapy in mild COVID-19 as it can effectively suppress the SARS-CoV-2 viral load with a favorable safety profile. Virological and symptomatic rebound, although transient with low infectivity, may occur after treatment. Nirmatrelvir-ritonavir should be considered for use in patients with CKD, including stage 5 CKD on dialysis.
Clinical Trials Registration. Clinical Trials.gov; identifier: NCT05624840.
Funder
Charlie Lee Charitable Foundation
Baxter Healthcare
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
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