1. Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019.
- Author
-
Chan, Gordon Chun Kau, Lui, Grace Chung Yan, Wong, Candy Ngai Sze, Yip, Sindy Sin Ting, Li, Timothy Chun Man, Cheung, Catherine Siu King, Sze, Ryan Kin Ho, Szeto, Cheuk Chun, and Chow, Kai Ming
- Subjects
- *
TREATMENT of chronic kidney failure , *DRUG efficacy , *GLOMERULAR filtration rate , *VIRAL pneumonia , *PROTEASE inhibitors , *COMBINATION drug therapy , *COVID-19 , *CLINICAL trials , *DRUG tolerance , *CONFIDENCE intervals , *MYALGIA , *VIRAL load , *MULTIPLE regression analysis , *MULTIVARIATE analysis , *COVID-19 vaccines , *ANTIVIRAL agents , *IMMUNOLOGY technique , *COMPARATIVE studies , *DISEASE relapse , *SEVERITY of illness index , *RHINORRHEA , *RITONAVIR , *DESCRIPTIVE statistics , *COUGH , *QUESTIONNAIRES , *XEROSTOMIA , *HEMODIALYSIS , *DRUG side effects , *TERMINATION of treatment , *POLYMERASE chain reaction , *FATIGUE (Physiology) , *STATISTICAL models , *LONGITUDINAL method , *COMORBIDITY , *DRUG administration , *DRUG dosage - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF