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Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019.
- Source :
-
Clinical Infectious Diseases . 11/15/2023, Vol. 77 Issue 10, p1406-1412. 7p. - Publication Year :
- 2023
-
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]
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 77
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 173688235
- Full Text :
- https://doi.org/10.1093/cid/ciad371