tetano
Editor, Senior Moderator
Clin Infect Dis
. 2023 Aug 2;ciad371.
doi: 10.1093/cid/ciad371. Online ahead of print. Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019 (COVID-19)
Gordon Chun Kau Chan[SUP] 1 [/SUP], Grace Chung Yan Lui[SUP] 1 2 [/SUP], Candy Ngai Sze Wong[SUP] 2 [/SUP], Sindy Sin Ting Yip[SUP] 1 [/SUP], Timothy Chun Man Li[SUP] 1 [/SUP], Catherine Siu King Cheung[SUP] 1 [/SUP], Ryan Kin Ho Sze[SUP] 3 [/SUP], Cheuk Chun Szeto[SUP] 1 [/SUP], Kai Ming Chow[SUP] 1 [/SUP]
Affiliations
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.
Keywords: chronic kidney disease; dialysis; nirmatrelvir-ritonavir; rebound.
. 2023 Aug 2;ciad371.
doi: 10.1093/cid/ciad371. Online ahead of print. Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019 (COVID-19)
Gordon Chun Kau Chan[SUP] 1 [/SUP], Grace Chung Yan Lui[SUP] 1 2 [/SUP], Candy Ngai Sze Wong[SUP] 2 [/SUP], Sindy Sin Ting Yip[SUP] 1 [/SUP], Timothy Chun Man Li[SUP] 1 [/SUP], Catherine Siu King Cheung[SUP] 1 [/SUP], Ryan Kin Ho Sze[SUP] 3 [/SUP], Cheuk Chun Szeto[SUP] 1 [/SUP], Kai Ming Chow[SUP] 1 [/SUP]
Affiliations
- PMID: 37531093
- DOI: 10.1093/cid/ciad371
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.
Keywords: chronic kidney disease; dialysis; nirmatrelvir-ritonavir; rebound.