ArticleClinical pharmacology and therapeutics2026
Safety, Pharmacokinetics, and Dose Recommendations for Nirmatrelvir/Ritonavir in Individuals with Mild to Moderate COVID-19 and Severe Renal Impairment.
Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05487040 (A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1, open-label, non-randomized study to investigate the safety and pk following multiple oral doses of pf-07321332 (nirmatrelvir)/ritonavir in adult participants with covid-19 and severe renal impairment either on hemodialysis or not on hemodialysis
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Patients with severe renal impairment and COVID-19 are at high risk for severe disease and death. Nirmatrelvir/ritonavir, an antiviral therapy for COVID-19, is eliminated by renal excretion and can accumulate in patients with severe renal impairment. The phase 1 Evaluation of Protease Inhibition for COVID-19 in Patients with Severe Renal Impairment (EPIC-SRI) study evaluated the safety and pharmacokinetics of nirmatrelvir/ritonavir for this population. Fifteen participants (3 not requiring hemodialysis, 12 requiring intermittent hemodialysis) received oral nirmatrelvir/ritonavir 300/100 mg on Day 1, followed by nirmatrelvir/ritonavir 150/100 mg once daily on Days 2-5. No treatment-related adverse events were reported. Geometric mean (coefficient of variation) maximum plasma concentration, plasma trough concentration, and area under the concentration-time curve from 0 to 24 hours for daily dosing of nirmatrelvir for participants from the Intermittent Hemodialysis Cohort were 3280 ng/mL (48%), 2188 ng/mL (81%), and 65,700 ng*h/mL (59%), respectively. Geometric mean (coefficient of variation) nirmatrelvir hemodialysis clearance and fraction removed from the body by hemodialysis were 30.5 mL/min (35%) and 6.9% (138%), respectively. Population pharmacokinetic modeling demonstrated that simulated distributions of nirmatrelvir maximum plasma concentration, minimum trough concentration, and area under the concentration-time curve from 0 to 24 hours for daily dosing at the studied regimen were similar to those for virtual subjects with normal to moderate renal function receiving the approved dose of nirmatrelvir/ritonavir. SARS-CoV-2 RNA levels were substantially reduced across both cohorts. Findings suggest that the studied regimen is well tolerated, achieves and maintains adequate exposure, and is suitable for patients with COVID-19 and severe renal impairment. NCT05487040.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.