Nirmatrelvir/ritonavir (NR) use has not yet been described in solid organ transplant recipients (SOTRs) with mild COVID‐19. The objective was to evaluate outcomes among SOTR and describe the drug–drug interaction of NR. This is an IRB‐approved, retrospective study of all adult SOTR on a calcineurin inhibitor (CNI) or mammalian target of rapamycin inhibitor who were prescribed NR between December 28, 2021 and January 6, 2022. A total of 25 adult SOTR were included (
n
= 21 tacrolimus,
n
= 4 cyclosporine,
n
= 3 everolimus,
n
= 1 sirolimus). All patients were instructed to follow the following standardized protocol during treatment with 5 days of NR: hold tacrolimus or mTOR inhibitor or reduce cyclosporine dose to 20% of baseline daily dose. Four patients (16%) were hospitalized by day 30; one for infectious diarrhea and three for symptoms related to COVID‐19. No patients died within 30 days of receipt of NR. Median tacrolimus level pre‐ and post‐NR were 7.4 ng/ml (IQR, 6.6–8.6) and 5.2 (IQR, 3.6–8.7), respectively. Four patients experienced a supratherapeutic tacrolimus concentration after restarting tacrolimus post‐NR. Our results show the clinically significant interaction between NR and immunosuppressive agents can be reasonably managed with a standardized dosing protocol. Prescribers should carefully re‐introduce CNI after the NR course is complete.
Treatment outcomes associated with the use of novel COVID‐19 therapeutics in solid organ transplant recipients (SOTR) are not well described in the literature. The objective of this analysis was to characterize 30‐day hospitalization and other key secondary endpoints experienced by outpatient SOTR with mild–moderate COVID‐19 treated with nirmatrelvir/ritonavir (NR), sotrovimab, or no SARS‐CoV‐2 specific treatment. This IRB‐approved, retrospective study included 154 SOTR with a documented positive SARS‐CoV‐2 infection between December 16, 2021 and January 19, 2022 (a predominant Omicron BA.1 period in New York City). Patients who received NR (
N
= 28) or sotrovimab (
N
= 51) experienced a lower rate of 30‐day hospitalization or death as compared to those who received no specific treatment (
N
= 75) (
p
= .009). A total of three deaths occurred, all among patients who initially received no specific treatment prior to hospitalization. These results suggest a role for SARS‐CoV‐2 specific agents in the treatment of SOTR with COVID‐19, and that there does not appear to be any difference in effectiveness when comparing NR versus sotrovimab.
Background
To investigate the impact of delayed calcineurin inhibitor (CNI) initiation in liver transplant recipients (LTR) with peri‐operative renal insufficiency receiving basiliximab induction, we compared renal outcomes of LTR stratified by the degree of achieved post‐operative renal recovery (RR) prior to CNI initiation.
Methods
All adult LTR transplanted between 01/2007 and 12/2015 who received basiliximab were included. Patients who received multi‐organ transplantations, were repeat transplant recipients, or expired prior to post‐operative day (POD) 90 were excluded. The primary outcome of our retrospective analysis was renal function at POD 90.
Results
A total of 210 patients were included in our final analysis. Most patients were Caucasian males undergoing liver transplantation for liver disease secondary to hepatitis C virus. Baseline characteristics were similar among the evaluable population. Estimated GFR was significantly higher among patients with the greatest degree of post‐operative renal recovery at POD 90; however, this difference did not persist at POD 180. There was no significant difference in incidence or severity of biopsy‐proven acute rejection (BPAR) at any measured time point.
Conclusions
Delayed CNI initiation following liver transplantation in patients with post‐operative renal insufficiency who receive basiliximab induction does not adversely affect the incidence of BPAR or long‐term renal outcomes.
The recommended initial weight-based dose of extended-release (XR) tacrolimus (Envarsus XR) in kidney transplant recipients (KTR) is 0.14 mg/kg/day. However, no data exist regarding dosing recommendations for obese patients specifically. The aim of this study was to evaluate weight-based dosing requirements in a cohort of obese KTR who were initiated on de novo tacrolimus XR post-transplantation. The primary outcome was weight-based dosing requirements (mg/kg/day) on post-operative day (POD) 7 and 14. Of the 254 KTR, 81 (31%) were obese. The median therapeutic dose on POD7 was 0.1 versus 0.12 vs. 0.14 mg/kg/day in the BMI > 30 kg/m 2 , BMI 25-30 kg/m 2 , and BMI < 25 kg/m 2 , respectively, (p = .0001). This result was similar on POD14; median therapeutic dose was 0.09 versus 0.11 versus 0.15 mg/kg/day in the BMI > 30 kg/m 2 , BMI 25-30 kg/m 2 , and BMI < 25 kg/m 2 , respectively, (p < .001).Therapeutic dose on POD7 and POD14 based on ideal body was similar in all cohorts (p = .238, p = .923, respectively). This finding was supported by a strong linear relationship between ideal body weight (IBW) and therapeutic dose (r = .929). In both obese and non-obese KTR, IBW had a stronger correlation with the therapeutic dose for tacrolimus XR.
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