Prevalence of Drug-Related Transaminitis in Post-Renal Transplant Recipients: A Single-Center Study in Peshawar

Abstract

ABSTRACT

OBJECTIVES

This study aimed to estimate the prevalence, timing, pattern, and predictors of drug-related transaminitis among kidney-transplant recipients at a tertiary center in Khyber Pakhtunkhwa, Pakistan.

METHODOLOGY

The study was conducted at a tertiary care academic hospital in Peshawar, Pakistan, enrolling consecutive adult kidney transplant recipients who attended the transplant service between February 2022 and August 2025 (N=99). The Primary outcome was drug-related transaminitis defined by standard DILI thresholds (ALT/AST ≥3× ULN or ALP ≥2× ULN) with RUCAM causality assessment and CTCAE severity grading. Prespecified predictors included high tacrolimus trough (>10 ng/mL after day 7), azole co-administration, CMV viremia, HCV serostatus, obesity, and age/sex.

RESULTS
Prevalence of drug-related transaminitis was 26.3% (26/99; 95% CI 18.6-35.7). Median time to onset was 27 days post-transplant and 16 days from culprit-drug exposure. The injury pattern was predominantly hepatocellular (73.1%); 46.2% mild, 30.8% moderate, and 23.1% severe, according to CTCAE. On multivariable analysis, high tacrolimus trough (aOR 3.9; p=0.009), azole co-administration (aOR 2.7; p=0.047), and CMV viremia (aOR 3.1; p=0.035) were independently associated with events. Most cases resolved with dose modification or withdrawal (84.6%) in a median of 21 days; 11.5% required hospitalization; no graft loss or death was attributed to hepatotoxicity.

CONCLUSION

Approximately one in four post-renal transplant recipients developed drug-related transaminitis, with the strongest signals from supratherapeutic tacrolimus exposure, azole interactions, and CMV viremia. Routine therapeutic-drug monitoring, vigilant interaction checks, and targeted viral surveillance can mitigate risk and expedite recovery.