Raymond A. Tetteh1,2, Edmund T. Nartey 3, Margaret Lartey 4, Barbara Yankey 6 , Aukje K. Mantel-Teeuwisse1 , Hubert G. M. Leufkens 1,5 , and Alexander N. O. Dodoo3
1.Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands
2.Pharmacy Department, Korle-Bu Teaching Hospital, Korle-Bu, Accra, Ghana
3.Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry,University of Ghana
4.Department of Medicine, School of Medicine and Dentistry, University of Ghana, Legon
5.Medicines Evaluation Board, Utrecht, the Netherlands
6.Georgia State University, Atlanta, Georgia, USA
Corresponding author: raymond_tetteh@hotmail.com

Background: The association of tenofovir disoproxil fumarate (TDF) with renal dysfunction has remained an area of interest. The purpose of this study was to estimate the long-term effects of TDF on renal profile and identify potential risk factors associated with renal impairment.

Method: 300 consecutive HIV-positive patients (with baseline creatinine clearance (CrCl) above 50 mL/min) initiated on TDF-based antiretroviral treatment from 2008 were selected from a database capturing all patients on antiretroviral therapy at the Korle-Bu Teaching Hospital. Socio-demographic details, clinical characteristics, laboratory and antiretroviral regimens were collected from patients’ medical records. CrCl was calculated using the Cockcroft-Gault equation at baseline and as per institutional guidelines for renal function tests. Renal impairment was categorised as moderate (reduction between 30 mL/min and 49.9 mL/min) and severe (reduction below 30 mL/min). Proportion of patients with moderate or severe renal impairment was calculated. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for factors associated with renal impairment.

Results and discussion: Median follow up time was 2.9 years. Females were dominant (n=213, 71.1%) and the mean age was 39.1 ± 11.1 years. The Median CrCl rate at initiation was 76.8 mL/min. At the study endpoint, 63 participants (21%) recorded a CrCl rate below 50 ml/min indicating incident renal impairment, comprised 18.3% moderate and 2.3% severe renal impairment. Factors associated were increasing age (RR=1.04) per year, decrease in creatinine clearance rate at baseline (RR=1.05) per every 1 mL decrease, WHO HIV stage III (RR=3.78) or Stage IV (RR=3.42) compared with stage I and participants with BMI <18.5 kg/m² underweight (RR=3.87) compared with patients with BMI >18.5-24.9 kg/m2.

Conclusion: The use of TDF based regimen may have led to 18.3% moderate and 2.3% severe renal impairment. Patients with identified risk factors should be targeted and monitored effectively to prevent renal injury.