The Incidence and Clinical Characteristics of Acute Serum Creatinine Elevation more than 1.5 mg/dL among the Patients Treated with Tenofovir/Emtricitabine-containing HAART Regimens

Abstract

BackgroundThe combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has been the first choice nucleoside reverse transcriptase inhibitor (NRTI) according to many reliable antiretroviral treatment (ART) guidelines because of its high efficacy. However, TDF-related renal toxicity reported in Western countries is a challenging issue regarding clinical use. We conducted this study to evaluate the incidence and characteristics of an acute increase in serum creatinine (Cr) level > 1.5 mg/dL among TDF/FTC-based highly active antiretroviral treatment (HAART)-treated patients.Materials and MethodsWe retrospectively reviewed the medical records of 205 HIV-infected patients treated with TDF/FTC-containing regimens between 1 February 2010 and 30 April 2014. Three groups of TDF/FTC + ritonavir-boosted protease inhibitor (PI/r), TDF/FTC + non-nucleoside reverse transcriptase inhibitor (NNRTI), and TDF/FTC + integrase strand transfer inhibitor (INSTI), and three PI/r subgroups of TDF/FTC + lopinavir (LPV)/r, TDF/FTC + atazanavir (ATV)/r, TDF/FTC + darunavir (DRV)/r were evaluated.ResultsA total 136 patients (91 in the TDF/FTC + PI/r group, 20 in the TDF/FTC + NNRTI group and 25 in the TDF/FTC + INSTI group) were included in the statistical analysis. Four cases (4.9%; all in the TDF/FTC + PI/r group) among 136 patients showed an acute increase in serum Cr more than 1.5 mg/dL, so the overall incidence was 2.8 cases per 100 patient-years. One case was a patient treated with TDF/FTC + LPV/r, and the others were treated with TDF/FTC + ATV/r. No case of an acute increase in serum Cr was observed in the TDF/FTC + DRV/r group. The incidence of serum Cr increase more than 1.5 mg/dL in TDF/FTC + PI/r group was 4.0 cases per 100 patient-years.ConclusionAlthough only a small number of patients were evaluated retrospectively from a single center, the TDF/FTC + PI/r regimen may have been related with relatively higher tendency of increment of serum Cr level. These findings reinforce the importance of close follow-ups of HIV-infected patients treated with the TDF/FTC + PI/r regimens.

Incidence and risk factors for tenofovir-associated nephrotoxicity among human immunodeficiency virus-infected patients in Korea

“…Despite the possibility of some differences in the incidence or prevalence of TDF-associated nephrotoxicity according to the measuring methods of eGFR and definition of TDF-associated nephrotoxicity, the results were broadly in line with those of other studies [6,9,15,16]. A retrospective study conducted in Korea showed that the incidence of acute Scr elevation > 1.5 mg/dL regardless of baseline Scr level among patients treated with TDF-containing regimens was 2.8 per 100 PYs [17].…”

Prevalence of Nephrotoxicity in HIV Patients Treated with Tenofovir Disoproxil Fumarate: A Single-center Observational Study

“…For eGFR and serum creatinine, TDF-associated dysfunction was defined as a 25% drop in the eGFR or a 1.5-fold increase in serum creatinine while others did not define any cutoff values for either when comparing TDF versus TAF for renal toxicity but found the TAF group had a lower reduction in eGFR. 39,40…”

Evaluation of the Side Effects of Antiretroviral Treatment

“…In two of these three patients, eGRF increased after dose adjustment. Jin et al [19] reviewed a total of 136 patients taking TDF/FTC and observed a sharp increase (>1.5 mg/dL) in serum creatinine in 4.9% of the patients, all of whom were in the PI group. In our study, two of the three patients who developed nephrotoxicity were receiving a PI-based regimen.…”