title: Exploratory Analysis for the Evaluation of Estimated Glomerular Filtration Rate, Cholesterol and Triglycerides after Switching from Tenofovir/Emtricitabine plus Atazanavir/Ritonavir (ATV/r) to Abacavir/Lamivudine plus ATV/r in Patients with Preserved Renal Function.
abstract: OBJECTIVE
  Renal toxicity due to tenofovir (TDF) has been largely described in patients with HIV infection. However, other antiretroviral drugs (such as atazanavir [ATV], especially when boosted by ritonavir, ATV/r) could perpetuate some degrees of renal impairment with or without TDF co-administration. Also, possible benefits of stopping TDF in patients without renal diseases is not well known. This study aimed at exploring evolution of renal function and lipid profile after switching from tenofovir/emtricitabine (TDF/FTC) to abacavir/lamivudine (ABC/3TC), maintaining the ATV/r component of the regimen.
  
  
  METHODS
  Patients in the Italian MASTER Cohort, who switched from TDF/FTC plus ATV/r to ABC/3TC plus ATV/r were included, provided that major renal diseases were not diagnosed before switching (i.e., baseline). Serum creatinine, estimated glomerular filtration rate (eGFR), total cholesterol, HDL and triglycerides were evaluated at baseline and at month 18 after switching.
  
  
  RESULTS
  126 patients were selected (80% males). Patients were mostly Italians (92%). 79% had undetectable HIV-RNA and 44% were co-infected by HBV and/or HCV. Median age at switch was 47 years (IQR 43-55). A small but significant decrease in serum creatinine [from 1.06 mg/dl (SD: 0.3) to 0.94 mg/dl (SD: 0.2); p<0.001] with an improvement in eGFR [from 86.8 ml/min (SD: 33) to 96.4 ml/min (SD: 37); p<0.001] were observed in per protocol analysis at month 18. Also ITT analysis showed a decrease in mean serum creatinine [from 1.08 mg/dl (SD: 0.35) to 0.95 mg/dl (SD: 0.24); p<0.001] with an improvement in mean eGFR [from 86.9 ml/min/1.73m2 (SD: 24.11) to 95.8 ml/min/1.73m2 (SD: 19.99); p<0.001]. Total cholesterol increased [from 188 mg/dl (SD: 42) to 206 mg/dl (SD: 44); p<0.001] but also HDL increased as well [from 46 mg/dl (SD: 14) to 54 mg/dl (SD: 19); p=0.015]. An increase in triglycerides concentration was observed [from 162 mg/dl (SD: 144) to 214 mg/dl (SD: 109); p=0.027] in per protocol analysis. Also ITT analysis showed increases of both total cholesterol [from 187 mg/dl (SD: 43.69) to 203 mg/dl (SD: 44.10); p<0.001] and HDL fraction [from 46 mg/dl (SD: 15.49) to 52 mg/dl (SD: 17.13); p=0.002] at month 18.
  
  
  CONCLUSIONS
  This analysis reports an improvement in eGFR and an increase in total cholesterol and HDL fraction at month 18 after switching to ABC/3TC plus ATV/r. Given the fact that renal function was not significantly affected at baseline, our findings may suggest the utility of a proactive switch from TDF to ABC, when otherwise indicated, in patients who cannot avoid using a nucleoside backbone.
authors: Unit of Infectious and Tropical Diseases, University "Magna Graecia" Catanzaro, Italy.
authors: Maria Concetta
authors: MC
authors: Postorino
authors: Infectious and Tropical Diseases Institute, University of Brescia, Brescia, Italy.
authors: Eugenia
authors: E
authors: Quiros-Roldan
authors: "Papa Giovanni XXIII" Hospital, Bergamo, Italy.
authors: Franco
authors: F
authors: Maggiolo
authors: Catholic University of Sacred Heart, Rome, Italy.
authors: Simona
authors: S
authors: Di Giambenedetto
authors: Policlinico di Bari, Bari, Italy.
authors: Nicoletta
authors: N
authors: Ladisa
authors: "San Gerardo" Hospital, Monza, Italy.
authors: Giuseppe
authors: G
authors: Lapadula
authors: "Istituti Ospitalieri", Cremona, Italy.
authors: Silvia
authors: S
authors: Lorenzotti
authors: "Cona" Hospital, Ferrara, Italy.
authors: Laura
authors: L
authors: Sighinolfi
authors: "Spedali Civili", Brescia, Italy.
authors: Filippo
authors: F
authors: Castelnuovo
authors: "Santa Maria Annunziata" Hospital, Florence, Italy.
authors: Massimo
authors: M
authors: Di Pietro
authors: Infectious and Tropical Diseases Institute, University of Brescia, Brescia, Italy.
authors: Daria
authors: D
authors: Gotti
authors: MISI Foundation, Brescia, Italy.
authors: Nicola
authors: N
authors: Mazzini
authors: Unit of Infectious and Tropical Diseases, University "Magna Graecia" Catanzaro, Italy.
authors: Carlo
authors: C
authors: Torti
keywords: Atazanavir; Cholesterol; Highly Active Antiretroviral Therapy; Nephrotoxicity; Tenofovir; eGFR