Evolution of renal function in African patients initiating second-line antiretroviral treatment: findings from the ANRS 12169 2LADY trial.

Abstract:

BACKGROUND:To investigate change in renal function in African patients initiating second-line antiretroviral therapy (ART) including ritonavir-boosted protease inhibitor (PI/r) with or without tenofovir disoproxil fumarate (TDF). METHODS:HIV-1-positive adults, failing standard first-line ART were randomized to either TDF/emtricitabine (FTC)+LPV/r, abacavir + didanosine +LPV/r or TDF/FTC+ darunavir (DRV)/r and followed for 18 months. Patients with an estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m2 at baseline were included in this analysis. RESULTS:Data from 438 out of 454 randomized patients were analysed. Median age was 38 years and 72% were women. Initiation of PI/r-based second-line regimen induced a marked eGFR decline of -10.5 ml/min/1.73 m2 at week 4 in all treatment groups with a greater decrease in TDF/FTC+LPV/r arm (-15.1 ml/min/1.73 m2). At month 18, mean eGFR in the non-TDF containing regimen recovered its baseline level and was significantly greater than eGFR 18-month levels in the TDF-containing regimens that experienced only partial recovery (difference: -10.7; CI -16.8, -4.6; P=0.001 in TDF/FTC+LPV/r and -6.4; CI -12.5, -0.3; P=0.04 in TDF/FTC+DRV/r). At 18 months, prevalence of stage 3 chronic kidney disease was low (<3%) and not associated with treatment. One treatment discontinuation and five TDF dosage reductions for renal toxicities were reported in TDF-containing arms. CONCLUSIONS:Overall, these results suggest a reasonable renal tolerance of a regimen associating TDF/FTC+PI/r in African patients with eGFR>60 ml/ml/1.73 m2 at baseline. They also support the recommendation of reassessing renal function 1 month after initiation of treatment including ritonavir to account for the ritonavir-related artefactual decrease of eGFR and determine the new reference baseline value.

journal_name

Antivir Ther

journal_title

Antiviral therapy

authors

Cournil A,Hema A,Eymard-Duvernay S,Ciaffi L,Badiou S,Kabore FN,Diouf A,Ayangma L,Le Moing V,Reynes J,Koulla-Shiro S,Delaporte E,2LADY Study Group.

doi

10.3851/IMP3097

subject

Has Abstract

pub_date

2017-01-01 00:00:00

pages

195-203

issue

3

eissn

1359-6535

issn

2040-2058

journal_volume

22

pub_type

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