Tenofovir alafenamide versus tenofovir disoproxil fumarate in women: Pooled analysis of seven clinical trials
Thompson M, Brar I, Brinson C, Creticos C, Hagins D, Koenig E, Martorell C, Mussini C, Waters L, Guo S, Liu YP, Temme L, SenGupta D, and Das M. Tenofovir alafenamide versus tenofovir disoproxil fumarate in women: Pooled analysis of seven clinical trials. HIV Med 2019; 20:23.
Background: Tenofovir alafenamide (TAF) has demonstrated an improved renal and bone safety profile relative to tenofovir disoproxil fumarate (TDF) in multiple randomised trials. We pooled 7 studies to evaluate the efficacy and safety of TAF vs. TDF for ART initiation or switch in women Methods: Data from cis-women who initiated or switched to TAF- or TDFbased regimens in 7 randomised, double-blind clinical trials (2 treatmentnaïve, 5 virologically suppressed adults) were compared. Virologic suppression (VS; HIV-1 RNA < 50 c/ml) rates (FDA snapshot analysis); bone mineral density (BMD) and the renal tubular biomarkers urine beta-2-microglobulin (B2 m):creatinine (Cr) ratio and retinol binding protein (RBP):Cr ratio are reported at W96. Differences were compared using Wilcoxon rank sum test. Results: 779 women were enrolled (n=429 TAF, n=350 TDF). Treatment-naïve women (WTN) and Women with VS (WVS) had a median age of 37 vs 47 years, and median CD4 365 vs 711 cells/mm3, respectively. Of WTN, 86% (TAF) and 85% (TDF) achieved VS (p=0.71) at W96. VS was maintained in 86% of WVS switching to TAF and 85% continuing TDF (p=0.99). Overall TAF and TDF were well tolerated. Discontinuation due to adverse event/death was 0% (TAF) vs. 1.6% (TDF) in WTN and 1.3% vs. 2.2% in WVS. Initiating or switching to TAF was associated with significantly less impact on, or improvements in % change in BMD and tubular proteinuria at W96 (Table P19.1). (Table Presented) Conclusions: Women who initiated or switched to TAF had significantly improved bone and renal safety parameters compared to TDF, with similar rates of virologic suppression through W96. These pooled data demonstrate a safety advantage of TAF compared to TDF in women.