Tenofovir alafenamide versus tenofovir disoproxil fumarate in women: Pooled analysis of seven clinical trials

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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.





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