期刊
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
卷 75, 期 2, 页码 211-218出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/QAI.0000000000001350
关键词
tenofovir alafenamide; integrase inhibitor; randomized controlled trial; HIV; bone mineral density; renal safety
资金
- Gilead Sciences, Inc. (Gilead)
- Gilead Sciences (Gilead)
- ViiV
- Janssen Therapeutics (Janssen)
- AbbVie
- Bristol-Myers Squibb (BMS)
- Merck Laboratories (Merck)
- Gilead Sciences
- BMS
- GeoVax
- Kowa Research Institute
- Merck
- Pfizer
- Tobira
- Janssen
- GlaxoSmithKline (GSK)
- Gilead
- GSK
- Abbott Laboratories
- Achillion Pharmaceuticals
- Avexa
- Idenix
- Sangamo
- Taimed
In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95% confidence interval: 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P < 0.001), with no cases of proximal tubulopathy for TAF vs 4 for TDF. There were greater increases in lipids with TAF vs TDF, with no difference in the total cholesterol to high-density lipoprotein ratio. For initial HIV therapy, E/C/F/TAF is superior to E/C/F/TDF in efficacy and bone and renal safety.
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