Journal
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Volume 72, Issue 1, Pages 58-64Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/QAI.0000000000000940
Keywords
tenofovir alafenamide; integrase inhibitor; randomized controlled trial; HIV; bone mineral density; renal safety
Categories
Funding
- Gilead Sciences
- Gilead
- Merck
- ViiV
- Janssen
- AbbVie
- MSD
- Torii Pharmaceutical
- Japan Tobacco Inc.
- BMS
- Synergy
- Shionogi
- Astra Zeneca
- Sangamo
- GSK
- Novo Nordisc
- Theratech
- Sliagen
- Jansen
- Tibotech
- Roche
- CytoDyn
- Themis
- Vertex
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In 2 double-blinded Phase 3 trials, 1733 antiretroviral-naive participants were randomized to tenofovir alafenamide (TAF), a tenofovir prodrug versus tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 96 weeks, 86.6% in the TAF arm and 85.2% in the TDF arm had HIV-1 RNA <50 c/mL [difference 1.5%; (95% CI: -1.8% to 4.8%)]. With TAF, there are smaller declines in bone mineral density and more favorable changes in proteinuria, albuminuria, and tubular proteinuria, and no cases of proximal tubulopathy compared with 2 for TDF. These longer-term data support E/C/F/TAF as a safe, welltolerated, and durable regimen for initial HIV-1 treatment.
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