Abstract | OBJECTIVES: DESIGN: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study. METHODS: RESULTS: Patients on both E/C/F/TAF (n = 112) and E/C/F/TDF (n = 58) had high rates of virologic suppression (<50 HIV copies per milliliter) at week 24 (86.6%; 89.7%) and at week 48 (88.4%; 87.9%), and had similar improvements in CD4 at week 48 (177; 204), respectively. Both treatments were well tolerated, and most adverse events were self-limiting and of mild to moderate severity. Compared with patients on E/C/F/TDF, patients on E/C/F/TAF had smaller reductions in estimated creatinine clearance (-5.5 vs. -10.1 mL/min, P = 0.041), significantly less renal tubular proteinuria, and smaller changes in bone mineral density for hip (-0.62% vs. -2.39%, P < 0.001) and spine (-1.00% vs. -3.37%, P < 0.001). Patients on E/C/F/TAF had higher increases in total cholesterol, low-density lipoprotein, and high-density lipoprotein, but the total cholesterol/ high-density lipoprotein ratio was unchanged for both. CONCLUSIONS: Treatment-naive patients given the STR that contained either TAF or TDF achieved a high rate of virologic success. Compared with those receiving TDF, patients on E/C/F/TAF experienced significantly smaller changes in estimated creatinine clearance, renal tubular proteinuria, and bone mineral density.
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Authors | Paul E Sax, Andrew Zolopa, Indira Brar, Richard Elion, Roberto Ortiz, Frank Post, Hui Wang, Christian Callebaut, Hal Martin, Marshall W Fordyce, Scott McCallister |
Journal | Journal of acquired immune deficiency syndromes (1999)
(J Acquir Immune Defic Syndr)
Vol. 67
Issue 1
Pg. 52-8
(Sep 01 2014)
ISSN: 1944-7884 [Electronic] United States |
PMID | 24872136
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Prodrugs
- RNA, Viral
- Cholesterol
- Tenofovir
- Creatinine
- tenofovir alafenamide
- Adenine
- Alanine
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Topics |
- Absorptiometry, Photon
- Adenine
(administration & dosage, analogs & derivatives, pharmacokinetics)
- Administration, Oral
- Adult
- Alanine
- Bone Density
- CD4 Lymphocyte Count
- Cholesterol
(blood)
- Creatinine
(urine)
- Double-Blind Method
- Female
- HIV Infections
(drug therapy, metabolism, virology)
- HIV-1
(isolation & purification)
- Humans
- Male
- Prodrugs
(administration & dosage, pharmacokinetics)
- Proteinuria
- RNA, Viral
(blood)
- Tenofovir
(analogs & derivatives)
- United States
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