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J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):294-298.

Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults.

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*Southwest CARE Center, Santa Fe, NM; †Family and Community Medicine, University of Toronto, Ontario, Canada; ‡Crofoot Research Center, Houston, TX; §Be Well Medical Center, Berkley, MI; ‖Southern California Men's Medical Group, Los Angeles, CA; ¶Central Texas Clinical Research, Austin, TX; #AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan; and **Gilead Sciences, Inc., Foster City, CA.


Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has high efficacy and improved renal and bone safety in multiple phase 3 trials; TAF single agent is being studied in 2 phase 3 trials in patients with chronic hepatitis B. We report the results of an open-label, noncomparative switch study evaluating the efficacy and safety of E/C/F/TAF in HIV/hepatitis B virus (HBV)-coinfected adults. At 48 weeks, 91.7% of the 72 participants maintained or achieved virologic suppression (HIV-1 RNA <50 copies/mL; HBV DNA <29 IU/mL). Seroconversion occurred in 2.9% of hepatitis B surface antigen-positive participants and in 3.3% of HBV e antigen-positive participants; 40% of those with abnormal alanine aminotransferase normalized. E/C/F/TAF was associated with improved renal function and reduced bone turnover. These data support the use of E/C/F/TAF in treating HIV/HBV coinfection.

[Indexed for MEDLINE]
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Conflict of interest statement

J.G. reports receiving consulting/advisory fees from Bristol Myers Squibb (BMS), Gilead, Janssen Therapeutics, Merck, ViiV/GlaskoSmithKilne (GSK) and institutional grant support from AbbVie, BMS, Gilead, Janssen, Merck, Sangamo BioSciences, and GSK/ViiV outside the submitted work. J.B. has received study-related reimbursement from Gilead during the conduct of the study; conference sponsorship from Gilead Canada, Merck Canada, ViiV Canada, and Janssen Canada; speaker fees from Gilead Canada and Merck Canada; and consultant fees from Gilead Canada, Merck Canada, ViiV Canada, and Abbvie Canada outside the submitted work. G.C. reports grants from Gilead during the conduct of the study; grants and personal fees from Gilead, ViiV, Janssen, and Merck outside of the submitted work; and personal fees from Gilead and ViiV outside the submitted work. P.B. reports receiving other fees (Speakers Bureau, study-related reimbursement, advisory boards) from Gilead outside the submitted work. C.B. has received grants Gilead, Theratech, BMS, SlieaGen, ViiV/GSK, Daiichi Sankyo, Vertex, Novo Nordisk, Sanofi, Shionogi; advisory board fees from Gilead, Theratech, VMS, and ViiV/GSK; speaker fees from Gilead; and consultant fees from ViiV/GSK during the conduct of the study; and grants from Theratech, BMS, SlieaGen, ViiV/GSK, Daiichi Sankyo, Vertex, Novo Nordisk, Sanofi, Shionogi, Elcelyx; advisory board fees from Theratch and BMS; and speaker fees from Theratch outside the submitted work. S.O. has received research grants from Merck Sharp & Dohme (MSD) and honoraria from MSD, ViiV, Trii Pharmaceuticals, AbbVie, Japan Tobacco, and Janssen outside the submitted work. A.C., W.G., M.F., M.D., and S.M. are employees of Gilead and hold stock interest in the company. J.G., J.B., G.C., P.B., A.M., C.B. were principal investigators and A.C., W.G., M.F., M.D., and S.M. were employees of Gilead Sciences and were the scientific, medical, and operational leaders responsible for this study's design, conduct, oversight, and analyses. All authors have reviewed the results of this study and approved the manuscript.

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