title: 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.
abstract: 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.
authors.affiliation: *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.
authors.forename: Joel
authors.initials: J
authors.lastname: Gallant
authors.forename: Jason
authors.initials: J
authors.lastname: Brunetta
authors.forename: Gordon
authors.initials: G
authors.lastname: Crofoot
authors.forename: Paul
authors.initials: P
authors.lastname: Benson
authors.forename: Anthony
authors.initials: A
authors.lastname: Mills
authors.forename: Cynthia
authors.initials: C
authors.lastname: Brinson
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
authors.forename: Andrew
authors.initials: A
authors.lastname: Cheng
authors.forename: Will
authors.initials: W
authors.lastname: Garner
authors.forename: Marshall
authors.initials: M
authors.lastname: Fordyce
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Scott
authors.initials: S
authors.lastname: McCallister
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000409:Alanine; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D000069547:Cobicistat / Q000008:administration & dosage / Q000009:adverse effects; D060085:Coinfection; D004338:Drug Combinations; D057915:Drug Substitution; D000068679:Emtricitabine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000276:immunology; D006509:Hepatitis B / Q000150:complications* / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects; D000068698:Tenofovir / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D015363:Quinolones; C509700:elvitegravir; D000068698:Tenofovir; C442442:tenofovir alafenamide; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat; D000409:Alanine