PMID- 29481486
OWN - NLM
STAT- MEDLINE
DCOM- 20190502
LR  - 20211204
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 78
IP  - 2
DP  - 2018 Jun 1
TI  - Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, 
      Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically 
      Suppressed Women.
PG  - 209-213
LID - 10.1097/QAI.0000000000001663 [doi]
AB  - BACKGROUND: The integrase inhibitor regimen 
      [elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (TDF)] 
      demonstrated superior efficacy when compared with a protease inhibitor regimen 
      [ritonavir-boosted atazanavir (ATV + RTV) and FTC/TDF] in 575 treatment-naive 
      women at week 48. We investigated the efficacy, safety, and tolerability of 
      switching to a TAF-based, single-tablet regimen containing elvitegravir, 
      cobicistat, FTC, and tenofovir alafenamide (E/C/F/TAF) versus remaining on ATV + 
      RTV plus FTC/TDF. METHODS: After completing the initial randomized, blinded 
      phase, virologically suppressed (HIV-1 RNA <50 copies/mL) women on ATV + RTV plus 
      FTC/TDF were rerandomized (3:1) to receive open-label E/C/F/TAF versus remaining 
      on their current regimen. The primary end point was proportion of participants 
      with plasma HIV-1 RNA <50 copies per milliliter at week 48 (U.S. FDA snapshot 
      algorithm), with a prespecified noninferiority margin of 12%. Safety [adverse 
      events (AEs)] and tolerability were also assessed. RESULTS: Of 575 women 
      originally randomized and treated in the blinded phase, 159 were rerandomized to 
      switch to E/C/F/TAF and 53 to remain on ATV + RTV plus FTC/TDF. At week 48, 
      virologic suppression was maintained in 150 (94%) of women on E/C/F/TAF and 46 
      (87%) on ATV + RTV plus FTC/TDF [difference 7.5% (95% confidence interval -1.2% 
      to 19.4%)], demonstrating noninferiority of E/C/F/TAF to ATV + RTV and FTC/TDF. 
      Incidence of AEs was similar between groups; study drug-related AEs were more 
      common with E/C/F/TAF (11% versus 4%). CONCLUSIONS: Switching to E/C/F/TAF was 
      noninferior to continuing ATV + RTV plus FTC/TDF in maintaining virologic 
      suppression and was well tolerated at 48 weeks.
FAU - Hodder, Sally
AU  - Hodder S
AD  - West Virginia University Health Sciences Center, Morgantown, WV.
FAU - Squires, Kathleen
AU  - Squires K
AD  - Division of Infectious Diseases, Thomas Jefferson University, Philadelphia, PA.
FAU - Kityo, Cissy
AU  - Kityo C
AD  - Joint Clinical Research Centre, Kampala, Uganda.
FAU - Hagins, Debbie
AU  - Hagins D
AD  - Georgia Department of Public Health, Coastal Health District, Chatham Care 
      Center, Savannah, GA.
FAU - Avihingsanon, Anchalee
AU  - Avihingsanon A
AD  - HIV Netherlands Australia Thailand Research Collaboration, The Thai Red Cross 
      AIDS Research Centre.
AD  - Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.
FAU - Kido, Anna
AU  - Kido A
AD  - Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, 
      Inc., Foster City, CA.
FAU - Jiang, Shuping
AU  - Jiang S
AD  - Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, 
      Inc., Foster City, CA.
FAU - Kulkarni, Rima
AU  - Kulkarni R
AD  - Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, 
      Inc., Foster City, CA.
FAU - Cheng, Andrew
AU  - Cheng A
AD  - Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, 
      Inc., Foster City, CA.
FAU - Cao, Huyen
AU  - Cao H
AD  - Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, 
      Inc., Foster City, CA.
LA  - eng
GR  - U54 GM104942/GM/NIGMS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Integrase Inhibitors)
RN  - 0 (Protease Inhibitors)
RN  - 0 (Quinolones)
RN  - 0 (RNA, Viral)
RN  - 4GDQ854U53 (elvitegravir)
RN  - 99YXE507IL (Tenofovir)
RN  - EL9943AG5J (tenofovir alafenamide)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JAC85A2161 (Adenine)
RN  - LW2E03M5PG (Cobicistat)
RN  - OF5P57N2ZX (Alanine)
SB  - IM
MH  - Adenine/administration & dosage/*analogs & derivatives/pharmacology
MH  - Adult
MH  - Alanine
MH  - Anti-HIV Agents/administration & dosage/*pharmacology
MH  - Antiretroviral Therapy, Highly Active/methods
MH  - Cobicistat/administration & dosage/*pharmacology
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Drug Resistance, Viral
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Emtricitabine/administration & dosage/*pharmacology
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - HIV-1
MH  - Humans
MH  - Integrase Inhibitors/pharmacology
MH  - Protease Inhibitors/pharmacology
MH  - Quinolones/administration & dosage/*pharmacology
MH  - RNA, Viral/blood
MH  - Tenofovir/analogs & derivatives
PMC - PMC6425939
MID - NIHMS960887
EDAT- 2018/02/27 06:00
MHDA- 2019/05/03 06:00
PMCR- 2019/06/01
CRDT- 2018/02/27 06:00
PHST- 2018/02/27 06:00 [pubmed]
PHST- 2019/05/03 06:00 [medline]
PHST- 2018/02/27 06:00 [entrez]
PHST- 2019/06/01 00:00 [pmc-release]
AID - 10.1097/QAI.0000000000001663 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):209-213. doi: 
      10.1097/QAI.0000000000001663.