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J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):209-213. doi: 10.1097/QAI.0000000000001663.

Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.

Author information

1
West Virginia University Health Sciences Center, Morgantown, WV.
2
Division of Infectious Diseases, Thomas Jefferson University, Philadelphia, PA.
3
Joint Clinical Research Centre, Kampala, Uganda.
4
Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA.
5
HIV Netherlands Australia Thailand Research Collaboration, The Thai Red Cross AIDS Research Centre.
6
Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.
7
Departments of Clinical Research, Biometrics, and Virology, Gilead Sciences, Inc., Foster City, CA.

Abstract

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.

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