Table 3.

Prespecified Primary and Secondary Outcome Measures at 48 Weeks After Antiretroviral Therapy Initiation (n = 29^a)

Outcome	No. of Participants
Primary outcome
Death	0
New WHO stage 3 or 4 event	0
Virologic failure: FDA Snapshot
HIV-2 plasma viral load
>50 copies/mL	1b
>400 copies/mL	0
Secondary outcome
Grade 3 or 4 adverse events
Clinical	1
Laboratory	7
CD4 T-cell count less than baseline	0
CD4 T-cell increase <50/μL from baseline	2
Switching off E/C/F/TDF	0
HIV-2 drug resistance mutations	1b RT = K65R IN = G140S, Q148R

Abbreviations: E/C/F/TDF, elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate; FDA, US Food and Drug Administration; HIV-2, human immunodeficiency virus type 2; IN, integrase; RT, reverse transcriptase; WHO, World Health Organization.

^aOne participant of the 30 enrolled was lost to follow-up/self-withdrew at week 4.

^bAt virologic failure (week 36), the HIV-2 viral load was 236 copies/mL; data available for integrase only (no drug resistance mutation [DRM] detected); at 48 weeks the same study participant had a HIV-2 viral load = 214 copies/mL and DRM: K65R + G140S/Q148R.