Outcomes
AIDS
EVENTS, AIDS, ADVERSE EVENT
The primary outcome was proportion of participants with virological suppression, defined as HIV-1 RNA less than 50 copies per mL at week 24, analysed in the modified intention-to-treat population and according to the US Food and Drug Association snapshot approach, which defines failure as any one of the following: HIV-1 RNA of 50 copies per mL or greater, missing HIV-1 RNA within the window period (±16 days), or if ART is discontinued. We did not regard switching of tenofovir or lamivudine for intolerance as a failure.Secondary outcomes included proportion of participants with HIV-1 RNA of less than 50 copies per mL at weeks 12 and 48, analysed in the modified intention to treat and per-protocol populations; change in CD4 count from baseline to weeks 24 and 48; proportion of participants with dolutegravir trough concentrations above the PA-ICAdverse events were recorded at every visit and graded according to the Division of AIDS (DAIDS) adverse event grading tables.