Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial

RCT (n=1053) suggests that medium- and long-term metabolic and clinical consequences of the considerable increase in bodyweight observed in participants given these antiretroviral regimens and trajectory of this weight gain over time, especially among women, require further study

SPS commentary:

This paper reports the key secondary efficacy endpoint of the proportion of participants who had a plasma HIV-1 RNA concentration < 50 copies per mL at week 96 visit. Proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups but mean weight gain was substantial (7.1kg in the tenofovir alafenamide, emtricitabine, and dolutegravir group; 4.3kg in tenofovir disoproxil fumarate, emtricitabine,and dolutegravir group, and 2.3kg in tenofovir disoproxil fumarate, emtricitabine,and efavirenz group).

The Lancet HIV