48 Week body composition changes in persons with HIV switching to dolutegravir plus lamivudine: a planned subanalysis of the DOLAM randomized clinical trial.

BACKGROUND

Switching to dolutegravir plus lamivudine has been associated with weight gain. We aimed to assess factors associated with weight gain and changes in body composition in people with HIV switching to dolutegravir plus lamivudine in the DOLAM trial (EudraCT 201500027435).

METHODS

People with HIV on suppressive triple therapy were randomized to switch to dolutegravir plus lamivudine or to continue triple therapy. Weight and height were measured, and dual X-ray absorptiometry (DXA) scans were performed at baseline and 48 weeks. Factors associated with 48 week weight change were estimated using linear regression models adjusted for weight at baseline. DXA-derived changes were assessed using age- and sex-adjusted linear or log-linear mixed-effects regression models.

RESULTS

One hundred and eighty (68% of the DOLAM trial participants) (dolutegravir plus lamivudine, n = 88; triple therapy, n = 92) participants contributed with paired baseline and 48 week DXA scans. Mean (95% CI) weight changes were 1. 362 kg (0.437-2.287) in the dolutegravir plus lamivudine arm and 0.199 kg (-0.742 to 1.140) in the triple therapy arm. Treatment with dolutegravir plus lamivudine and age were independently associated with greater weight change at 48 weeks. DXA-derived changes in body fat mass (<0.5% in both arms), lean mass (<7% in both arms) and bone mineral density scans (<0.5% in both arms) did not differ between arms.

CONCLUSIONS

Although weight at 48 weeks increased with dolutegravir plus lamivudine but not with triple therapy in the DOLAM study, we did not detect any significant DXA-derived changes in body fat, lean mass or bone mineral density between arms.