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Only Small Weight Gains After Trial Switch to Doravirine/3TC/TDF
  AIDS 2020: 23rd International AIDS Conference Virtual, July 6-10, 2020
Mark Mascolini
More than 2 years after virologically suppressed adults switched to fixed-dose combination doravirine/lamivudine/tenofovir (DOR/3TC/TDF), average weight increased only 1.2 to 1.4 kg in the DRIVE- SHIFT trial [1]. Almost three quarters of participants switching to the doravirine regimen had less than a 5% weight gain at week 144.
Weight gains seen after starting or switching antiretrovirals have raised concern and generated a mountain of research data. Gains appear to be greater with integrase inhibitors, especially dolutegravir, than with protease inhibitors or nonnucleosides, and greater with tenofovir alafenamide (TAF) than with tenofovir disoproxil fumarate (TDF).
DRIVE-SHIFT investigators analyzed weight changes in trial participants who started the nonnucleoside doravirine coformulated with 3TC and TDF. The open-label trial randomized adults with virologic suppression while taking another regimen to start DOR/3TC/TDF immediately or to delay the switch for 24 weeks. The researchers analyzed the immediate-switch group and the delayed group separately through 144 weeks after the switch.
The 447 people in the immediate-switch arm and the 209 in the delayed-switch arm had a median age of 43 years. Proportions of immediate/delayed men were 83% and 87%, whites 77% and 77%, blacks 12.5% and 14%, and Hispanics 22% and 19%. Baseline CD4 count averaged 665 in the immediate group and 656 in the delayed group. Respective baseline weights were 79.5 kg and 78.8 kg.
At week 48 adjusted weight gains averaged 0.7 kg in the immediate arm and 0.5 kg in the delayed arm. Respective gains at 96 weeks were 1.1 and 0.8 kg, and at 144 weeks 1.4 and 1.2 kg. (Weight change was adjusted for weight at regimen switch, race, ethnicity, gender, age, baseline CD4 count, and HIV load.) Average adjusted weight change through 144 weeks did not differ substantially by gender, race (black or nonblack), or ethnicity (Hispanic or other).
Adjusted weight change at week 144 was lower in people switching from an integrase inhibitor (0.79 kg immediate, 0.63 kg delayed) than in those switching from a nonnucleoside (1.45 kg immediate, 1.29 kg delayed) or a protease inhibitor (1.41 kg immediate, 1.25 kg delayed).
At week 144 proportions of participants with a 10% or greater weight gain were 8.4% in the immediate arm and 7.9% in the delayed arm. Respective proportions with a 5% to 10% gain were 17.9% and 20.3%, with a 0 to 5% gain 29.9% and 33.3%, and with no gain 43.9% and 38.4%.
Among 257 participants with normal body mass index at the switch, proportions in the immediate and delayed arms who became underweight at week 144 were 3% and 1.1%, who remained normal weight 81.9% and 80.2%, who became overweight 14.5% and 17.6%, and who became obese 0.6% and 1.1%. Among 176 people overweight at the switch, proportions in the immediate and the delayed arms who were normal weight at week 144 were 10.5% and 6.5%, still overweight 81.6% and 82.3%, and obese 7.9% and 11.3%.
DRIVE- SHIFT researchers stressed that average weight gains after the switch to DOR/3TC/TDF averaged less than 1 kg after 12 months. More than 70% of trial participants gained less than 5% of their initial weight, and fewer than 10% of participants gained 10% or more weight.
1. Kumar P, Johnson M, Xu ZJ, Martin E, Sklar P, Greaves W. Weight changes after switch to doravirine/lamivudine/TDF in the DRIVE-SHIFT trial. AIDS 2020: 23rd International AIDS Conference Virtual. July 6-10, 2020. Abstract PEC0740.