Changes in weight and body mass index with first-line doravirine-based therapy: a pooled analysis of three randomized controlled trials.

Objective To evaluate changes in weight and body mass index in adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included doravirine, ritonavir-boosted darunavir, or efavirenz. Design Post hoc analysis of pooled data from three randomized controlled trials. Methods We evaluated weight change from baseline, weight gain ≥10%, and increase in body mass index (BMI) after 48 and 96 weeks of treatment with doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens. Risk factors for weight gain and metabolic outcomes associated with weight gain were also examined. Results Mean [and median] weight changes were similar for doravirine (1.7 [1.0] kg) and ritonavir-boosted darunavir (1.4 [0.6] kg) and were lower for efavirenz (0.6 [0.0] kg) at week 48 but were similar across all treatment groups at week 96 (2.4 [1.5], 1.8 [0.7], and 1.6 [1.0] kg, respectively). No significant differences between treatment groups were found in the proportion of participants with ≥10% weight gain or the proportion with BMI class increase at either time point. Low CD4+ T-cell count and high HIV-1 RNA at baseline were associated with ≥10% weight gain and BMI class increase at both timepoints, but treatment group, age, sex, and race were not. Conclusions Weight gains over 96 weeks were low in all treatment groups and were similar to the average yearly change in adults without HIV-1. Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.