Patient-Reported Outcomes Among Virally Suppressed People Living with HIV Switching to Dolutegravir/Lamivudine vs. Continuing Bictegravir/Emtricitabine/Tenofovir Alafenamide from the Randomized DYAD Study.

Abstract

In the DYAD study, switching to dolutegravir/lamivudine (DTG/3TC) was noninferior to continuing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed adults. Here, we present changes in patient-reported outcomes (PROs) among participants who completed Week (W) 48. DYAD used PRO measures to evaluate HIV- and antiretroviral-related symptoms (HIV-SI) and treatment satisfaction (HIVTSQ/c) at baseline, W24, and W48. Symptoms described as bothersome versus not bothersome were compared across time by treatment group using chi-squared testing. Changes from baseline in HIV-SI and HIVTSQ/c scores were compared between treatment groups using adjusted ANCOVA models. Overall, 134 on DTG/3TC and 65 on B/F/TAF completed W48. At W24, 16% on DTG/3TC reported headache as bothersome versus 6% on B/F/TAF (p = 0.04); however, at W48, there was no significant difference in headache. At W48, 10% on DTG/3TC reported diarrhea as bothersome versus 0% on B/F/TAF (p = 0.01); however, there was no significant difference in diarrhea at W24. There were no other significant differences in bothersome symptoms through W48. At W48, both DTG/3TC and B/F/TAF participants demonstrated small, nonsignificantly different reductions in HIV-SI symptom score (-5.9 versus -4.3; adjusted treatment difference, -1.6; 95% confidence interval [CI]: -4.8, 1.5) and treatment satisfaction score (-3.7 versus -3.2; adjusted treatment difference, -0.5; 95% CI: -6.5, 5.5). In DYAD, both DTG/3TC and B/F/TAF were associated with similar, small reductions in overall symptom burden and stable treatment satisfaction scores at W48. These data support DTG/3TC as a switch option with comparable symptom burden and treatment satisfaction to modern 3-drug integrase inhibitor-based regimens.