Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials.

Abstract

Background: Females and persons of Black race are often underrepresented in clinical trials. This post hoc analysis of data from three phase 3 studies evaluated the efficacy and safety of doravirine (DOR) by sex and race in adults living with HIV-1.

Methods: DRIVE-FORWARD and DRIVE-AHEAD open-label extensions were pooled; participants randomized to first-line DOR-based regimen continued from week (W) 96 to W192 (DOR-continued group) and participants randomized to comparators switched to DOR from W96 to W192 (DOR-switch group). In DRIVE-SHIFT, virologically suppressed adults were randomized to switch to a DOR-based regimen on day 1 (immediate-switch group) or W24 (delayed-switch group) and continued through W144. Results are reported by sex assigned at birth (male vs female) and race (Black vs non-Black).

Results: Across trials, female and Black participants each represented <20% of study populations. After continuing or switching to DOR, percentages of participants with HIV-1 RNA <50 copies/mL were comparable between sex and race subgroups. Mean changes in CD4+ T-cell counts and proportions of participants with drug-related adverse events or serious adverse events were generally similar between subgroups. In DRIVE-SHIFT, higher rates of nontreatment-related discontinuations were observed within Black versus non-Black subgroups. Differences in median weight change were generally larger between race subgroups than sex subgroups, although interquartile ranges were wide for all.

Conclusions: Participants who continued or switched to DOR generally had comparable efficacy and safety outcomes across sex and race subgroups. However, the sample size was limited. Future studies should ensure greater diversity when investigating factors leading to outcome disparities. ClinicalTrials.gov: NCT02275780, NCT02403674, NCT02397096.