Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials
Bibliographic record
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: NCT02275780, NCT02403674, NCT02397096.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.017 | 0.010 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".