Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1: results from a randomized trial
Bibliographic record
Abstract
OBJECTIVE: This study evaluated the efficacy (day 8) and safety (week 49) of doravirine/islatravir (DOR/ISL; 100 mg/0.75 mg) plus baseline antiretroviral therapy (ART) and optimized background therapy (OBT) in heavily treatment-experienced (HTE) adults living with detectable HIV-1 RNA. DESIGN AND METHODS: HTE adults with confirmed plasma viral load more than 500 copies/ml receiving a stable ART regimen for at least 3 months were randomly assigned 1 : 2 : 1 : 1 to receive once-daily ISL alone, DOR alone, DOR/ISL, or matching placebo for 7 days; at day 8, baseline ART was optimized and all participants received DOR/ISL and OBT through week 49. The primary efficacy endpoint was percentage of participants receiving DOR/ISL achieving at least 0.5 log 10 decline in viral load from baseline (day 1) to day 8. Secondary efficacy endpoints included HIV-1 RNA levels and CD4 + T-cell counts through week 49. RESULTS: Thirty-five of the planned 100 participants were enrolled; most were White (57.1%) and men (77.1%) with median age of 50 years. From days 1 to 8, an at least 1.0 log 10 decrease in HIV-1 RNA was achieved in 85.7% of the DOR/ISL group compared with 0 in the placebo group. At week 49, HIV-1 RNA less than 50 copies/ml was achieved in 22 participants (71%) and the mean increase in CD4 + T-cell count was 87 cells/μl. Adverse events were reported in 29 participants (82.9%) through week 49; 9 (25.7%) were considered related to DOR/ISL. CONCLUSION: DOR/ISL plus OBT improved HIV-1 suppression in HTE adults living with HIV-1 and was generally well tolerated. CLINICALTRIALSGOV: NCT04233216.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".