Meta-Analysis of Efficacy and Safety of Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Among People Living with HIV
Bibliographic record
Abstract
Integrase strand transfer inhibitor (InSTI)-based antiretroviral regimens have become the recommended antiretroviral therapy for people living with HIV (PLWH) who are antiretroviral-naïve or stably antiretroviral-treated. This meta-analysis aimed to systematically review the efficacy and safety of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among PLWH. Randomized controlled trials (RCTs) were included to compare the efficacy and safety between BIC/FTC/TAF and other antiretroviral regimens containing a non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or integrase strand transfer inhibitor plus two nucleos(t)ide reverse transcriptase inhibitors. A Mantel–Haenszel model was used to investigate the combination or interaction of a group of independent studies. I 2 was used to determine whether a fixed-effect model or random-effect model was to be used. A total of seven published randomized clinical trials including 3547 participants were analyzed; three studies were conducted in antiretroviral-naïve PLWH and four in stably antiretroviral-treated PLWH. At week 48, the efficacy with BIC/FTC/TAF was not statistically significantly different from that with control regimens [odds ratio (OR) 1.01 (95% CI 0.79, 1.30)]. BIC/FTC/TAF had comparable safety profiles to control regimens: OR for all adverse effects (AEs) was 0.92 (95% CI 0.78, 1.09); OR for any grade 3 or grade 4 AEs was 0.96 (95% CI 0.66, 1.39); and OR for treatment-related AEs was 1.31 (95% CI 0.68, 2.53). This meta-analysis of published randomized clinical trials of antiretroviral-naïve and stably antiretroviral-treated PLWH suggests that BIC/FTC/TAF is as safe and efficacious as are its comparators at week 48. The interstudy differences in selected populations and control regimens may lead to the high heterogeneity of the meta-analysis.
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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 | 0.030 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.018 | 0.050 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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 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".