Switch to bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV aged 65 years or older: BICOLDER study – IMEA 057
Bibliographic record
Abstract
BACKGROUND: Polymedication and comorbidities are frequent in aging people with HIV (PWH) and often associated with elevated incidences of adverse events (AEs) and drug-drug interactions (DDIs). The objective of this study was to evaluate the efficacy, safety and practicality of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), an antiretroviral (ARV) therapy with limited DDIs, in an elderly virologically-controlled PWH population. MATERIALS AND METHODS: This study was prospective, multicentric, single-arm conducted in HIV-1 controlled PWH aged over 65 years who switched from a ritonavir- or cobicistat-boosted containing regimen to B/F/TAF. The primary outcome was the proportion of participants maintaining plasma HIV-1 RNA < 50 copies/mL at Week24. Secondary endpoints included biological endpoints and co-morbidity (Charlson) and frailty (Fried) scores. Median (IQR) results are presented. RESULTS: 24 participants aged 69 years (67-73), 79.2 % Caucasian, were analyzed in the intention-to-treat analysis. 75 % of participants were receiving an elvitegravir/cobicistat based regimen. At week24 and week48, 91.7 % of participants maintained a plasma HIV-1 RNA < 50 copies/mL. Study treatment was discontinued in one participant due to virologic failure at week12, possibly related to adherence issues following AE. Drug-related AEs were reported in 6 participants, with one discontinuation at week4 (nightmare/mood disorder). No life-threatening AEs or deaths were reported. No significant modifications from baseline were reported in weight, co-morbidities, kidney parameters, cardiovascular risk or frailty scores at W48. A mild decrease of total cholesterol and triglycerides was reported. CONCLUSIONS: The findings indicate that B/F/TAF is both safe and effective for elderly PWH patients with a prolonged and documented history of HIV infection, multiple co-morbidities and concomitant medication.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".