IDDF2020-ABS-0060 Impact of prior tenofovir disoproxil fumarate (TDF) treatment duration on tenofovir alafenamide (TAF) safety profile in virally suppressed chronic HBV patients switched from TDF to TAF
Bibliographic record
Abstract
Background TAF demonstrated noninferior efficacy to TDF with a superior bone and renal safety profile, in viremic chronic HBV (CHB) patients through week 96, and in virally suppressed patients switched from TDF to TAF at 48 weeks. The duration of prior TDF therapy may influence the degree and rate of recovery of bone and renal function following switch to TAF. Here, we evaluate the impact of prior TDF treatment duration on the safety profile of TAF in virally suppressed patients. Methods In a double-blind, randomized, multicenter, active-controlled, Phase 3 study, 488 CHB patients who were virologically suppressed on TDF for 1 year, and on TDF monotherapy for 6 months were randomized 1:1 to switch to TAF or continue TDF for 48 weeks. In patients originally randomized to receive TAF, renal, bone, and lipid parameters were categorically evaluated by the duration of prior TDF treatment: Results Of the 243 patients switched to TAF from TDF, 105 (43%) and 138 (57%) had received TDF for 50 years, 74% male, 80% Asian, median eGFRCG91 mL/min, 4% and 12% had osteoporosis at hip and spine, respectively. Similar changes in renal, bone, and lipid parameters following 48 weeks of TAF treatment were observed by TDF treatment duration. A comparable increase in median eGFRCG, decreases in tubular biomarkers (beta-2 microglobulin/creatinine ratio, retinol binding protein/creatinine ratio), increases in mean percent change in hip and spine BMD, and decreases in bone turnover markers (C-type collagen sequence, procollagen type 1 N-terminal propeptide) were observed among patients previously treated with <4 and ≥4 years of TDF, respectively (table 1). Changes in fasting lipid parameters were not influenced by treatment duration. Conclusions In virally suppressed patients on TDF a median of 4 years who switched to TAF treatment, improvements in bone and renal parameters and changes in fasting lipids were not impacted by prior duration of TDF use.
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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 | 0.000 |
| 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.035 | 0.006 |
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".