IDDF2019-ABS-0169 A phase 3 study comparing switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) with continued TDF treatment in virologically-suppressed patients with chronic hepatitis B (CHB): week 48 efficacy and safety results
Bibliographic record
Abstract
Background TAF has shown efficacy non-inferior to TDF with improved renal and bone safety in viremic CHB patients at Weeks 48 and 96. We evaluated efficacy and safety in stable, virally-suppressed patients who were switched from TDF to TAF vs. continued TDF for an additional year. Methods CHB patients on TDF for ³48 weeks with HBV DNA CG), and markers of bone turnover and renal tubular function. Viral resistance was evaluated by population sequencing those patients who experienced virologic breakthrough or viremia at the time of discontinuation. Results 488 patients were randomized and treated. At baseline the groups were similar: median age 52 y, 71% male, 82% Asian, 68% HBeAg-negative, median ALT 23 U/L, median eGFRCG90.5 mL/min; 45% and 50% had low BMD by T scores at hip and spine, respectively. Median (Q1, Q3) duration of prior TDF was 222 (145, 305) weeks. Key efficacy/safety results are summarized (table 1). TAF demonstrated non-inferior efficacy to TDF with a similar rate (0.4%) of having HBV DNA ³20 IU/mL at Week 48. TAF resulted in hip/spine BMD increases with less impact on bone turnover makers; switching from TDF to TAF resulted in eGFRCG increases and decreased tubular function markers. Rates of ³Grade 2 adverse events (AEs) and serious AEs were low and similar between groups. No viral resistance was observed. Conclusions Virologically-suppressed CHB patients who were switched to TAF demonstrated noninferior efficacy to continued TDF with improved bone and renal safety.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 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".