IDDF2019-ABS-0168 Bone and renal safety are improved in chronic hbv patients 1 year after switching to tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF)
Bibliographic record
Abstract
Background TAF has shown efficacy non-inferior to that of TDF at Week 96 with less bone and renal effects. Following implementation of a protocol amendment to extend double-blind (DB) treatment for an additional year, 50% of patients were able to continue on DB treatment while the remainder had already rolled-over to open-label (OL) TAF at Week 96. Here we compared the efficacy and safety from Week 96 to 144 in patients randomized to TDF in whom treatment was either continued or switched to TAF at Week 96. Methods In 2 identically-designed studies, 1298 HBeAg-negative and HBeAg-positive CHB patients (873 TAF, 425 TDF) were randomized and treated. In the TDF group, 211 remained on TDF (DB TDF) while 180 patients were switched to OL TAF (TDF→TAF) at Week 96. Safety assessments including changes in bone (hip and spine BMD) and renal (CrCl by Cockcroft-Gault [eGFRCG], serum creatinine) parameters, viral suppression, and biochemical responses were assessed in all patients from Week 96 to Week 144. Results Patient characteristics were similar for those who continued TDF and those switched to TAF. In the TDF→TAF group, improvements in eGFRCG were observed, while those remaining on DB TDF showed a continued decrease in eGFRCG at Week 144 (table 1). Similarly, significant improvements in hip and spine BMD were seen over 1 year in TDF→TAF patients while those remaining on TDF either had continued BMD declines or smaller increases (figure 1). High rates of virologic suppression (HBV DNA <29 IU/mL) were maintained in both groups (TDF→TAF 84% and DB TDF 88%; M=F), while a greater rate of ALT normalization (by 2018 AASLD criteria) was seen in TDF→TAF patients at 1 year following switch (45% vs 29%; M=F). Conclusions Virologic control was maintained and ALT normalization was increased following switch from TDF to TAF. However, compared to those remaining on TDF for an additional year, patients switched to TAF had 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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".