IDDF2024-ABS-0201 Long-term safety profile of tenofovir alafenamide in chronic hepatitis B patients; final 8-year results of 2 phase 3 studies
Bibliographic record
Abstract
Background In 2 similarly designed double-blind (DB), randomized (2:1), Phase 3 studies (Study 108 in HBeAg-negative [N=425] and Study 110 in HBeAg-positive [N=873] patients), tenofovir alafenamide (TAF) demonstrated non-inferior efficacy with superior renal and bone safety compared to tenofovir disoproxil fumarate (TDF) at week 96. After completing DB treatment, all patients were eligible to receive open-label (OL) TAF through week 384 (year 8). Here, we present the final safety results at year 8. Methods In a pooled analysis, treatment-emergent adverse events (AEs), serious AEs (SAEs), discontinuations, and laboratory abnormalities were assessed in patients who received OL TAF. Changes from baseline in estimated GFR (by Cockcroft-Gault; eGFRCG) and changes in hip and spine bone mineral density (BMD) by dual x-ray absorptiometry (DXA) scans were assessed. Results Of 1298 randomized and treated patients, 1157 (89%; 775 TAF; 382 TDF) entered the OL phase. Overall, 974 (75%) participants completed OL study treatment. The overall incidence of patients experiencing AEs was similar among groups (IDDF2024-ABS-0201 Table 1). Rates of Grade 3/4 AEs and AEs leading to discontinuation (D/C) were low and similar among groups. Few Grade 3/4 AEs or SAEs were related to the study drug. Overall, the most common Grade 3/4 lab abnormalities (>2%) were increased amylase (TAF 1.9%, TDF-TAF 2.7%), creatine kinase (TAF 1.4%, TDF-TAF 2.1%), fasting cholesterol (TAF 1.4%, TDF-TAF 2.9%), fasting LDL (TAF 5.9%, TDF-TAF 8.0%), and urine glucose (TAF 5.2%, TDF-TAF 2.7%). After experiencing declines in eGFRCG and hip/spine BMD with TDF treatment in the DB phase, renal and bone outcomes improved following the switch to OL TAF with minimal change through year 8. Overall, low rates of hepatocellular carcinoma (HCC) were observed over 8 years, with 11 cases occurring in the DB and 10 in the OL phases of the study. Conclusions Long-term TAF treatment was safe and well tolerated, with minimal changes in eGFRCG and BMD occurring over 8 years.
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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 | 0.004 | 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 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".