IDDF2021-ABS-0077 Efficacy and safety of tenofovir alafenamide (TAF) vs tenofovir disoproxil fumarate (TDF) in east asian chronic hepatitis B patients following 5-years of treatment
Bibliographic record
Abstract
Background Pivotal studies GS-US-320-0108 (HBeAg-negative) and GS-US-320-0110 (HBeAg-positive), demonstrated non-inferior antiviral efficacy of TAF vs. TDF with superior renal/bone safety through 5-years, after up to 3 years of double-blind (DB) treatment, open-label (OL) TAF was available through year 8. We analyzed TAF efficacy and safety among patients of Asian Ethnicity in Studies 108/110. Methods Efficacy was assessed by individual study and included virologic, biochemical, and serologic assessments. Safety data were pooled including estimated GFR (by Cockcroft-Gault method; eGFRCG) and hip and spine bone mineral density (BMD) changes. Results Among 1298 patients randomized and treated, 591 (45.5%) were Asian (TAF n=410, while n=84 and n=106 received TDF-OL-TAF-3 years and TDF-OL-TAF-2 years, respectively. Virologic control was achieved and maintained in patients receiving TAF (95%) and for TDF-OL-TAF-3 years (100%) and TDF-OL-TAF-2 years (98%). ALT normalization rates were comparable among groups (TAF: 79%, TDF-OL-TAF-3 years: 80%; TDF-OL-TAF-2-years: 79%). HBeAg loss/seroconversion was similar (TAF: 38.6%/27.4%, TDF-OL-TAF-3 years: 46.9%/37.5%; TDF-OL-TAF-2-years: 47.1%/29.4%). Rates of HBsAg loss/seroconversion were similar in all groups (≤1%). Rates of Grade ¾ adverse events (AEs) and AEs leading to discontinuation were low (1.5%) among all 3 groups. After experiencing declines in eGFRCG and in hip/spine BMD over 2 or 3 years of TDF treatment, renal and bone outcomes were improved following the switch to OL TAF. Conclusions After 5 years of treatment, virologic suppression remained high, and TAF was safe and well-tolerated with improved renal and bone safety among patients of Asian Ethnicity switching from TDF.
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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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".