IDDF2021-ABS-0079 Switching from tenofovir disoproxil fumarate (TDF) and/or other oral antivirals (OAVS) to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with hepatic impairment: final 2-year efficacy and safety results from a phase 2
Bibliographic record
Abstract
Background We have previously shown that in hepatically impaired CHB patients, switching to TAF from TDF and/or other OAVs maintains high rates of viral suppression with stable bone and renal safety parameters through 48 weeks. Here we present our final 2-year (Week 96) results. Methods In this Phase 2 study (NCT03180619), virally suppressed CHB patients (HBV DNA CG], serum creatinine) parameters, viral suppression, and serological and biochemical responses were serially assessed. Results Of 31 patients enrolled, mean age was 55 y (29% ≥60 y), 68% male, 81% Asian, and 90% HBeAg-negative; median (Q1, Q3) CTP and MELD scores were 6 (5, 8) and 10 (7.5, 14.2), respectively, median eGFRCG98.5 mL/min; 19% had osteoporosis on spine DXA. Twenty-five (81%) patients completed 96 weeks of TAF treatment (6 discontinued early: 2-withdrew consent, 1-adverse event [AE; Grade 2 creatinine increase], 1-investigator decision, and 2-death [respiratory failure and aspiration pneumonia - both not treatment-related]). Week 96 efficacy/safety results are summarized in the Table. 96% of patients on TAF treatment had HBV DNA <20 IU/mL with a high proportion having normal ALT levels. Bone and renal parameters remained stable. TAF was well tolerated with no patients having a Grade 3 or 4 AE or a serious AE related to treatment. Conclusions At 2 years, CHB patients with hepatic impairment who were switched to TAF maintained high rates of viral suppression and normal ALT values while bone and renal parameters remained stable.
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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 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.002 |
| 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".