S1070 A Phase 3 Study Comparing Switching: Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) With Continued TDF Treatment in Virologically Suppressed Patients With Chronic Hepatitis B: Final Week 96 Results
Bibliographic record
Abstract
INTRODUCTION: We have previously demonstrated at Week 48 that switching to TAF vs continued TDF treatment in CHB patients who were virally suppressed on long-term TDF has shown noninferior efficacy of TAF to TDF with superior bone and renal safety. Here we report the final, efficacy and safety results from this study at Week 96. METHODS: In this Phase 3 study (NCT02979613), CHB patients taking TDF for ≥48 weeks with HBV DNA < LLOQ (local lab) for ≥12 weeks and < 20 IU/mL at screening were randomized (1:1) to TAF 25 mg QD or TDF 300 mg QD, each with matching placebo, and treated for 48 weeks in a double-blind (DB) fashion. At Week 48, all patients received open-label (OL) TAF 25 mg once daily for an additional 48 weeks. Safety assessments including changes in bone (hip and spine BMD) and renal (CrCl by Cockcroft-Gault [eGFRCG], serum creatinine) parameters; viral suppression, and serological and biochemical responses were also assessed in all patients. RESULTS: Of 488 (TAF 243, TDF 245) patients randomized and treated, 472 (97%; TAF 235, TDF 237) completed 48 weeks of DB treatment, and 465 (95%; TAF 233, TDF 232) completed study treatment through Week 96. At baseline, patient characteristics were similar between groups and have been previously reported. Key efficacy/safety results are summarized in the Table. Virologic suppression (HBV DNA < 20 IU/mL) was similarly maintained at Week 96 in patients switched to TAF treatment at BL vs those switched to TAF after 48 weeks of DB TDF treatment; rates of ALT normalization were increased in both groups at Week 96. In patients switched to TAF at BL vs those switched at Week 48, similar increases in spine BMD were seen while increases in hip BMD were smaller. In the TDF group, eGFRCG decreased at Week 48 (-2.7mL/min); an improvement was seen after switching to TAF at Wk96 (-0.39mL/min). CONCLUSION: In CHB patients on long-term TDF treatment, viral suppression was maintained, ALT normalization increased, and bone and renal safety parameters were improved at Week 96.Table 1
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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 | 0.002 | 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 | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".