IDDF2024-ABS-0195 Long-term efficacy of tenofovir alafenamide in HBeAg-positive and -negative chronic hepatitis B patients treated for up to 8 years in 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 patients [N=425] and Study 110 in HBeAg-positive patients [N=873]), tenofovir alafenamide (TAF) demonstrated non-inferior efficacy relative to tenofovir disoproxil fumarate (TDF) in the blinded assessments. After completing up to 3 years (yr) of DB treatment, all patients were eligible to receive open-label (OL) TAF through week 384 (yr 8). Here, we present the final 8-yr results. Methods Efficacy was assessed for each study by missing equals excluded (M=E) approach of the full analysis set and included serial assessments for viral suppression (HBV DNA < 29 IU/mL), ALT normalization by 2018 AASLD criteria, serologic responses, and fibrosis change by serum FibroTest. Resistance analyses, including deep sequencing of HBV pol/RT (at baseline and annually), for those with virologic breakthrough/blip, persistent viremia, or treatment discontinuation with viremia were performed, as was phenotyping of qualifying samples. Results Of 1298 randomized and treated patients, 1157 (89%; 775 TAF; 382 TDF) entered the OL phase, including 180 and 202 TDF-treated patients who began OL TAF at week 96 (TDF-OL TAF 6 yr) or week 144 (TDF-OL TAF 5 yr) based on the timing of a protocol amendment. Overall, 974 (75%) participants completed OL study treatment. The most common reasons for discontinuation were withdrawal of consent, loss to follow-up, or investigator discretion. Similar high rates of virologic suppression and ALT normalization were achieved and maintained over 8 yr in all treatment groups (IDDF2024-ABS-0195 Table 1). Sequence/phenotyping analysis through 6 yr showed no resistance to TAF; resistance analyses at yr 8 are ongoing. Conclusions After 8 yr of treatment with TAF or up to 6 yr after switching from TDF, virologic suppression rates remained high across all groups; up to 33% achieved HBeAg/HBeAb seroconversion, while HBsAg loss was low (≤5%).
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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 | 0.003 | 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) | 0.005 | 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".