A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV‐HIV Co‐infected Adults in North America
Bibliographic record
Abstract
Background and Aims Histological and clinical outcomes in HBV‐HIV coinfection in the era of combination antiretroviral therapy (cART) are poorly defined. Approach and Results Adult patients co‐infected with HBV‐HIV from eight North American sites were enrolled in this National Institutes of Health (NIH)–funded prospective observational study (n = 139). Demographic, clinical, serological, and virological data were collected at entry and every 24 weeks for ≤ 192 weeks. Paired liver biopsies were obtained at study entry and at ≥ 3 years of follow‐up. Biopsies were assessed by a central pathology committee using the modified Ishak scoring system. Clinical outcome rate and changes in histology are reported. Among participants with follow‐up data (n = 114), median age was 49 years, 91% were male, 51% were non‐Hispanic Black, and 13% had at‐risk alcohol use, with a median infection of 20 years. At entry, 95% were on anti‐HBV cART. Median CD4 count was 562 cells/mm 3 and 93% had HIV < 400 copies/mL. HBeAg was positive in 61%, and HBV DNA was below the limit of quantification (< 20 IU/mL) in 61% and < 1,000 IU/mL in 80%. Clinical events were uncommon across follow‐up: one hepatic decompensation, two HCC, no liver transplants, and one HBV‐related deaths, with a composite endpoint rate of 0.61/100 person‐years. Incident cirrhosis (n = 1), alanine aminotransferase flare (n = 2), and HBeAg loss (n = 13) rates were 0.40, 0.65, and 6.86 per 100 person‐years, respectively. No participants had HBsAg loss. Paired biopsy (n = 62; median 3.6 years apart) revealed minimal improvement in Histologic Activity Index (median [interquartile range]: 3 [2‐4] to 3 [1‐3]; P = 0.02) and no significant change in fibrosis score (1 [1‐2] to 1 [0‐3]; P = 0.58). Conclusions In a North American cohort of adults with HBV‐HIV on cART with virological suppression, clinical outcomes and worsening histological disease were uncommon.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".