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A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV‐HIV Co‐infected Adults in North America
Author(s) -
Sterling Richard K.,
King Wendy C.,
Khalili Mandana,
Chung Raymond T.,
Sulkowski Mark,
Jain Mamta K.,
LiskerMelman Mauricio,
Ghany Marc G.,
Wong David K.,
Hinerman Amanda S.,
Bhan Atul K.,
Wahed Abdus S.,
Kleiner David E.
Publication year - 2021
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.31823
Subject(s) - medicine , gastroenterology , cirrhosis , hbeag , coinfection , prospective cohort study , hepatitis b , serology , viral load , hepatitis b virus , hbsag , human immunodeficiency virus (hiv) , immunology , antibody , virus
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.