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Abstract Details
A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America
Hepatology. 2021 Mar 20. doi: 10.1002/hep.31823. Online ahead of print.
Richard K Sterling1, Wendy C King2, Mandana Khalili3, Raymond T Chung4, Mark Sulkowski5, Mamta K Jain6, Mauricio Lisker-Melman7, Marc G Ghany8, David K Wong9, Amanda S Hinerman2, Atul K Bhan4, Abdus S Wahed2, David E Kleiner8, HIV-HBV Cohort Study of the Hepatitis B Research Network
Author information
1Virginia Commonwealth University, Richmond.
2University of Pittsburgh, Graduate School of Public Health, Pittsburgh.
3University of California San Francisco, San Francisco.
4Massachusetts General Hospital, Harvard Medical School, Boston.
5Johns Hopkins University, Baltimore.
6University of Texas Southwestern, Dallas.
7Washington University School of Medicine, St. Louis.
8National Cancer Institute, Bethesda.
9University Health Network, Toronto.
Abstract
Introduction: Histological and clinical outcomes in HBV-HIV coinfection in the era of combination antiretroviral therapy (cART) are poorly-defined.
Methods: Adult HBV-HIV co-infected patients from 8 North American sites were enrolled in this 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 Modified Ishak scoring system. Clinical outcome rate and changes in histology are reported.
Results: 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/mm3 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%; <1000 IU/mL in 80%. Clinical events were uncommon across follow-up: 1 hepatic decompensation, 2 hepatocellular carcinoma, no liver transplants and 1 HBV-related deaths, with a composite endpoint rate of 0.61/100 person-years. Incident cirrhosis (n=1), ALT flare (n=2), and HBeAg loss (n=13) rates were 0.40, 0.65 and 6.86/100 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 [IQR]: 3 [2-4] to 3 [1-3]; P=.02) and no significant change in fibrosis score (1 [1-2] to 1 [0-3]; P=.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.