Histological and clinical outcomes in HBV-HIV coinfection in the era of combination antiretroviral therapy (cART) are poorly-defined.
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.
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 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).
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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