Supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health (R01-DK94818) as an ancillary study (NCT01924455) of the Hepatitis B Research Network; National Institutes of Health (NIH; K24AA022523); and the Intramural Research Program of the NIH, National Cancer Institute.

In a cohort of 114 adults with HBV-HIV followed for approximately 4 years, the composite clinical endpoint (hepatic decompensation/HCC/liver transplant/HBV-related death) and HBeAg loss were uncommon. In those with paired liver biopsies, there was slight improvement in liver inflammation but no significant change in fibrosis severity.

Potential conflict of interest: Dr. Chung received grants from Gilead, AbbVie, Merck, Bristol-Myers Squibb, Boehringer-Ingelheim, Roche, and GlaxoSmithKline. Dr. Lisker-Melman is on the speakers’ bureau for Gilead and AbbVie. Dr. Sulkowski consults and received grants from Assembly. He consults for Gilead and Arbutus. Dr. Khalili consults and received grants from Gilead. She received grants from Intercept. Dr. Jain advises and received grants from Gilead. She received grants from Merck and Janssen. Dr. Wong received grants from AbbVie. Dr. Sterling received grants from Abbott, Roche, AbbVie, and Gilead. He is on the data security monitoring board for AskBio and Pfizer. Dr. King received grants from Abbott.

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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/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% 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.

Supporting Information

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Volume74, Issue3

September 2021

Pages 1174-1189

A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America

Abstract

Background and Aims

Approach and Results

Conclusions

Supporting Information

References

Citing Literature

References

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A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America

Abstract

Background and Aims

Approach and Results

Conclusions

Supporting Information

References

Citing Literature

References

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