Abstract | BACKGROUND AND AIMS: 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.
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Authors | Richard K Sterling, Wendy C King, Mandana Khalili, Raymond T Chung, Mark Sulkowski, Mamta K Jain, Mauricio Lisker-Melman, Marc G Ghany, David K Wong, Amanda S Hinerman, Atul K Bhan, Abdus S Wahed, David E Kleiner, HBV-HIV Cohort Study of the Hepatitis B Research Network |
Journal | Hepatology (Baltimore, Md.)
(Hepatology)
Vol. 74
Issue 3
Pg. 1174-1189
(09 2021)
ISSN: 1527-3350 [Electronic] United States |
PMID | 33743541
(Publication Type: Journal Article, Observational Study, Research Support, N.I.H., Extramural, Research Support, N.I.H., Intramural)
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Copyright | © 2021 by the American Association for the Study of Liver Diseases. |
Chemical References |
- Antiviral Agents
- Hepatitis B Surface Antigens
- Hepatitis B e Antigens
- Reverse Transcriptase Inhibitors
- Lamivudine
- entecavir
- Guanine
- Tenofovir
- Alanine Transaminase
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Topics |
- Adolescent
- Adult
- Aged
- Alanine Transaminase
(blood)
- Antiviral Agents
(therapeutic use)
- Coinfection
- Drug Therapy, Combination
- Female
- Guanine
(analogs & derivatives, therapeutic use)
- HIV Infections
(complications, drug therapy)
- Hepatitis B Surface Antigens
(blood)
- Hepatitis B e Antigens
(blood)
- Hepatitis B, Chronic
(blood, complications, drug therapy, pathology)
- Humans
- Lamivudine
(therapeutic use)
- Liver
(pathology)
- Male
- Middle Aged
- North America
- Prospective Studies
- Reverse Transcriptase Inhibitors
(therapeutic use)
- Tenofovir
(therapeutic use)
- Treatment Outcome
- Young Adult
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