1 Virginia Commonwealth University, Richmond.
2 University of Pittsburgh, Graduate School of Public Health, Pittsburgh.
3 National Institutes of Health, Bethesda.
4 University of California San Francisco, San Francisco.
5 Johns Hopkins University, Baltimore.
6 Massachusetts General Hospital, Boston.
7 UT Southwestern Medical Center, Dallas.
8 Washington University School of Medicine, St. Louis.
9 Medicine, University of Toronto, 200 Elizabeth StreetEN9-228, M5G 2C4, Toronto, Ontario, Canada.
BACKGROUND AND AIMS:
Non-invasive biomarkers are increasingly used to assess fibrosis in patients with chronic liver disease. We determined the utility of dual cut-offs for non-invasive biomarkers to exclude and confirm advanced fibrosis in HBV-HIV co-infected patients receiving combined anti-retroviral therapy (cART).
PATIENTS AND METHODS:
Participants were anti-HIV/HBsAg positive adults from 8 clinical sites in the US and Canada of the Hepatitis B Research Network. Fibrosis was staged by a central pathology committee using the Ishak fibrosis score (F). Clinical, laboratory and vibration-controlled transient elastography (VCTE) data were collected at each site. Dual cut-offs for three non-invasive biomarkers (APRI, FIB-4 and liver stiffness by VCTE) with the best accuracy to exclude or confirm advanced fibrosis (F ≥3) were determined using established methodology.
Of 139 enrolled participants, 108 with a liver biopsy and having ≥1 non-invasive biomarker were included; 22% had advanced fibrosis; 54% had normal ALT. The median (IQR) of APRI (n=106), FIB-4 (n=106) and VCTE (n=63) were 0.34 (0.26-0.56), 1.35 (0.99-1.89), and 4.9 (3.8-6.8) kPa, respectively. The AUROC for advanced fibrosis was 0.69 for APRI, 0.66 for FIB-4, and 0.87 for VCTE. VCTE cut-offs of ≤5.0 kPa (to exclude) and ≥8.8 kPa (to confirm) advanced fibrosis had a sensitivity=92.3% and specificity=96.0%, respectively, and accounted for 65.1% of participants. Among the 34.9% with values between the cut-offs, 26.1% had advanced fibrosis. Considering APRI or FIB-4 jointly with VCTE did not improve the discriminatory capacity.
VCTE is a better biomarker of advanced fibrosis compared to APRI or FIB-4 in HBV/HIV co-infected adults on cART. Using VCTE dual cut-offs approximately two thirds of patients could avoid biopsy to determine advanced fibrosis.