title: Discriminant value of serum HBV DNA levels as predictors of liver fibrosis in chronic hepatitis B.
abstract: Current guidelines recommend antiviral therapy in chronic hepatitis B (HBV) patients with significant histological disease. We aimed to compare histological fibrosis (METAVIR, ≥F2) in patients with HBV DNA ≥20,000 IU/mL vs. ≥2000 IU/mL and identify predictors of fibrosis. We performed prospective liver biopsies on 203 HBeAg-negative patients in four groups: Group I (n = 55): HBV DNA ≥20,000 IU/mL and persistently elevated alanine aminotransferase (ALT) levels (PEALT; >40 U/L); Group II (n = 34): HBV DNA ≥20,000 IU/mL and persistently normal ALT (PNALT); Group III (n = 40): HBV DNA <20,000 IU/mL and PEALT; and Group IV (n = 74): HBV DNA <20,000 IU/mL, and PNALT. We reanalysed all groups in relation to updated cut-off for treatable viremia (2000 IU/mL). Genotype D was detected in 86% of patients. Hepatic fibrosis ≥F2 was detected in 72.7%, 52.9%, 57.5% and 18.9% in Groups I-IV, respectively (P < 0.0001). Except in Group II with a trend for lower ≥F2 fibrosis (P = 0.067), there was no significant difference by using HBV DNA cut-off 20,000 vs. 2000 IU/mL. Multivariate logistic regression analysis identified study Group IV (OR, 0.0276; CI: 0.088-0.868; P = 0.0276) and milder (A0-1) necroinflammatory grade (OR, 0.135; CI: 0.063-0.287; P < 0.0001) as independent predictors of ≥F2 fibrosis. The specificity, positive and negative predictive values for PEALT in detection of ≥F2 fibrosis for viremia ≥2000 IU/mL (80%, 69% and 65%, respectively) or ≥20,000 IU/mL (86%, 73% and 63%, respectively) were similar, with a marginal gain in sensitivity (51% vs. 42%, respectively). Significant fibrosis is prevalent in a large proportion of HBeAg-negative patients with high viremia and persistently normal ALT. Lower HBV DNA cut-offs could be adopted with marginal gains in fibrosis detection and without loss of diagnostic accuracy.
authors.affiliation: Department of Hepatobiliary Sciences, King Abdulaziz Medical City, Riyadh, KSA. sanaifa@ngha.med.sa
authors.forename: F M
authors.initials: FM
authors.lastname: Sanai
authors.forename: A
authors.initials: A
authors.lastname: Helmy
authors.forename: K I
authors.initials: KI
authors.lastname: Bzeizi
authors.forename: M A
authors.initials: MA
authors.lastname: Babatin
authors.forename: A
authors.initials: A
authors.lastname: Al-Qahtani
authors.forename: H A
authors.initials: HA
authors.lastname: Al-Ashgar
authors.forename: A S
authors.initials: AS
authors.lastname: Al-Mdani
authors.forename: A
authors.initials: A
authors.lastname: Al-Akwaa
authors.forename: S
authors.initials: S
authors.lastname: Almutharea
authors.forename: M Q
authors.initials: MQ
authors.lastname: Khan
authors.forename: A S
authors.initials: AS
authors.lastname: Alghamdi
authors.forename: T
authors.initials: T
authors.lastname: Farah
authors.forename: W
authors.initials: W
authors.lastname: Al-Hamoudi
authors.forename: M
authors.initials: M
authors.lastname: Saadeh
authors.forename: A A
authors.initials: AA
authors.lastname: Abdo
mesh_terms: D000328:Adult; D000367:Age Factors; D000410:Alanine Transaminase / Q000097:blood*; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000150:complications*; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012737:Sex Factors; D000509:alpha-Fetoproteins / Q000032:analysis
chemical_list: D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000509:alpha-Fetoproteins; D000410:Alanine Transaminase; D001663:Bilirubin