Large spontaneous HBV DNA fluctuations and potential usefulness of a single point measurement of combined HBV DNA and quantitative HBsAg for the exclusion of HBeAg negative chronic hepatitis B: A prospective Tunisian cohort study
Abstract Background/Aims: We aimed to describe spontaneous short-term hepatitis B Virus (HBV) DNA level fluctuations and to assess the usefulness of quantitative HBsAg (qHBsAg) in Tunisian patients with HBeAg-negative chronic HBV infection.Patients and methods: We included 174 treatment-naïve patients with chronic HBeAg-negative HBV. A one-year prospective follow-up was carried out with serial determinations of HBV DNA, alanine aminotransferase levels and qHBsAg. Patients were classified into three groups: inactive carriers (G1), patients with HBeAg negative chronic hepatitis B (CHB) (G2) and patients with indeterminate state (G3). For this latter group, a liver biopsy was indicated.Results: Only genotype D was detected. During the follow-up, 21.6% and 19.5% of patients with low initial (<2000 IU/mL) and intermediate viral load (2000-20000 IU/mL), experienced a subsequent increase in their HBV DNA levels above 2000 and 20000 IU/mL, respectively. Significant variations of HBV DNA levels (≥0.5 log10 IU/mL) were observed in 61.1% of patients at 6 months-interval. Among the 174 patients, 89 (51.1%) belonged to G1, 33 (19%) to G2 and 52 (29.9%) to G3. Fourteen patients have undergone liver biopsy, among whom 7 (50%) showed moderate to severe liver disease. Combination of HBV DNA <2000 IU/mL and qHBsAg <832 IU/mL excluded CHB in 98.4% of cases.Conclusions: This study highlights the large short-term HBV DNA fluctuations in Tunisian patients with HBeAg negative chronic HBV of genotype D. HBV DNA < 2000 IU/mL along with qHBsAg < 832 IU/mL excluded CHB in 98.4% of cases. Significant proportion of patients with indeterminate state within genotype D would have HBeAg negative CHB.