Efficacy of serum HBV DNA levels to differentiate various stages of chronic hepatitis B infection and its relationship with serologic markers and biochemical profile

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Background: In Chronic Hepatitis B (CHB) patients, ongoing debate is to differentiate between Inactive carrier and HBeAg negative CHB with normal ALT. Cut-off value of HBV DNA to define these two phases of CHB is still not known. Aim: To determine HBV DNA levels in serum of patients in different stages of CHB infection and to assess its relationship with serologic markers and Biochemical profile. To determine serum HBV DNA level that would differentiate HBeAg negative CHB patients from Inactive carriers. Methods: We prospectively analyzed 324 CHB patients between April 2008 and April 2011 at SMS Hospital, Jaipur. On basis of HBeAg and ALT, patients were further categorized into four groups. (i)Inactive Carriers (141; HBeAg negative, normal ALT), (ii) HBeAg negative CHB (126; HBeAg negative, elevated ALT), (iii) HBeAg positive CHB (38; HBeAg positive, elevated ALT), (iv) Immune Tolerance (19; HBeAg positive, normal ALT). Serum samples of patients were tested for liver biochemistry, markers of HBV and Viral load estimation. Results: Of 324 patients (mean Age 34.85 ± 13.25, 274 males), mean HBV DNA levels of patients with HBeAg positive CHB and Immune tolerant phase was significantly higher than HBeAg negative CHB patients. Statistically significant correlation was found between serum HBV DNA levels and ALT in Inactive carriers (p=0.047 Spearman correlation test). In ROC curve AUC was 0.71 (p=0.0001; CI: 0.65-0.76) and HBV DNA cut-off of 6.2x102 IU/ml had moderate sensitivity (62.1%) & specificity (63.8%) in differentiating HBeAg negative CHB from Inactive carriers. Conclusion: HBeAg positive patients had significantly higher HBV viremia than HBeAg negative patients. There was positive co-relation between HBV DNA levels and ALT levels in Inactive Carriers but not in HBeAg negative CHB. HBV DNA level of 6.3x102 IU/ml had moderate sensitivity and specificity in differentiating between HBeAg negative CHB patients from Inactive carriers.