Early changes in HBV RNA serum levels are a predictor of HBeAg seroconversion in patients with chronic hepatitis B receiving treatment with Peg-interferon alpha-2a (40KD).

Introduction: We explored HBV RNA as a predictor of HBeAg seroconversion in patients with chronic hepatitis B (CHB).

Methodology: 16 pairs of patients with HBeAg positive CHB (HBeAg seroconversion vs. non-seroconversion, matched by country and genotype) treated with Peg-IFN alpha-2a for 48 weeks and observed for additional 24 weeks were retrospectively studied. HBV RNA was quantified from serum samples collected at baseline, at weeks 12 and 24 of treatment. The factors HBV RNA, HBV DNA, HBsAg and ALT levels at baseline, week 12 and 24 were explored for their association with HBeAg seroconversion in a multivariate model.

Results: At baseline, in patients achieving HBeAg seroconversion compared to patients without seroconversion mean serum levels were lower in HBV DNA (6.9 ± 1.2 vs. 8.1 ± 0.8 log₁₀ copies/mL, p = 0.002), in HBV RNA (5.5 ± 1.5 vs. 6.7 ± 0.7 log₁₀ copies/mL, p = 0.007), and in HBsAg (3.5 ± 1.0 vs. 4.6 ± 0.3 IU/mL, p = 0.001). At weeks 12 and 24 of treatment, patients with compared to those without HBeAg seroconversion had lower levels in HBV DNA (4.9 ± 1.5[2.7 – 7.6] vs. 7.1 ± 0.9, p < 0.0001 and 3.4 ± 1.6[1.52 – 6.3] vs. 6.8 ± 0.7[5.7 – 8.2], p < 0.0001), HBV RNA (3.5 ± 0.9[2.9 – 5.7] vs. 5.6 ± 0.6[4.3 – 6.6], p < 0.0001and 3.1 ± 0.3[3 – 4.1] vs. 5.2 ± 0.6[4 – 6.3], p < 0.0001) and HBsAg levels (3.0 ± 0.7[1.8 – 4.9] vs. 4.2 ± 0.4[3.3 – 5.1], p < 0.0001 and 2.5 ± 1.1[0.05 – 4.4] vs. 4 ± 0.8[3.2 – 5.1], p < 0.0001). The area under the curve (AUC) for the prediction of HBeAg seroconversion by HBV RNA levels at baseline, week 12 and 24 was 0.65, 0.95 and 1, respectively.

Conclusion: HBV RNA levels represent a novel baseline and on-treatment marker for early prediction of response to treatment with PEG-IFN in patients with HBeAg positive CHB. [HH1]Shouldn't be a variable anymore as it was balanced already