Abstract
A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN-γ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.
Highlights
Hepatitis B virus (HBV) infection continues to be prevalent worldwide. It was reported by the World Health Organization (WHO) that an estimated two billion people have been infected with HBV all over the world, and of these, some 350 million develop chronic infection [1]
Eligible patients comprised males and females infected by HBV, with clinical diagnosis confirming to chronic hepatitis B carrier
In this study, compared with placebo, the Chinese Herbal Formula significantly increased the proportion of patients with reductions in serum HBV DNA of ≥2log10 IU/mL from baseline, whereas it does not enhance the rate of patients with undetectable serum HBV DNA level after 52 weeks of treatment
Summary
Hepatitis B virus (HBV) infection continues to be prevalent worldwide. It was reported by the World Health Organization (WHO) that an estimated two billion people have been infected with HBV all over the world, and of these, some 350 million develop chronic infection [1]. Patients in the immune tolerant phase are usually seropositive for HBeAg and have high viral loads (>2 × 106 IU/mL) but with a normal serum alanine aminotransferase (ALT) and normal or nearly normal findings on liver histology [6]. The latter are termed asymptomatic chronic HBV carriers. A prospective cohort study with an 11-year followup in China indicated that viral load was associated with increased mortality from hepatocellular carcinoma (HCC) and chronic liver disease among HBV carriers [7]. It is possible that HBV carriers in immune tolerant phase, characterized with high level of HBV DNA replication and normal or low ALT level, still have high infectivity and the risk of progress to cirrhosis and HCC
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