BACKGROUND: Interferon alpha (IFNalpha) therapy has been widely used in the treatment of chronic hepatitis B (CHB) for decades. Nucleos(t)ide analogues are also increasingly used to treat CHB recently. More and more studies are being carried out concerning the clearance or seroconversion of HBsAg, which is recognized as an ideal goal of CHB therapy. This study conducted a meta-analysis to estimate the effect of pegylated interferon alpha (peginterferon alpha, PEG-IFNalpha)-based therapy on HBsAg clearance or seroconversion in CHB.
METHODS: All available controlled clinical trials, published from 2004 to 2010, with the following antiviral therapies for CHB patients: PEG-IFNalpha combined with lamivudine (LAM), PEG-IFNalpha only, conventional IFNalpha and LAM, with a course [greater than or equal to]24 weeks, were meta-analysed for HBsAg clearance and seroconversion.
RESULTS: Fourteen trials (involving a total of 2,682 patients) were identified, including seven high-quality and seven low-quality studies. The analysis results of the different antiviral therapies on HBsAg clearance or seroconversion were as follows: 1. No significant difference in HBsAg clearance or seroconversion was observed between the combination therapy group and PEG-IFNalpha monotherapy group [odds ratio (OR) = 1.16, 95% confidence intervals (CI) (0.73-1.85), P = 0.54 and OR = 1.07, 95% CI (0.58-1.97), P = 0.82, respectively]; 2. HBsAg clearance and seroconversion rates in patients with combination therapy were markedly higher than in those with LAM monotherapy [OR = 9.41, 95% CI (1.18-74.94), P = 0.03, and OR = 12.37, 95% CI (1.60-95.44), P = 0.02, respectively]; 3. There was significant difference in HBsAg clearance between the PEG-IFNalpha group and IFNalpha monotherapy group [OR = 4.95, 95% CI (1.23-20.00), P = 0.02], but not in seroconversion [OR = 2.44, 95% CI (0.35-17.08), P = 0.37]; 4. PEG-IFNalpha was superior to LAM in HBsAg seroconversion [OR = 14.59, 95% CI (1.91-111.49), P = 0.01].
CONCLUSIONS: PEG-IFNalpha facilitated HBsAg clearance or seroconversion in CHB patients. PEG-IFNalpha-based therapy was more effective than LAM monotherapy in achieving HBsAg clearance or seroconversion for both HBeAg-positive and HBeAg-negative CHB patients. There was no significant difference in HBsAg clearance or seroconversion between PEG-IFNalpha/LAM combination therapy and PEG-IFNalpha monotherapy. PEG-IFNalpha was obviously superior to conventional IFNalpha in HBsAg clearance, but not in HBsAg seroconversion. Although PEG-IFNalpha produced significantly higher rates of HBsAg clearance and seroconversion, the absolute change in the proportion of HBsAg clearance and seroconversion was low (about 3-6%). Therefore, additional interventions are needed to improve the rate of positive outcomes