Antiviral therapy with nucleotide/nucleoside analogues in chronic hepatitis B: A meta-analysis of prospective randomized trials

Abstract

Nucleotide/nucleoside analogues (antiviral therapy) are used in the therapy of HBeAg positive and HBeAg negative chronic hepatitis B. We analyzed ten selected randomized controlled with 2557 patients to estimate the effect of antiviral drugs in chronic hepatitis B with compared to placebo. Virological response, biochemical response, histological response, seroconversion of HBeAg, and loss of HBeAg were estimated as primary efficacy measures. The included studies were subjected for heterogeneity and publication bias. The heterogeneity was assessed with χ2 and I(2) statistics. Publication bias was assessed by funnel plot. Greater rates of improvement obtained in antiviral group for virological response [43.96 % vs. 3.15 %, RR = 0.57, 95 % CI = 0.54-0.61, p-value <0.00001], biochemical response [58.37 % vs. 21.87 %, RR = 0.52, 95 % CI = 0.48-0.56, p-value <0.00001], histological response [58.99 % vs. 27.13 %, RR = 0.56, 95 % CI = 0.50-0.63, p-value <0.0001], seroconversion of HBeAg [10.66 % vs. 5.56 %, RR = 0.94, 95 % CI = 0.91-0.97, p-value = 0.0005], and HBeAg loss [14.59 % vs. 9.64 %, RR = 0.92, 95 % CI = 0.88-0.96, p-value = 0.0002]. The safety analysis were carried out for adverse events such as headache [17.22 % vs. 17.34 %, OR = 1.09, 95 % CI = 0.81-1.46, p-value = 0.58], abdominal pain [16.46 % vs. 14.34 %, OR = 1.24, 95 % CI = 0.90-1.72, p-value = 0.19], and pharyngitis [22.22 % vs. 18.23 %, OR = 1.12, 95 % CI = 0.86-1.45, p-value = 0.40]. Excluding adverse events, all primary efficacy measures shown statistical significant result for chronic hepatitis treatment (p-value <0.05). Antiviral therapy provided significant benefit for the treatment of chronic hepatitis B with no measurable adverse effects.

Keywords: Antiviral drugs; Chronic hepatitis B; Meta-analysis; Nucleotide analogue; Randomized trials.