Abstract
The objective of this study was to evaluate the effectiveness and safety of entecavir (ETV) and interferon (IFN) combination therapy in the treatment of chronic hepatitis B (CHB) mono-infection via a meta-analysis of randomized controlled trials (RCTs). All eligible RCTs evaluating combination therapy for treating CHB were identified from nine electronic databases. A meta-analysis was performed in accordance with the Cochrane Systemic Review handbook. Eleven trials encompassing 1010 participants were included in this meta-analysis. It showed that at 12 and ≥ 96 weeks of therapy, the combination of ETV and IFN was not better than ETV in improving the undetectable HBV DNA (12 weeks: RR=1.12, 95% CI=0.88-1.42; ≥ 96 weeks: RR = 0.64, 95% CI=0.21-1.98, respectively) and HBeAg seroconversion rates (12 weeks: RR=1.35, 95% CI=0.60-3.04; ≥ 96 weeks: RR=1.36, 95% CI=0.75-2.64, respectively). But at 48 weeks of therapy and approximately 2 years of follow up, combination therapy was superior to ETV in improving the undetectable HBV DNA (48 weeks: RR=1.46, 95% CI=1.13-1.90; follow up: RR=2.20, 95% CI=1.26-3.81, respectively) and HBeAg seroconversion rates (48 weeks: RR=1.82, 95% CI=1.44-2.30; follow up: RR=1.92, 95% CI=1.19-3.11, respectively). When compared to IFN group, at 24 and 48 weeks of therapy, combination group showed a greater undetectable HBV DNA (24 weeks: RR=2.14, 95% CI=1.59-2.89; 48 weeks: RR=2.28, 95% CI=1.54-3.37, respectively) and ALT normalization rate (24 weeks: RR=1.56, 95% CI= 1.24-1.96; 48 weeks: RR=1.55, 95% CI = 1.16-2.07, respectively). At 48 weeks of therapy, combination group achieved a greater HBeAg seroconversion rate than IFN (48 weeks: RR=1.58, 95% CI=1.24-2.00). No significant differences were observed in the side effects of the three therapies. So we can conclude that ETV and IFN combination therapy is more effective than ETV or IFN mono-therapy in CHB treatment. ETV, IFN, and the combination of the two are safe in CHB treatment.
Highlights
Liver disease associated with persistent hepatitis B virus (HBV) infection represents a major health problem with global impact
At 48 weeks of therapy and approximately 2 years of follow up, combination therapy was superior to ETV in improving the undetectable HBV DNA (48 weeks: RR=1.46, 95% CI=1.13-1.90; follow up: RR=2.20, 95% CI=1.26-3.81, respectively) and HBeAg seroconversion rates (48 weeks: RR=1.82, 95% CI=1.44-2.30; follow up: RR=1.92, 95% CI=1.19-3.11, respectively)
2 billion people have been infected with HBV at one point, and over 350 million people suffer from chronic hepatitis B (CHB) worldwide [1]
Summary
Liver disease associated with persistent hepatitis B virus (HBV) infection represents a major health problem with global impact. 2 billion people have been infected with HBV at one point, and over 350 million people suffer from chronic hepatitis B (CHB) worldwide [1]. Antiviral therapy is an effective way of preventing disease progression and even reversing liver fibrosis and cirrhosis [3,4,5,6]. The major advantages of the NAs are their high tolerability, effective suppression of HBV DNA replication and a high rate of on-treatment response. The drawbacks of NAs are noteworthy; patients suffer from an indefinite treatment duration and drug resistance triggered by long-term therapy. IFN is an immunomodulatory drug with a low rate of resistance, a finite course of treatment and potential long-term post-treatment responses. Responses to IFN are only attained in a minority of patients, and severe adverse reactions make IFN poorly tolerated [9,10,11]
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