Antiviral therapy for patients with chronic hepatitis B in the immune-tolerant phase: A systematic review

ObjectiveObjective To systematically evaluate the efficacy and safety of antiviral therapy in patients with chronic hepatitis B (CHB) in the immune-tolerant phase. MethodsPubMed, Embase, Cochrane Library, CNKI, and Wanfang Data were searched for clinical trials of antiviral therapy for CHB patients in the immune-tolerant phase published up to September 2020. Related data were extracted after quality assessment for systematic review. HBV DNA clearance rate was the primary outcome. ResultsA total of 9 studies involving 821 patients were included. Eight studies reported HBV DNA clearance rate in the treatment group, among which 6 studies had an HBV DNA clearance rate of ＞60%, which was significantly higher than that in the untreated patients (0%-29.1%), and the combination therapy group had a better clearance rate than the monotherapy group. However, virologic recurrence was more common in the long term. Eight studies reported HBeAg seroconversion, and only 2 studies of the treatment of children with interferon-α (IFN-α) reported a seroconversion rate of ＞20% in the treatment group, which was higher than that in the untreated group. HBsAg clearance was observed in 2 studies of IFN-α treatment, while HBsAg seroconversion was not observed. One study reported the risk of liver cirrhosis and hepatocellular carcinoma (HCC) and showed that antiviral therapy could reduce the risk of liver cirrhosis and HCC in patients. The incidence rate of adverse events ranged from 4.1%-13.0% in the treatment with nucleos(t)ide analogues and reached 100% in the treatment with IFN-α, and serious adverse events were rare. ConclusionThe majority of CHB patients in the immune-tolerant phase show satisfactory virologic response after antiviral therapy, but they tend to experience recurrence after drug withdrawal and have a low seroconversion rate. Antiviral therapy has good safety. Current evidence suggests that such patients can be dynamically observed if there is no clear evidence for disease progression