HBV : PE-007 ; Clinical courses of chronic hepatitis B patients with insufficient viral suppression to entecavir therapy = HBV : PE-007 ; Clinical courses of chronic hepatitis B patients with insufficient viral suppression to entecavir therapy

다국어 초록 (Multilingual Abstract)

Background: In patients with an insufficient virologic suppression, i.e., a detectable hepatitis B virus (HBV) DNA during antiviral treatment, a drug change or addition of a more efficacious drug is recommended. However, the clinical courses of patients with insufficient virologic suppression in chronic hepatitis B (CHB) patients with entecavir (ETV) therapy are unclear. Methods: The retrospective cohort study investigated the long-term clinical outcomes of ETV treatment of more than 3 years in 266 nucleos(t)ide-naive CHB patients, particularly those with insufficient virologic suppression. Results: All of the patients were genotype C2. Virologic response (VR) was achieved in 244 patients (91.7%) at 3 years of treatment. Virologic breakthrough was observed in four (1.5%) patients. Of these four patients, only one (0.4%) had genotypic resistance to ETV. The insufficient virologic suppression was defined as primary non-response (PNR), inadequate (IVR), or partial VR (PVR) according to residual HBV DNA levels at 12, 24, and 48 weeks of treatment, respectively. PNR, IVR, and PVR were evident in 5 (1.9%), 20 (7.5%), and 39 (14.7%) patients, respectively. During continuous prolonged ETV therapy, VR of patients with PNR, IVR, and PVR was achieved in five (100%), 10 (50%), and 22 (56.4%) patients, respectively. Conclusions: The vast majority of CHB patients achieved VR through prolonged ETV therapy, with only 0.4% chance of viral resistance up to 3 years of treatment. Furthmore, most patients with the insufficient virologic suppression such as PVR, as well as PNR and IVR could achieve VR without adjustment of antiviral therapy.