HBV : PE-005 ; Long-term treatment efficacy of entecavir therapy in naive patients with chronic hepatitis B with partial virological response = HBV : PE-005 ; Long-term treatment efficacy of entecavir therapy in naive patients with chronic hepatitis B with partial virological response

다국어 초록 (Multilingual Abstract)

Background: Partial virological response (PVR) to less potent nucleos(t)ide analogues was associated with risk of antiviral resistance in naive chronic hepatitis B (CHB) patients. However, there were limited data for PVR to more potent drug entecavir (ETV). The objective of this study was to investigate the continuous long-term treatment efficacy of ETV in naive CHB patients with PVR. Methods: This study included 227 naive patients who were treated with ETV 0.5mg for more than 12 months between March 2007 and June 2011. PVR was defined as more than 1 log10 decline of viremia from baseline but a detectable serum HBV DNA by PCR (>20 IU/mL) at week 48. Complete virologic response (CVR) was defined as undetectable serum HBV DNA by PCR (<20 IU/mL) at week 48. Results: At week-48, CVR was 162/227 (71.4%) and PVR was 65/227 (28.6%). HBeAg positivity, baseline serum HBV DNA level (≥8 log10IU/mL), serum HBV DNA at week 12 ≥2,000 IU/mL, serum HBV DNA at week 24 ≥2,000 IU/mL were independently associated with PVR at week 48. Cumulated probabilities of virologic response (<20 IU/mL) at week 96 and 144 in patinets with PVR were 50.9% and 76.2%. In subgroup analysis, patients with PVR and low serum HBV DNA level at week 48 (20-2,0000 IU/mL) showed significantly higher achievement of virologic response at week 96 and 144 than those with PVR and high viral load (≥2,0000 IU/mL) during long-term ETV monotherapy (64.9% vs. 25% and 75.0% vs. 25%, p=0.044). Cumulative probabilities of virological breakthrough at week 96, 144 were 1.6%, 1.6% in patients with CVR and 0%, 5.9% in those with PVR, respectively (p=0.092). However, genotypic resistance was 0% and 5.9% in those with CVR and PVR, respectively (p=0.067) Conclusions: Long-term continuous ETV monotherapy in NA-naive patients with PVR at week 48 could achieve further virologic response without significant antiviral resistance.