Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B

• Published in: Antiviral therapy 2011-01, Vol.16 (4), p.469-477
• Main Authors: YOUNG EUN CHON, SEUNG UP KIM, JUN YONG PARK, DO YOUNG KIM, CHAE YOON CHON, HAN, Kwang-Hyub, SANG HOON AHN, CHUN KYON LEE, HEO, Jeong, JA KYUNG KIM, KI TAE YOON, CHO, Mong, KWAN SIK LEE, DONG HWAN KIM, EUN HEE CHOI
• Format: Article
• Language: English
• Subjects: Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Antiviral Agents - therapeutic use; Biological and medical sciences; DNA, Viral - blood; Female; Guanine - analogs & derivatives; Guanine - therapeutic use; Hepatitis B virus - drug effects; Hepatitis B virus - genetics; Hepatitis B virus - physiology; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - virology; Human viral diseases; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Predictive Value of Tests; Time Factors; Treatment Outcome; Viral diseases; Viral hepatitis
• ISSN: 1359-6535; 2040-2058
• DOI: 10.3851/IMP1772

The proposed definition of a partial virological response (PVR) to nucleos(t)ide analogue therapy in the 2009 European Association for the Study of the Liver (EASL) guidelines is based on limited evidence, especially in terms of the cutoff HBV DNA level and the time point at which to judge it. This study assessed optimal PVR criteria for predicting virological response (VR) at week 96 in treatment-naive patients with chronic hepatitis B (CHB) receiving entecavir (ETV). A total of 175 patients (126 men, 49 women) who completed 96 weeks of first-line ETV therapy were prospectively recruited. For predicting VR at week 96, the area under the receiver operating characteristic curve (AUC) was used to find the optimal time point and the Youden index was used to calculate the optimal cutoff HBV DNA level. After 96 weeks of ETV therapy, 139 (79.4%) patients achieved VR. The AUC at week 48 was significantly better than that at week 24 for predicting VR at week 96 (P=0.023). The optimal cutoff HBV DNA level at week 48 was 35 IU/ml. Forty-one (23.4%) patients met this PVR criteria of ETV (HBV DNA level >35 IU/ml at week 48). An HBV DNA level >35 IU/ml at week 48 is the optimal PVR criteria for predicting non-VR at week 96 in treatment-naive patients with CHB who are receiving ETV. This study supports the proposed EASL PVR for ETV based on scientific evidence.