Chia-Chi Wang1, Chih-Lin Lin2, Tsai-Yuan Hsieh3, Kuo-Chih Tseng4, Cheng-Yuan Peng5, Tung-Hung Su6, Sheng-Shun Yang7, Yu-Chun Hsu8, Tsung-Ming Chen9, Jia-Horng Kao10,11. 1. Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. uld888@yahoo.com.tw. 2. Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan. DAB53@tpech.gov.tw. 3. Department of Gastroenterology, Tri-service General Hospital, Taipei, Taiwan. tyh1216@ms46.hinet.net. 4. Department of Hepatology, Da-Lin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. tsengkuochih@gmail.com. 5. Department of Gastroenterology, China Medical University Hospital, Shenyang, China. cypeng@mail.cmuh.org.tw. 6. Graduate Institute of Clinical Medicine and Hepatitis Research Center, College of Medicine and Hospital, National Taiwan University, Taipei, Taiwan. tunghungsu@gmail.com. 7. Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. yansh@vghtc.gov.tw. 8. Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan. 77149@cch.org.tw. 9. Department of Gastroenterology and Hepatology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan. reilybabybaby@yahoo.com.tw. 10. Graduate Institute of Clinical Medicine and Hepatitis Research Center, College of Medicine and Hospital, National Taiwan University, Taipei, Taiwan. kaojh@ntu.edu.tw. 11. Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, 1 Chang-Te Street, Taipei, 100, Taiwan. kaojh@ntu.edu.tw.
Abstract
BACKGROUND/ PURPOSE: A subgroup analysis of a GLOBE study identified subgroups of chronic hepatitis B (CHB) patients with excellent outcomes to telbivudine (LdT) treatment. The aim of this study was to validate this concept using a real-world clinical population. METHODS: This prospective, retrospective, and multicenter study examined both HBeAg-positive and HBeAg-negative CHB patients treated with LdT for 2 years. RESULTS: A total of 116 CHB patients were recruited. Of the 64 HBeAg-positive patients, 35 had favorable baseline characteristics [hepatitis B virus (HBV) DNA ≤ 9 log(10) copies/mL and alanine aminotransferase ≥ 2× the upper limit of normal (ULN)], but only 40% (14/35) achieved polymerase chain reaction (PCR) negativity at week 24. Among the 14 patients with favorable baseline characteristics and on-treatment response, the rates of virologic, biochemical, and serologic response and genotypic resistance were 78.6% (11/14), 64.3% (9/14), 50% (7/14), and 7.1% (1/14), respectively, at week 104 of therapy. Of the 52 HBeAg-negative patients, 34 met the criteria of a baseline serum HBV-DNA level less than 7 log(10) copies/mL, and 29 (85.3%) achieved PCR negativity at week 24. Among the 29 patients with favorable baseline characteristics and on-treatment response, the rates of virologic and biochemical response and genotypic resistance were 96.6% (28/29), 72.4% (21/29), and 6.9% (2/29), respectively. In addition, the PCR negativity at week 24 was the only factor associated with the virologic response and genotypic resistance to LdT treatment. CONCLUSION: The efficacy and resistance to LdT treatment in CHB patients with favorable predictors were comparable between a real-world clinical population and the GLOBE study. In addition, PCR negativity at week 24 could predict virologic response and genotypic resistance to LdT treatment.
BACKGROUND/ PURPOSE: A subgroup analysis of a GLOBE study identified subgroups of chronic hepatitis B (CHB) patients with excellent outcomes to telbivudine (LdT) treatment. The aim of this study was to validate this concept using a real-world clinical population. METHODS: This prospective, retrospective, and multicenter study examined both HBeAg-positive and HBeAg-negative CHB patients treated with LdT for 2 years. RESULTS: A total of 116 CHB patients were recruited. Of the 64 HBeAg-positive patients, 35 had favorable baseline characteristics [hepatitis B virus (HBV) DNA ≤ 9 log(10) copies/mL and alanine aminotransferase ≥ 2× the upper limit of normal (ULN)], but only 40% (14/35) achieved polymerase chain reaction (PCR) negativity at week 24. Among the 14 patients with favorable baseline characteristics and on-treatment response, the rates of virologic, biochemical, and serologic response and genotypic resistance were 78.6% (11/14), 64.3% (9/14), 50% (7/14), and 7.1% (1/14), respectively, at week 104 of therapy. Of the 52 HBeAg-negative patients, 34 met the criteria of a baseline serum HBV-DNA level less than 7 log(10) copies/mL, and 29 (85.3%) achieved PCR negativity at week 24. Among the 29 patients with favorable baseline characteristics and on-treatment response, the rates of virologic and biochemical response and genotypic resistance were 96.6% (28/29), 72.4% (21/29), and 6.9% (2/29), respectively. In addition, the PCR negativity at week 24 was the only factor associated with the virologic response and genotypic resistance to LdT treatment. CONCLUSION: The efficacy and resistance to LdT treatment in CHB patients with favorable predictors were comparable between a real-world clinical population and the GLOBE study. In addition, PCR negativity at week 24 could predict virologic response and genotypic resistance to LdT treatment.
Entities:
Keywords:
Hepatitis B virus; Roadmap concept; Super-responder; Telbivudine