Henry L.Y. Chan, MD; E. Jenny Heathcote, MD; Patrick Marcellin, MD; Ching-Lung Lai, MD; Mong Cho, MD; Young M. Moon, MD; You-Chen Chao, MD; Robert P. Myers, MD; Gerald Y. Minuk, MD; Lennox Jeffers, MD; William Sievert, MD; Natalie Bzowej, MD, PhD; George Harb, MD; Ralf Kaiser, PhD; Xin-Jian Qiao, ScD; Nathaniel A. Brown, MD; and the 018 Study Group
Chan HL, Heathcote EJ, Marcellin P, Lai C, Cho M, Moon YM, et al. Treatment of Hepatitis B e Antigen–Positive Chronic Hepatitis with Telbivudine or Adefovir: A Randomized Trial. Ann Intern Med. 2007;147:745-754. doi: 10.7326/0003-4819-147-11-200712040-00183
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Published: Ann Intern Med. 2007;147(11):745-754.
Optimal regimens for suppressing virus in chronic hepatitis B infection are unclear.
In this 52-week open label trial, 135 adults with hepatitis B e antigen–positive chronic hepatitis B were randomly assigned to telbuvidine, adefovir, or adefovir for 24 weeks followed by telbivudine for 28 weeks. The telbivudine and the adefovir-to-telbivudine groups experienced similar reductions in viral levels that were greater than those in the adefovir group.
The small trial did not establish long-term drug resistance or effects on clinical outcomes.
Telbivudine and switching from adefovir to telbivudine suppressed viral levels more than adefovir in adults with chronic hepatitis B.
Primary exclusion criteria are listed; some patients met more than 1 exclusion criterion. One patient assigned to adefovir withdrew before initiation of treatment; thus, the intention-to-treat sample was 135 patients, of whom 45, 44, and 46 were assigned to receive telbivudine, adefovir, or adefovir for 24 weeks and then telbivudine for the remaining 28 weeks, respectively. One adefovir recipient withdrew before the week-24 analysis; 1 additional adefovir recipient and 2 telbivudine recipients withdrew before the week-52 analysis. ALT = alanine aminotransferase; HBeAg = hepatitis B e antigen; HBV = hepatitis B virus.
Top. Mean serum HBV DNA levels. Bottom. Proportion of patients with hepatitis B e antigen (HBeAg) seroconversion. ADV = adefovir; ADV/LdT = adefovir to telbivudine; LdT = telbivudine.
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Gastroenterology/Hepatology, Infectious Disease, Liver Disease.
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