Hepatology. 2013 Jan 30.
doi: 10.1002/hep.26277. [Epub ahead of print]
Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with
chronic hepatitis b with high baseline viral load (≥ 9 log10 copies/mL).
高基线病毒载量≥9 log10拷贝/ mL)患者替诺240周的疗效
Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB,
Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Source Henry Ford
Health System, Detroit, MI, USA. [email protected].
Abstract
We evaluated the antiviral response of patients with chronic hepatitis B
who had baseline high viral load (HVL), defined as having hepatitis B virus
(HBV) DNA = 9 log(10) copies/mL, following 240 weeks of tenofovir
disoproxil fumarate (TDF) treatment. A total of 641 HBeAg-negative and
HBeAg-positive patients (129 with HVL) received 48 weeks of TDF 300 mg (HVL
n=82) or adefovir dipivoxil (ADV) 10 mg (HVL n=47), followed by open-label
TDF for an additional 192 weeks. Patients with confirmed HBV DNA = 400
copies/mL on or after Week 72 had the option of adding emtricitabine (FTC).
By Week 240, 98.3% of HVL and 99.2% of non-HVL patients on treatment
achieved HBV DNA <400 copies/mL. Both groups had similar rates of
histologic regression between baseline and Week 240. Patients with HVL
generally took longer to achieve HBV DNA <400 copies/mL than non-HVL
patients, but by Week 96 the percentages of patients with HBV DNA <400
copies/mL were similar in both groups. Among HVL patients, time to
achieving HBV DNA <400 copies/mL was shorter among those initially
receiving TDF compared to ADV. No patient with baseline HVL had persistent
viremia at Week 240 or amino acid substitutions associated with TDF
resistance.