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Abstract Details
Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis b with high baseline viral load (≥ 9 log10 copies/mL)
Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Hepatology. 2013 Jan 30. doi: 10.1002/hep.26277. [Epub ahead of print]
Source
Henry Ford Health System, Detroit, MI, USA. SGordon3@hfhs.org.
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. Conclusion: Chronic hepatitis B patients with HVL can achieve HBV DNA negativity with long-term TDF treatment, although time to HBV DNA <400 copies/mL may be longer relative to patients with non-HVL.