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Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load
Author(s) -
Gordon Stuart C.,
Krastev Zahary,
Horban Andrzej,
Petersen Jörg,
Sperl Jan,
Dinh Phillip,
Martins Eduardo B.,
Yee Leland J.,
Flaherty John F.,
Kitrinos Kathryn M.,
Rustgi Vinod K.,
Marcellin Patrick
Publication year - 2013
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.26277
Subject(s) - medicine , adefovir , hbeag , viral load , hepatitis b virus , emtricitabine , viremia , hepatology , gastroenterology , hepatitis b , lamivudine , hbsag , virology , virus
We evaluated the antiviral response of patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as having hepatitis B virus (HBV) DNA ≥9 log 10 copies/mL, after 240 weeks of tenofovir disoproxil fumarate (TDF) treatment. A total of 641 hepatitis B e antigen (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 : CHB 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. (H epatology 2013;58:505–513)