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Title: Five-year efficacy and safety of tenofovir-based salvage therapy for patients with chronic hepatitis B who previously failed LAM/ADV therapy.
Austin Authors: Lim, Lucy ;Thompson, Alexander;Patterson, Scott J ;George, Jacob;Strasser, Simone;Lee, Alice;Sievert, William;Nicoll, Amanda;Desmond, Paul;Roberts, Stuart;Marion, Kaye;Bowden, Scott;Locarnini, Stephen;Angus, Peter
Affiliation: Victorian Liver Transplant Unit, Austin Health, Heidelberg, Victoria, Australia
Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
Gastroenterology Department, St Vincent's Hospital, Melbourne, Victoria, Australia
Molecular Research & Development Laboratory, Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia
University of Melbourne, Melbourne, Victoria, Australia
Storr Liver Centre, Westmead Millennium Institute for Medical Research, Westmead Hospital & University of Sydney, Sydney, NSW, Australia
AW Morrow Gastroenterology & Liver Centre, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
Gastroenterology Department, Concord Hospital, Sydney, NSW, Australia
Gastroenterology Department, Monash Medical Centre, Melbourne, Victoria, Australia
Gastroenterology & Hepatology Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Gastroenterology Department, Eastern Health, Melbourne, Victoria, Australia
Gastroenterology Department, Alfred Hospital, Melbourne, Victoria, Australia
Mathematical & Geospatial Sciences Department, RMIT University, Melbourne, Victoria, Australia
Issue Date: Jun-2017 2016-12-22
Publication information: Liver international : official journal of the International Association for the Study of the Liver 2017; 37(6): 827-835
Abstract: Multidrug-resistant HBV continues to be an important clinical problem. The TDF-109 study demonstrated that TDF±LAM is an effective salvage therapy through 96 weeks for LAM-resistant patients who previously failed ADV add-on or switch therapy. We evaluated the 5-year efficacy and safety outcomes in patients receiving long-term TDF±LAM in the TDF-109 study. A total of 59 patients completed the first phase of the TDF-109 study and 54/59 were rolled over into a long-term prospective open-label study of TDF±LAM 300 mg daily. Results are reported at the end of year 5 of treatment. At year 5, 75% (45/59) had achieved viral suppression by intent-to-treat analysis. Per-protocol assessment revealed 83% (45/54) were HBV DNA undetectable. Nine patients remained HBV DNA detectable, however 8/9 had very low HBV DNA levels (<264IU/mL) and did not meet virological criteria for virological breakthrough (VBT). One patient experienced VBT, but this was in the setting of documented non-compliance. The response was independent of baseline LAM therapy or mutations conferring ADV resistance. Four patients discontinued TDF, one patient was lost to follow-up and one died from hepatocellular carcinoma. Long-term TDF treatment appears to be safe and effective in patients with prior failure of LAM and a suboptimal response to ADV therapy. These findings confirm that TDF has a high genetic barrier to resistance is active against multidrug-resistant HBV, and should be the preferred oral anti-HBV agent in CHB patients who fail treatment with LAM and ADV.
DOI: 10.1111/liv.13331
PubMed URL: 27896895
Type: Journal Article
Subjects: antiviral therapy
hepatitis B
viral hepatitis
Appears in Collections:Journal articles

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