SixYears of Treatment With Tenofovir DF for ChronicHepatitis B Virus Infection is Safe and Well Tolerated and Associated WithSustained Virological, Biochemical, and Serological Responses With NoDetectable Resistance
Reportedby Jules Levin AsianPacific Association for the Study of the Liver (APASL) Liver Week, June 6–10,2013, Singapore
NaokyTsai1, Maria Buti2, Edward Gane3, William Sievert4, Ira M. Jacobson5, PhillipDinh6, John F. Flaherty6, Kathryn M. Kitrinos6, John G.McHutchison6, GeorgeGermanidis7, Patrick Marcellin8 1University of Hawaii atManoa, Honolulu, HI, USA; 2Hospital General Universitari Vall d’Hebron andCiberehd, Barcelona, Spain; 3Auckland City Hospital, Auckland, New Zealand; 4Monash University andMonash Medical Centre, Melbourne, VIC, Australia; 5Weill Cornell MedicalCollege, New York, NY, USA; 6Gilead Sciences, Inc., FosterCity, CA, USA; 7AHEPA University Hospital, Aristotle University Medical School,Thessaloniki, Greece; 8Hôpital Beaujon, Clichy, France
CONCLUSIONS
Virologic, biochemical, and serologic responses were maintained through 6 years
– Sustained virologic suppression remained consistent with Year 5 results
– HBeAg loss/seroconversion rates of 50%/37% through 6 years
– 11% of patients had confirmed HBsAg loss (8% with seroconversion)
No resistance to TDF was detected through 6 years
– No conserved site changes seen; all polymorphic site changes were unique
– 7 of 8 patients eligible for genotyping had documented non adherence
Treatment with TDF was well tolerated
– 80% of 585 patients entering the open-label phase remained on study at Year 6; 73% of enrolled patients remained on study
– <2% of patients discontinued TDF due to an AE
– Renal AEs were uncommon (≤1.5%) and manageable with dose modification
– No evidence of bone loss over 2-year follow-up
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