Seven-Year Efficacy and Safety of Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Virus Infection

Maria Buti, Naoky Tsai, Joerg Petersen, Robert Flisiak, Selim Gurel, Zahary Krastev, Raul Aguilar Schall, John F. Flaherty, Eduardo B. Martins, Prista Charuworn, Kathryn M. Kitrinos, G. Mani Subramanian, Edward Gane, Patrick Marcellin

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 (240 weeks) and no TDF resistance through 6 years (288 weeks). Aim: We assessed the efficacy, safety, and resistance of TDF for up to 7 years (336 weeks) in HBeAg-positive and HBeAg-negative CHB patients. Methods: Patients who completed 1 year (48 weeks) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years (384 weeks). Results: Of 641 patients initially randomized, 585 (91.3 %) entered the open-label phase; 437/585 (74.7 %) remained on study at year 7. For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and in HBeAg-positive patients, 84/154 (54.5 %) and 25/154 (11.8 %) achieved HBeAg and HBsAg loss, respectively. One/375 (0.3 %) HBeAg-negative patients achieved HBsAg loss. No resistance to TDF was detected through 7 years. During the open-label phase, grade 3/4 drug-related adverse events were uncommon (1.0 %); ten (1.7 %) patients had elevation of serum creatinine ≥0.5 mg/dL above baseline. No significant change in bone mineral density was observed from year 4 to year 7 (week 192 to week 336). Conclusions: Long-term TDF treatment was associated with sustained virologic, biochemical, and serologic responses, without resistance. TDF treatment was well tolerated, with a low incidence of renal and bone events. These data confirm the safety and efficacy of long-term TDF for CHB.

Original languageEnglish (US)
Pages (from-to)1457-1464
Number of pages8
JournalDigestive diseases and sciences
Volume60
Issue number5
DOIs
StatePublished - May 1 2015

Keywords

  • Antiviral agent
  • Cirrhosis
  • Hepatitis B e antigen
  • Liver disease

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

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