Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

Patrick Marcellin, Edward J Gane, Maria Buti, Nezam H Afdhal, William Sievert, Ira M Jacobson, Mary Kay Washington, George Germanidis, John F Flaherty, Raul Aguilar Schall, Jeffrey D Bornstein, Kathryn M Kitrinos, G Mani Subramanian, John G McHutchison, E Jenny Heathcote

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Whether long-term suppression of replication of hepatitis B virus (HBV) has any beneficial effect on regression of advanced liver fibrosis associated with chronic HBV infection remains unclear. We aimed to assess the effects on fibrosis and cirrhosis of at least 5 years treatment with tenofovir disoproxil fumarate (DF) in chronic HBV infection. METHODS: After 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg) were eligible to enter a 7-year study of open-label tenofovir DF treatment, with a pre-specified repeat liver biopsy at week 240. We assessed histological improvement (>/=2 point reduction in Knodell necroinflammatory score with no worsening of fibrosis) and regression of fibrosis (>/=1 unit decrease by Ishak scoring system). FINDINGS: Of 641 patients who received randomised treatment, 585 (91 ) entered the open-label phase, and 489 (76 ) completed 240 weeks. 348 patients (54 ) had biopsy results at both baseline and week 240. 304 (87 ) of the 348 had histological improvement, and 176 (51 ) had regression of fibrosis at week 240 (p/=1 unit decrease in score), whereas three of 252 patients without cirrhosis at baseline progressed to cirrhosis at year 5 (p
Original languageEnglish
Pages (from-to)468 - 475
Number of pages8
JournalThe Lancet
Issue number9865
Publication statusPublished - 2013

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