Most Hepatitis B Patients Who Respond to Tenofovir Show Improved Liver Health at 5 Years


Treatment with tenofovir (Viread) remains safe and effective over 5 years, and people who achieve sustained viral load suppression experience improvement in liver histology, including regression of fibrosis and cirrhosis, according to study findings described in the December 7, 2012, advance online edition of The Lancet.

Over years or decades, chronic hepatitis B virus (HBV) infection can lead to serious liver disease including advanced fibrosis, cirrhosis (scarring), and hepatocellular carcinoma. Antiviral treatment with nucleoside/nucleotide analogs can suppress viral replication, but its long-term effects on liver health are not fully understood.

Patrick Marcellin from Hôpital Beaujon in Clichy, France, and colleagues analyzednearly 500 participants in Gilead Sciences' Study 102 (HBeAg negative) and Study 103 (HBeAg positive), which compared tenofovir disoproxil fumarate vs adefovir dipivoxil (Hepsera) for chronic hepatitis B.

After the 48-week randomized treatment period, patients had the option to remain on open-label tenofovir and undergo long-term follow-up including liver biopsies. Out of 641 patients who initially received randomized treatment, 585 (91%) entered the open-label phase, 489 (76%) completed 240 weeks of treatment, and 348 (54%) had biopsy results at baseline and week 240.


Based on these findings, the study authors concluded, "In patients with chronic HBV infection, up to 5 years of treatment with tenofovir DF was safe and effective. Long-term suppression of HBV can lead to regression of fibrosis and cirrhosis."



P Marcellin, E Gane, M Buti, et al. Regression of Cirrhosis during Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B: a 5-Year Open-label Follow-up Study. The Lancet S0140-6736(12)61425-1. December 7, 2012 (Epub ahead of print).