Published in Journal Watch Infectious Diseases January 9, 2013
Nearly three quarters of hepatitis B virus–infected patients with cirrhosis at baseline were no longer cirrhotic after 5 years of tenofovir therapy.
Hepatitis B virus (HBV) is a common cause of cirrhosis, end-stage liver disease, and hepatocellular carcinoma, particularly in areas of the world where infection rates are high. Although short-term studies have shown that tenofovir and other antiviral drugs lead to improvement in liver histology, the effect of extended treatment on severe hepatic fibrosis or cirrhosis is less certain. Now, investigators have evaluated the effect of long-term tenofovir use on liver histology in a large number of HBV-infected patients.
Of 641 patients participating in double-blind, phase III trials comparing tenofovir with adefovir therapy for 48 weeks, 585 entered a manufacturer-sponsored, open-label study in which they were to receive 7 additional years of tenofovir therapy; 348 of these patients had liver biopsies performed at baseline and again after 240 weeks of treatment. Liver histology was improved in 87% of these patients at year 5; individuals with the most pretherapy liver injury showed the greatest improvement. Strikingly, of 96 patients with cirrhosis prior to treatment, 74% were no longer cirrhotic at year 5 of therapy. Patients with lower body-mass indexes were more likely to have fibrosis regression. Only 12 patients developed hepatocellular carcinoma, and only 2 developed decompensated liver disease. Virologic breakthrough was uncommon, and no resistance to tenofovir was detected.
Comment: This large trial demonstrates that long-term suppression of HBV replication results in improved liver histology, even in patients who have previously developed cirrhosis. The low rates of hepatocellular carcinoma and end-stage liver disease in patients receiving tenofovir suggest that effective antiviral therapy will lead to improved survival — as has recently been demonstrated in patients treated successfully for hepatitis C virus infection (JAMA 2012; 308:2584).
Marcellin P et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: A 5-year open-label follow-up study. Lancet 2012 Dec 10; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(12)61425-1)