Source

Hacettepe University School of Medicine, Department of Gastroenterology, Ankara, Turkey. Electronic address: gskoklu@yahoo.com.

Abstract

BACKGROUND & AIMS:

Data are limited on the efficacy and safety of tenofovir and entecavir when given for more than 1 year to patients with hepatitis B-related cirrhosis. We investigated the long-term safety and efficacy of these antiviral drugs in patients with chronic hepatitis B virus (HBV) infection, with compensated or decompensated cirrhosis, and compare results with those from lamivudine.

METHODS:

We performed a retrospective analysis of data from 227 adult patients with chronic HBV infection who were diagnosed with cirrhosis, beginning in 2005, at 18 centers throughout Turkey; 104 had decompensated cirrhosis, 197 were treatment naïve before 72 received tenofovir (followed for 21.4±9.7 months), 77 received entecavir (followed for 24.0±13.3 months), and 74 received lamivudine (followed for 36.5±24.1 months). We collected data on patient demographics and baseline characteristics. Laboratory test results, clinical outcomes, and drug-related adverse events were compared among groups.

RESULTS:

Levels of HBV DNA <400 copies/mL were achieved in 91.5%, 92.5%, and 77% of patients receiving tenofovir, entecavir, or lamivudine, respectively. Levels of alanine aminotransferase normalized in 86.8%, 92.1%, and 71.8% of patients that received tenofovir, entecavir, and lamivudine, respectively. Child-Turcotte-Pugh scores increased among 8.5% of patients that received tenofovir, 15.6% that received entecavir, and 27.4% that received lamivudine. Frequencies of complications from cirrhosis, including hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, and mortality were similar among groups. Lamivudine had to be changed to another drug for 32.4% of the patients.

CONCLUSION:

Tenofovir and entecavir are effective and safe for long-term use in patients with compensated or decompensated cirrhosis from HBV infection.