Original article
Liver, pancreas, and biliary tract
Long-term Efficacy and Safety of Lamivudine, Entecavir, and Tenofovir for Treatment of Hepatitis B Virus–Related Cirrhosis

https://doi.org/10.1016/j.cgh.2012.10.003Get rights and content

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 compared 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. There were 104 patients who had decompensated cirrhosis, and 197 patients were treatment naive before. Seventy-two patients received tenofovir (followed up for 21.4 ± 9.7 mo), 77 patients received entecavir (followed up for 24.0 ± 13.3 mo), and 74 patients received lamivudine (followed up for 36.5 ± 24.1 mo). 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 less than 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 who received tenofovir, entecavir, and lamivudine, respectively. Child–Turcotte–Pugh scores increased among 8.5% of patients who received tenofovir, 15.6% who received entecavir, and 27.4% who 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.

Conclusions

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

Section snippets

Materials and Methods

This retrospective study enrolled adult patients with chronic hepatitis B–associated cirrhosis treated with antiviral therapy beginning from 2005 in 18 centers throughout Turkey. The study protocol was approved by the Ethics Committee of the Ankara Education and Research Hospital before study initiation. To be eligible, living patients had to use any antivirals for more than 12 months after a diagnosis of cirrhosis. Patients had to have basal and last visit clinical and laboratory outcomes.

Patient Demographics

All HBV-associated cirrhosis patients diagnosed after the beginning of 2005 were enrolled. In all, 227 patients were included. Seventy-two, 77, and 74 patients were initiated with tenofovir, entecavir, or lamivudine, respectively. Adefovir was the choice for the remaining patients. Demographic data and baseline laboratory test results of all patients are summarized in Table 1. Among 227 patients, 51 had liver biopsies. A total of 104 patients had at least one of the components of decompensated

Discussion

In this study we showed that entecavir and tenofovir have better long-term biochemical outcomes than lamivudine in HBV-related advanced cirrhosis. However, clinical outcomes with respect to cirrhosis-related complications were comparable. All had a low adverse event frequency, however, as expected, lamivudine had a higher resistance rate as in noncirrhotic patients. Tenofovir and entecavir provided better long-term improvement or stabilization of liver functions in decompensated cirrhosis.

All

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    Conflicts of interest The authors disclose no conflicts.

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