Objective: Hepatitis B virus (HBV) infection is a common cause of cirrhosis and hepatocellular carcinoma. Interferons and nucleos(t)ide analogs are being used for the treatment of chronic HBV infection. Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the strongest oral antiviral agents. In this study, we aimed to investigate efficacy and safety of ETV and TDF in treatment of naive cirrhotic patients infected with HBV.
Methods: A total of 58 cirrhotic patients infected with HBV who were treatment-naïve and initiated ETV or TDF as first therapy regimen were included in the study. Their demographic features such as sex, age, Child-Pugh and model for end-stage liver disease (MELD) scores and HBV DNA, HBsAg, HBeAg, serum alanine aminotransferase, creatinine, phosphorus and total creatine kinase levels were recorded at baseline and at 3rd, 6th, 12th, 18th, and 24th months of therapy. Drug side effects and complications of cirrhosis were also determined in the follow-up period. ETV and TDF groups were compared in terms of response to treatment.
Results: There were 32 and 26 patients in TDF and ETV groups, respectively. Majority of patients in both groups were Child-Pugh class A. Sex and age distribution and baseline laboratory parameters were similar in both groups (p>0.05). Percentage of patients who were their HBV DNA becoming negative were higher significantly in ETV group only at the 6th month of therapy (p=0.04), however there were no statistically significant differences at 12th, 18th and 24th months between groups. HBV DNA was negative in 100% of patients in TDF group and 89% of patients in ETV group at the end of follow-up period (24th month) (p=0.31). In the follow-up period, there were significant increases in creatinine levels in both groups (p=0.04), however, this was within normal ranges and there was no statistically significant difference between the groups (p=0.71). There were significant declines in both mean MELD and Child-Pugh scores in TDF group (p=0.02 and p=0.001, respectively), and there was a significant decrease at mean Child-Pugh score and no significant difference at MELD score in ETV group (p=0.003 and p=0.14 respectively) at the end of the follow-up period.
Conclusions: Both ETV and TDF are considerably safe and effective in treatment-naïve patients with HBV-positive cirrhosis. The efficacy of these two drugs is similar.
Klimik Dergisi 2020; 33(3): X.
Cite this article as: Alkan E, Akın M, Tuna Y. [Entecavir and tenofovir treatment in patients with hepatitis B virus-related cirrhosis: A comparison of results of two-year treatment]. Klimik Derg. 2020; 33(3): 264-9. Turkish.