Efficacy and safety of long-term therapy with Entecavir (ETV) or Tenofovir (TDF) in patients with HBV-related cirrhosis

Abstract

Background: In virological suppressed patients the goal of therapy is the prevention of liver disease progression, hepatic decompensation, HCC development and need for OLT. Aims: To assess the impact of long-term ETV or TDF therapy on the progression of HBV-related liver disease and verify the safety profile in cirrhotic patients. Patients and methods: 48 patients with HBV-related liver cirrhosis Child A, HBeAg-negative, treated with ETV (25 patients) or TDF (23 patients) for a median of 34 months (range 1–78) were enrolled. Nine patients had HBV/HDV coinfection. The patients were subjected to periodicmonitoring of liver and kidney function, and surveillance forHCC. At the time of therapy initiation and every 2–3 years, patients performed esophagogastroduodenoscopy. In TDF patients, bone densitometry was performed at baseline and after 2 years. Results: All patients had virological response after 12 months of treatment. No patient had ascitic decompensation, except 3 HDV-positive patients. At baseline, in the TDF group, 9 patients had esophageal varices (6 = F1, F2 =2, F3 =1); at the end of FU, 5 remained stable, 2 improved and 2 worsened. In the ETV group, 3 patients had esophageal varices F1 that remained stable. At the time of TDF therapy initiation, 5 patients already had a HCC. During FU, 4/5 patients recurred and 3 of these died for HCC. A new diagnosis of HCC was reported in 6 cases (4 TDF, 2 ETV). ETV or TDF therapy was well tolerated, only 1 patient showed reduction eGFR <50ml/min and reduced TDF dose. After at least 2 years of therapy, 19/23 TDF patients repeated MOC, which remained stable in 13 cases, worsened in 3 and improved in 3 cases. Conclusions: Antiviral treatment has a favorable impact on the natural history of HBV-related cirrhosis,while not reducing the risk of HCC.