Effectiveness and Safety of Treatment with Nucleo(s)tide Analogues in Patients with Hepatitis B-related Cirrhosis

Abstract

Data from Bulgaria are limited on the long-term effects of nucleo(s)tide analogues (NAs) to patients with hepatitis B-related cirrhosis. The study aimed to evaluate the overall efficacy and renal safety of NAs in such cohort of patients, comparing treated with high to low-barrier NAs. We retrospectively analyzed 58 patients with HBV cirrhosis (74.1% in compensated stage) for a period of 5 years. Thirty-five patients received NAs with high-barrier of resistance: Tenofovir disoproxil fumarate and Entecavir (followed up for 51.63 ± 30.3) and 23 received NAs with low-barrier of resistance: Lamivudine and Telbivudine (followed up for 56.7 ± 48.4). After a median treatment time of 53.7 months virological response (VR) rates (HBV DNA<10 IU/ml) were 91.4% in high barrier and 87.0% in low barrier NAs groups. Undetectability of HBVDNA was influenced most by the treatments’ duration. Serological response reached 57.1%, similar for the two treatment groups. One patient (1.7%) cleared HBsAg and discontinued NAs (TDF). Multidrug resistance (MDR) occurred in 15.5% of LAM recipients only. One-, 3-, 5-, 8- year MDR rates were 0.0%; 11.1%; 33.3% and 77.6%. A slight improvement of the renal function was observed in 85.7% and 69.6% of the patients treated with high and low-barrier NAs. Dose reduction for renal toxicity was required in 1.7%. Decompensated cirrhosis and T2DM were the main risk factors for renal function decline. Long-term therapy with high and low barrier NAs was equally effective and renally safe in patients with HBV-related cirrhosis.