Revista de Gastroenterologia Clínica

Efficacy and Safety of Tenofovir Alafenamide in Treatment Naive Patients with Hepatitis B-Virus Related Decompensated Cirrhosis: A Prospective Observational Study

Abstract

Sanjeev Jha*, Ravikant Kumar, Saurabh Kumar, Ravi Keshri, Aditya V. Singh, Gaurav Kumar and Samir S. Bhagwat

Background: The effect of Tenofovir Alafenamide (TAF) therapy on viral suppression and hepatic function in patients of Hepatitis B Virus (HBV) related decompensated cirrhosis is not known. Aim of this study was to evaluate the efficacy and safety of TAF therapy in these patients.

Methods: We analyzed 55 consecutive HBV-infected treatment naive patients with decompensated cirrhosis treated with 25 mg/day TAF and evaluated the treatment outcomes. Treatment efficacy was evaluated by measuring virological, serological, biochemical responses and changes in hepatic function over period of 6 month.

Results: At month 6, undetectable HBV-DNA level, HBeAg loss, HBeAg seroconversion and ALT normalization was seen in 65.2%, 22.2%, 5.5% and 74.5% patients respectively. Virological and biochemical responses were similar in HBeAg positive and negative patients. CTP (8.38 ± 1.56 vs. 6.73 ± 1.05), MELD-Na (16.00 ± 6.22 vs. 12.00 ± 4.50), bilirubin [1.65 (0.4-16.7) mg/dL vs. 1.20 (0.7-3.2) mg/dL], INR (1.45 ± 0.35 vs. 1.32 ± 0.32), albumin (2.88 ± 0.58 vs. 3.05 ± 0.39 g/dL), and ALT (68 IU/L (19-390) vs. 36 IU/L (11-94)) was significantly improved after 6 months of TAF treatment. 45.5% and 47.2% patients showed improvement in CTP and MELD-Na score by ≥ 2 points after 6 months. There was no significant difference in eGFR measured respectively at baseline and at month 6 (94.82 ± 38.66 vs. 92.93 ± 25.75 mL./minute, p=0.64).

Conclusion: TAF therapy is effective in decreasing HBV DNA levels, normalizing ALT, improving hepatic function and is well tolerated in decompensated cirrhosis patients.