Tenofovir in Chronic Hepatitis B Infection: Safety and Efficacy in a Single-Center

Abstract

Purpose: The treatment of chronic hepatitis B (CHB) may be life-long in the majority of patients; therefore a safe treatment with elevated efficacy is crucial. Clinical trials of tenofovir disoproxil fumarate (TDF) showed a good safety profile and potent anti-viral properties. Methods: Eighty-one patients treated with TDF for CHB during the period of January 2009 and December 2010 were retrospectively analyzed in our department. Safety and efficacy parameters were evaluated, as well as demographic characteristics such as gender, age, previous treatments, genotype, resistance profile and the evolution of viral loads and ALT levels. Results: Most patients were males (68%) and the mean age was 49+15 years. Mean treatment duration was 14+6 months. Patients were AgHBe positive in 24.7% of cases and genotype D was the most frequent (78%). Cirrhosis and hepatocellular carcinoma were detected in 21% and 6% of patients, respectively. About 25% were treatment naive. Significant decreases in viral loads (p=0.006) and ALT levels (p<0.001) were found during treatment. No significant differences were detected when comparing AgHBe positive and negative patients, patients with or without cirrhosis, and experienced and naive patients. Glomerular filtration rates using Modification of Diet in Renal Disease (MDRD) formula (GFR MDRD) in patients over 50 years of age diminished significantly during treatment (p=0.015) with a reduction in dose in one case. One patient was considered intolerant due to gastrointestinal manifestations. Conclusion: TDF significantly decreases viral loads and ALT levels in a heterogeneous group of patients with CHB. No significant decline in phosphatemia was found. GFR decreased significantly in patients over 50 years of age.