The Efficacy of Tenofovir in Chronic Hepatitis B Patients.

Efficacy of Tenofovir in Chronic Hepatitis B Patients

Abstract

Background: Aim: To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a tertiary care setting. Subjects and Methods: We performed a retrospective analysis of treatment outcomes among treatment-nae patients receiving a minimum 3 month tenofovir therapy in Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh. Patients were excluded in the setting of HIV, hepatitis C or hepatitis D co-infection, pregnancy and uncontrolled HCC or were less than 18 years of age.  We considered virological and biochemical response, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus (HBV) DNA using sensitive assays; biochemical response was determined via serum liver function tests; histological response was determined from  fibroscan; safety analysis focused on  renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/mL. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen (HBeAg)/HB surface antigen loss and seroconversion over time. Results: 100 patients were identified who fulfilled the enrolment criteria. Median follow-up was 24 month (range 6- 36). Mean age was 46 (24-72) years, 64 patients (70%) were male and 36 (36%) were females. All patients were treatment-nae. Majority of the patients (70%) were HBeAg-negative. Overall, complete virological suppression was achieved in 86% of the patients with a median time to suppression of 6 months. Rates of complete virological suppression were 70% at 12 months, (57/82), 85% at 24 months, (42/50), and 100% at 36 months, (30/30). Partial virological response (HBV DNA 20-2000 IU/mL) was achieved in 97% of the patients. ALT normalization was achieved in 80% of the patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level (OR = 0.897, 95%CI: 0.833-0.967, P = 0.0047) and HBeAg positive status (OR = 0.373, 95%CI: 0.183-0.762, P = 0.0077). Three cases of virological breakthrough occurred in the setting of probable non-compliance. Tenofovir therapy was well tolerated. Conclusion: Tenofovir is an efficacious, safe and well-tolerated. Our data are similar to the reported experience from various other studies.