Abstract

There are about 350 million hepatitis B virus (HBV) carriers worldwide and chronic HBV is considered a major public health problem. The objective of the present study was to assess the effectiveness of the nucleos(t)ide analogues tenofovir (TDF) and entecavir (ETV) in the treatment of chronic HBV. A cross-sectional study was carried out from March-December 2013, including all patients with chronic HBV, over 18 years of age, undergoing therapy through the public health system in southern Brazil. Only the data relating to the first treatments performed with TDF or ETV were considered. Retreatment, co-infection, transplanted or immunosuppressed patients were excluded. Six hundred and forty patients were evaluated, of which 336 (52.5%) received TDF and 165 (25.8%) ETV. The other 139 (21.7%) used various combinations of nucleos(t)ide analogues and were excluded. The negativation of viral load was observed in 87.3% and 78.8% and the negativation of hepatitis B e antigen was achieved in 79% and 72% of those treated with ETV or TDF, respectively. Negativation of hepatitis B surface antigen was not observed. There was no occurrence of adverse effects. This is a real-life study demonstrating that long-term treatment with ETV and TDF is both safe and effective.

Highlights

  • About 40% of the world population present serological evidence of present or past infection by hepatitis B virus (HBV), corresponding to around 300-350 million HBV carriers worldwide (Hahné et al 2013)

  • The goal of antiviral therapy in chronic hepatitis B patients is the suppression of HBV-DNA, the negativation of hepatitis B e antigen (HBeAg), its seroconversion, and, at last, to obtain the negativation of hepatitis B surface antigen (HBsAg) with seroconversion to antiHBs

  • There is only one study conducted in South America that assessed treatmentnaïve patients treated with ETV in real-life (Ridruejo et al 2014) and there are no studies assessing the use of TDF or comparing two analogues in HBV patients

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Summary

Introduction

About 40% of the world population present serological evidence of present or past infection by hepatitis B virus (HBV), corresponding to around 300-350 million HBV carriers worldwide (Hahné et al 2013). Two drug classes are available for the treatment of chronic infections by HBV: nucleos(t)ide analogues, which directly inhibit HBV-DNA replication, and interferon (IFN) alpha-based drugs, which can modulate the host response as well as viral replication. While international consensus establishes nucleos(t) ide analogues of high genetic barrier as firs-rate drugs in the treatment of HBV, the Brazilian public health system (MS 2009) prioritises TDF over ETV, probably for economic reasons. There are no real-life studies in Brazil assessing the long-term response to nucleos(t)ide analogues as well as the occurrence of adverse events and the emergence of resistance in the treatment of patients with chronic hepatitis by HBV. The objective of the present study is to assess the effectiveness of the nucleos(t)ide analogues available through the public health system in Brazil (ETV and TDF) for the treatment of chronic hepatitis by HBV

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