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Hepat Mon. 2015 May 23;15(5):e25749. doi: 10.5812/hepatmon.15(5)2015.25749. eCollection 2015 May.

Efficacy of tenofovir disoproxil fumarate therapy in nucleoside-analogue naive Iranian patients treated for chronic hepatitis B.

Author information

1
Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran.
2
Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, IR Iran.
3
Middle East Liver Diseases Center (MELD), Tehran, IR Iran.
4
Epidemiology Department, Pasteur Institute of Iran, Tehran, IR Iran.
5
Virology Department, School of Medicine, Iran University of Medical Sciences, Tehran, IR Iran.
6
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, IR Iran.

Abstract

BACKGROUND:

Tenofovir disoproxil fumarate (TDF) is a new effective treatment option for patients with chronic hepatitis B (CHB).

OBJECTIVES:

To evaluate TDF efficacy in nucleos(t)ide analogues (NAs)-naive Iranian patients with CHB.

PATIENTS AND METHODS:

The NA-naive patients received TDF for at least six months. The primary endpoint was the proportion of patients achieving a complete virological response (CVR) during the treatment. Multivariate Cox regression analysis determined predictive factors independently associated with the time to CVR. The secondary endpoints were biochemical and serological responses, frequency of virological breakthrough, genotypic resistance development, safety and tolerability.

RESULTS:

In all, 93 patients (64.5% hepatitis B e antigen [HBeAg]-negative) were eligible. Of these, 70 patients completed 24 months of treatment. The cumulative CVR rates in HBeAg-negative and HBeAg-positive patients were 87% versus 53% at 24 months, respectively. The multivariate Cox regression model showed only HBeAg positivity at baseline and a high baseline HBV DNA level were independent factors predicting a CVR. No patient achieved hepatitis B surface antigen (HBsAg) and HBeAg loss or seroconversion and no virologic breakthrough occurred. A new amino acid substitution (rtD263E) was observed to develop in 60% of patients with viremia.

CONCLUSIONS:

The cumulative CVR rates showed that patients with HBeAg-negative have better virologic respond than those with HBeAg-positive during the same period. The rtD263E mutation might be associated with partial resistance to TDF.

KEYWORDS:

Chronic Hepatitis B; Tenofovir; nucleoside analogue

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