Author/Authors :
Bakhshizadeh، Fatemeh نويسنده Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran Bakhshizadeh, Fatemeh , Hekmat، Soheila نويسنده Department of Hepatitis and AIDS, Pasteur Institute of Iran, Tehran, IR Iran , , Keshvari، Maryam نويسنده Iranian Blood Transfusion Organization research Center, Tehran, IR Iran , , Alavian، Seyed-Moayed نويسنده , , Mostafavi، Ehsan نويسنده Department of Epidemiology, Pasteur institute of Iran, Tehran, IR Iran , , Keivani، Hossein نويسنده Virology Department of Tehran, University of Medical Sciences, Tehran, IR Iran , , Doosti Irani، Amin نويسنده Department of Epidemiology & Biostatistics, School of Public Heath, Hamedan University of Medical Sciences, Hamedan, Iran , , Motevalli، Fatemeh نويسنده Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran Motevalli, Fatemeh , Behnava، Bita نويسنده Baqiyatallah University of Medical Sciences, Baqiyatallah Research Center for Gastroenterology and Liver diseases, Tehran, IR Iran ,
Abstract :
Tenofovir disoproxil fumarate (TDF) is a new effective treatment option for patients with chronic hepatitis B (CHB). To evaluate TDF efficacy in nucleos(t)ide analogues (NAs)-naive Iranian patients with CHB. 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. 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. 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.
