Abstract
This study evaluated the long-term (up to 4 years) efficacy and safety of entecavir ETV treatment and analysed the significance of baseline and on-treatment factors in long-term ETV outcomes in adolescents with chronic hepatitis B (CHB). We determined the cumulative virological and serological outcomes of 44 adolescents with CHB receiving ETV for up to 4 years. To investigate the dynamics of HBV DNA, ALT activity and hepatitis B e antigen (HBeAg) seroconversion over time and their associations with the considered factors, generalized estimating equation (GEE) models were used. The cumulative rates of undetectable HBV DNA (<20 IU/ml) and HBeAg seroconversion after 4 years were 89.7% and 55.4%, respectively. In the study group, we showed that having undetectable HBV DNA at the 6th or 12th month of therapy predicted the achievement of a sustained response rate (SRR, defined as the loss of HBV DNA, loss of HBeAg and ALT normalization) at year 3 of ETV therapy (P = 0.048, OR = 5.83; P = 0.012; OR = 14.57, respectively). The GEE analysis indicated that of the different factors, the duration of ETV therapy had a strong impact on the achievement of virological suppression, HBeAg seroconversion and SRR in adolescents. Each month after the initiation of therapy, the odds of loss of HBV DNA increased by approximately 5% (OR = 1.05, P<0.0001), on average. Additionally, the GEE analysis revealed that adolescents with an age at infection of ≥10 years had 3 times higher odds of achieving undetectable HBV DNA than patients with a younger infection age (OR = 3.67, P = 0.028). None of the ETV-treated patients reported significant adverse effects. ETV is an effective and safe treatment option for adolescents with CHB. Undetectable HBV DNA in the 6th and/or 12th month of ETV treatment and older age at infection could predict maintained virological suppression.
Highlights
Hepatitis B virus (HBV) infection is still one of the most important infectious diseases, with 2 billion people infected worldwide and more than 600,000 deaths each year [1]
In our previous study conducted with 30 children, we showed that 24 weeks of treatment with ETV results in the suppression of HBV DNA in 40.0% of children with chronic hepatitis B (CHB) who had been previously treated ineffectively [12]
Regarding the most predictive factor, undetectable HBV DNA in the 12th month of treatment was selected as the best predictor of assessed virological suppression; the results of our study demonstrated that undetectable HBV DNA in the 6th month of treatment can be considered an early predictive factor of virological outcomes up to year 3 of ETV therapy
Summary
Hepatitis B virus (HBV) infection is still one of the most important infectious diseases, with 2 billion people infected worldwide and more than 600,000 deaths each year [1]. Despite the availability of effective and safe vaccination programs, chronic HBV infection constitutes a serious public health problem. Children infected with HBV perinatally or in the first year of life have a high risk of chronicity, with the development of severe clinical consequences such as liver cirrhosis or hepatocellular carcinoma (HCC). Haber et al observed the occurrence of vertical HBV infection in 5% of infants despite appropriate immuno-prophylaxis and vaccination [2]. HBV infections in young children often involve a long phase of immunotolerance in which patients have a high viral load, HBeAg presence and normal ALT activity
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