Sequential therapy with entecavir and pegylated interferon in a cohort of young patients affected by chronic hepatitis B.

The treatment of patients affected by active chronic hepatitis B (CHB) could be performed using a finite-time therapy with pegylated-interferon alpha (PEG-IFN) or indefinite time treatment with nucleos(t)ide analogues (NAs). Current practice guidelines do not provide the combined use of PEG-IFN and NAs, but some studies analyzed various combined approach with NAs and PEG-IFN with encouraging result. In this perspective study, we have treated 39 patients with different hepatitis B virus (HBV) genotypes, hepatitis B "e" antigen (HBeAg)-positive/negative using a sequential therapy with entecavir (ETV) 0.5 mg/day monotherapy for 12 weeks followed by combination of ETV and PEG-IFN α-2a 180 µg/week for 12 weeks, then PEG-IFN monotherapy for 36 weeks. HBeAg seroconversion rate was 68.2%; HBsAg loss was 33.3%; sustained virological response (SVR) was 64.1%; primary non-response was observed in eight patients (20.5%) after 12 weeks of PEG-IFN therapy; virological relapse was reported in six (15.3%) patients. Viral genotype and hepatitis B surface antigen (HBsAg) decline were the most important predictive factor for PEG-IFN response. The stopping rule after 12 weeks of PEG-IFN therapy is useful for identify the non-responders. Our study offers interesting and promising results using a sequential combined therapy with ETV and PEG-IFN in a cohort of young patient with active CHB. These results, however, should not be generalized and further investigations are required for the confirmation of advantage of this combination approach. J. Med. Virol. 88:1953-1959, 2016. © 2016 Wiley Periodicals, Inc.