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BMJ Open Gastro 2016; 3:e000081 doi:10.1136/bmjgast-2016-000081
An evaluation of entecavir treatment among nucleos(t)ide-naïve Moroccan patients with chronic hepatitis B
Amal Chakkor1, Fedoua Rouibaa1, Safiaa Elaboudi2, Aziz Aourarh1,
Author Affiliations
1Gastroenterology Unit “I”, Mohamed V Military Hospital, Mohamed V University, Rabat, Morocco
2Medecine “C” Unit, Ibn Sina University Hospital, Mohamed V University, Rabat, Morocco
Received:
27 January 2016
Accepted:
21 March 2016
Published Online:
26 April 2016
Abstract
Objective
To analyse the efficacy and safety of entecavir (ETV) treatment in nucleos(t)ide (NUC)-naïve Moroccan patients with chronic hepatitis B.
Methods
We retrospectively analysed 41 NUT-naïve Moroccan patients with chronic hepatitis B who received ETV 0,5 mg/day monotherapy for at least 3 months, of whom 3 were HBV envelope antigen (HbeAg) positive and 38 were HBeAg negative. The primary end point was the proportion of patients achieving virological response. Secondary end points included biochemical response (alanine transaminase (ALT) normalisation), serological response (HbeAg and HBV surface antigen (HBsAg) loss or seroconversion) and safety.
Results
The median follow-up duration was 74 weeks (48–144 weeks) and mean age was 43.8 years. Of 41 patients, 6 were primary non-responders and 2 achieved partial virological response at week 48, whereas 35 achieved undetectable hepatitis B virus (HBV) DNA at month 12. Viral suppression was maintained in 97.6% of patients after 3 years of ETV treatment. One patient experienced a virological breakthrough at month 12 of treatment. ALT normalisation occurred in 100% of the patients after 1 year of treatment. Only three patients in our study were HbeAg positive, of whom one has experienced seroconversion at month 12 of treatment. However, HBsAg loss or seroconversion was not achieved during the period of the study. No serious adverse event was reported.
Conclusions
These preliminary results showed that ETV is a safe and potent inhibitor of HBV in NUC-naïve Moroccan patients, but we need to observe more patients for a longer period of time, in order to assess the long-term effectiveness, safety, resistance profile and predictive factors for virological and serological response of ETV.
Keywords: HEPATITIS B, TOLERANCE, ANTIVIRAL THERAPY
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