Response to Pegylated Interferon in Hepatitis B patients with HBe Ag-Negative: Long-Term Results and Predictors of Sustained-Off VIirological Response

Introduction: Chronic Hepatitis B (CHB) is a major  public health problem in Morocco and worldwide. According to our real-life experience, genotype D and mutant phenotype are prominent in Moroccan population. In this study, we aimed to evaluate the place of PEG INF in HBe Ag Negative patients and to define good responders’ profile. Methods: It’s a mono-centric study including all naive HBV-carriers treated by PEG INF since 2004. Patients with treatment failure and relapsers were not excluded. Patients with less than 24Wof  regular follow-up after end of treatment and patients with HIV or HCV co-infection were excluded. Considered data were: age, gender, body mass index (BMI), initial ALT rates, initial viral loads, histological activity and fibrosis according to METAVIR score. The major endpoints of the study were Virological response (VR) and sustained off-treatment virological response (SVR) rates. Results : From a total of 80 treated patients, 50 were considered for the study. Mean age was 41 years old and 74% of patients were male. HVB genotyping was performed in only 28 patients. Four patients were genotype A and 24 were genotype D. Ten patients were obese. Hepatic fibrosis was severe (F3- F4) in 6 patients. Treatment failure and relapse were reported in 9 patients (18%) and then only 41 patients achieved 48 weeks of treatment. They all achieved 72  weeks of regular follow-up. HBV DNA was undetectable by polymerase chain reaction in respectively 10% and 6% of patients at both 72W and 96W (respectively n=5/50 and n=3/50). Virological response was achieved by 34% of patients at 72W (n= 17/50) and SVR was obtained in 18% at 96W (n=9/50). No HBs seroconversion was reported. Gender, age< 50 years old, genotype and initial cytolysis were not significant predictors of SVR. Low initial DNA viral level (<4log) was the only significant factor associated to SVR ( p= 0,002 ) Conclusion: The advantage of PEG- INF  is the short duration of treatment. In our population - where HBe antigen negative profile and genotype D are prominent-, DNA negativation rates were very low (only 6%) and SVR was achieved in 18%. A national randomized study will help to assess the efficacy of extended PEG-INF treatment duration in our HBe Ag negative CHB patients with genotype D.