Assessment of Anti-HBV Immunogenicity in chronic Hepatitis C non-cirrhotic carriers after being exposed to two Hepatitis B vaccine regimens

INTRODUTION: Hepatitis B virus (VHB) vaccination is regarded as the most effective method for the prevention and control of VHB infection. Studies showed a reduced VHB vaccine response between patients with chronic hepatitis C (VHC), but studies exploring VHB vaccine efficacy in this population have equivocal results. OBJECTIVES: To evaluate VHB vaccine response in patients with VHC submitted to two different (20 µg vs 40 µg in 0, 1 and 6 months) anti-HBV vaccine schemes and administer the 4th additional dose in non-responders as well as assess the maintenance of seroprotectors titers. METHODS: This randomized controlled trial included 141 VHC who received double dose (40ug) or standard dose (20ug) and 70 healthy volunteers who received standard dose (20ug) at 0, 1 and 6 months. Anti-HBs titers were measured at 1 month after last dose. Vaccine response was defined by anti-HBs =10 U/L. Non-responders received the fourth dose according to the group that were previously randomized. Multivariate regression was modeled as a logistic regression. RESULTS: 128 completed the study. Median age 51 years, 61% female, 52% white, 40% F2-3, and 75% GT1, median 6 log10 VHC-RNA. Overall seroconversion rate was 76.7% (n=60) in double dose and 73.5% (n=68) in standard dose, compared to 92.6% in controls (n=68). 23 patients received the fourth dose; 7 seroconverted (30.4%) and seroconversion rate for double and standard doses were 42.9% and 11.1%, respectively (p=0.18). Controlling for confounders, only older age (p<0.001) and GT1 (p=0.005) were associated with a decreased anti-HBs response. CONCLUSION: In VHC-infected patients without cirrhosis, responses to VHB vaccination are significantly impaired and this reduced response cannot be overcome by the use double dose. Besides that, 4th dose VHB vaccination can be a strategy efficacious this vulnerable population