Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and nonresponding adults.

Approximately 5% of the healthy adult population respond inadequately to the commercial recombinant hepatitis B vaccines. As the recombinant vaccines all have an aluminium-based adjuvant, we tried to enhance the immune response by adding a cytokine-based adjuvant. This new adjuvant AI20, containing 20 µg recombinant human IL-2 attached to 20 µg aluminium hydroxide, was added to HBVaxPro©-10 µg (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naïve subjects were randomized to receive either HBAI20 or commercial HBVaxPro©-10 µg vaccine. In an open-label study, 10 nonresponders received HBAI20 vaccine. All participants received 3 vaccinations (0, 1 and 6 months). In the RCT, the occurrence of any adverse events or severe events was similar between the trial arms. At month 7, all naïve participants were seroprotected; moreover, 92% in the HBAI20 group had protective antibodies 10 days after the second vaccination vs 58% in the HBVaxPro©-10 µg group, P = .16. In the open-label study, no serious adverse events were noted. The HBAI20 vaccine was able to elicit protective anti-HBs titres in 90% of nonresponders, 1 month after the third vaccination. According to these results, the new HBAI20 vaccine seems safe, well-tolerated and may promote more rapid protection against hepatitis B infection.

A long-term study of liver-related events in Caucasian hepatitis B patients with normal ALT values and high viremia.

Background and study aims: There is ongoing debate whether antiviral therapy should be initiated in hepatitis B e antigen (HBeAg)-negative patients with normal alanine aminotransferase (ALT) levels but high HBV DNA levels >2,000 IU/mL. Since the need for antiviral therapy might be different between Asian and Caucasian patients, we studied the long-term disease outcome in Caucasian patients living in Western Europe. Patients and methods: One hundred sixteen patients with high HBV DNA levels (>2,000 IU/mL) at diagnosis were included in the high viremia group, while those with HBV DNA <2,000 IU/mL were used as controls (n = 327). All patients were Caucasian, HBeAg negative, had normal ALT levels and had no significant liver disease at diagnosis. Results: Median follow-up was 7 + 9.8 years in the high viremia group and this was 10 + 12.5 years in controls. The cumulative probability of a liver-related event over 10 years was 4.8% vs 0.0% in the control group (p=.008). In multivariable analysis, high viremia group was associated with the occurrence of a liver-related event (hazards ratio (HR) 95% confidence interval (CI): 1.20-11.98, p=.023). In this subgroup, older age at diagnosis (HR 95% CI: 1.01-1.16, p=.023) predicted a higher risk of liver-related event. In the high viremia group, liver-related mortality was 0.9% and none of the patients developed hepatocellular carcinoma. Conclusions: HBV DNA >2,000 IU/mL influences the long-term disease outcome in Caucasian HBeAg-negative patients living in Western Europe. Nevertheless, the risk of liver-related events is low.

Uptake of hepatitis C virus screening and treatment in persons under opioid substitution therapy between 2008 and 2013 in Belgium.

BACKGROUND: Hepatitis C is a viral infection caused by the hepatitis C virus (HCV) with people who inject drugs as the main group at risk worldwide. AIM: This study investigated the differences in uptake for HCV screening and treatment between persons in opioid substitution therapy (OST) and the other members of the Christian Health Insurance Fund in Belgium. METHODS: Invoice data were retrospectively collected from the Christian Health Insurance Fund, representing 42% of the healthcare users. Information on demographics, screening, diagnostic tests, treatment and disease progression was obtained from 2008 till 2013. All people in this study were aged 20-65 year. Persons in the OST group were identified as having at least one prescription reimbursed for methadone. This group was compared to the other members of the Insurance Fund not on OST (NOST). RESULTS: The Insurance Fund registered 8,409 unique OST and 3,525,190 members in the general group. HCV RNA screening rate was higher in the OST group after correction for age and gender (4.3% vs. 0.2%). Ribavirin reimbursement, did not differ between the OST and NOST group screened for HCV RNA (16.9% vs. 14.4%), though the probability of having ribavirin reimbursed was smaller for females than for males. Procedures concerning disease progression were reimbursed less frequently in the HCV RNA screened OST group compared to the NOST group (0.3% vs. 1.2%). CONCLUSION: People on OST were screened more often for HCV RNA. However, the general uptake for HCV screening and treatment in both populations remained suboptimal.

Horizontal hepatitis B virus transmission through non-sexual close contact in Turkish chronic hepatitis B patients living outside of Turkey.

BACKGROUND AND AIMS: Hepatitis B virus (HBV) infection is a global threat and with the growing cultural diversity in Western Europe, knowledge on routes of infection in order to decrease HBV spreading is essential. This study assessed the risk of horizontal transmission through non-sexual close contact in the chronic hepatitis B (CHB) population in Maastricht (the Netherlands) and Genk (Belgium), with a main focus on the differences between ethnic groups. METHODS: In this multicenter retrospective study, 166 CHB patients, who were still under follow-up between December 2009 to December 2014, were recruited from the Hepatology Outpatient Departments of two hospitals, one in Maastricht and one in Genk. Ethnicity (defined as country of origin (COO)) and routes of transmission were collected from all patients. RESULTS: The CHB population in Maastricht and Genk consisted of 98 and 68 patients, respectively. In Maastricht, 31% were of Dutch and 16% of Chinese origin. In Genk, mainly Belgian (15%) and Turkish (50%) patients were included. The percentage of horizontal transmission in the total study cohort was 9%. Moreover, the COO groups Dutch/Belgian (n=40), Turkish (n=38) and Chinese (n=18) differed in the number of cases infected by horizontal transmission (4%, 30% and 6%, p=0.030). CONCLUSION: Although the prevalence of horizontal transmission in the total study cohort is low, non-sexual close contact may play a role in the migrant population, particularly the Turkish. This should be an important public health target with respect to the prevention of HBV spreading.