Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Summary

With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.

Conditions

• Hepatitis B
• Liver Cirrhosis
• Carcinoma, Hepatocellular

Interventions

OTHER

ELISA testing

Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

OTHER

Rapid testing

A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases

  collaborator OTHER_GOV

• Gilead Sciences

  collaborator INDUSTRY

• Roche Pharma AG

  collaborator INDUSTRY

• Mairie de Paris

  collaborator UNKNOWN

• BioMérieux

  collaborator INDUSTRY

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

  lead OTHER

Principal Investigators

• Julie Bottero, MD · Hôpital Saint-Antoine

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-07-31

Completion

2013-01-31

Countries

• France

Study Locations