Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana

NCT ID: NCT04886102

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-02-01

Brief Summary

In South America, the prevalence of HBV is variable but high (> 8%) in the Amazon basin. In some areas, a third of HBsAg carriers are also infected with HDV, a major comorbidity factor. The pre-core mutations are associated with the negative HBe Ag phenotype which is associated with a more severe course. These mutations are of increasing and high frequency. French Guiana is populated by populations of African, European and Asian origins with chains of viral transmission which are not known and viruses probably of different origins with variable virulence and transmission potentials.

Detailed Description

Human demography and migrations play a crucial role in the phylogeography of viral populations. Hepatitis B viruses are characterized by a high genetic diversity which results from the fact that this virus uses a reverse transcriptase during its replicative cycle, which induces errors and therefore variation. A dozen genotypes have so far been described and are subdivided into sub-genotypes which have a distinct ethnogeographic distribution. Genotypes A and D are ubiquitous and represent the most common genotypes in Europe; genotypes B and C are very common in Asia and Oceania, genotype E in Central Africa and West Africa, genotypes H and F in Latin America and Alaska, and Genotype I in Southeast Asia. The populations originating from these different continents are all represented in Guyana and it is therefore interesting to understand what are the chains of transmission and the phylodynamic aspects of the epidemic in French Guiana. In addition, the different genotypes have variable clinical consequences, and this in different ways depending on the ethnicity of the host. Thus, in Mexico, the F and H genotypes appear to be rather benign in the Amerindians among whom they have circulated for a long time. On the other hand, genotypes F, A and D are of rather severe evolution in Mexicans of Caucasian origin, thus suggesting that the immunogenetic factors of the host are important determinants of the pathogenic power of the viruses (Roman and al WJG 2014).

Some pre-core mutations leave the virus with the capacity to replicate. The absence of the HBe antigen deprives the immune system of an important target and the virus can therefore continue to replicate. These pre-core mutations are associated with the HBe Ag negative phenotype (7 to 30% of patients) which is associated with a more severe course of chronic hepatitis. These mutations are of increasing and high frequency (Funk ML, and al 2001).

Addiction to crack cocaine is widespread in French Guiana and appears to be one of the drivers of the epidemic. The pipes used to smoke crack cause burns on the lips and when sharing the pipe could contribute to increasing the risk of transmission (Fischer and al 2008). Risky sexual behavior is associated with the use of crack cocaine, suggesting that there may be specific chains of transmission around crack users.

Primary objective Identify the factors associated with different genotypes (age, sex, country of birth, sexual orientation, sexual risk taking, notion of IV drug addiction, crack ...) in order to identify specific chains of transmission in French Guiana.

Secondary objectives

• Describe the molecular epidemiology of hepatitis B (AgS and pre-core mutations) in French Guiana
• Carry out the phylodynamic study of the different HBV genotypes in order to reconstruct the history of the epidemic in French Guiana
• Identify the clinical prognostic factors associated with the different genotypes and phylogenetic aspects in order to identify the viruses with the greatest pathogenic potential in French Guiana
• Describe the molecular epidemiology of hepatitis D in B-D coinfected in French Guiana

Cross-sectional, monocentric, observational study with biological collection.

Research protocol involving the human person (Category 3 - Non-interventional research_ not related to a health product)

Conditions

Hepatitis B, Chronic; Adults

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital

Research protocol involving the human person (Category 3 - Non-interventional research\_ not related to a health product) Serology, molecular biology, phylogenetic and phylodynamic analyzes of hepatitis B and D

Intervention Type: OTHER

Other Intervention Names

Molecular biology analyzes of hepatitis B and D; Phylogenetic and phylodynamic analyzes of hepatitis B; Phylogenetic and phylodynamic analyzes of hepatitis C

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Person with confirmed chronic hepatitis B
• Person who does not object to their participation in the protocol
• HBV viral load> = 500 copies / mL
• Person who has planned / is willing to have their next HBV assessment of current care taken at the Cayenne Hospital center

Exclusion Criteria

• Refusal to participate
• Age <18 years old
• Person opposing their participation in the protocol
• HBV viral load <500 copies / mL
• Person who has not planned / been unwilling to have their next HBV assessment of current care taken at the Cayenne Hospital center

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Avicenne

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier de Cayenne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu NACHER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Cayenne

Locations

General Hospital of Cayenne

Cayenne, , French Guiana

Site Status: RECRUITING

Countries

French Guiana

Central Contacts

Roxane SCHAUB, MD

Role: CONTACT

roxane.schaub@ch-cayenne.fr

+594 594 39 55 96

DRISP General Hospital of Cayenne

Role: CONTACT

cicec@ch-cayenne.fr

+594 594 39 53 85

Facility Contacts

Mathieu Nacher, MD, PhD

Role: primary

mathieu.nacher@ch-cayenne.fr

+594 594 39 50 24 ext. 5024

Other Identifiers

EMOHCAY

Identifier Type: -

Identifier Source: org_study_id