Clinical trial NCT04886102: Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana
Official title: Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Adults
Keywords: Hepatitis B, Chronic
Hepatitis B Virus Infection
Adults
French Guiana
Hepatitis C Virus Infection
Co-infection
Chain of transmission
Epidemiology, molecular
Viral phylodynamics
Viral phylogenetics
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Hospital Avicenne
name: University Hospital, Montpellier
name: Direction Générale de l'Offre de Soins
First posted: 2021-05-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients infected with hepatitis B followed at the Cayenne hospital center (adult day hospital consultations, consultations with the infectious and tropical diseases department and hepatology B medicine consultations)

Estimated size of target population: 1000

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)

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

Primary outcomes:
measure: Hepatitis B virus (HBV) sequencing
timeFrame: 2 years
Secondary outcomes:
measure: Hepatitis D virus (VHD) sequencing
timeFrame: 2 years
measure: Liver function Markers
timeFrame: 2 years
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: General Hospital of Cayenne
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Mathieu NACHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: