French HIV-HBV Cohort

Study Overview
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Brief Summary
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The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

Detailed Description
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The French HIV-HBV Cohort is an observational, non-interventional study including 308 HIV-infected patients with chronic HBV infection (HBsAg-positive serology >6 months) in seven clinical centers. Patients were recruited in 2002-2003 and followed prospectively every three to twelve months, during two phases, until 2010-2011. Extensive information on a variety of HIV- and HBV-related parameters were collected during these study visits. This particular study aims to extend follow-up of the French HIV-HBV Cohort using a different type of design. Patients who completed at least one study phase of the French HIV-HBV Cohort are selected for participation. Patients continuing follow-up at a participating clinical center are asked to undergo their routine clinical visit, during which time medical data from the years since last cohort visit until their routine visit are extracted. For those who died, information from the years since last cohort visit until death will be collected. The primary objective for this cohort extension is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses. The following secondary objectives are as follows: To establish the extent of persistent viremia (PV) of HBV, quantified either in serum or within the hepatocyte To understand whether this persistence effects clinically-relevant serological outcomes (i.e. HBeAg and HBsAg seroclearance and seroconversion along with HBsAg quantification) after prolonged follow-up To quantify the evolution of liver fibrosis using non-invasive methods and, in a small subset of patients, liver biopsies, while investigating the virological and immunological factors associated with its progression and regression To describe the causes of liver-related and non-liver-related morbidity and mortality and the direct effect of persistent HBV DNA replication on these outcomes

Official Title
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Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B

Conditions
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Hepatitis B, HIV, Liver Cirrhosis, End Stage Liver Disease

Intervention / Treatment
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* Other: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg seropositivity for >6 months (at initial cohort inclusion) HIV-positive serology confirmed with Western blot (at initial cohort inclusion) Karnofsky score >70 (at initial cohort inclusion) Age ≥18 years old (at initial cohort inclusion) Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort Obtained signed written informed consent Exclusion Criteria: Refusal to participate Any severe physical, clinical or mental condition preventing participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-HBV co-infected individuals<br>No interventions will be administered. Individuals will be undergoing routine care. | Other: Routine care<br>* Routine care recommended for patients co-infected with HIV and hepatitis B virus (per European Association for the Study of the Liver and European AIDS Clinical Society guidelines).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA replication | Proportion of patients with detectable HBV DNA levels, as determined by a commercially-available PCR assay (>60 international units/mL), at the beginning and end of follow-up | 14 years | 
| HBeAg-seroclearance | Proportion of hepatitis B e antigen (HBeAg)-positive patients who lose HBeAg-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up | 14 years | 
| HBsAg-seroclearance | Proportion of patients who lose hepatitis B surface antigen (HBsAg)-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up | 14 years | 
| Liver fibrosis (FibroTest) | Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroTest (non-invasive biochemical score) with a level >= 0.59, at the beginning and end of follow-up | 14 years | 
| Liver fibrosis (FibroScan) | Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroScan (transient elastography) with a level >= 7.6 kPa, at the beginning and end of follow-up | 14 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver-related morbidity | Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up | 14 years | 
| Liver-related mortality | Proportion of patients who died due to liver-specific disease by the end of follow-up | 14 years |