Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

Study Overview
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Brief Summary
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This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.

Detailed Description
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The study will take place during routinely scheduled ART visits as per Ministry of Health guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive liver scan) to address other aims. The study will be implemented at two sites in Southern Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.

Official Title
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Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa: a Collaborative Multi-country Prospective Cohort Analysis for International Epidemiologic Databases to Evaluate AIDS- Southern Africa (HIV/HBV-coinfection in IeDEA-SA)

Conditions
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Hepatitis B Virus, HIV, Africa, Antiretroviral Therapy, Liver Fibrosis, Alcohol Use Disorder

Intervention / Treatment
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* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected Male or female aged ≥18 years ART naïve ART eligible as defined by Zambian or WHO treatment guidelines Initiating an ART regimen including at least 3 drugs at one of the study sites. Willing to provide signed informed consent and be followed at the clinical site. Exclusion Criteria: Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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<br>150-200 patients in Zambia and 250-300 across all sites | Other: Standard of care<br>* routine standard of care per Ministry of Health protocol including blood draws and examinations.<br>|
| HIV mono-infected<br>700-750 patients in Zambia and 1600-1700 across all sites | Other: Standard of care<br>* routine standard of care per Ministry of Health protocol including blood draws and examinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response | A linear mixed effect model will be used to evaluate immunological response to ART in patients with and without viral hepatitis | 12 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV virological response | Virological response will be evaluated using Cox regression analyses. | 12 months post enrollment | 
| Mortality | Deaths will be ascertained | 12 months | 
| Hepatotoxicity events | These events will be defined as an increase in the level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 time the upper limit within the first year of ART. | 6 and 12 months | 
| Prevalence liver fibrosis | The prevalence of liver fibrosis will be measured to compare HIV/hepatitis coinfected versus HIV monoinfected patients using transient elastography. | Baseline and one year after start of ART | 
| HBV drug resistance | The presence of HBV drug resistance in co-infected patients who fail treatment after 1 year will be measured | 1 and 2 years post enrollment | 
| Incidence of HBV infection | The incidence of HBV infection during ART will be measured. | 12 and 24 months post enrollment | 
| Prevalence of HIV/HCV coinfection | Describe prevalence of coinfection at ART initiation | Baseline | 
| Alcohol use patterns | Describe the proportion with unhealthy levels of drinking before and after ART | Baseline, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiretroviral therapy, Hepatitis C virus