Hepatitis B and HIV Co-Infection in Patients in Uganda

While there are around 25 million HIV-infected persons in sub-Saharan Africa, there are also an estimated 50 million with chronic hepatitis B virus (HBV) infection. Yet data from Africa on the prevalence and clinical implications of HIV/HBV co-infection are sparse or unavailable. The scale-up of' HIV treatment with antiretroviral medication (ARVs) in Africa, should result in substantial reductions in morbidity and mortality. In developed countries, however, improved survival with highly active antiretroviral therapy (HAART) has been associated with notable increases in mortality due to liver disease among HIV-infected persons. Also, persons co-infected with hepatitis viruses have significantly higher liver-related toxicity with ARVs compared to persons infected with HIV alone. Our protocol will investigate predictors of liver disease among co-infected participants. The proposed study directly addresses the problem of HIV/HBV co-infection by examining the association of HBV viral markers with the development of significant liver fibrosis (defined by transient elastography). In addition to strengthening the clinical research capacity of our Ugandan colleagues, completion of our study aims will provide needed information for understanding the complex interaction of HBV and HIV, for projecting the future burden of liver disease related to the HIV epidemic, for clinical management of HBV infection in the setting of co-infection with HIV, and for optimizing the benefits while mitigating the potential deleterious consequences of antiretroviral programs in Africa.

Serological screening will be performed on up to 11,000 subjects in order to identify up to 2,400 subjects to be recruited into the clinical protocol. All people who choose to participate in the study will be asked to come to the clinic for at least 1 visit. If continuing funding is obtained, participants may be asked to return for additional yearly follow-up visits.