Observational Study of Hepatitis B Virus (HBV) in Patients Co-Infected with Human Immunodeficiency Virus (HIV)

Since the introduction of highly active antiretroviral therapy (ART) in 1996, there has been a dramatic reduction in morbidity and mortality among those living with HIV. However, chronic liver disease due to co-infection with hepatitis B virus (HBV) or C (HCV) has emerged as the second leading cause of mortality among HIV-infected persons. The natural history of HBV infection is altered in those with HIV. Current guidelines recommend that most co-infected patients be treated for both HIV and HBV infection using combinations of ART that include tenofovir (TDF). Despite widespread adoption in the U.S., the effect of this regimen on long-term outcomes of HBV disease such as histologic severity, progression, risk of emergence of resistant HBV variants, and the long-term risks of TDF therapy remains unanswered.

The Hepatitis B Research Network (HBRN) was the first major effort to elucidate the natural history and treatment outcomes of persons with chronic HBV in the U.S. This HBRN ancillary study provided a unique opportunity to fill major gaps in HBV-HIV knowledge and to compare HBV-HIV infected persons to those with HBV monoinfection participating in the HBRN.