Study Design: Observational
Conditions: Hepatitis B, Hepatitis, Viral, Liver Diseases
Division: DDN
Duration: April 2014 - March 2019
# Recruitment Centers: 7
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT01924455
Data Package Version Number: 1 (February 28, 2023)
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.
The specific aims of the HBRN ancillary study were to:
The primary outcome measure was liver disease severity over time. The secondary outcome measure was the longitudinal outcome of viral suppression.
Inclusion criteria:
Exclusion criteria:
At entry into the study, 95% of participants were on anti-HBV combination antiretroviral therapy (cART). Clinical events were uncommon during follow-up and no participants had HBsAg loss. Paired biopsy showed minimal improvement in the Histologic Activity Index without significant change in the fibrosis score. Among the cohort, clinical outcomes and worsening histological diseases were uncommon.