Public Release Type:
Journal
Publication Year: 2012
Authors:
Ghany MG,
Terrault N,
Khalili M,
Sterling RK,
Di Bisceglie AM,
Lau D,
Lok AS,
Wong DK
Studies:
Hepatitis B Research Network
The HBRN is a cooperative network that includes 20 clinical sites which recruit adults into an observational cohort study from diverse regions and populations in the United States and Canada to better understand the natural history of chronic hepatitis B. Methods: All sites were instructed to create a screening log for all HBsAg-positive patients who attended liver clinics. Demographic and the most current clinical and laboratory data available at time of screening were recorded. Those eligible were invited to enroll in a longitudinal observational cohort study. Data from the first 16 months of this ongoing study are presented here. Results: From January 2011 to April 23, 2012, 5054 HBsAg+ adult patients were screened. Patients were excluded if any of the following predefined criteria were met: history of hepatic decompensation (3%), HCC (3%), liver transplant (0.8%), HIV co-infection (3%), and those currently receiving antiviral therapy (43%). Of those on antiviral therapy, HBeAg was positive in 33% of the 1978 with documented HBeAg status and HBV DNA was undetectable in 69% of the 1915 with available HBV DNA levels. Duration and type of antiviral therapy were not captured. 2012 patients met eligibility criteria of whom 1159 (58%) were enrolled. The major reasons for patients who were eligible for the study but not enrolled were refusal of consent and inability to comply with the protocol follow-up. Table 1 summarizes characteristics of the patients screened, those who were eligible for enrollment and those who enrolled in the cohort study. Conclusion: Use of antiviral therapy was widespread among tertiary care centers in the HBRN and its ongoing use was the most common reason for exclusion from the cohort study. Among those eligible, 58% were enrolled and enrollment rate was similar regardless of demographics or disease characteristics suggesting that barriers to enrollment in an observational study are similar across racial-ethnic groups.