medLow Incidence of Adverse Outcomes in Adults with Chronic Hepatitis B Virus Infection in the Era of Antiviral Therapy.

BACKGROUND AND AIMS Outcomes of persons with chronic HBV infection in the era of antiviral therapy are not well characterized. We determined the incidence and factors associated with clinical outcomes in a multiethnic, North American cohort of adults with chronic HBV infection, who were not on antiviral therapy at enrollment. METHODS Adults with chronic HBV infection, not receiving antiviral therapy, and without a history of decompensation, HCC or OLT were prospectively followed. Participants with known HIV, HCV or HDV coinfection were excluded. During follow-up, treatment could be initiated per standard of care. Clinical outcomes included: incident cirrhosis, decompensation, HCC, OLT and HBV-related death. RESULTS Among 1418 participants analyzed, 51.5% were women, median age 41.1 years, 75% Asian, 10% white, 13% black, 24% HBeAg(+), and 1.5% cirrhosis at baseline. During the study, 274 started treatment, 83 had an ALT flare, 118/330 initially HBeAg(+) became HBeAg(-), and 90/1329 became HBsAg(-). After 6641 person-years follow-up, 8 participants (4/21 with baseline cirrhosis) had 12 clinical outcomes (2 decompensation, 5 HCC, 2 OLT, 3 HBV-related deaths) and 19/1397 had incident cirrhosis. 21/26 participants had first outcome before treatment, none had become HBsAg(-) while 5/9 HBeAg(+) had become HBeAg(-) at time of first outcome. Cumulative percentage of clinical outcomes was 16% at year 4 in participants with baseline cirrhosis, and 2% (including incident cirrhosis) at year 7 in those without. CONCLUSIONS Incidence of adverse outcomes was low in this closely monitored large cohort of North American adults with predominantly inactive, non-cirrhotic chronic HBV. Our data highlight the benefits of HBsAg loss and the importance of early diagnosis and treatment to prevent cirrhosis and other complications of chronic HBV infection.