Exclusion from HBV therapy by AASLD criteria often leads to adverse outcomes

WASHINGTON — Nearly half of patients with hepatitis B who developed adverse outcomes did not meet AASLD guideline treatment criteria at presentation and one-quarter never met guideline criteria prior to development of adverse events, according to a study presented at Digestive Disease Week 2018.

“Although there have been periodic updates to keep pace with new evidence, guideline treatment eligibility criteria are still based on the serum HBV DNA and aminotransferase level, HBV e antigen status and presence of cirrhosis,” Dong Hyun Lee, MD, from Stanford University in California, said in his presentation. “These surrogate markers of liver disease cannot predict long-term outcomes of all chronic HBV patients and precise levels are uncertain below which adverse outcomes may not develop.”

Lee and colleagues reviewed the data of 3,145 patients from the U.S. and 3,635 patients from Taiwan with chronic HBV. While the U.S. cohort had a mix of treatment experience, all patients in the Taiwan cohort were treatment-naive.

Using the AASLD 2015 chronic HBV treatment guideline, the researchers evaluated patient eligibility for antiviral treatment at baseline and during follow-up. According to Lee, the 2015 guideline was chosen as the 2018 guideline revised few details.

In the U.S. cohort, 202 patients experienced adverse outcomes including death or need for liver transplantation (46%), hepatocellular carcinoma (21%) and cirrhosis (33%), of whom 39.6% were ineligible for treatment at baseline. Of those ineligible at baseline, 63.8% remained ineligible at a median follow-up of 5.7 years. Fifty-one of the 202 patients never met treatment criteria.

In the Taiwan cohort, 476 patients developed either HCC (50%) or cirrhosis (50%), of whom 86.3% were ineligible for treatment as baseline. At a median follow-up of 16.8 years, 24.1% remained ineligible. Ninety-nine of the 476 never met criteria.

“It is important to remember that chronic HBV is a dynamic disease with fluctuating courses of activity,” Lee said. “AASLD 2015 treatment guidelines should thus address patients who progress to serious liver-related complications.” – by Talitha Bennett

Reference:

Lee DH, et al. Abstract 249. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.

Disclosure: Lee reports no relevant financial disclosures. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.