Sustained HBV DNA Undetectability With Entecavir Monotherapy
SAN FRANCISCO, CA—New data reported at The Liver Meeting® 2015 indicate that entecavir monotherapy without hepatitis B immune globulin (HBIG) effectively prevents graft loss and death from recurrent hepatitis B after liver transplantation in patients with chronic hepatitis B (CHB) without prior drug resistant mutations.
"The rate of HBsAg [hepatitis B surface antigen] negativity and HBV DNA undetectability is sustainable with excellent long-term outcome and survival," reported lead study author James Fung, MD, and colleagues from the University of Hong Kong, in Hong Kong, China.
The researchers studied 165 consecutive patients to assess long-term outcomes following CHB liver transplant among patients treated with entecavir alone. Patients with CHB who received liver transplantation during November 2007–December 2011 were included in the study.
Indications for liver transplantation included hepatitis B cirrhosis (31%), severe acute flare of CHB with liver failure (36%), and hepatitis B-related hepatocellular carcinoma (33%). None of the patients had preexisting virological resistance prior to transplantation.
“Patients were followed up initially at weekly intervals on discharge from hospital, with a subsequent follow-up interval of up to 3 months, once stable," Dr. Fung reported. "Standard laboratory tests for liver biochemistry, HBsAg, anti-HBs, and hepatitis B e-antigen (HBeAg) were performed at each follow-up visit."
At a median follow-up of 59 months,"the cumulative rate of HBsAg [negativity] after liver transplantation was 85.6%, 92.8%, and 95.7% at 1, 2, and 5 years, respectively," Dr. Fung reported.
The cumulative HBV DNA-undetectability rate was "82.9%, 90.5%, and 98.7% at 6 months, 1 year, and 3 years, respectively," reaching 100% by 44 months.
"HBV DNA-undetectability rates were sustainable, with 100% of patients being undetectable at 7 years after transplantation," Dr. Fung noted. "There was no virological rebound observed." Twenty patients remained positive for HBsAg at the time of last follow up, all with undetectable HBV DNA.
The overall 7-year survival was 87.1%, concluded Dr. Fung. There were 20 deaths during the follow-up period but none were due to hepatitis B recurrence.
"In post-transplant CHB patients without prior drug resistance, entecavir monotherapy without HBIG is highly effective in preventing graft loss and death from recurrent hepatitis B in the long-term," Dr. Fung concluded.