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Baraclude prevents post-LT HBV reactivation in chronic patients

Long-term Baraclude monotherapy was highly effective in preventing hepatitis B reactivation after liver transplantation in patients with chronic HBV, according to results of a recently published study. The monotherapy also had significantly high rates of hepatitis B surface antigen seroclearance, undetectable HBV DNA and long-term survival.

“For patients undergoing liver transplantation for hepatitis B-related complications, effective antiviral prophylaxis has improved both the short and long term outcome and survival by preventing graft loss and death due to hepatitis B recurrence,” the researchers wrote.

The researchers enrolled 265 patients who underwent liver transplantation between Jan. 1, 2007, and Dec. 31, 2014, to test the efficacy of Baraclude (entecavir, Bristol-Myers Squibb) monotherapy as primary antiviral prophylaxis. Median patient age was 53 years (range, 23-68 years) and 83% of the patients were men. The primary indications for transplant included chronic decompensation (n = 75), severe acute flares of chronic HBV (n = 93) and hepatocellular carcinoma (n = 97).

Nine patients were unavailable for HBsAg serological testing. The rate of HBsAg seroclearance for the remaining patients was 77% at 3 months, 90% at 1 year and 95% at 5 years. Thirty-six patients had HBsAg reappearance, of which 22 patients had fluctuating HBsAg status throughout follow-up and 14 had persistent HBsAg at the end of the study.

HBV DNA was undetectable in 95% of patients at 1 year and in all patients at years 5 and 8. At 1 year after transplant, the HBsAg seroclearance rate was 98% for HBV DNA at transplant of undetectable levels, 92% for 4 logs IU/mL or less, 81% for more than 4 logs IU/mL up to 6 logs IU/mL, and 60% for over 6 logs IU/mL (P < .001).

At the time of transplant, 97 patients had HCC. HBsAg seroclearance rates after transplant were 88.3% persistent, 10.6% transient and 1.1% negative. Of the 13 patients with HCC recurrence after transplant, HBsAg reappearance rates were higher compared with patients with no recurrence (45.5% vs. 7.4%; P = .003).

There was no significant difference in liver stiffness between patients with and without HCC or between patients who were persistently positive for HBsAg and those who achieved seroclearance and maintained HBsAg negativity.

There were no side effects attributed to entecavir or deaths attributed to HBV reactivation. There were 37 deaths, the causes of which included sepsis or infection (n = 20), HCC recurrence (n = 9), malignancy (n = 4), cardiac arrest (n = 3) or traumatic cerebrovascular event (n = 1).

“Although approximately 15% of patients remain HBsAg positive throughout the duration of follow up, this did not signify HBV reactivation, as HBV DNA remained completely suppressed. It also does not signify HBV recurrence, as chronically infected patients are rarely able to completely eliminate HBV, even after transplantation,” the researchers wrote. “The level of HBsAg for those without HBsAg seroclearance or those with HBsAg reappearance after transplantation has been shown to remain at a very low level.” – by Talitha Bennett

Disclosure: The researchers report no relevant financial disclosures.