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SVR to HBV therapy improves survival after decompensation

Patients with hepatitis B-related decompensated cirrhosis who achieved virologic response after treatment with either Baraclude or Epivir had significantly improved long-term and transplant-free survival, according to results of a 10-year observational study.

“Our study demonstrates for the first time that the benefits of [a sustained virologic response] are maintained for up to 10 years with significantly improved liver function even after decompensation, but patients are still at risk for [hepatocellular carcinoma (HCC)], highlighting the importance of close HCC surveillance,” Jeong Won Jang, MD, from the Catholic University of Korea, and colleagues wrote.

The study comprised 179 patients who began treatment with Baraclude (entecavir, Bristol-Myers Squibb) and 116 patients who began treatment with Epivir (lamivudine, GlaxoSmithKline) after decompensation. Neither group displayed significant demographic, biochemical or serum virological differences.

During a mean follow-up of 62.3 months, 60.1% of patients survived for 5 years and 45.7% survived for 10 years without need for liver transplantation, resulting in a median survival time of 7.7 years.

Of the 68 patients who developed hepatocellular carcinoma, 59 patients developed HCC after 1 year and nine patients developed HCC within 1 year. The researchers excluded those nine patients from further analysis as they assumed pre-existing HCC was not detected at baseline.

Multivariate analysis showed that multiple complications (HR = 3.6; 95% CI, 1.71-7.55) and a baseline MELD score of less than 20 (HR = 8.32; 95% CI, 3.98-17.41) independently predicted short-term mortality; and old age (HR = 1.89; 95% CI, 1.12-3.2), alanine aminotransferase levels (HR = 1.87; 95% CI, 1.1-3.16), and SVR (HR = 2.3; 95% CI, 1.6-3.29) independently predicted long-term mortality.

Patients who achieved SVR (n = 116) had significantly longer liver transplantation-free survival times (P < .001). Those who achieved SVR had lower 5-year (22.9% vs. 39.5%) and 10-year (41% vs. 43.9%) cumulative incidence rates of HCC compared with patients who did not.

After adjusting for baseline liver function, the researchers found that patients who achieved SVR exhibited a greater decrease from baseline in Child-Turcotte Pugh class and MELD scores at 4 years, which remained over time up to 10 years.

The researchers observed no significant difference in SVR rates between treatment groups.

“Although regional guidelines recommend urgent antiviral therapy for decompensated cirrhosis, the HBV DNA level to achieve long-term survival has never been specified,” Jang and colleagues wrote. “The overall findings, however, clearly support initiating potent antivirals for the patients even with a low-level viremia, ensuring that complete and durable suppression of HBV is mandatory to confer long-term survival after decompensation.” – by Talitha Bennett

Disclosure: Jang reports he has served as a consultant and speaker for Bristol-Myers Squibb, Gilead and Merck Sharp & Dhome. Please see the full study for the other researchers’ relevant financial disclosures.