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What Are the Effects of Virologic Response to Treatment on Outcomes of Patients With Chronic HBV Infection and Decompensated Cirrhosis?

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Maintained virologic response to entecavir or lamivudine associates with short- and long-term transplant-free survival of patients with hepatitis B virus (HBV)-related decompensated cirrhosis, researchers report in the December issue of Clinical Gastroenterology and Hepatology. The benefits are maintained for up to 10 years, but patients are still at risk for hepatocellular carcinoma (HCC).

(A) Overall transplant-free survival in the entecavir (ETV) vs lamivudine (LAM) groups. (C) Transplant-free survival between patients with and without MVR.

Only 14% to 35% of patients with decompensated cirrhosis (characterized by ascites, variceal bleeding, encephalopathy, or other events) survive for 5 years, compared to 80% to 85% for patients with compensated cirrhosis. Active HBV replication with high levels of HBV DNA is associated with a worse outcome compared with a low or undetectable level of HBV DNA.

Oral nucleos(t)ide analogues rapidly inhibit HBV replication, reducing liver inflammation in patients with HBV-related decompensation. Entecavir is a potent antiviral drug with minimal drug resistance in treatment-naive patients and has good safety profiles, and superior efficacy compared with lamivudine. However, it is not clear if either drug associates with better outcomes of patients with decompensated cirrhosis. Little is known about their effects on the long-term incidence of HCC and liver function.

Jeong Won Jang et al investigated whether a maintained virologic response (MVR, persistently undetectable HBV DNA during therapy) is associated with short-term (less than 6 months) and long-term (6–120 months) survival of patients with HBV-related decompensated cirrhosis. In a 10-year observational study in Korea, Jang et al followed 295 patients with chronic HBV infection who immediately began treatment with entecavir (n = 179) or lamivudine (n = 116) after decompensation.

The median survival time of the cohort was 7.7 years: 60.1% of the patients survived for 5 years and 45.7% survived for 10 years without transplant. An MVR was observed in 116 patients (39.3%); these patients had significantly longer times of transplant-free survival than patients without MVR (see figure).

The 5- and 10-year cumulative incidences of HCC were 22.9% and 41.0% for patients with MVR and 39.5% and 43.9% for patients without MVR. Survival times associated with the occurrence of HCC. Survival of patients without HCC was excellent, with only a 25.3% mortality between 6 months and 10 years. Survival of patients with HCC decreased with time.

A baseline model for end-stage liver disease (MELD) score above 20 and multiple complications were associated with short-term mortality.

MVR was the factor most strongly associated with long-term transplant-free survival. Significantly higher proportions of patients who received entecavir survived 10 years compared with patients who received lamivudine, but no difference was observed among patients with MVRs. Patients with MVRs had significant improvement in hepatic function over time, but nonsignificant reductions in risk of HCC or HCC-related mortality.

When Jang et al adjusted for baseline liver function, patients with an MVR had a greater decrease from baseline in Child–Turcotte–Pugh and MELD scores at 4 years than patients without an MVR. Afterward, the patients maintained the decrease in the scores over time for up to 10 years.

Jang et al conclude that durable suppression of HBV load is required to increase overall survival of patients  with decompensation. The increased long-term survival of patients with MVRs was obtained with significant improvements in hepatic function. However, an MVR to therapy has only modest effects on the incidence of HCC. The authors were able to calculate a minimum on-therapy level of HBV DNA (<20 IU/mL) that should be maintained to optimize outcomes for patients with decompensated cirrhosis.

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About The Author:

Dr. Kristine Novak

Dr. Kristine Novak

Dr. Kristine Novak is a science writer and editor based in San Francisco. She has extensive experience covering gastroenterology, hepatology, immunology, oncology, clinical, and biotechnology research discoveries.

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