Background: Selection of high versus low potency antiviral drugs and the impact of maintained virologic response (MVR) on short-term and long-term outcome in patients with hepatitis B virus (HBV)-related decompensated cirrhosis are poorly established....
Background: Selection of high versus low potency antiviral drugs and the impact of maintained virologic response (MVR) on short-term and long-term outcome in patients with hepatitis B virus (HBV)-related decompensated cirrhosis are poorly established. This study aimed to evaluate the outcome regarding antiviral potency and HBV suppression in such patients followed for 10 years.
Methods: This was an ancillary analysis of data collected in a prospective, multicenter study in which patients with first-onset decompensation were recruited since 2005. Eligible patients were HBV subjects who immediately initiated either entecavir or lamivudine at enrollment. The primary endpoint was liver transplantation (LT)-free survival. Other endpoints included the incidence of hepatocellular carcinoma (HCC) and changes in the Child-Turcotte-Pugh (CTP) and MELD scores on follow- up.
Results: Of the 1,595 original cohorts, 295 (179 entecavir-treated and 116 lamivudine-treated patients) who met the eligibility criteria were included in this analysis. Overall, the median LT-free survival of the entire patients was 7.7 years. During the follow-up, 51 (17.3%) and 76 (25.8%) died or underwent LT before and after 6 months, respectively. Multiple decompensated complications and CTP class C were independent predictors of short-term mortality, whereas age and MVR remained independently predictive of long-term survival. The type of anti- HBV medications was not predictive of survival, but early and maintained VR predicted short-term and long-term survival, respectively. Particularly, MVR still significantly improved long-term survival for both the entire and baseline risk factor-adjusted groups. When stratified across the HBV DNA levels during follow-up, patients achieving maintained HBV suppression < 20 IU/mL exhibited a significantly better 10-year survival than those with fluctuating levels up to 200, 2,000, and persistently high >20,000 IU/mL (82.5%, 33.9%, 74.1%, and 45.9%, respectively; P<0.004). MVR resulted in significant improvement in hepatic function over time, but only marginal reduction in HCC development.
Conclusions: Early and maintained suppression of HBV <20 IU/mL with anti-HBV therapy yields significant short- and long-term clinical benefits in decompensated patients. The survival benefits from MVR appear to be derived from progressive improvement in liver function rather than a reduction in HCC incidence.