Outcome of sustained virological responders with histologically advanced chronic hepatitis C.

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Hepatology. 2010 May 14. [Epub ahead of print]

Outcome of sustained virological responders with histologically advanced chronic

hepatitis C.

TR, Ghany MG, Kim HY, Snow KK, Shiffman ML, De Santo JL, Lee WM, Di

Bisceglie AM, Bonkovsky HL, Dienstag JL, Morishima C, KL, Lok AS; and

the HALT¡¾C Trial Group.

Division of Gastroenterology, University of California Irvine, Irvine, CA.

Abstract

Retrospective studies suggest that subjects with chronic hepatitis C and

advanced fibrosis who achieve a sustained virological response (SVR) have a

lower risk of hepatic decompensation and hepatocellular carcinoma (HCC). In this

prospective analysis, we compared the rate of death from any cause or liver

transplantation, and of liver-related morbidity and mortality, after antiviral

therapy among patients who achieved SVR, virologic nonresponders (NR), and those

with initial viral clearance but subsequent breakthrough or relapse (BT/R) in

the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) Trial.

Laboratory and/or clinical outcome data were available for 140 of the 180

patients who achieved SVR. Patients with nonresponse (NR; n = 309) or who

experienced breakthrough or relapse (BT/R; n = 77) were evaluated every 3 months

for 3.5 years and then every 6 months thereafter. Outcomes included death,

liver-related death, liver transplantation, decompensated liver disease, and

HCC. Median follow-up for the SVR, BT/R, and NR groups of patients was 86, 85,

and 79 months, respectively. At 7.5 years, the adjusted cumulative rate of

death/liver transplantation and of liver-related morbidity/mortality in the SVR

group (2.2% and 2.7%, respectively) was significantly lower than that of the NR

group (21.3% and 27.2%, P < 0.001 for both) but not the BT/R group (4.4% and

8.7%). The adjusted hazard ratio (HR) for time to death/liver transplantation

(HR = 0.17, 95% confidence interval [CI] = 0.06-0.46) or development of

liver-related morbidity/mortality (HR = 0.15, 95% CI = 0.06-0.38) or HCC (HR =

0.19, 95% CI = 0.04-0.80) was significant for SVR compared to NR. Laboratory

tests related to liver disease severity improved following SVR. Conclusion:

Patients with advanced chronic hepatitis C who achieved SVR had a marked

reduction in death/liver transplantation, and in liver-related

morbidity/mortality, although they remain at risk for HCC.

(HEPATOLOGY 2010;).

PMID: 20564351 [PubMed - as supplied by publisher]

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