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Clinical, Virological, Biochemical Outcomes After 20 Years of Sustained Virological Response
(SVR) in Chronic Hepatitis C: The NIH Experience.
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Reported by Jules Levin
AASLD Nov 2 2010 Boston
C.Koh; T.Heller; V.Haynes-Williams; K.Hara; J.Feld; Y.Rotman; M.G.Ghany; T.Liang; J.H.Hoofnagle
Liver Diseases Branch, NIH-NIDDK, Bethesda, MD
Introduction: The short-term goal of therapy of hepatitis C is viral eradication; but the long-term goal is prevention of liver-related disability or death. Although the short-term benefits of an SVR after therapy are established, the long-term clinical benefits are less defined. Aims: To assess changes in non-invasive markers of disease activity and fibrosis in a cohort of pts followed for up to 22 yrs after SVR.
Methods: The first 103 patients (pts) to achieve SVR after being treated at the National Institutes of Health, starting in 1984, using standard or peginterferon with or without ribavirin were evaluated. Serum markers of hepatic inflammation, synthetic function and fibrosis before treatment and at the last visit were compared. Pts evaluated since 2007 underwent transient elastography.
Results: Three of the 103 pts relapsed; 0.7, 6.4 and 6.5 years after therapy (10-year relapse rate of 5.7% by Kaplan-Meier analysis). The 100 remaining pts included 56 men; 88 whites, 4 African Americans, 8 Asians; average age at last visit 56 years (range 17 - 84); HCV genotype 1 in 45%, 2 and 3 in 53%, other in 2%. Pretreatment liver histology (99 pts) showed mild fibrosis (Ishak score 0-2) in 64, moderate (3-4) in 25, and cirrhosis (5-6) in 10. After SVR, pts were followed for 0.5 to 22 (median = 7.6) yrs. There were no cases of hepatic decompensation or liver cancer. Serum markers improved in all long-term responders, including mean ALT (from 152 to 27 U/L), AST (86 to 24 U/L), alkaline phosphatase (78 to 69 U/L), globulin (3.2 to 2.8 gm/dL), IgG (1462 to 1113 mg/dL), alpha fetoprotein (4.6 to 2.9 ng/mL), GGT (47 to 28 U/L), rheumatoid factor (38% to 19% positive), platelet count (208,000 to 239,000/uL) and AST-platelet ratio index (APRI: 0.99 to 0.25) (p < 0.001 for all). Transient elastography was successful in 75 pts and was normal (< 7.0 kPa) in 60%; moderately elevated (7.1-13.8) in 31%; and in the cirrhotic range (> 13.8) in 9%. Of 7 pts with cirrhosis before therapy, 6 had abnormal elastography at follow up. Elastography readings but not serum markers at the time of last follow up correlated with pre-treatment liver fibrosis (p=<0.001).
Conclusions: In long-term follow up, 97% of patients with an SVR maintained a virological response. No patients died of liver-related causes. Despite long-term SVR, patients with pre-existing cirrhosis still had evidence of hepatic fibrosis by transient elastography. Noninvasive markers of liver disease all improve over time. In chronic hepatitis C, SVR is associated with both short term and long-term benefits.
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