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Biopsies Before and After Treatment/Results:
SVR – 5 Years Later
Alan Franciscus, Editor-in-Chief
April 09
Does the health of the liver improve after someone achieves a sustained virological response? That’s what researchers Sarah L. George and colleagues set out to answer with a long-term study of patients who achieved an SVR.
A total of 150 patients who had achieved a sustained virological response (SVR = HCV RNA (viral load) undetectable 24 weeks post-treatment) and who were originally biopsied and scored with fibrosis stage 2 or higher (Ishak system – with 0 being no fibrosis and 6 being cirrhosis) were enrolled in the study between June 1997 and April 2002. The average age at time of study enrollment was 49 years old; 49% were female, 98% were Caucasian and the genotype distribution was similar to the genotype distribution generally seen in the United States. Almost all of the patients (87%) were treated with standard interferon (3 shots a week) plus ribavirin daily. Ninety-eight patients (65%) were treated for one year and the other 35% were treated for 6 months. Out of the original 150 patients enrolled, 128 patients (85%) were followed through their fourth year and 108 patients (72%) were followed for five or more years after achieving an SVR.
Pretreatment and long-term follow-up biopsies were performed in 49 patients and blindly scored – that is the person evaluating the biopsy did not have patient information or knowledge of the previous biopsy score.
Of the patients biopsied, 40 patients (82%) had a decrease in fibrosis score, and 45 (92%) had a decrease in the combined inflammation score. Ten patients (20%) who had follow-up biopsy had near or nearly normal livers.
Two patients with pre-treatment cirrhosis developed hepatocellular carcinoma (HCC-liver cancer) and one patient died. However, all of the other patients with pre-treatment cirrhosis or advanced fibrosis had improved fibrosis scores on their long-term follow-up biopsy.
This was the longest and largest study of its kind and the results are very encouraging. But, the bad news is that one of those patients with pre-treatment cirrhosis died even after achieving an SVR. These results confirm previous findings that have had similar outcomes. The two important messages from this study are:
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The vast majority of people who achieve an SVR have improved inflammation and fibrosis scores. But larger and longer studies are needed to confirm these findings.
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People with pre-treatment cirrhosis should be closely monitored even when an SVR is achieved because there is a risk that a small minority of patients will continue to have severe disease progression leading to death.
Reference
George, S. et al. Clinical, virologic, histologic, and biochemical
outcomes after successful HCV therapy: A 5-year follow-up of 150
patients. Hepatology. Volume 49 Issue 3
http://www.hcvadvocate.org/news/newsLetter/2009/advocate0409.html#3