http://www.hcvadvocate.org/news/reports/AASLD_2006/Abstracts/Monday%20Posters_HC
V%20Therapy_%20Pre-clinical.htm#preclin_927

LB9. Sustained Virologic Response Is Associated with Eradication of Hepatitis
C Virus and Fibrosis Regression in Patients Treated for Chronic Hepatitis C.
S. Maylin; M. Martinot -Peignoux; N. Boyer; M. Ripault; D. Cazals-Hatem; N.
Giuily; C. Castelnau; C. Féray; M. Nicolas-Chanoine; P. Bedossa; P. Marcellin

Background:

It is unclear whether hepatitis C virus (HCV) is eradicated in patients with
chronic hepatitis C who achieve a sustained virologic response [SVR). During
this long-term follow-up study, HCV-RNA was measured in serum, liver, and
peripheral blood mononuclear cells [PBMCs) in patients with chronic hepatitis
C who had a SVR and in whom liver histology was assessed.

Patients/Methods:

345 patients with SVR after treatment were studied. SVR was defined by the
absence of detectable serum HCV-RNA 6 months after treatment cessation. 242
(70%) patients received PEG-IFN plus ribavirin therapy (215 PEG-IFN alpha 2b
and 27 PEG-IFN alpha 2a). HCV-RNA was tested: -(1) in serum for all the 345
patients every years and at the time of PBMCs and/or liver tissue collection,
-(2) in PBMCs collected in 159 patients 3.9±3.4 (0.5-18) years after
treatment, -(3) in liver tissue in 116 patients, (32 at the end of treatment,
32 six months after treatment cessation and 52 at 3.9±3.4 (1-14) years post
treatment. Both PBMCs and liver tissue were available in 60 patients. Serum,
liver tissue samples and PBMCs were kept frozen at -80°C until use. HCV-RNA
was detected with VERSANT HCV-RNA Qualitative assay (Qual TMA, Bayer
Healthcare, LLc, Tarrytown, N.Y. USA) (sensitivity 10 IU/ml). We assessed the
TMA sensitivity using 3 WHO standard dilutions tested 10 times. 100%, 100% and
60 % of the WHO dilutions set at 5 IU/ml, 2.5 IUml and 1 IU/ml were detected
with TMA.

Results:

Patients were followed up for a mean of 4.0±3.01 (range, 0.5 -18) years. Serum
HCV RNA remained undetectable in all the patients (1624 samples). Normal serum
ALT levels were maintained in most of the patients; HCV-RNA was detectable in
the PBMCs for 2 patient (3 years after treatment cessation), and in the liver
tissues for 2 patients, (1 at 1 year; 1 at 6 years). The 2 patients with
detectable HCV-RNA in liver tissue had available PBMCs with undetectable
HCV-RNA. Pre and post-treatment liver biopsy specimens were available for 126
patients. Fibrosis stage was improved in 56%, stable 32% and deteriorated in
12%. Regression of cirrhosis was observed in 9 out of 14 patients. No
cirrhosis decompensation was observed.

Conclusion:

·        These data are some of the longest follow-up data available (up to 18
years after treatment cessation) in patients successfully treated fro chronic
hepatitis C.

·        None of the 345 patients in this study had a late relapse

·        210 (98.6%) of 213 patients had undetectable HCV RNA in PBMCs or
liver tissue, determined by the sensitive TMA assay.

·        These results confirm observations from our earlier study:  clearance
of serum HCV RNA is durable and associated with undetectable hepatic HCV RNA
and market histologic improvement.

·        Our data show the importance of using a very sensitive assay (TMA) to
assess SVR.

·        Risk for hepatocellular carcinoma remained in patients who attain an
SVR, underscoring the need for continue surveillance of this cohort if
*cirrhosis* persists. (emphasis added by moi)

·        These results support the hypothesis that HCV is eradicated in
patients who attain an SVR after receiving IFN-based therapy.

Cheers

/greyhackles