Fwd: [NATAP] Studies Show HCV is Not Persistent & SVR is Durable
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NATAP - www.natap.org
Studies Showing that HCV is Not Persistent & SVR is Durable
Reported by Jules Levin
This week in the Jan 2005 journal of Hepatology there was a study reported finding that for a small percent of patients who achieved an SVR these researchers found HCV several years later in lymphocytes and in the liver. You can find this study reported in HCV section on NATAP website. Are these findings reliable? Many studies have been reported in the last several years that find the opposite. Several studies have conducted liver biopsies years later in patients following their achieving a SVR and found no HCV. Numerous studies have followed patients for as long as 10 years after an SVR was achieved and find no or few relapsers. In speaking with well known clinicians, researchers, & HCV virologists they are in agreement that they do not see relapse years after patients achieve SVR in their practices, as many studies find. Leading virologists question the reliability of the PCR techniques used by researchers who say they find HCV in cells or in the liver years after SVR was achieved;
they do not feel HCV can be found in lymphocytes. I think the bottom line is--do we see relapse years after SVR is achieved? and the answer appears to be no. Below is a series of links to studies and articles on this topic. You will find published reviews and studies following patients who achieved SVR and studies from researchers who performed liver biopsies in patients who achieved SVR.
How Durable is the HCV Sustained Viral Response?
... 10 Years of Long-Term Outcome Studies of Interferon Therapy for HCV Infection, with durable SVR...
Durability of SVR, 5 Year follow-up Pegasys plus Copegus
".....This study was reported at the 2004 AASLD conference just completed and shows from putting together from numerous Pegasys/Copegus studies that >99% of patients with SVR have maintained SVR for up to 5 years, as long as study has followed these patients so far. If you look at the table below you'll see some description of the 5/558 relapsers....."
Pegasys/RBV Improves Fibrosis in Responders, relapsers & Nonresponders with Advanced Fibrosis
".....Patients with sustained viral response had best histological improvements, but viral relapsers & nonresponders also showed improvement although they were less likely & to lesser degree..."
Long-term histologic improvement and loss of detectable intrahepatic HCV RNA in patients with chronic hepatitis C and sustained response to interferon-alpha therapy
Ann Intern Med 1997 Nov 15;127(10):875-81
Marcellin P, Boyer N, Gervais A, Martinot M, Pouteau M, Castelnau C, Kilani A, Areias J, Auperin A, Benhamou JP, Degott C, Erlinger S Hopital Beaujon, Clichy, France.
In summary, in patients with chronic hepatitis C, the persistence of normal serum ALT levels (monitored every month during the 6 months after interferon-a therapy) and the absence of detectable serum HCV RNA 6 months after treatment seem to be reliable indicators of long-term biochemical and virologic remission with histologic improvement. Clearance of serum HCV RNA is associated with clearance of intrahepatic HCV RNA, and this suggests that viral infection might be eradicated and patients might be cured of disease.
This supports the hypothesis that persons with sustained responses to interferon-alpha therapy have a low risk for further relapse of viral infection and a low risk for development of cirrhosis or hepatocellular carcinoma.
Response to Hepatitis C Therapy Can Last for Years
".....The present study with prolonged follow-up of >5 years showed that the clearance of liver HCV RNA was sustained up to 12 years after therapy for all 15 patients. Neither positive strands nor negative strands were found in any liver biopsy specimens. Sustained reductions in HCV core antibody titers at a constant rate further corroborated complete HCV eradication. One report available in the literature showed that liver HCV RNA was not found in five SVRs 10--11 years after therapy [Lau et al., 1998]. Collectively, these findings suggest that HCV seroclearance at 6 months after IFN therapy withdrawal would usually imply virological cure..."
Is HCV Curable?
Of 400 sustained virologic responders (SVR), 393 (98%) had undetectable hepatic HCV RNA, whereas 7 (2%) had detectable hepatic HCV RNA; 5 have been followed and 2 have had reappearance of serum HCV RNA 12 months after therapy. In conclusion, measurement of hepatic HCV RNA before or after therapy reflects changes observed in serum HCV RNA, and correlates inversely with hepatic inflammation and fibrosis, but otherwise has minimal clinical use. (HEPATOLOGY 2002;35:688-693. Author: McHutichison et al)
Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C
"...a significant percent of nonresponders, sustained responders, & relapsers showed inproved..." histology.
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