I pulled this off an old thread here, but no link, short of the thread.. (thought Jim posted a study at one point)
"THREE MONTH HCV RNA BY PCR POST IFN AND RIBAVIRIN THERAPY FOR SUCCESSFULLY TREATED CHRONIC ACTIVE HEPATITIS C (HCV) CAN BE USED TO DETERMINE SUSTAINED VIROLOGICAL RESPONSE (SVR)
Lino J. De Guzman, Bradley Collins, Inland Empire Digestive Diseases & Liver Center, Redlands, CA.
AIM:
The purpose of this trial was to evaluate the earliest time point (one or three months) before patients (pts) can be classified as having a SVR after a complete response (CR) to HCV treatment (TX). Currently, the standard is to wait 6 months after TX before identifying pts with a SVR. It is estimated that 98% of pts with a SVR at 6 months will remain virus free indefinitely unless re-exposed and infected.
Methods:
A total of 60 HCV pts who had a CR had quantitative HCV RNA by PCR collected at the end of TX and at 1, 3 and 6 month intervals thereafter. There were 33 males, 35 pts were Genotype (G)1, 11 pts G 2 and 14 pts G 3. In order to qualify, pts must have completed 24 weeks if G2 or G3 or 48 weeks if G1 of either PEG IFN or standard IFN plus ribavirin. Metavir scores were the following: F0 (7 pts), F1 (22 pts), F2 (14 pts ), F3 (11 pts) and F4 (6 pts). This trial also examined if any underlying relationship existed between a pts total white blood cell count (WBC) and amino alanine transferase (ALT) levels after cessation of therapy to predict ultimate response or relapse.
Results:
HCV RNA by PCR taken at 1 and 3 months after completing TX correlated highly with viral loads obtained at 6 months. A total of 13 of the 60 pts (21.6%) with CR relapsed. All of the 3 month HCV RNA measurements were in exact agreement with those taken at 6 months (100% specificity). Only one (G 3) pt who had a CR after 24 weeks of TX became HCV RNA(+) between the 1 and 3 month blood draws (98% specificity).
Conclusion:
The specificity of the HCV RNA by PCR at 1 and 3 months post HCV TX for pts with a CR is similar to the viral load at 6 months. Based on the results of this data, we feel that SVR can be made with assurance at 3 months post HCV TX. and perhaps as early as 1 month after the end of TX. There was no significant relationships between WBC or ALT levels in predicting SVR.
http://www.medhelp.org/forums/hepatitis/messages/39034.html