Some of us that just finished tx might find this study from the 2008 liver meeting very interesting.
Can someone please explain to me if I am correct in my understanding of this study,
does the 4 wk post eot UND pcr = 96% svr rate in this study ?
What I get out of this study is, if you get a UND, TMA VL test, 4wks after end of tx, you have a 96% chance of SVR ...pretty good odds
At 12 wks after tx, in this study, UND, TMA VL test, was a 100% chance of SVR.
http://aasld2008.abstractcentral.com/planner?NEXT_PAGE=ITINERARY_ABS_DET_POP&SESSION_ABSTRACT_ID=332272&ABSTRACT_ID=504907&SESSION_ID=35383&PROGRAM_ID=2214
AASLD 2008 Annual Meeting
ID# 1253
Nov 03 8:00 AM - 5:30 PM
Q07. HCV: Treatment
Assessment of serum HCV RNA at week 12 post-treatment is as relevant as week 24 to predict SVR in patients with chronic hepatitis C treated with Pegylated interferon plus ribavirin
M. Martinot-Peignoux1; M. Ripault2; S. Maylin1; L. Leclere1; N. Boyer2; P. Marcellin2, 1
1. INSERM U773 -CRB3, HOPITAL BEAUJON, Clichy, 92110, France.
2. Service d'Hépatologie, HOPITAL BEAUJON, Clichy, 92110, France.
Sustained Virologic response (SVR), in patients with chronic hepatitis C treated with pegylated interferon alpha (PEG-IFN) + ribavirin (RBV) is defined by undetectable serum HCV RNA at the end of the 24 weeks post-treatment follow-up period. Once achieved SVR is durable.
The aim of our study was to evaluate if 12 weeks post-treatment serum HCV RNA assessment could be as relevant as 24 weeks to identify patients with SVR.
Methods: 137 patients, consecutively treated with standard of care regimens of PEG-IFN alpha 2b + RBV, with an end of treatment response were included in the study. Serum HCV RNA was measured at 12 weeks and 24 weeks, after treatment cessation. A subset group of patients was analyzed 4 weeks after treatment cessation. SVR was defined as undetectable serum HCV RNA at the end of the 24 weeks post-treatment follow-up. Virologic relapse (VR) was defined as reappearance of detectable HCV RNA during the 24 weeks post-treatment follow-up. Serum HCV RNA was measured with the VERSANTR HCV RNA Qualitative Assay (TMA) (Siemmens). We evaluated the positive predictive value (PPV) of an undetectable serum HCV RNA to identify patients with SVR at week 4 and week 12 post-treatment follow-up.
Results. At the end of the 24 weeks-post treatment follow-up 108/137 (79%) of the patients demonstrated a SVR and 29/137 (21%) patients demonstrated a VR. At week 12 post-treatment follow-up serum HCV RNA was undetectable in 108 patients, all were SVR: PPV for SVR was 100%; 100 patients had normal serum alanine aminotransferase (ALT) level 97 were SVR: PPV for SVR was 97% (CI: 95%-99%). In the patients with VR viral load was: 6.56±0.59 and 6.11± 0.59 log copies/ml (ns) at baseline and at week 12 post-treatment, respectively. At week 4 post-treatment follow-up serum HCV RNA measurements were available for 60 patients (11 VR and 49 SVR), serum HCV RNA was undetectable in 51/60 patients, the PPV for SVR was 96% (CI 93.3%-98.7%).
Conclusions. Our results show that the assessment of serum HCV RNA at week 12 post-treatment follow-up (PPV 100% is as effective as week 24 to predict SVR). This result emphasizes that post-treatment follow-up to identify patients with SVR or VR could be shortened to 12 weeks.
Abstract Central® (patent pending). © ScholarOne, Inc., 2008.