"12 weeks' stopping rule" in the treatment of genotype 1 chronic hepatitis C: two prognostic categories under the same label?

Abstract:

OBJECTIVE:The current guidelines recommend maintenance of combined therapy for hepatitis C virus (HCV) genotype-1 chronic hepatitis when HCV-RNA is undetectable or < or = 2 log10 of baseline after 12 weeks of therapy. The aim of this study was to investigate whether the probability of obtaining sustained viral (SVR) response is similar when HCV-RNA is undetectable or is present at < or = 2 log10 level after 12 weeks of therapy. MATERIAL AND METHODS:Retrospective analysis was carried out in 208 HCV genotype-1 chronic hepatitis patients treated with pegylated interferon and ribavirin with available data on HCV viral load after 12 weeks of therapy and definite data on the results of therapy. RESULTS:Seventy-six (68.5%) out of 111 patients with undetectable HCV-RNA and 4 (11.8%) out of 34 patients with HCV-RNA < or = 2 log10 from baseline at week 12 reached SVR (odds ratio 16.29, 95% CI 5.08-67.12; p < 0.001). Sixty-three patients did not meet any of these criteria and therapy was discontinued. CONCLUSIONS:The "12-week stopping rule" includes two different categories of responders considered candidates for maintained therapy, but the probability of obtaining SVR is very low in patients with HCV-RNA that is still detectable at this time of treatment. We suggest that, in these partial responders, the prolongation of therapy should be decided on an individual basis.

journal_name

Scand J Gastroenterol

authors

Ladero JM,López-Alonso G,Devesa MJ,Cuenca F,Agreda M,Ortega L,Suárez A,Díaz-Rubio M

doi

10.1080/00365520801989969

subject

Has Abstract

pub_date

2008-08-01 00:00:00

pages

979-83

issue

8

eissn

0036-5521

issn

1502-7708

journal_volume

43

pub_type

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