“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 ≤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 ≤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 ≤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.

• Antiviral therapy
• hepatitis C
• pegylated interferon
• ribavirin