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24-week treatment regimen with peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) in HCV genotype 1 or 4 'super-responders' -Week 4 Rapid Viral Response (RVR)
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Peter Ferenci, MD
Medical University of Vienna, Vienna, Austria
On behalf of the Austrian Hepatitis Study Group
Reported by Jules Levin
EASL, April 27, 2006, Vienna, Austria
AUTHOR CONCLUSIONS
By ITT analysis, 77% of genotype 1 and 4 patients with an RVR to peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) achieved an SVR following
24 weeks' treatment
- SVR rates in genotype 1 and genotype 4 patients were 84% and 100% (PP analysis)
The highest SVR rates are achieved in those patients with the lowest HCV RNA level after 4 weeks' treatment (note from Jules: lower baseline HCV RNA was also predictive, see table below)
- Results with the more sensitive assay (TaqMan, Roche Diagnostics) showed that the greater the viral suppression at week 4, the lower the chance of relapse
This analysis indicates that a treatment duration of only 24 weeks is effective in those genotype 1 and 4 patients who achieve an RVR
- Thus, treatment duration may be best customised based on HCV RNA level at week 4
The benefit of a shorter treatment duration in this subset of genotype 1 and 4 patients should be assessed in randomised controlled trials
BACKGROUND
The recommended treatment for patients infected with HCV genotypes 1 and 4 is a pegylated interferon plus ribavirin 1000/1200 mg/day for 48 weeks1,2
However, some genotype 1 patients may be able to achieve an SVR after 24 weeks of treatment3,4
1Strader DB, et al. Hepatology 2004; 40: 1147-71
2NIH Consens State Sci Statements 2002; 19: 1-46
3Zeuzem S, et al. J Hepatol 2006; 44: 97-103
4Jensen D, et al. Hepatology (In press)
Patients who fail to achieve an EVR after 12 weeks' treatment are highly unlikely to achieve an SVR1
- NPV (negative predictive value) of 98% in genotype 1 patients receiving peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS)2
An RVR after 4 weeks of treatment has been shown to be a strong predictor of response
- 88% of genotype 1 patients with an RVR achieved an SVR following 24 weeks' treatment with peginterferon alfa-2a (40KD) plus ribavirin 1000/1200 mg/day in a randomised, multinational phase III study3
1Strader DB, et al. Hepatology 2004; 40: 1147-71
2Ferenci P, et al. J Hepatol 2005; 43: 425-433
3Jensen D, et al. Hepatology. In press
MAIN OBJECTIVE
We prospectively investigated the customisation of combination therapy in patients infected with HCV genotypes 1 and 4 based on HCV RNA level at
weeks 4 and 12
- In this interim analysis, SVR rates (PP, ITT) in patients with an RVR who were treated for 24 weeks are presented
- SVR rates in patients with a 'hyper' response to therapy (HCV RNA <10 IU/mL at week 4; TaqMan, Roche Diagnostics) are also given
PATIENTS
- Treatment naive
- Age 18-65 years
- Quantifiable HCV RNA (>600 IU/mL) in serum
- HCV genotype 1 or 4 infection
- Elevated serum ALT levels
- Liver biopsy within 6 months consistent with a diagnosis of chronic hepatitis C
- Compensated liver disease
Study design
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