BASELINE CHARACTERISTICS AND WEEK 4 RESPONSE AMONG CHRONIC HEPATITIS C PATIENTS

BASELINE CHARACTERISTICS AND WEEK 4 RESPONSE AMONG CHRONIC HEPATITIS C PATIENTS INFECTED WITH HCV GENOTYPE 1, 2, 3 OR 4: INTERIM RESULTS OF THE PROPHESYS TRIAL--

EASL April 23-26 2009 Copenhagen Reported by Jules Levin

G. Dusheiko,1 F.A. Caruntu,2 M. Bourlière,3 D. Ouzan,4 S. Pol,5 C. Ferrari,6 M. Puoti,7 A. Tice,8 G.F. Silva,9 G. Lengyel,10 C. Ghent,11 D. Messinger,12 A. Tietz,13 A. Mangia14 1Centre for Hepatology, Royal Free and University College School of Medicine, London, UK; 2National Institute of Infectious Diseases, Bucharest, Romania; 3Hôpital Saint-Joseph, Marseille, France; 4Institut Arnault-Tzanck, Saint-Laurent-du-Var, France; 5Hôpital Necker, Paris, France; 6Azienda Ospedaliera - Ospedali Riuniti, Parma, Italy; 7University of Brescia, Brescia, Italy; 8University of Hawaii, Honolulu, USA; 9Botucatu School of Medicine, Botucatu, Brazil; 102nd Department of Medicine, Semmelweis University, Budapest, Hungary; 11London Health Sciences Centre, London, Canada; 12Biometrics, IST GmbH, Mannheim, Germany; 13Roche, Basel, Switzerland; 14Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy

This study was sponsored by Roche, Basel, Switzerland

AUTHOR CONCLUSIONS

In this large cohort of patients, marked differences were observed in patient demographics when grouped by genotype. In particular, genotype 3-infected patients tended to be younger, were more likely to be male and were less likely to be obese or to have advanced fibrosis than patients infected with HCV genotype 1 or 2.

An RVR was achieved in a high proportion of patients, especially among those infected with HCV genotype 2 or 3 (81.7% and 73.0%, respectively).

The proportion of genotype 1 patients with an RVR at week 4 (21%) was similar to the rate observed in a large randomised pivotal study (20%),[5, 7] despite the use of a much more sensitive qualitative assay in the present study (limit of detection 15 IU/mL versus 50 IU/mL, respectively).

There are a substantial number of patients without an RVR who experience a decrease in HCV RNA of ≥2 log10. The predictive value of these responses for SVR will be evaluated as more results become available.

Baseline factors strongly associated with an RVR in genotype 1-infected patients (HCV RNA level, race, age, histological diagnosis and ALT ratio) were similar to those observed in large randomised clinical trials.