Large International, Observational Study of Patients with Chronic Hepatitis B Infection Treated with Peginterferon Alfa-2a [40KD] (PEGASYS)

Large International, Observational Study of Patients with Chronic Hepatitis B Infection Treated with Peginterferon Alfa-2a [40KD] (PEGASYS): the S-Collate Cohort - see attached full poster report



Reported by Jules Levin

Presented at the 20th Conference of the Asian Pacific Association for the Study of the Liver (APASL), 25–28 March 2010, Beijing, China

Marcellin P,1 Xie Y,2 Chen XP,3 Lou GQ,4 Chen YP,5 Rothe V,6 Martins EB,7 Jia J,8 Wei L9. 1Service d’Hepatologie and Centre de Recherches Biologiques Beaujon (Inserm CRB3), University of Paris, Clichy, France; 2Beijing DiTan Hospital, Beijing, China; 3Guangdong General Hospital, Guangdong Academy of Medical Science, Guangzhou, China; 4The Sixth People’s Hospital of Hangzhou, Hangzhou, China; 5The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China; 6IST GmbH, Mannheim, Germany; 7Genentech, A Member of the Roche Group, San Francisco, California, USA; 8Beijing Friendship Hospital, Capital Medical University, Beijing, China; 9Peking University People’s Hospital, Department of Hepatology, Beijing, China



CONCLUSIONS

It is anticipated that the valuable data on predictors of response that will be generated from this large, multinational, non-interventional cohort study may help identify CHB patients most likely to respond to peginterferon alfa-2a and thereby help to develop a personalized approach to therapy. The observation that HBsAg quantification is being carried out in a high proportion of samples reflects the recognition of the dual mode of action of peginterferon alfa-2a and acknowledgment of the potential value of HBsAg level to monitor response to therapy



Summary

This international, non-interventional, observational cohort will provide ‘real-life’ data about the efficacy of peginterferon alfa-2a

Analysis of the database may help validate and improve predictors of sustained response in a real-life setting

Recruitment is progressing well with over 24% of the anticipated total number of patients already enrolled by the beginning of 2010

The preliminary data shown here demonstrate the variety of baseline characteristics exhibited by patients being treated with peginterferon alfa-2a and highlight the complexity of CHB. Clinical study data are beginning to show the need to provide individualized therapy for patients with CHB and it is anticipated that future results from S-Collate may provide valuable information on how this can be achieved

The data collected so far confirm that genotyping is not routinely performed in clinical practice. Encouragingly, a large proportion of patients have had serologic markers of infection quantified at baseline. The focus of many recent clinical studies has been how to use these markers to identify the patients most likely to respond to peginterferon alfa-2a therapy.

It is envisaged that regular monitoring of these parameters during this cohort study will provide further information about the relevance of these markers in predicting post-treatment response