The EMEA has reposted draft guidance on the “Clinical Evaluation of Direct Acting Antivial Agents Intended for the Treatment of Chronic Hepatitis C”. the guidance was originaly posted in April 2008, but the EMEA has re-posted it.  the contents don’t appear to have altered and in summary:

• The guidlines are focused on testing new therapies as add-on to current gold standard (Pegalated-interferon alpha 2a and 2b).
• A special concers is the high mutation rate of HepC with the attendant risk of selection of drug resistant variants.
• Initial studies should enrol subjects naive to Standard of Care who do not have advanced fibrosis or HIV co-infection.
• The next study coudl enrole patients with genotype 1 infections who have had a sub-optimal response to standard of care or relapsed.
• Once effect of the add-on therapy have been described later studies can look at specific groups such astumour types, HIV infected patients and mornull  responders to standard treatments

There is also discussion of epidemiology of infection  quoting around 3% of the worlds population has been infected and around 200 million people at risk of developing serious liver morbidity. The natural course of infection is also discussed around 60 to 80% of infected individuals becoming chronic carriers.and after about 20 years 20 to 30% of them have progressed cirrhosis, the five-year risk of hepatic decompensation is around 15 to 20% and that of hepatocellular carcinoma around 10%.

Guidance is provided on the design of exploratory and confirmatory clinical studies considered to be of relevance for the evaluation of direct acting anti-hepatitis C compounds as add on to standard of care in different populations. Guidance is given on subjects characteristics and selection of subjects, guidance is also provided on genotyping, primary endpoints the recommendation in this case sustained virological response defined as undetectable virus RNA six months after completion of therapy. Secondary endpoints are also described, end of treatment response and time to confirmed undetectable viral load, rapid viral response and early viral response, liver histology guidance is also provided.

Guidance goes on to describe the pharmacokinetic studies that are required the pharmacodynamic studies that are required, the guidance then goes on to describe appropriate for one studies in special populations; transplant patients and  studies in children.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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