In phase III clinical trials of boceprevir and telaprevir, participants were in general good health, with mostly mild-to-moderate levels of liver damage from chronic HCV infection. Only a relatively small proportion of participants had severe liver damage -- cirrhosis.
In the real world outside a clinical trial, some people with HCV infection will likely be more seriously ill than those in a clinical trial and therefore in urgent need of HCV treatment. However, because such patients are not in good health, it is possible that they may experience more adverse effects from therapy. French researchers with that country's premier HIV and HCV research agency, ANRS (Agence nationale de recherches sur le sida et les hépatites virales), collected health-related data from telaprevir and boceprevir compassionate use programs. Such programs were instituted prior to the licensure of both drugs by the French regulatory agency Afssaps. This analysis of compassionate use data was called the Cupic study.
Researchers analysed data collected from 455 participants in 55 clinics across France. Participants began triple therapy between February 2011 and April 2012.
Among the 296 participants who received telapravir, the average profile prior to entering Cupic was as follows:
Researchers presented results from the first 16 weeks of therapy. Note that participants received triple therapy with telaprevir for 12 weeks followed by 36 weeks of dual therapy with peginterferon and ribavirin.
About 50% of telapravir users experienced serious adverse events during the study and 15% of telaprevir users had to leave the study prematurely because of this.
About 2% of telapravir users died, mostly from the following causes:
Other complications (not causing death) were distributed as follows:
Triple therapy with telaprevir was very effective at suppressing HCV levels, even in those who were very ill and had a history of a poor response/relapse to peginterferon and ribavirin, By the 4th week of therapy in Cupic, 51% of telapravir users had undetectable HCV levels in their blood. Moreover by the 16th week of the study, 71% had undetectable HCV levels. This finding shows that even very ill people can benefit from triple therapy. Long-term monitoring is continuing to assess rates of cure and relapse from triple therapy.
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