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If your wellbeing is affected by advanced hepatitis C (HCV), you may be one of the 40% of people who can benefit from triple therapy. This is according to Helene Fontaine, MD, of Cochin Hospital AP-HP in Paris, who says that even cirrhosis and previous treatment failures won’t get in the way of the wellness benefits of this treatment.
As Fontaine reported at the meeting of the European Association for the Study of the Liver (EASL), her team performed an interim analysis of a large cohort of patients in France and found that patients benefited from treatment with one of the recently approved HCV protease inhibitors – telaprevir (Incivek) or boceprevir (Victrelis) – when each was combined with pegylated interferon and ribavirin. However, she also noted that this benefit was counterbalanced by a high risk of serious side effects.
Laurent Castera, MD, PhD, of Centre Hospitalier Universitaire in Bordeaux, France, who was not involved in the study but moderated an EASL press conference, commented that triple therapy has been shown to improve outcomes for most HCV patients, but as very sick patients have been largely left out of clinical trials, and those who have been treated have generally had poor outcomes, it’s not well understood how they will respond to treatment. ‘The paradox is that for the patients who most need treatment – patients with cirrhosis and treatment-experienced patients – results have been pretty disappointing,’ he noted, adding that this new study may help to clarify what can be expected from triple therapy in very sick patients.
For the CUPIC study (for Compassionate Use of Protease Inhibitors in viral C Cirrhosis) 295 patients were treated with telaprevir (Incivek) and 190 with boceprevir (Victrelis), both of which were combined with pegylated interferon and ribavirin, Fontaine said. The study was not randomised, which means that the choice of treatment was left to the patient and his or her doctor. At week 12 of treatment, the telaprevir patients’ response rates (which were defined as undetectable HCV viremia) reached a high of 81%, but then tailed off to 56% at week 48, which was the end of treatment, and lowered to 40% twelve weeks later.
There was a percentage point difference among the boceprevir patients, but Fontaine pointed out that the rates of serious adverse events were also high in both groups. In the telaprevir group, which was made up of 160 patients, there were 535 serious adverse events, including seven deaths, and 63 patients stopped treatment because of serious adverse events. Of the 97 boceprevir patients, there were 321 serious adverse events, including three deaths, and 27 patients stopped treatment.