Dermatological adverse events (AEs) are an existing concern during hepatitis C virus (HCV) infection and peginterferon/ribavirin treatment. HCV infection leads to dermatological and muco-cutaneous manifestations including small-vessel vasculitis as part of the mixed cryoglobulinemic syndrome. Peginterferon/ribavirin treatment is associated with well-characterized dermatological AEs tending towards a uniform entity of dermatitis.
New direct-acting antivirals have led to significant improvements in sustained virologic response rates, but several have led to an increase in dermatological AEs versus peginterferon/ribavirin alone.
In telaprevir trials, approximately half of treated patients had rash.
More than 90% of these events were Grade 1 or 2 (mild/moderate) and in the majority (92%) of cases, progression to a more severe grade did not occur.
In a small number of cases (6%), rash led to telaprevir discontinuation, whereupon symptoms commonly resolved.
Dermatological AEs with telaprevir-based triple therapy were generally similar to those observed with peginterferon/ribavirin (xerosis, pruritus, and eczema). A few cases were classified as severe cutaneous adverse reaction (SCAR), also referred to as serious skin reactions, a group of rare conditions that are potentially life-threatening. It is therefore important to distinguish between telaprevir-related dermatitis and SCAR. The telaprevir prescribing information does not require telaprevir discontinuation for Grade 1 or 2 (mild/moderate) rash, which can be treated using emollients/moisturizers and topical corticosteroids.
For Grade 3 rash, the prescribing information mandates immediate telaprevir discontinuation, with ribavirin interruption (with or without peginterferon) within 7 days of stopping telaprevir if there is no improvement, or sooner if it worsens.
In case of suspicion or confirmed diagnosis of SCAR, all study medication must be discontinued.
2012-01-18
Eng.
Journal of Hepatology
Department of Internal Medicine, Assistance Publique-Hopitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, and Université Pierre et Marie Curie, Paris, France. patrice.cacoub [at] psl.aphp.fr
J Hepatol. 2012 Feb;56(2):455-63
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