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.