title: Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals.
abstract: 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.
authors: Department of Internal Medicine, Assistance Publique-Hopitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, and Université Pierre et Marie Curie, Paris, France. patrice.cacoub@psl.aphp.fr
authors: Patrice
authors: P
authors: Cacoub
authors: Marc
authors: M
authors: Bourlière
authors: Jann
authors: J
authors: Lübbe
authors: Nicolas
authors: N
authors: Dupin
authors: Peter
authors: P
authors: Buggisch
authors: Geoffrey
authors: G
authors: Dusheiko
authors: Christophe
authors: C
authors: Hézode
authors: Odile
authors: O
authors: Picard
authors: Ramon
authors: R
authors: Pujol
authors: Siegfried
authors: S
authors: Segaert
authors: Bing
authors: B
authors: Thio
authors: Jean-Claude
authors: JC
authors: Roujeau
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects*; D003875:Drug Eruptions / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects; D009842:Oligopeptides / Q000009:adverse effects; D012254:Ribavirin / Q000009:adverse effects; D012871:Skin Diseases / Q000209:etiology*
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir