Saturday, September 3, 2011

Dermatological side effects-Patient management in the era of direct-acting antivirals

Dermatological side effects of hepatitis c and its treatment: Patient management in the era of direct-acting antivirals

Received 23 June 2011; received in revised form 26 July 2011; accepted 2 August 2011. published online 30 August 2011. Accepted Manuscript

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, agroup 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.

Blog Note;
SCAR- Severe Cutaneous Adverse Reactions Cutaneous drug reactions occur when your skin has a reaction to a drug.

DRESS-(Drug Reaction with Eosinophilia and Systemic Symptoms) Japanese Dermatologists call this syndrome DIHS (Drug Induced Hypersensitivity Syndrome) while European and American dermatologists suggested the acronym of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

DRESS is one of several terms that has been used to describe a severe idiosyncratic reaction to a drug that is characterized by a long latency of onset after exposure to the offending medication, a rash, involvement of internal organs, hematologic abnormalities and systemic illness.

Also View;
Hepatitis C Drug Incivek (telaprevir); What are the side effects ?
Use of New HCV Protease Inhibitors ‘Not That Simple’

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