Telaprevir-Related Dermatitis

Roujeau, Jean‐Claude; Mockenhaupt, Maja; Tahan, Steven R.; Henshaw, Joshua; Martin, Emily C.; Harding, Matt; Baelen, B. Van; Bengtsson, Leif; Singhal, Priya; Kauffman, Robert S.; Stern, Robert S.

doi:10.1001/jamadermatol.2013.938

Cited by 55 publications

(58 citation statements)

References 26 publications

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“…21 The demographic factors that have an influence on development of DAEs in our study were similar with findings in other studies. 12 The association between coexistence of autoimmune thyroiditis with skin rashes during BOC therapy as well as, correlation between comorbidity of AT with anorectal discomfort were not previously observed.…”

Section: J Dermatol Case Rep 2014 4 Pp 95-102mentioning

confidence: 87%

“…5,[12][13][14] DAEs in both treatments (TVR, BOC) together occurred in 25,6% of patients. The data from clinical trials with TVR presented that the 55% and 51% of patients developed rash and the pruritus, respectively, during the triple therapy, compared with 33% and 26% on placebo with PEG-INF and RBV.…”

Section: Discussionmentioning

confidence: 99%

“…14,[26][27][28] Cases of SCARs occurred only in TVR group during clinical trials and they were also reported in post registration's studies. 12,14,26,[29][30][31][32][33][34][35] The most common skin rashes reported during the study were characterized as mild or moderate (24 patients -85,72%). The morphological pattern of skin rashes was similar in all patients.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9] The DAEs associated with triple therapy using TVR during the phase II/III clinical trials involving over 3800 patients have been reported with a higher frequency and more severe presentations than seen with dual therapy PEG-INF/RBV (56% of patients in triple therapy compared to 34% in dual therapy). 2,3,5,[10][11][12][13] Because of high rates of DAEs noted in phase II trials of TVR, a grading system and management protocol was implemented for the future use in clinical trials. 14 Grading rash events into four grades is shown in Table 1.…”

Section: Introductionmentioning

confidence: 99%

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Dermatologic adverse events of protease inhibitor-based combination therapy in patients with chronic hepatitis C

Kłujszo¹,

Parcheta²,

Zarębska-Michaluk

et al. 2014

J Dermatol Case Rep

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Background: Combination therapy with pegylated interferon, ribavirin and a firstgeneration NS3/4A protease inhibitor, telaprevir or boceprevir, is the new strategy for treatment of genotype 1 chronic hepatitis C virus infection. This combination improves therapeutic efficacy but it also increases the risk of adverse events. Objective:The aim of the study was to analyze frequency and severity of dermatological adverse events during protease inhibitor-based therapy and to evaluate the risk factors for their development. Patients and methods:This is a retrospective study of 109 patients with genotype 1 chronic hepatitis C treated with boceprevir (n=33) or telaprevir (n=76) based triple therapy. A logistic regression for relationship between clinical, demographic and laboratory factors and cutaneous adverse events was performed.Results: Dermatological adverse events (skin rash, pruritus, anorectal paresthesia) occurred in both treatments (boceprevir and telaprevir) with similar frequency: 28% in telaprevir and 21% in boceprevir. In patients treated with telaprevir, men were more predisposed to develop skin rashes compared to women (OR 4,1 p=0,014) and age above 45 years was associated with occurrence of pruritus in men (OR 8,16 p=0,014). Being a female, coexistence of autoimmune thyroiditis and advanced liver fibrosis were independent factors predisposing to development of anorectal paresthesia (OR 4,13 p=0,041, OR 4,25 p=0,029, OR 4,54 p=0,018 respectively) in this group. In patients treated with boceprevir, coexistence of autoimmune thyroiditis predisposed to skin rashes (OR 10,22 p=0,017) and being a female predisposed to pruritus (OR11,2 p=0,033). The adverse events occurred after a mean time of 8,6 (range 1-24) weeks after initiation of therapy. Conclusions:In patients with chronic hepatitis C who received the triple therapy, the anorectal paresthesias were observed only in patients treated with telaprevir. The predisposing factors for this adverse event were: female gender and advanced liver fibrosis. The risk factors for other dermatological adverse were: 1) being a male over 45 years, for skin rashes and pruritus (for telaprevir), 2) coexistence of autoimmune thyroiditis for skin rashes (for boceprevir), 3) being a female, for pruritus (for boceprevir). (J Dermatol Case Rep. 2014; 8(4): 95-102)

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Section: J Dermatol Case Rep 2014 4 Pp 95-102mentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Dermatologic adverse events of protease inhibitor-based combination therapy in patients with chronic hepatitis C

Kłujszo¹,

Parcheta²,

Zarębska-Michaluk

et al. 2014

J Dermatol Case Rep

View full text Add to dashboard Cite

show abstract

“…Whereas no previous reports have mentioned deep head and neck infections after combined telaprevir therapy, cytopenia might be attributed topathologies causing immune deficiency. Second, our patient had been prescribed prednisolone (20 mg/day) for 2 months because of the telaprevir-related dermatitis [15]. Patients affected by pathologies causing immune deficiency or who are taking immunosuppressive medications may display a unique clinical picture in comparison with patients without systemic disease [16,17].…”

Section: Discussionmentioning

confidence: 99%