Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir

Bichoupan, Kian; Schwartz, Joseph; Martel-Laferrière, Valérie; Giannattasio, Emily; Marfo, Kwaku; Odin, Joseph A.; Liu, L. U.; Schiano, Thomas D.; Perumalswami, Ponni V.; Bansal, Meena B.; Gaglio, Paul J.; Kalia, Harmit; Dieterich, Douglas T.; Branch, Andrea D.; Reinus, John F.

doi:10.1111/apt.12560

Cited by 16 publications

(16 citation statements)

References 28 publications

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“…However, this study finds rates similar to a 2 centerbased study of U.S. CHC patients and a study of CHC treatment in France. 18,24 In a chart review study conducted among HCV patients in the United States, Bichoupan et al (2014) found that 52% of telaprevir patients discontinued therapy early, which is comparable to the approximately 54% of telaprevir patients who did not complete therapy in our study. 18 Similarly, a French multicenter prospective cohort reported early discontinuation rates of 47% among telaprevir patients; however, 42% of boceprevir patients discontinued therapy early, a finding that is lower than the current study.…”

Section: Resource Utilization and Costssupporting

confidence: 79%

“…Previous studies have examined the use of DAAs in specific subpopulations, such as the Veterans Administration (VA) health care system in the United States [14][15][16][17] or in small scale health center-based studies. 18,19 However, few of them investigated the treatment patterns or health care utilization and cost outcomes. This study seeks to contribute to the growing literature on real-world use of DAA therapies by describing the treatment patterns (e.g., initiation, duration, and noncompletion of a minimum duration of therapy as per the …”

Section: Patient Characteristicsmentioning

confidence: 99%

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Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir

Kalsekar²,

Macaulay³

et al. 2015

JMCP

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BACKGROUND: Chronic hepatitis C (CHC) is associated with substantial morbidity and mortality, with the future burden of disease predicted to significantly increase. The recent addition of 2 direct-acting antiviral (DAA) protease inhibitors, telaprevir and boceprevir, to peginterferon alfa (PEG) and ribavirin (RBV) therapy has been shown to significantly improve sustained virologic response rates and thus has become standard of care. While the efficacy and safety of DAAs has been assessed in the clinical trial setting, less is known about real-world use of these new therapies.

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Section: Resource Utilization and Costssupporting

confidence: 79%

Section: Patient Characteristicsmentioning

confidence: 99%

Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir

Kalsekar²,

Macaulay³

et al. 2015

JMCP

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“…[15][16][17] There is more data available regarding the safety profile of the PIs from "real-life" and this data revealed increased risk for severe complications of PI-based treatment in cirrhotic patients. [18][19][20][21] However skin adverse reactions in contrast with other adverse events were comparable with results in clinical trials.…”

Section: Introductionsupporting

confidence: 77%

“…Advanced liver fibrosis was found to be an adverse event associated with anorectal discomfort in Bichoupan et al study. 20 We also found such correlation (OR 4,54 p=0,018). This finding could be due to immune compromise in patients with advanced fibrosis.…”

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

confidence: 66%

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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“…There is evidence suggesting that this is true in reports of the outcomes of triple therapy with regimens including interferon, ribavirin, and a first-generation protease inhibitor. 10,11 Conversely, untreated patients may die of causes unrelated to hepatitis C before they can be expected to experience any benefit of successful therapy. In balance, based on reports of adverse events related to treatment and those documenting slow stage-specific progression of fibrosis secondary to HCV infection and gradual development of hepatic decompensation in many persons with HCV cirrhosis, it is possible that some patients with barriers to HCV treatment might have better or the same outcomes without anti-viral therapy.…”

mentioning

confidence: 99%

Limited Fibrosis Progression but Significant Mortality in Patients Ineligible for Interferon-Based Hepatitis C Therapy

Izzy

Jibara

Aljanabi

et al. 2016

Journal of Clinical and Experimental Hepatology

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Background: Individuals ineligible for interferon-based hepatitis C therapy may have a worse prognosis than patients who have failed or not received treatment. Aims: To provide information about the limitations of medical treatment of hepatitis C in real-world patients. Methods: We studied 969 treatment-ineligible patients and 403 treated patients enrolled between 1/1/01 and 6/30/06; data were collected until 3/31/13. Treatment barriers were grouped into five categories and classified as health-related or health-unrelated. Fibrosis stage was assessed initially and at the end of follow-up. Mortality was determined by search of the Social Security database. Death certificates of treatment-ineligible patients were reviewed. Results: Initially, 288 individuals had advanced fibrosis and compensated disease; 87 untreated patients developed advanced fibrosis during follow-up. Health-related treatment barriers were more commonly associated with fibrosis progression and worse survival. During followup, 247 untreated patients died: 47% of liver-related and 53% of liver-unrelated causes. Patients with significant comorbid illness had the worst five-year (70%) and ten-year (50.5%) survival. Despite high mortality (47%) in persons with decompensated liver disease, no treatment barrier was associated with a greater incidence of liverrelated death. Only significant comorbid medical illness was an independent predictor of disease progression; however, it was not associated with a greater incidence of liver-related death. Furthermore, treated patients had better 10-year survival than untreated patients on Kaplan-Meier analysis (80.3% vs. 74.5%, P = 0.005). Conclusion: Many patients with hepatitis C will die of non-liver-related causes and may not be helped by anti-viral treatment. ( J CLIN EXP HEPATOL 2016;6:100-108)

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Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir

Cited by 16 publications

References 28 publications

Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir

Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir

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

Limited Fibrosis Progression but Significant Mortality in Patients Ineligible for Interferon-Based Hepatitis C Therapy

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