60 Svr12 Rates and Safety of Triple Therapy Including Telaprevir or Boceprevir in 221 Cirrhotic Non Responders Treated in the French Early Access Program (Anrs Co20-Cupic)

Fontaine, H.; Hézode, C.; Dorival, Céline; Larrey, Dominique; Zoulim, Fabien; Lédinghen, Victor de; Canva, V.; Alric, Laurent; Bourlière, Marc; Pol, Stanislas; Poynard, Thierry; Riachi, Ghassan; Bernard, Pierre–Henri; Raabe, J.-J.; Gournay, Jérôme; Métivier, Sophie; Pawlotsky, J.-M.; Samuel, Didier; Barthe, Yoann; Carrat, Fabrice; Bronowicki, Jean Pierre

doi:10.1016/s0168-8278(13)60062-8

Cited by 35 publications

(30 citation statements)

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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%

“…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. 24 This difference is potentially due to the prospective cohort study nature that requires monitoring and assessment of patients throughout the study and clearly defined treatment protocol for lead-in therapy as part of boceprevir treatment in the French study. 24 Several other real-world studies of telaprevir and boceprevir used the U.S.…”

Section: Resource Utilization and Costsmentioning

confidence: 99%

“…24 This difference is potentially due to the prospective cohort study nature that requires monitoring and assessment of patients throughout the study and clearly defined treatment protocol for lead-in therapy as part of boceprevir treatment in the French study. 24 Several other real-world studies of telaprevir and boceprevir used the U.S. Veteran's Affairs (VA) electronic medical record database and found rates of therapy discontinuation generally lower than those observed in this study.…”

Section: Resource Utilization and Costsmentioning

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: Resource Utilization and Costsmentioning

confidence: 99%

Section: Resource Utilization and Costsmentioning

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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“…Los estudios de registro mostraron que además de incrementar la eficacia, la combinación de estos IP suponía un mayor número de efectos adversos, predominantemente hematológicos y cutáneos 8 . Además, estudios en la práctica clínica han demostrado que los efectos adversos derivados de esta terapia pueden suponer, además, un mayor riesgo para aquellos pacientes con hepatopatía avanzada, en los que se ha descrito un incremento del número de infecciones graves (46%), descompensaciones clínicas (34%) e, incluso, muerte 9 . Estos efectos adversos graves no fueron reportados en los estudios de registro, probablemente debido al número relativamente bajo de cirróticos incluidos y a la excelente función hepática de los pacientes con cirrosis, que no presentaban hipertensión portal significativa.…”

Section: Opciones De Tratamientounclassified

Tratamiento de la infección crónica por los virus de la hepatitis C y B

Morillas

Planas

2015

FMC - Formación Médica Continuada en Atención Primaria

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“…The French early-access programme Agence Nationale de Recherche sur le SIDA (ANRS) C020-CUPIC enrolled 674 monoinfected cirrhotic patients with HCV genotype 1 and reported SVR 12 rates of 40% in the telaprevir group and 41% in the boceprevir group. In a subgroup analysis, patients with previous paR and NR had substantially lower treatment responses, with SVR rates at week 12 of 32% and 29% in the telaprevir group, and of 40% and 11% in the boceprevir group, respectively [10]. Recently, a European cohort study of HIV/HCV-coinfected patients reported real-life on-treatment data: in the ANRS CO13-HEPAVIH cohort/ESCMID European Study, 69% of 65 participants were previous nonresponders, 80% were infected with HCV genotype 1a, and the mean transient elastometry was 19.3 kPa [11].…”

mentioning

confidence: 92%

Efficacy of lead‐in silibinin and subsequent triple therapy in difficult‐to‐treat HIV/hepatitis C virus‐coinfected patients

et al. 2014

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ObjectivesThe efficacy of current hepatitis C virus (HCV) triple therapy, including a protease inhibitor, is limited in HIV/HCV-coinfected patients with advanced liver fibrosis and nonresponse to previous peginterferon-ribavirin. These patients have a low chance (only 30%) of achieving a sustained virological response (SVR) during triple therapy and cannot wait for next-generation anti-HCV drugs. In a pilot study, we investigated the efficacy of a lead-in therapy with silibinin before triple therapy in difficult-to-treat patients. MethodsInclusion criteria were HIV/HCV coinfection with advanced liver fibrosis and documented failure of previous peginterferon-ribavirin treatment. Intervention was lead-in therapy with intravenous silibinin 20 mg/kg/day for 14 days. Subsequently, peginterferon-ribavirin combined with telaprevir was initiated for 12 weeks, followed by peginterferon-ribavirin dual therapy until week 48 after initiation of triple therapy. The outcome measurements were HCV RNA after silibinin lead-in, at weeks 2, 4 and 12 of triple therapy, and SVR at week 24 after the end of treatment. ResultsWe examined six HIV/HCV-coinfected patients (four infected with genotype 1a). All had fibrosis grade METAVIR ≥F3 and were on fully suppressive antiretroviral therapy. Mean HCV RNA decline after silibinin therapy was 2.6 log10 IU/mL (range 2-3 log10 IU/mL). Five of the six patients were virologically suppressed at weeks 2 and 4, and all six at week 12 of triple therapy. One experienced a viral breakthrough thereafter. Four of five patients (80%) showed an SVR 24. One patient had an SVR 12 but has not yet reached week 24. ConclusionsA lead-in with silibinin before triple therapy is highly effective and increases the probability of HCV treatment success in difficult-to-treat HIV/HCV-coinfected patients with advanced liver fibrosis and previous failure of peginterferon-ribavirin.Keywords: advanced liver fibrosis, hepatitis C virus, HIV/hepatitis C virus coinfection, nonresponse, null response, silibinin. A promising drug is silibinin, which targets different steps in the HCV lifecycle [5]. A pilot study showed that administration of 20 mg/kg intravenous silibinin significantly reduced HCV RNA (reduction 3.02 mean ± standard deviation 1.01 log 10 IU/mL) in 20 HCV-monoinfected patients with previous null response to peginterferon-ribavirin therapy [6].Encouraged by these findings, we investigated the use of intravenous silibinin followed by TT in HIV/HCVcoinfected patients with advanced liver fibrosis and previous failure of peginterferon-ribavirin therapy. We used intravenous silibinin as a lead-in therapy with the aim of rapidly lowering HCV RNA before TT initiation, and thus increasing the chance of treatment success. We report the efficacy and tolerability of silibinin in six difficult-to-treat coinfected patients as a proof of principle. Methods ObjectivesThe primary aim was to describe the efficacy and safety of a 14-day lead-in of intravenous silibinin in HIV/HCVcoinfected patients with advanced liver fibrosis wh...

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60 Svr12 Rates and Safety of Triple Therapy Including Telaprevir or Boceprevir in 221 Cirrhotic Non Responders Treated in the French Early Access Program (Anrs Co20-Cupic)

Cited by 35 publications

References 0 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

Tratamiento de la infección crónica por los virus de la hepatitis C y B

Efficacy of lead‐in silibinin and subsequent triple therapy in difficult‐to‐treat HIV/hepatitis C virus‐coinfected patients

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