Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

Ascione, Antonio; Adinolfi, Luigi Elio; Amoroso, P; Andriulli, Angelo; Armignacco, Orlando; Ascione, Tiziana; Babudieri, Sergio; Barbarini, Giorgio; Brogna, Michele; Cesario, Francesco; Citro, Vincenzo; Claar, Ernesto; Cozzolongo, Raffaele; D’Adamo, Giuseppe; D'Amico, E; Dattolo, P; Luca, Massimo De; Maria, Vincenzo De; Siena, Massimo De; Vita, Giovanni De; Giacomo, Antonio Di; Marco, Rosanna De; Stefano, G. de; Stefano, Giulio De; Salvo, Sebastiano Di; Sarno, Raffaele Di; Farella, Nunzia; Felicioni, L; Fimiani, Basilio; Fontanella, Luca; Furlan, Caterina; Giancotti, Francesca R.; Giolitto, Giancarlo; Gravina, Tiziana; Guerrera, Barbara; Gulminetti, Roberto; Iacobellis, A.; Imparato, Michele; Iodice, Angelo; Iovinella, Vincenzo; Izzi, Antonio; Liberti, A; Leo, Pietro; Lettieri, Gennaro; Luppino, Ileana; Marrone, Aldo; Mazzoni, Ettore; Messina, Vito; Monarca, Roberto; Narciso, Vincenzo; Nosotti, L.; Pellicelli, A.; Perrella, Alessandro; Piai, G.; Picardi, Antonio; Pierri, P; Pietromatera, G; Resta, Francesco; Rinaldi, Luca; Romano, Mario R.; Rossini, Angelo; Russello, Maurizio; Russo, Grazia; Sacco, Rodolfo; Sangiovanni, Vincenzo; Schiano, A; Sciambra, Antonio; Scifo, G.; Simeone, Filomena; Sullo, Annarita; Tarquini, Pierluigi; Tundo, Paolo; Vallone, Alfredo

doi:10.4254/wjh.v8.i22.949

Cited by 6 publications

(13 citation statements)

References 13 publications

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“…Regarding the variables associated with SVR, evidence suggested that the diagnosis of cirrhosis is associated with a lower chance of SVR. This finding corroborates findings from several other studies, including phase 3 clinical trials and reallife studies 2,3,[17][18][19][20] , in addition to a meta-analysis published by Pecoraro et al 21 . The type of response to previous treatment was another variable statistically associated with SVR.…”

Section: Discussionsupporting

confidence: 91%

“…The type of response to previous treatment was another variable statistically associated with SVR. Relapsers after dual therapy were more likely to achieve SVR than patients who have had another type of response since this also corroborates findings from other studies 3,4,17,20,22,23 . A binary logistic regression analysis indicated that absence of cirrhosis would be more strongly associated with SVR.…”

Section: Discussionsupporting

confidence: 88%

“…On the other hand, they were lower than those found in the pre-marketing clinical trials of the above-mentioned PIs. Considering real-life data, the SVR rates were similar to those described in two European studies, one of which was a multicenter study involving 47 different centers in Italy 16,17 and higher than the SVR rates of real-life studies conducted in the USA 18,19 . The non-statistical association of the SVR with the PI used can be explained by the important difference between samples that limits the robustness of the analysis and by the similarity of the groups in relation to the variables associated with the SVR.…”

Section: Discussionsupporting

confidence: 75%

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First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

Chachá

Rodrigues

Araújo

et al. 2018

Rev. Soc. Bras. Med. Trop.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 75%

See 1 more Smart Citation

First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

Chachá

Rodrigues

Araújo

et al. 2018

Rev. Soc. Bras. Med. Trop.

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“…In a multicentre study evaluating the response of TVR and boceprevir treatment, this rate was reported as 44% in patients with cirrhosis. However, the previous treatment responses of these cirrhotic patients were not indicated throughout this study [14]. In our study, this rate may be higher due to insufficient number of patients and being relapser in the previous treatment.…”

Section: Discussionmentioning

confidence: 43%

Telaprevir-based triple therapy for re-treatment Chronic HCV patients with Genotype 1, including the Null-Response: A single center experience from Turkey

Çelik¹,

Dursun²,

Türe³

et al. 2017

Virol Res Rev

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Background: Telaprevir with peginterferon/ribavirin (TVR/PR) leads to significantly higher sustained virological response (SVR) rates with partial response or relapse after prior treatment with peginterferon alpha (PegIFN)/ribavirin (RBV) in patients infected with hepatitis C. We studied the efficacy of TVR/PR in patients with prior treatment failure, including those with a null response (<2 Log10 decline in HCV RNA), to peginterferon/ribavirin).

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“…After this, another response rates weighted means for F0/ F1/F2 and for F3/F4 groups was made. The studies were an Italian multicenter real-life study, and four pre-marketing studies that were essential for the approval of BOC and TVR 5,6,7,26,27 . Moreover, data from the study of which the pharmacoeconomic analysis treated in this article was part of were also considered.…”

Section: Nmb = (Ceiling Price For Therapy × Re (Tt ÷ Dt)) -Cost Of Thmentioning

confidence: 99%

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C

et al. 2020

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Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

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Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

Abstract: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.

Cited by 6 publications

References 13 publications

First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

Telaprevir-based triple therapy for re-treatment Chronic HCV patients with Genotype 1, including the Null-Response: A single center experience from Turkey

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C

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