Cost-effectiveness of boceprevir or telaprevir for previously treated patients with genotype 1 chronic hepatitis C

Capursi, Vincenza; Enea, Marco; Craxı̀, Antonio; Cammà, Calogero; Petta, Salvatore; Cabibbo, Giuseppe; Ruggeri, Matteo; Alberti, Alberto; Gasbarrini, Antonio; Bruno, Raffaele

doi:10.1016/j.jhep.2013.05.019

Cited by 53 publications

(28 citation statements)

References 30 publications

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“…For details about the study design, please refer to original publication. 30 The SF-6D scores were derived from the SF-36 questionnaire that was implemented at baseline, weeks 4,12,16,20,24,28 and 40 (only those with undetectable HCV RNA at week 20 were followed up at subsequent visits). The NEUTRINO study was an open-label uncontrolled study that evaluated 12 weeks of triple sofosbuvir, ribavirin and pegylated interferon therapy in treatment-naive patients with HCV genotype 1, 4, 5 and 6.…”

Section: Study Cohortmentioning

confidence: 99%

“…19 Despite the adverse event profile and high costs, even earlier generations of anti-HCV therapies were found to be cost-effective. [20][21][22] Still, with newer emerging therapies being superior both in efficacy and safety profile, an opportunity for improvement of cost-utility balance is expected to open. Treatment of CH-C involves the use of pegylated interferon and ribavirin with first generation protease inhibitors, and is associated with significant side effects including fatigue, anaemia, dizziness and nausea which usually result in compromised health status.…”

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confidence: 99%

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Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Stepanova

Nader

Cure

et al. 2014

Aliment Pharmacol Ther

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Summary Background Health utilities measure patients' preferences for a health state. Aim To assess health utilities for sofosbuvir‐containing therapy for chronic hepatitis C. Methods The SF‐6D utility scores were derived from the SF‐36 instrument administered at baseline, during and post‐treatment to participants of the previously reported clinical trials of sofosbuvir. EQ‐5D utility scores were also approximated from the SF‐36 using a regression model. Results Nine hundred and ninety‐four patients were enrolled. Baseline SF‐6D and EQ‐5D scores were 0.66 ± 0.13 and 0.71 ± 0.22, respectively (the POSITRON trial), 0.71 ± 0.16 and 0.76 ± 0.23 (FISSION), 0.70 ± 0.14 and 0.75 ± 0.22 (FUSION), 0.72 ± 0.15 and 0.79 ± 0.22 (NEUTRINO). In all studies, SF‐6D and EQ‐5D scores were highly correlated with each other. (r = 0.83–0.87, P < 0.0001). After 12 weeks, patients receiving sofosbuvir + ribavirin (POSITRON) had similar utility scores to placebo (P > 0.05). Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin (FUSION) had similar utility scores (P > 0.05). In FISSION, patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin (P < 0.001). Patients receiving sofosbuvir + ribavirin + interferon (NEUTRINO) had a decrease in utilities during treatment (SF‐6D: from 0.72 to 0.62, EQ‐5D: 0.79 to 0.65; P < 0.0001) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION (0.72 to 0.62 and 0.77 to 0.65, respectively, P < 0.0001). After 12 weeks post‐treatment, patients with SVR (FUSION) had improvement in SF‐6D (+0.026 from baseline, P = 0.013) and EQ‐5D (+0.043, P = 0.013). In multivariate analyses, baseline depression, anxiety, fatigue, insomnia and treatment‐related anaemia were the most consistent predictors of utilities. Conclusions Patients' health utilities are minimally impacted by sofosbuvir + ribavirin treatment, as compared to interferon‐based, therapy regardless of treatment duration. Clinical trials' numbers: NCT01542788 (POSITRON), NCT01497366 (FISSION), NCT01604850 (FUSION), NCT01641640 (NEUTRINO).

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Section: Study Cohortmentioning

confidence: 99%

mentioning

confidence: 99%

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Stepanova

Nader

Cure

et al. 2014

Aliment Pharmacol Ther

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“…3 Thus, we consider life years gained (LYGs) the main outcome of all cost-effectiveness analyses published by our group. 4,5 Concerning the two sources of bias raised by Cortese et al about our study, we provide the following answers.…”

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confidence: 63%

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Petta¹,

Cabibbo²,

Cammà³

2015

Hepatology

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“…Pharmacoeconomic analyses and clinical studies suggest that the "cost per SVR" still favours the use of pegIFN-RBV dual-therapy, rather than PI-based triple-therapy, in patients complying "easyto-treat criteria", such as those who exhibit excellent viral response during the first 4 weeks of treatment with pegIFN and RBV alone [30,[32][33][34][35]. On the other hand, for patients who do not fully comply with predictors of viral-response (i.e.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

Cento

Paolo

Carlo

et al. 2015

Digestive and Liver Disease

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a b s t r a c tBackground: Triple therapy with telaprevir/boceprevir + pegylated-interferon + ribavirin can achieve excellent antiviral efficacy, but it can be burdened with resistance development at failure. Aims: To evaluate kinetics of hepatitis C virus (HCV) RNA decay and early resistance development, in order to promptly identify patients at highest risk of failure to first generation protease inhibitors. Methods: HCV-RNA was prospectively quantified in 158 patients receiving pegylatedinterferon + ribavirin + telaprevir (N = 114) or + boceprevir (N = 44), at early time-points and during per protocol follow-up. Drug resistance was contextually evaluated by population sequencing. Results: HCV-RNA at week-2 was significantly higher in patients experiencing virological failure to triple-therapy than in patients with sustained viral response (2.3 [1.9-2.8] versus 1.2 [0.3-1.7] log IU/mL, p < 0.001). A 100 IU/mL cut-off value for week-2 HCV-RNA had the highest sensitivity (86%) in predicting virological success. Indeed, 23/23 (100%) patients with undetectable HCV-RNA reached success, versus 26/34 (76.5%) patients with HCV-RNA < 100 IU/mL, and only 11/31 (35.5%) with HCV-RNA > 100 IU/mL (p < 0.001). Furthermore, differently from failing patients, none of the patient with undetectable HCV-RNA at week-2 had baseline/early resistance. Cento et al. / Digestive and Liver Disease xxx (2014) xxx-xxx Conclusions: With triple therapy based on first generation protease inhibitors, suboptimal HCV-RNA decay at week-2 combined with early detection of resistance can help identifying patients with higher risk of virological failure, thus requiring a closer monitoring during therapy.

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Cost-effectiveness of boceprevir or telaprevir for previously treated patients with genotype 1 chronic hepatitis C

Cited by 53 publications

References 30 publications

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

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Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

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