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Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study.

Ferrante SA, Chhatwal J, Brass CA, El Khoury AC, Poordad F, Bronowicki JP, Elbasha EH - BMC Infect. Dis. (2013)

Bottom Line: The model projected approximately 38% and 43% relative reductions in the lifetime incidence of liver complications in the BOC/RGT and BOC/PR48 regimens compared with PR48, respectively.The ICER for BOC/PR48 compared with BOC/RGT was $807,804.Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: SPRINT-2 demonstrated that boceprevir (BOC), an oral hepatitis C virus (HCV) nonstructural 3 (NS3) protease inhibitor, added to peginterferon alfa-2b (P) and ribavirin (R) significantly increased sustained virologic response rates over PR alone in previously untreated adult patients with chronic HCV genotype 1. We estimated the long-term impact of triple therapy vs. dual therapy on the clinical burden of HCV and performed a cost-effectiveness evaluation.

Methods: A Markov model was used to estimate the incidence of liver complications, discounted costs (2010 US$), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) of three treatment strategies for treatment-naïve patients with chronic HCV genotype 1. The model simulates the treatment regimens studied in SPRINT-2 in which PR was administered for 4 weeks followed by: 1) placebo plus PR for 44 weeks (PR48); 2) BOC plus PR using response guided therapy (BOC/RGT); and 3) BOC plus PR for 44 weeks (BOC/PR48) and makes projections within and beyond the trial. HCV-related state-transition probabilities, costs, and utilities were obtained from previously published studies. All costs and QALYs were discounted at 3%.

Results: The model projected approximately 38% and 43% relative reductions in the lifetime incidence of liver complications in the BOC/RGT and BOC/PR48 regimens compared with PR48, respectively. Treatment with BOC/RGT is associated with an incremental cost of $10,348 and an increase of 0.62 QALYs compared to treatment with PR48. Treatment with BOC/PR48 is associated with an incremental cost of $35,727 and an increase of 0.65 QALYs compared to treatment with PR48. The ICERs were $16,792/QALY and $55,162/QALY for the boceprevir-based treatment groups compared with PR48, respectively. The ICER for BOC/PR48 compared with BOC/RGT was $807,804.

Conclusion: The boceprevir-based regimens used in the SPRINT-2 trial were projected to substantially reduce the lifetime incidence of liver complications and increase the QALYs in treatment-naive patients with hepatitis C genotype 1. It was also demonstrated that boceprevir-based regimens offer patients the possibility of experiencing great clinical benefit with a shorter duration of therapy. Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.

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Related in: MedlinePlus

Schematic Diagram of HCV Therapy and Disease Progression. Y – yes; N – no; Tx – treatment; ETR – end of treatment response; SVR – sustained virologic response; F0 – no fibrosis; F1 – portal fibrosis without septa; F2 – portal fibrosis with few septa; F3 – numerous septa without cirrhosis; F4 – cirrhosis; DC – decompensated cirrhosis; HCC – hepatocellular carcinoma; LT – liver transplantation; PLT – post-liver transplantation; Lv-death – liver-related death.
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Figure 1: Schematic Diagram of HCV Therapy and Disease Progression. Y – yes; N – no; Tx – treatment; ETR – end of treatment response; SVR – sustained virologic response; F0 – no fibrosis; F1 – portal fibrosis without septa; F2 – portal fibrosis with few septa; F3 – numerous septa without cirrhosis; F4 – cirrhosis; DC – decompensated cirrhosis; HCC – hepatocellular carcinoma; LT – liver transplantation; PLT – post-liver transplantation; Lv-death – liver-related death.

Mentions: We created an Excel-based (Microsoft Corp., Redmond, Washington) Markov model to project health-related outcomes and to estimate the expected costs and quality adjusted life-years (QALYs) associated with the three treatment strategies studied in SPRINT-2. The structure of the model was based on other published health economic models of HCV disease [22-27]. The model consists of two phases: the first phase corresponds to the treatment strategies and follow-up period and the second phase corresponds to post-treatment, which includes the natural history of HCV of cured or uncured patients (Figure 1).


Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study.

Ferrante SA, Chhatwal J, Brass CA, El Khoury AC, Poordad F, Bronowicki JP, Elbasha EH - BMC Infect. Dis. (2013)

Schematic Diagram of HCV Therapy and Disease Progression. Y – yes; N – no; Tx – treatment; ETR – end of treatment response; SVR – sustained virologic response; F0 – no fibrosis; F1 – portal fibrosis without septa; F2 – portal fibrosis with few septa; F3 – numerous septa without cirrhosis; F4 – cirrhosis; DC – decompensated cirrhosis; HCC – hepatocellular carcinoma; LT – liver transplantation; PLT – post-liver transplantation; Lv-death – liver-related death.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3643851&req=5

Figure 1: Schematic Diagram of HCV Therapy and Disease Progression. Y – yes; N – no; Tx – treatment; ETR – end of treatment response; SVR – sustained virologic response; F0 – no fibrosis; F1 – portal fibrosis without septa; F2 – portal fibrosis with few septa; F3 – numerous septa without cirrhosis; F4 – cirrhosis; DC – decompensated cirrhosis; HCC – hepatocellular carcinoma; LT – liver transplantation; PLT – post-liver transplantation; Lv-death – liver-related death.
Mentions: We created an Excel-based (Microsoft Corp., Redmond, Washington) Markov model to project health-related outcomes and to estimate the expected costs and quality adjusted life-years (QALYs) associated with the three treatment strategies studied in SPRINT-2. The structure of the model was based on other published health economic models of HCV disease [22-27]. The model consists of two phases: the first phase corresponds to the treatment strategies and follow-up period and the second phase corresponds to post-treatment, which includes the natural history of HCV of cured or uncured patients (Figure 1).

Bottom Line: The model projected approximately 38% and 43% relative reductions in the lifetime incidence of liver complications in the BOC/RGT and BOC/PR48 regimens compared with PR48, respectively.The ICER for BOC/PR48 compared with BOC/RGT was $807,804.Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: SPRINT-2 demonstrated that boceprevir (BOC), an oral hepatitis C virus (HCV) nonstructural 3 (NS3) protease inhibitor, added to peginterferon alfa-2b (P) and ribavirin (R) significantly increased sustained virologic response rates over PR alone in previously untreated adult patients with chronic HCV genotype 1. We estimated the long-term impact of triple therapy vs. dual therapy on the clinical burden of HCV and performed a cost-effectiveness evaluation.

Methods: A Markov model was used to estimate the incidence of liver complications, discounted costs (2010 US$), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) of three treatment strategies for treatment-naïve patients with chronic HCV genotype 1. The model simulates the treatment regimens studied in SPRINT-2 in which PR was administered for 4 weeks followed by: 1) placebo plus PR for 44 weeks (PR48); 2) BOC plus PR using response guided therapy (BOC/RGT); and 3) BOC plus PR for 44 weeks (BOC/PR48) and makes projections within and beyond the trial. HCV-related state-transition probabilities, costs, and utilities were obtained from previously published studies. All costs and QALYs were discounted at 3%.

Results: The model projected approximately 38% and 43% relative reductions in the lifetime incidence of liver complications in the BOC/RGT and BOC/PR48 regimens compared with PR48, respectively. Treatment with BOC/RGT is associated with an incremental cost of $10,348 and an increase of 0.62 QALYs compared to treatment with PR48. Treatment with BOC/PR48 is associated with an incremental cost of $35,727 and an increase of 0.65 QALYs compared to treatment with PR48. The ICERs were $16,792/QALY and $55,162/QALY for the boceprevir-based treatment groups compared with PR48, respectively. The ICER for BOC/PR48 compared with BOC/RGT was $807,804.

Conclusion: The boceprevir-based regimens used in the SPRINT-2 trial were projected to substantially reduce the lifetime incidence of liver complications and increase the QALYs in treatment-naive patients with hepatitis C genotype 1. It was also demonstrated that boceprevir-based regimens offer patients the possibility of experiencing great clinical benefit with a shorter duration of therapy. Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.

Show MeSH
Related in: MedlinePlus