TY - JOUR
T1 - Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection
T2 - A US-based cost-effectiveness modeling study
AU - Ferrante, Shannon Allen
AU - Chhatwal, Jagpreet
AU - Brass, Clifford A.
AU - El Khoury, Antoine C.
AU - Poordad, Fred
AU - Bronowicki, Jean Pierre
AU - Elbasha, Elamin H.
N1 - Funding Information:
This study was sponsored by Schering-Plough (now part of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ). All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest and report the following: Drs. Ferrante, El Khoury, and Elbasha are current employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, and hold stock and/or stock options. Dr. Chhatwal is a former employee of Merck and has received consulting fees. Dr. Brass is a former employee of Merck and holds stock and/or stock options. Dr Poordad has received consultancy fees from Merck, Vertex, Abbott, Gilead, Achillion, Genentech, and Tibotec; has grants/grants pending from Merck; and has received payment for development of educational presentations and speaker fees from Merck, Genentech, Salix and Gilead. Dr Bronowicki has received consultancy fees from Schering-Plough (now part of Merck), Roche, Gilead, Bristol Myers Squibb, Janssen, Boehringer Ingelheim, Novartis, and Bayer; payment for lectures including service on speakers bureaus for Schering-Plough (now part of Merck), Roche, Bayer and Bristol Myers Squibb and travel/accommodations/meeting expenses unrelated to activities listed from Roche. The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis.
Funding Information:
We thank Drs. John R. Cook and Erik J. Dasbach (Merck) for providing helpful suggestions regarding model development and for reviewing the model. We also thank Jane Liao (Merck) for providing programming support in the analysis of data from SPRINT-2 and Dr. Heather L. Sings (Merck) for assistance in the preparation of this manuscript. This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ.
PY - 2013/4/27
Y1 - 2013/4/27
N2 - 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 $807,804.Conclusion: The boceprevir-based regimens used in the SPRINT-2 trial were projected to substantially reduce the lifetime incidence of liver complications and increase the QALYs in treatment-naive patients with hepatitis C genotype 1. It was also demonstrated that boceprevir-based regimens offer patients the possibility of experiencing great clinical benefit with a shorter duration of therapy. Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.
AB - Background: SPRINT-2 demonstrated that boceprevir (BOC), an oral hepatitis C virus (HCV) nonstructural 3 (NS3) protease inhibitor, added to peginterferon alfa-2b (P) and ribavirin (R) significantly increased sustained virologic response rates over PR alone in previously untreated adult patients with chronic HCV genotype 1. We estimated the long-term impact of triple therapy vs. dual therapy on the clinical burden of HCV and performed a cost-effectiveness evaluation.Methods: A Markov model was used to estimate the incidence of liver complications, discounted costs (2010 US$), 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.
KW - Boceprevir
KW - Cost-effectiveness
KW - Economic evaluation
KW - Hepatitis c virus
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U2 - 10.1186/1471-2334-13-190
DO - 10.1186/1471-2334-13-190
M3 - Article
C2 - 23621902
AN - SCOPUS:84876677878
SN - 1471-2334
VL - 13
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 190
ER -