Objectives
The phase 3 trial, RESPOND-2, demonstrated that the addition of boceprevir (BOC) to peginterferon-ribavirin (PR) resulted in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection as compared with PR alone. We evaluated the cost-effectiveness of treatment with boceprevir in previously treated chronic hepatitis C patients in the United States utilizing treatment related data from RESPOND-2 and PROVIDE.
Methods
We developed a Markov cohort model to project the burden of HCV disease, lifetime costs and quality-adjusted life years (QALY) associated with PR and two BOC-based therapies—response-guided therapy (BOC/RGT) and fixed-duration therapy for 48 weeks (BOC/PR48). We estimated treatment related inputs (efficacy, adverse events, and discontinuations) from clinical trials and obtained disease progression rates, costs and quality-of-life data from published studies. We estimated the incremental cost-effectiveness ratio (ICER) for BOC-based regimens as studied in RESPOND-2, as well as by patient’s prior response to treatment and IL-28B genotype.
Results
Boceprevir-based regimens were projected to reduce the lifetime incidence of liver-related complications by 43–53% in comparison with treatment with PR. The ICER of BOC/RGT in comparison with PR was $30,200, and the ICER of BOC/PR48 in comparison with BOC/RGT was $91,500. At $50,000 willingness-to-pay, the probabilities BOC/RGT and BOC/PR48 being the preferred option were 0.74 and 0.25, respectively.
Conclusions
In patients previously treated for chronic HCV genotype-1 infection, boceprevir was projected to increase QALYs and reduce the lifetime incidence of liver complications. In addition, boceprevir-based therapies were projected to be cost-effective in comparison with PR alone at commonly used willingness-to-pay thresholds.
RVGE-associated hospitalizations and ED visits remain common in the second year of life but decrease in the third year of life. RV5 showed sustained protective efficacy against RVGE-associated hospitalizations and ED visits, regardless of rotavirus serotype, for up to 3.1 years after vaccination.
Rotavirus Efficacy and Safety Trial (REST) enrolled nearly 70,000 infants, of whom more than 23,000 were from Finland. REST determined the efficacy of the pentavalent rotavirus vaccine (RV5) against rotavirus-related hospitalisations and emergency department (ED) visits in the first year after vaccination. Finnish infants initially in REST transitioned into the Finnish Extension Study (FES), where they were followed for rotavirus-related hospitalisations and ED visits through their second year of life and beyond. FES identified 150 (31%) additional rotavirus gastroenteritis (RVGE) cases beyond those identified in REST in the Finnish participants. Overall, RV5 reduced RVGE hospitalisations and ED visits, regardless of the rotavirus serotype, by 93.8% (95% confidence interval [CI]: 90.8–95.9%) for up to 3.1 years following the last vaccine dose. Vaccine efficacy against combined hospitalisations and ED visits between ages 4 months to 11 months, 12 months to 23 months, and 24 months to 35 months was 93.9% (95% CI: 89.1–96.9%), 94.4% (95% CI: 90.2–97.0%), and 85.9% (95% CI: 51.6–97.2%), respectively. The reduction of hospitalisations and ED visits due to any acute gastroenteritis, rotavirus or not, was 62.4% (95% CI: 57.6–66.6%) over the entire follow-up period. The results from FES confirm that RV5 induces high and sustained protection against rotavirus-related hospitalisations and ED visits, and has a very substantial impact on all gastroenteritis-related hospitalisations and ED visits into the third year of life in Finnish children.
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 costeffectiveness 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%.
Adding boceprevir to PR was projected to reduce the number of liver complications and liver-related deaths, and to be cost effective in treating both previously untreated and treated patients.
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