1. From a computer simulation, the novel drug regimen of sofosbuvir and ledipasvir was the most cost-effective treatment strategy for hepatitis C virus (HCV) genotype 1.
2. This model also showed that usual care, with a pegylated interferon and ribavirin regimen, was more cost-effective for HCV genotypes 2 and 3 than newer treatment strategies.
Evidence Rating Level: 2 (Good)
Study Rundown: The newest drug therapies for hepatitis C virus (HCV) infection are able to attain high virologic responses in short time periods, with few side effects. However, these drugs are extremely expensive relative to usual care regimens; sofosbuvir, simeprevir, daclatasivr, and ledipasvir are $7000, $5500, $5500, and $875 per weeks, respectively. This study examined the cost-effectiveness of these new therapies over the lifetime of a patient. A computer model was developed to simulate the health-related quality of life, disease progression and direct medical costs for 10,000 hypothetical patients per treatment regimen. For HCV genotype 1, sofosbuvir-ledipasvir (S-L) was the optimal regimen relative to usual care with boceprevir-ribavirin-pegylated interferon (PEG). All treatment strategies were found to be more economical if patients were younger and at higher stages of liver fibrosis when treatment was initiated. For HCV genotypes 2 and 3, usual care with ribavirin-PEG was the optimal regimen relative to all sofosbuvir-based regimens. The major limitation of this study is inherent to the nature of a computer simulation, which cannot encompass every variable associated with caring for all of those with HCV eligible for these therapies. Nonetheless, this study may influence clinical care by guiding physicians in integrating cost-effectiveness into medical decision making for patients with HCV.
In-Depth [simulation study]: This study employed a discrete-event simulation model to extrapolate the cost-effectiveness of various new and old treatment strategies for HCV genotypes 1, 2 and 3 based on probabilistic data from prior large cohort studies. For genotype 1, S-L was found to be the optimal regimen, compared to multiple other sofosbuvir-based strategies and usual care with boceprevir-ribavirin-PEG, with an increased number of quality-adjusted life-years (QALYs) at a lifetime cost of $115 358 compared to $100 926 for usual care. Relative to usual care, the incremental cost-effectiveness ratio for S-L was $12 825 per QALY gained. Additionally, S-L would have been cost-saving relative to usual care, if sofosbuvir was priced at less than $5500 per week, compared to the cost-estimate used in the model of $7000 per week. Usual care with ribavirin-PEG was the optimal regimen for genotypes 2 and 3. However, if sofosbuvir was less than $4500 per week for genotype 2 or less than $5500 per week for genotype 3, then sofosbuvir-based regimens would have been optimal.
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