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1 Supplementary Material* Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, et al. Cost- Effectiveness of Novel Regimens for the Treatment of Hepatitis C Virus. Ann Intern Med. doi: /m Supplement Table. Characteristics of key studies that were used to inform model parameters Supplement Figure 1. Timing and duration of treatment regimens, by genotype Supplement Figure 2. Expected cost savings from each treatment strategy compared with usual care for genotype 1 for different prices of sofosbuvir, simeprevir, daclatasvir, and ledipasvir Supplement Figure 3. Results of one-way sensitivity analysis for genotype 1 Supplement Figure 4. Expected cost savings from each treatment strategy compared with usual care for genotype 2 for different prices of sofosbuvir and daclatasvir Supplement Figure 5. Results of one-way sensitivity analysis for genotype 2 Supplement Figure 6. Expected cost savings from each treatment strategy compared with usual care for genotype 3 for different prices of sofosbuvir and daclatasvir Supplement Figure 7. Results of one-way sensitivity analysis for genotype 3 * This supplementary material was provided by the authors to give readers further details on their article. The material was reviewed but not copyedited.
2 Supplement Table. Characteristics of key studies that were used to inform model parameters. Lawitz et al Lawitz et al Lawitz et al Afdhal et al Afdhal et al Afdhal et al Afdhal et al Kowdley et al Kowdley et al Kowdley et al Sulkowski et al Lawitz et al Sulkowski et al Sulkowski et al Study name Study design HCV Treatment Treatment Measurement Sample Mean Fibrosis stage Men Alcohol genotypes history size age use LONESTAR RCT G1 TX naïve SOF+LDV (8W) SVR (95%) F0:F3:100% 70% NA LONESTAR RCT G1 TX naïve SOF+LDV+RBV (8W) SVR (100%) F0:F3:100% 57% NA LONESTAR RCT G1 TX naïve SOF+LDV (12W) SVR (95%) F0:F3:100% 58% NA ION1 RCT G1 TX naïve SOF+LDV (12W) SVR (99%) F4:16% 59% NA ION1 RCT G1 TX naïve SOF+LDV+RBV (12W) SVR (97%) F4:15% 59% NA ION1 RCT G1 TX naïve SOF+LDV (24W) SVR (98%) F4:17% 64% NA ION1 RCT G1 TX naïve SOF+LDV+RBV (24W) SVR (99%) F4:17% 55% NA ION3 RCT G1 TX naïve SOF+LDV (8W) SV R (94%) F0:F3: 100% F4: 0% ION3 RCT G1 TX naïve SOF+LDV+RBV (8W) SVR (93%) F0:F3: 100% F4: 0% ION3 RCT G1 TX naïve SOF+LDV (12W) SVR (95%) F0:F3: 100% F4: 0% AI RCT G1 TX naïve SOF+DCV (12 W) SVR (98%) F0-F1:35%; F2- F3: 49%; F4:13.5% COSMOS RCT G1 TX naive (48%) SOF+SMV (12 W) SVR (93%) F0-F1:20%; F2:28% F3: 28%; F4:25% AI RCT G2 TX naïve SOF+DCV (24 W) SVR (92%) F0-F1:41%; F2- F3: 46%; F4:16% AI RCT G3 TX naïve SOF+DCV (24 W) SVR (89%) F0-F1:41%; F2- F3: 46%; F4:16% 60% NA 54% NA 59% NA 51% NA 64% NA 50% NA 50% NA Lawitz et al NEUTRINO RCT G1 TX naïve SOF+RBV+PEG (12W) SVR (90%) F4 or higher: 64% NA (2013) 17% Lawitz et al FISSION RCT G2,3 TX naïve SOF+RBV(12W) SVR (67%) F4 or higher: 67% NA (2013) 20% Lawitz et al FISSION RCT G2,3 TX naïve RBV+PEG (24W) SVR (67%) F4 or higher: 64% NA (2013) 21% Zeuzem et al VALENCE RCT G2 TX naïve (44%) SOF+RBV(12W) SVR (93%) NA Zeuzem et al VALENCE RCT G3 TX naïve (18%) SOF+RBV(12W) SVR (27%) NA Zeuzem et al VALENCE RCT G3 TX naïve (42%) SOF+RBV(24W) SVR (85%) NA
3 Poordad et al (2011) Thompson et al (2010) Fried et al (2002) Poynard et al (1997) Thein et al (2008) SPRINT-2 RCT G1 TX naïve BOC[24-32W]+RBV+PEG [28-48W] SVR (67%) F0-F2:88%; F3- F4: 12% Observational G1 NA SVR F0:2%; F1:71%; F2:16%; F3:5%; F4:7% RCT Retrospective cohort G1:65%; G2:13%; G3:18%; G4:4% G1:63%; G2:13%; G3:15%; G4:8% Meta analysis G1: 54% G2,3,4: 26% RBV+PEG SVR (46%) F4 or higher: 13% 60% NA 61% NA 71% NA NA METAVIR score F0:10%; F1:36%; F2:21%; F3:15%; F4:18% 58% 11% % 19% studies McAdam- Marx et al (2011) Liu et al (2012) Claims data NA Costs F4 or higher: 22% Simulation G1 TX naïve Triple therapy(boceprevir or telaprevir) vs dual therapy Cost, QALYs NA 50 F0:30%/0; F1:41%/0; F2:29%/29%; F3:0%/23%; F4:0%/48% PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir; SVR: sustained virologic response; RCT: randomized clinical trial; QALY: quality adjusted life years. 62% 4% 50% NA
4 Supplement Figure 1. Timing and duration of treatment regimen, by genotype A) For genotypes 1 Week4 Week12 Week20 Week28 Week36 Week48 Week72 Old dual therapy W12: If EVR then countinue treatment. If no EVR, stop treatment. RBV+PEG W24: If virologic response then countinue treatment. If none, stop treatment. Usual care RBV+PEG BOC+RBV+PEG BOC+RBV+PEG RBV+PEG W28: Stopping criteria met then stop treatment. If not continue treatment. Newly approved regimen SOF+RBV+PEG PEG free regimen SOF+SMV PEG free regimen SOF+DCV PEG free regimen SOF+LDV B) For genotypes 2 Week12 Week24 Week40 Week48 Usual care RBV+PEG Newly approved PEG free regimen SOF+RBV PEG free regimen SOF+DCV C) For genotypes 3 Usual care RBV+PEG Week24 Week40 Week48 Newly approved PEG free regimen SOF+RBV PEG free regimen SOF+DCV PEG free regimen SOF+LDV+RBV PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir; SVR: Sustained virological response.
5 Supplement Figure 2. Expected cost savings from each treatment strategy compared with usual care for genotype 1 for different prices of sofosbuvir, simeprevir, daclatasvir, and ledipasvir.
6
7
8 PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir. Positive numbers indicate monetary saving.
9 Supplement Figure 3. Results of one-way sensitivity analysis for genotype 1.
10 PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir.svr: Sustained virological response; QALY: quality-adjusted life years; ICER: incremental cost-effectiveness ratio; HR: hazard ratio; DCC: decompensated cirrhosis; F0, F1, F2, F3, F4: METAVIR fibrosis stages. The tornado plots show ICER of treatment strategies vs. usual care for different values for parameters. Vertical line shows the incremental cost-effectiveness ratio under base case analyses.
11 Supplement Figure 4. Expected cost savings from each treatment strategy compared with usual care for genotype 2 for different prices of sofosbuvir and daclatasvir.
12 PEG: pegylated interferon; RBV: ribavirin; SOF: sofosbuvir; DCV: daclatasvir. Positive numbers indicate monetary saving.
13 Supplement Figure 5. Results of one-way sensitivity analysis for genotype 2 PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir.
14 SVR: Sustained virological response; QALY: quality-adjusted life years; ICER: incremental cost-effectiveness ratio; HR: hazard ratio; DCC: decompensated cirrhosis; F0, F1, F2, F3, F4: METAVIR fibrosis stages. The tornado plots show ICER of treatment strategies vs. usual care for different values for parameters. Vertical line shows the incremental cost-effectiveness ratio under base-case analyses.
15 Supplement Figure 6. Expected cost savings from each treatment strategy compared with usual care for genotype 3 for different prices of sofosbuvir and daclatasvir.
16
17 PEG: pegylated interferon; RBV: ribavirin; SOF: sofosbuvir; DCV: daclatasvir; LDV: ledipasvir. Positive numbers indicate monetary saving.
18 Supplement Figure 7. Results of one-way sensitivity analysis for genotype 3. Note: SOF+RBV was a dominated strategy for genotype 3 and has not been included in this analysis. PEG: pegylated interferon; RBV: ribavirin; BOC: boceprevir; SOF: sofosbuvir; SMV: simeprevir; DCV: daclatasvir; LDV: ledipasvir. SVR: Sustained virological response; QALY: quality-adjusted life years; ICER: incremental cost-effectiveness ratio; HR: hazard ratio; DCC: decompensated cirrhosis; F0, F1, F2, F3, F4: METAVIR fibrosis stages. The tornado plots show ICER of treatment strategies versus usual care for different values for parameters. Vertical line shows the incremental cost-effectiveness ratio under base-case analyses.
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