Background
Methods
Study design and setting
Method for cost determination
Costs of personnel, blood analysis tests and medical visits
Cost of antiviral drugs for CHC treatment
Strategies for treatment of GT1-HCV patients according to the BMoH guidelines
Guideline | Fibrosis staging | Prerequisite for treatment | Drugs | Duration (weeks) | Doses | Interventions |
---|---|---|---|---|---|---|
BMoH-2011 | Liver biopsy | METAVIR F ≥ 2 | PEG-IFN α-2a 180 mcg [Pegasys® - Roche] | 48 | 1 injection weekly | PEG-RBV for 48 weeks. Medical visit at screening, baseline, W2, W4 and every 4 weeks for W4 to W48. Response-guided therapy or stopping rules based on HCV-RNA at W4, W12 and W24. SVR at W72 |
RBV 250 mg [BMoH generic] | 48 | 5 capsules daily | ||||
BMoH-2013A | TE | LSM ≥ 9.6 kPa | PEG-IFN α-2a 180 mcg [Pegasys® - Roche] | 48 | 1 injection weekly | Leading-phase with PEG-RBV for 4 weeks and PEG-RBV/BOC for 44 weeks. Medical visit at screening, baseline, W2, W4, W5, W6 and W8, and every 4 weeks from W8 to W48. Response-guided therapy or stopping rules based on HCV-RNA on W4, W12 and W24. SVR at W72 |
RBV 250 mg [BMoHgeneric] | 48 | 5 capsules daily | ||||
BOC 200 mg [Victrelis® – Merk] | 44 | 12 tablets daily | ||||
BMoH-2013B | TE | LSM ≥ 9.6 kPa | PEG-IFN α-2a 180 mcg [Pegasys® - Roche] | 48 | 1 injection weekly | PEG-RBV/TEL for 12 weeks and PEG-RBV for 36 weeks. Medical visit at at screening, baseline, W1, W2 and W4, then every 4 weeks from W4 to W48. Response-guided therapy or stopping rules based on HCV-RNA on W4, W12 and W24. SVR at W72 |
RBV 250 mg [BMoH generic] | 48 | 5 capsules daily | ||||
TEL 375 mg [Incivek ® - Vertex] | 12 | 6 tablets daily | ||||
BMoH-2015A | TE or APRI or FIB-4 | LSM ≥ 9.6 kPa or APRI ≥1.5 or FIB-4 ≥ 3.25 | SOF 400 mg [Sovaldi® – Gilead] | 12 | 1 tablet daily | SOF/DCV for 12 weeks. Medical visits at screening, baseline, W2, W4, W8 and W12. No response-guided therapy or stopping rules. SVR at W24 |
DCV 60 mg [Daklinza® - BMS] | 12 | 1 tablet daily | ||||
BMoH-2015B | TE or APRI or FIB-4 | LSM ≥ 9.6 kPa or APRI ≥1.5 or FIB-4 ≥ 3.25 | SOF 400 mg [Sovaldi® – Gilead] | 12 | 1 tablet daily | SOF/SIM for 12 weeks or 24 weeks in presence of decompensated cirrhosis (Child-Pugh B/C). Medical visits at screening, baseline, W2, W4, W8 and W12. No response-guided therapy or stopping rules. SVR at W24 |
SIM 150 mg [Olysio – Janssen®] | 12 | 1 tablet daily |
Literature review for efficacy of SOF/DCV and SOF/SIM regimens in real-life scenario
Results
Costs for liver fibrosis assessment
Costs for GT1 HCV treatment
Cost per unit | PEG-RBV | PEG-RBV/BOC | PEG-RBV/TEL | SOF/DCV | SOF/SIM | ||
---|---|---|---|---|---|---|---|
US$ | PPP$ | n | n | n | n | n | |
Transient elastography | 53.35 | 95.32 | – | 1 | 1 | 1 | 1 |
Liver biopsy | 482.32 | 834.41 | 1 | – | – | – | – |
Blood analysis tests | |||||||
WBC. RBC and platelet | 10.62 | 19.11 | 15 | 17 | 16 | 6 | 6 |
Fasting glucose | 4.86 | 8.75 | 6 | 6 | 6 | 6 | 6 |
BUN/creatinine | 4.84 | 8.70 | 15 | 16 | 15 | 6 | 6 |
ALT | 4.85 | 8.73 | 15 | 16 | 15 | 6 | 6 |
AST | 4.86 | 8.74 | 15 | 16 | 15 | 6 | 6 |
Alkaline phosphatases | 4.77 | 8.58 | 6 | 6 | 6 | 6 | 6 |
GGT | 4.83 | 8.69 | 6 | 6 | 6 | 6 | 6 |
Total bilirubin | 4.84 | 8.71 | 6 | 6 | 6 | 6 | 6 |
Albumin | 5.07 | 9.12 | 6 | 6 | 6 | 6 | 6 |
INR | 6.68 | 12.02 | 6 | 13 | 14 | 6 | 6 |
HCV genotype | 156.33 | 281.22 | 1 | 1 | 1 | 1 | 1 |
HCV-RNA | 87.05 | 156.60 | 8 | 7 | 7 | 2 | 2 |
TSH | 26.26 | 47.23 | 6 | 6 | 6 | – | – |
Beta-hCG | 45.52 | 81.88 | 4 | 4 | 4 | 4 | 4 |
Medical follow-up | |||||||
GP’s medical visit | 54.54 | 98.11 | 1 | 1 | 1 | 1 | 1 |
Specialist’s medical visit | 62.92 | 113.19 | 14 | 14 | 14 | 5 | 5 |
Blood sample collection | 37.83 | 68.06 | 15 | 15 | 15 | 6 | 6 |
Nursing consultation | 31.83 | 57.26 | 5 | 5 | 5 | 4 | 4 |
Drugs | |||||||
PEG-IFN α-2a 180 mcg – SC injection | 360.22 | 648.00 | 48 | 48 | 48 | – | – |
Ribavirin 250 mg – PO capsule | 1.68 | 3.03 | 1680 | 1680 | 1680 | – | – |
Boceprevir 200 mg – PO tablet | 4.42 | 7.96 | – | 3612 | – | – | – |
Telaprevir 375 mg – PO tablet | 48.37 | 87.01 | – | – | 504 | – | – |
Sofosbuvir 400 mg – PO tablet | 80.54 | 144.89 | – | – | – | 84 | 84 |
Daclastavir 60 mg – PO tablet | 30.87 | 55.54 | – | – | – | 84 | – |
Simeprevir 150 mg - PO tablet | 42.98 | 77.32 | – | – | – | – | 84 |
PEG-RBV | PEG-RBV/BOC | PEG-RBV/TEL | SOF/DCV | SOF/SIM | ||||||
---|---|---|---|---|---|---|---|---|---|---|
US$ | PPP$ | US$ | PPP$ | US$ | PPP$ | US$ | PPP$ | US$ | PPP$ | |
TE | – | – | 53.35 | 95.32 | 53.35 | 95.32 | 53.35 | 95.32 | 53.35 | 95.32 |
Liver biopsy | 482.32 | 834.41 | – | – | – | – | – | – | – | – |
Total | 482.32 | 834.41 | 53.35 | 95.32 | 53.35 | 95.32 | 53.35 | 95.32 | 53.35 | 95.32 |
Blood analysis tests | ||||||||||
WBC. RBC and platelet | 159.39 | 286.72 | 180.64 | 324.95 | 170.02 | 305.84 | 63.76 | 114.69 | 63.76 | 114.69 |
Fasting glucose | 29.20 | 52.52 | 29.20 | 52.52 | 29.20 | 52.52 | 29.20 | 52.52 | 29.20 | 52.52 |
BUN/creatinine | 72.58 | 130.56 | 77.41 | 139.26 | 72.58 | 130.56 | 29.03 | 52.22 | 29.03 | 52.22 |
ALT | 72.78 | 130.92 | 77.63 | 139.65 | 72.78 | 130.92 | 29.11 | 52.37 | 29.11 | 52.37 |
AST | 72.91 | 131.16 | 77.78 | 139.91 | 72.91 | 131.16 | 29.17 | 52.47 | 29.17 | 52.47 |
AP | 28.61 | 51.46 | 28.61 | 51.46 | 28.61 | 51.46 | 28.61 | 51.46 | 28.61 | 51.46 |
GGT | 28.99 | 52.15 | 28.99 | 52.15 | 28.99 | 52.15 | 28.99 | 52.15 | 28.99 | 52.15 |
Total bilirubin | 29.04 | 52.24 | 29.04 | 52.24 | 29.04 | 52.24 | 29.04 | 52.24 | 29.04 | 52.24 |
Albumin | 30.44 | 54.75 | 30.44 | 54.75 | 30.44 | 54.75 | 30.44 | 54.75 | 30.44 | 54.75 |
INR | 40.10 | 72.14 | 86.89 | 156.30 | 93.57 | 168.32 | 40.10 | 72.14 | 40.10 | 72.14 |
HCV genotype | 156.33 | 281.22 | 156.33 | 281.22 | 156.33 | 281.22 | 156.33 | 281.22 | 156.33 | 281.22 |
HCV-RNA | 696.43 | 1252.80 | 609.38 | 1096.20 | 609.38 | 1096.20 | 174.11 | 313.20 | 174.11 | 313.20 |
TSH | 157.55 | 283.41 | 157.55 | 283.41 | 157.55 | 283.41 | – | – | ||
Beta-hCG | 182.07 | 327.53 | 182.07 | 327.53 | 182.07 | 327.53 | 182.07 | 327.53 | 182.07 | 327.53 |
Total | 1756.41 | 3159.58 | 1751.94 | 3151.54 | 1733.45 | 3118.27 | 849.94 | 1528.95 | 849.94 | 1528.95 |
Medical follow-up | ||||||||||
GP’s medical visit | 54.54 | 98.11 | 54.54 | 98.11 | 54.54 | 98.11 | 54.54 | 98.11 | 54.54 | 98.11 |
Specialist’s visit | 880.95 | 1584.73 | 880.95 | 1584.73 | 880.95 | 1584.73 | 314.62 | 565.97 | 314.62 | 565.97 |
Blood sample | 567.52 | 1020.90 | 567.52 | 1020.90 | 567.52 | 1020.90 | 227.01 | 408.36 | 227.01 | 408.36 |
Nursing consultation | 159.15 | 286.29 | 159.15 | 286.29 | 159.15 | 286.29 | 127.32 | 229.03 | 127.32 | 229.03 |
Total | 1662.15 | 2990.02 | 1662.15 | 2990.02 | 1662.15 | 2990.02 | 723.49 | 1301.47 | 723.49 | 1301.47 |
Drugs | ||||||||||
PEG-IFN 180 mcg | 17,290.59 | 31,103.78 | 17,290.59 | 31,103.78 | 17,290.59 | 31,103.78 | – | – | – | – |
Ribavirin 250 mg | 2828.69 | 5088.49 | 2828.69 | 5088.49 | 2828.69 | 5088.49 | – | – | – | – |
Boceprevir 200 mg | – | – | 15,991.51 | 28,766.88 | – | – | – | – | – | – |
Telaprevir 375 mg | – | – | – | – | 24,378.69 | 43,854.45 | – | – | – | – |
Sofosbuvir 400 mg | – | – | – | – | – | – | 6765.68 | 12,170.68 | 6765.68 | 12,170.68 |
Daclastavir 60 mg | – | – | – | – | – | – | 2593.44 | 4665.30 | – | – |
Simeprevir 150 mg | – | – | – | – | – | – | – | – | 3610.29 | 6494.49 |
Total | 20,119.28 | 36,192.27 | 36,110.79 | 64,959.15 | 44,497.97 | 80,046.72 | 9359.12 | 16,835.98 | 10,375.97 | 18,665.17 |
TOTAL COST | 24,020.16 | 43,176.28 | 39,578.23 | 71,196.03 | 47,946.92 | 86,250.33 | 10,985.90 | 19,761.72 | 12,002.75 | 21,590.91 |
Literature overview for efficacy of SOF/DCV and SOF/SIM regimens
Authors | Year | Local | Regimen | Overall | Non-cirrhosis | Cirrhosis | Naive | Experimented | GT 1a | GT 1b | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | SVR | n | SVR | n | SVR | n | SVR | n | SVR | n | SVR | n | SVR | ||||
Sofosbuvir (400 mg)/Daclastavir (60 mg) regimen studies | |||||||||||||||||
Pol et al. [17] | 2017 | France | SOF/DCV 12w | 160 | 92% | 66 | 98% | 94 | 87% | 64 | 88% | 96 | 95% | 73 | 95% | 83 | 89% |
SOF/DCV 24w | 439 | 95% | 97 | 97% | 342 | 94% | 48 | 85% | 391 | 96% | 210 | 95% | 209 | 95% | |||
Welzel et al. [16] | 2016 | Europe | SOF/DCV ± RBV 12w | 319 | 98% | – | – | – | – | – | – | – | – | 151 | 99% | 155 | 97% |
Sofosbuvir (400 mg)/Simeprevir (150 mg) regimen studies | |||||||||||||||||
Marino et al. [[28] | 2017 | Spain | SOF/SIM ± RBV 12w | 835 | 92% | – | – | 835 | 92% | – | – | – | – | – | – | – | – |
Ramos et al. [29] | 2017 | Spain | SOF/SIM 12w | 179 | 93% | – | – | – | – | – | – | – | – | – | – | – | – |
Chang et al. [27] | 2017 | USA | SOF/SIM 12w | 21 | 91% | – | – | – | – | – | – | – | – | – | – | – | – |
Sulkowski et al. [26] | 2016 | USA | SOF/SIM 12w | 639 | 85% | 272 | 91% | 367 | 81% | 65 | – | – | – | 371 | 83% | 185 | 90% |
Lutchtman et al. [25] | 2016 | USA | SOF/SIM 12w | 148 | 82% | 43 | 88% | 193 | 78% | 62 | 87% | 86 | 78% | 94 | 79% | 42 | 93% |
Pellicelli et al. [24] | 2016 | Italy | SOF/SIM/RBV 12w | 270 | 96% | – | – | 270 | 96% | – | – | – | – | – | – | – | – |
Roytman et al. [23] | 2016 | USA | SOF/SIM 12w | 138 | 89% | 43 | 93% | 95 | 87% | 76 | 87% | 55 | 92% | – | – | – | – |
Thornton et al. [22] | 2016 | USA | SOF/SIM 12w | 114 | 89% | – | – | – | – | – | – | – | – | – | – | – | – |
Jayasekera et al. [19] | 2016 | USA | SOF/SIM 12w | 35 | 86% | 13 | 92% | 22 | 82% | 7 | 86% | 28 | 86% | – | – | – | – |
Pillail et al. [20] | 2016 | USA | SOF/SIM ± RBV 12w | 113 | 84% | 23 | 91% | 90 | 82% | 57 | 89% | 56 | 79% | – | – | – | – |
Barron et al. [21] | 2016 | USA | SOF/SIM ± RBV 12w | 35 | 83% | – | – | – | – | – | – | – | – | – | – | – | – |
Backus et al. [18] | 2015 | USA | SOF/SIM 12w | 1130 | 75% | 664 | 81% | 462 | 68% | 699 | 78% | 431 | 71% | 632 | 73% | 366 | 80% |