Table 1 Description of strategies for treatment of genotype 1 chronic hepatitis C according to the Brazilian Ministry of Health from 2011 to 2015
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 250Â 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 250Â 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 250Â 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 |