[Amending the decision on determining main list Croatian Health Insurance]

2013 Official Gazette of the Republic of Croatia 47 (114, 120)

Indications: Chronic hepatitis C in patients aged 18-70 years who meet the following criteria:
- HCV RNA PCR positive (at least 2 months before the start of therapy), elevated ALT values in two consecutive measurements with the findings of genotype and histological evidence of chronic inflammation or elastography finding (FibroScan) greater than 8 kPa. In patients with normal serum ALT therapy is indicated in fibrosis stages F> = 2 (under Ishak Knodell Index) or FibroScan values greater than 8 kPa. [...]
For treatment is adapted according to the response of the patient and to the fibrosis stage. The fibrosis degree F5 by Ishak Knodell (or Metavir F4) is considered as equivalent to the liver stiffness greater than 14 kPa (FibroScan).
- The treatment of relapse - triple therapy (boceprevir with pegylated interferon alpha 2 or 2b with ribavirin) is indicated for patients with chronic hepatitis C genotype 1 who had medically documented relapse of infection after administration of dual therapy, aged 18-70 years, have compensated liver disease with evidence of the presence of HCV RNA in serum, with histological evidence of chronic hepatitis biopsy performed, the prior dual therapy, including all stages of fibrosis F1-4 by Metavir, or the elastography measurement value > 7 kPa (within three months of starting treatment). [...]
- For the treatment of partial responders - triple therapy (boceprevir with pegylated interferon afa 2a / 2b and ribavirin according to TT) is indicated in patients with chronic hepatitis C genotype 1 who had medically documented partial virologic response to previous dual therapy, aged 18 to 70 years have compensated liver disease with evidence of the presence of HCV RNA in serum, with fibrosis stage F3 and 4 per Metavir biopsy on the committed before the dual therapy, or the elastography measurement value > 9.5 kPa. [...]
- For the treatment of non-responders or unknown outcome of the previous dual therapy - triple therapy (boceprevir with pegylated interferon afa 2a / 2b and ribavirin according to TT) is indicated in patients aged 18-70 years, with medical documentation regarding the low response rates (<12 2log10x week dual therapy), aged 18-70 years, have compensated liver disease with evidence of the presence of HCV RNA in serum, with fibrosis stage F3 and 4 per Metavir biopsy on the committed before the dual therapy, or the elastography measurement value > 9.5 kPa. [...]
- The treatment protocol for patients with compensated cirrhosis (F4, Fibroscan> 14.5 kPa) - The treatment begins with a dual therapy with pegylated interfronom alfa-2a / 2b with ribavirin according to TT for 4 weeks. After 4 weeks of treatment was added in the boceprevir 3x800 mg dose. Treatment of triple therapy continues to be 44 weeks, while checking the HCV RNA at week 12. If the HCV RNA at week 12> 100 IU / ml of serum treatment is interrupted, if HCV-RNA <100 IU of HCV RNA / treatment is continued following 36 weeks of triple therapy, the condition of the HCV RNA negative at week 24. [...]

Chronic hepatitis B - Peginterferon alfa-2a HBsAg pos (regardless of HBeAg status), with the following criteria:
- HBV DNA greater than 2000 IU / mL (10,000 copies / ml of serum), elevated ALT values in two consecutive measurements, with histological evidence fibrosis> = F2 (by Ishak Knodell Index) or elastography measurement (FibroScan) greater than 8 kPa.
- Patients with a viral load of less than 2000 IU / mL and normal ALT treated if they have histologically or elastography indicator of advanced fibrosis under Ishak Knodell F> = 4 or FibroScan greater than 14 kPa.