Boceprevir (Victrelis) |
April 2013 |
Authority required (STREAMLINED)
4182
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be in combination with peginterferon alfa and ribavirin,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 32 weeks in patients without hepatic cirrhosis who were partial responders or relapsers to
the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks in patients without hepatic cirrhosis who were null responders to the prior
course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks for all patients with hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease after the first 8 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at
treatment week 12,
AND the Clinical criteria is:
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at
treatment week 24,
AND the Population criteria is:
Patient must be 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where
the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal.
Details of the intolerance must be documented in the patient's medical records.
For patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy, a maximum of 7
repeats may be prescribed.
For patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy, a maximum of 10 repeats may be
prescribed.
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed.
Authority required (STREAMLINED)
4202
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The treatment must be in combination with peginterferon alfa and ribavirin,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients without hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 44 weeks in patients with hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay attreatment week 24,
AND the Population criteria is:
Patient must be 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's
medical records.
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where
the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal.
Details of the intolerance must be documented in the patient's medical records.
For patients without hepatic cirrhosis, a maximum of 5 repeats may be prescribed.
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and(c) an established liver clinic. |
