General Statement for Drugs for the Treatment of Hepatitis C

Page last updated: 1 September 2018

Use the following criteria to determine patient eligibility for subsidisation under the PBS for hepatitis C treating agents.

By writing a PBS prescription, the prescriber is certifying the patient satisfies the qualifying criteria set out below and the use in accordance with the registered indications which differ between agents in this class – refer to the current Product Information for details.

Population criteria:
Patient must be aged 18 years or older.

Treatment criteria:
Must be treated by a medical practitioner or an authorised nurse practitioner 1 experienced in the treatment of chronic hepatitis C infection; or in consultation with a gastroenterologist, hepatologist or infectious diseases physician experienced in the treatment of chronic hepatitis C infection.

The following information must be provided at the time of application:

  • the hepatitis C virus genotype; and
  • the patient’s cirrhotic status (non-cirrhotic or cirrhotic)

The following information must be documented in the patient’s medical records:

  • evidence of chronic hepatitis C infection (repeatedly antibody to hepatitis C virus (anti-HCV) positive and hepatitis C virus ribonucleic acid (HCV RNA) positive); and
  • evidence of the hepatitis C virus genotype

The following matrices identify the regimens which are available for PBS prescription for eligible patients, based on the hepatitis C virus genotype and treatment history.

Hepatitis C - Non-cirrhotic patients

 

Treatment naïve

Treatment experienced

Genotype 1

LEDIPASVIR + SOFOSBUVIR
[8 or 12 weeks] 2

OR

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR
[12 weeks] 3

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV
[12 weeks] 4

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

LEDIPASVIR + SOFOSBUVIR
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[12 or 24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR
[12 weeks] 3

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV
[12 weeks] 4

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 5

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 or 12 or 16 weeks] 6

Genotype 2

SOFOSBUVIR and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

SOFOSBUVIR and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

Genotype 3

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[16 weeks]

Genotype 4

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 5

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

Genotype 5 & 6

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

KEY

PEG-IFN - peginterferon alfa-2a
RBV - ribavirin

Hepatitis C – Cirrhotic patients

 

Treatment naïve

Treatment experienced

Genotype 1

LEDIPASVIR + SOFOSBUVIR
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR and RBV
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

LEDIPASVIR + SOFOSBUVIR
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR and RBV
[12 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV
[12 or 24 weeks] 7

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 5

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 or 16 weeks] 9

Genotype 2

SOFOSBUVIR and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

SOFOSBUVIR and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

Genotype 3

SOFOSBUVIR and RBV
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

DACLATASVIR andSOFOSBUVIR andRBV
[12 or 24 weeks] 10

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8, 11

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

OR

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

DACLATASVIRandSOFOSBUVIRand RBV
[12 or 24 weeks] 10

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8, 11

OR

GLECAPREVIR + PIBRENTASVIR
[16 weeks]

Genotype 4

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 5

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

Genotype 5 & 6

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

SOFOSBUVIR and PEG-IFN and RBV
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR
[12 weeks] 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

KEY

PEG-IFN - peginterferon alfa-2a
RBV – ribavirin

1. Medicines for the treatment of hepatitis C are listed for prescribing by authorised nurse practitioners under the General Schedule only. Medicines for the treatment of hepatitis C are not listed for prescribing by authorised nurse practitioners under the S100 Highly Specialised Drugs Program.

2. LEDIPASVIR + SOFOSBUVIR [8 or 12 weeks] for treatment-naïve, non-cirrhotic patients:

  • consider treatment for 8 weeks where pre-treatment HCV RNA is less than 6 million IU/mL;
  • otherwise treatment for 12 weeks where pre-treatment HCV RNA is 6 million IU/mL or greater.

3. PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR [12 weeks] for treatment-naïve and treatment experienced, non-cirrhotic patients, treatment for 12 weeks in patients with genotype 1b HCV.

4. PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV [12 weeks] for treatment-naïve and treatment experienced, non-cirrhotic patients, treatment for 12 weeks in patients with genotype 1a HCV.

5. GRAZOPREVIR + ELBASVIR and RBV [16 weeks] for treatment-experienced, non-cirrhotic and cirrhotic patients, treatment for 16 weeks in patients with genotype 1a or 4 HCV who have experienced on-treatment virologic failure to prior treatment.

6. GLECAPREVIR + PIBRENTASVIR  [8 or 12 or 16 weeks]:

  • treatment for 8 weeks for treatment-experienced patients with genotype 1 who have failed regimens containing peginterferon, ribavirin, and/or sofosbuvir but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor;
  • treatment for 12 weeks for treatment-experienced patients with genotype 1 who have failed regimens containing an NS3/4A PI;
  • treatment for 16 weeks for treatment-experienced patients with genotype 1 who have failed regimens containing an NS5A inhibitor.

7. PARITAPREVIR + RITONAVIR + OMBITASVIR (&) DASABUVIR (&) RBV [12 or 24 weeks] for treatment-experienced, cirrhotic patients:

  • consider treatment for 12 weeks in patients with genotype 1a HCV (except prior null responders to PEG-IFN and RBV) and genotype 1b HCV; or
  • consider treatment for 24 weeks in patients with genotype 1a HCV who have had a previous null response to PEG-IFN and RBV.

8. SOFOSBUVIR + VELPATASVIR [12 weeks] for patients with decompensated cirrhosis. Use in combination with ribavirin.

9. GLECAPREVIR + PIBRENTASVIR [12 or 16 weeks]:

  • treatment for 12 weeks for treatment-experienced patients with genotype 1 who have failed regimens containing an NS3/4A PI;
  • treatment for 16 weeks for treatment-experienced patients with genotype 1 who have failed regimens containing an NS5A inhibitor.

10. DACLATASVIR and SOFOSBUVIR and RBV [12 or 24 weeks] for cirrhotic patients. Consider a 24 week regimen of where clinically appropriate.

11. SOFOSBUVIR + VELPATASVIR [12 weeks] for patients with genotype 3 infection with compensated cirrhosis. Consider addition of ribavirin.