General Statement for Drugs for the Treatment of Hepatitis C

Page last updated: 1 April 2020

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.

Treatment criteria:
Must be treated by a medical practitioner or an authorised nurse practitioner 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 patient’s cirrhotic status (non-cirrhotic or cirrhotic)
  • details of the previous treatment regimen (only for requests for sofosbuvir + velpatasvir + voxilaprevir (Vosevi®) or glecaprevir + pibrentasvir (Maviret®) for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

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
  • where possible, 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

All genotypes
(Pan-genotypic regimens)

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

GLECAPREVIR + PIBRENTASVIR
[8 weeks]

SOFOSBUVIR + VELPATASVIR
[12 weeks]

OR

SOFOSBUVIR + VELPATASVIR + VOXILAPREVIR
[12 weeks] 4

OR

GLECAPREVIR + PIBRENTASVIR
[8 or 12 or 16 weeks] 3

Genotype 1

LEDIPASVIR + SOFOSBUVIR
[8 or 12 weeks] 1

OR

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

LEDIPASVIR + SOFOSBUVIR
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[12 or 24 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 2

Genotype 2

SOFOSBUVIR and RBV
[12 weeks]

SOFOSBUVIR and RBV
[12 weeks]

Genotype 3

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

DACLATASVIR and SOFOSBUVIR
[12 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

Genotype 4

GRAZOPREVIR + ELBASVIR
[12 weeks]

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 2

Genotype 5 & 6

Refer to treatment naïve pan-genotypic regimens above.

Refer to treatment experienced pan-genotypic regimens above.

KEY

RBV - ribavirin

Hepatitis C – Cirrhotic patients

 

Treatment naïve

Treatment experienced

All genotypes
(Pan-genotypic regimens)

SOFOSBUVIR + VELPATASVIR

[12 weeks] 5, 8

OR

GLECAPREVIR + PIBRENTASVIR
[12 weeks]

SOFOSBUVIR + VELPATASVIR
[12 weeks] 5, 8

OR

SOFOSBUVIR + VELPATASVIR + VOXILAPREVIR
[12 weeks] 4

OR

GLECAPREVIR + PIBRENTASVIR
[12 or 16 weeks] 6

Genotype 1

LEDIPASVIR + SOFOSBUVIR
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR and RBV
[12 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

GRAZOPREVIR + ELBASVIR
[12 weeks]

LEDIPASVIR + SOFOSBUVIR
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR and RBV
[12 weeks]

OR

 

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 2

Genotype 2

SOFOSBUVIR and RBV
[12 weeks]

SOFOSBUVIR and RBV
[12 weeks]

Genotype 3

SOFOSBUVIR and RBV
[24 weeks]

OR

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

DACLATASVIR andSOFOSBUVIR andRBV
[12 or 24 weeks] 7

DACLATASVIR and SOFOSBUVIR
[24 weeks]

OR

SOFOSBUVIR and RBV
[24 weeks]

OR

DACLATASVIRandSOFOSBUVIRand RBV
[12 or 24 weeks] 7

Genotype 4

GRAZOPREVIR + ELBASVIR
[12 weeks]

GRAZOPREVIR + ELBASVIR
[12 weeks]

OR

GRAZOPREVIR + ELBASVIR and RBV
[16 weeks] 2

Genotype 5 & 6

Refer to treatment naïve pan-genotypic regimens above.

Refer to treatment experienced pan-genotypic regimens above.

KEY

RBV – ribavirin

1. 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.

2. 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.

3. GLECAPREVIR + PIBRENTASVIR  [8 or 12 or 16 weeks] for non-cirrhotic patients:

  • treatment for 8 weeks for treatment-experienced patients with genotypes 1, 2, 4, 5 or 6 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 16 weeks for treatment-experienced patients with genotype 3 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.

4.. SOFOSBUVIR + VELPATASVIR + VOXILAPREVIR [12 weeks] only for patients who have failed an NS5A inhibitor.

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

6. GLECAPREVIR + PIBRENTASVIR [12 or 16 weeks] for cirrhotic patients:

  • treatment for 12 weeks for treatment-experienced patients with genotypes 1, 2, 4, 5 or 6 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 16 weeks for treatment-experienced patients with genotype 3 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. DACLATASVIR and SOFOSBUVIR and RBV [12 or 24 weeks] for cirrhotic patients. Consider a 24 week regimen of where clinically appropriate.

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