Friday, 16 October 2015 22:18

ASHM Position Statement On HCV Generics

Written by
Rate this item
(3 votes)

NSW Health and ASHM (Australian Society of HIV/HBV/HCV Medicine) have joined forces to issue a position statement titled Importation of Generic HCV Drugs. You can follow the link or read the text below:

08 October 2015

Advice for HCV Clinicians

This communique is for clinicians experienced in the management and treatment of Hepatitis C using Direct Acting Antivirals (DAAs), who may be consulted by their patients who are considering importation of generic DAAs. It assumes an understanding of HCV management and new treatments.

Overview of the current status of DAAs in Australia:

All PBS subsidised treatment for hepatitis C in Australia currently consist of pegylated interferon and ribavirin with the addition of a DAA for genotype 1. These combinations are now not widely used due to side effects, duration of treatment and relatively poor cure rates.

Newer DAA regimens that are interferon-free, well tolerated and have shorter duration of treatment are available in the USA and Europe. They are detailed in the current EASL and AASLD​ evidence-based guidelines.

A number of DAAs have been approved in Australia by the TGA. In 2015, several interferon-free regimens for the treatment of hepatitis C were recommended by the PBAC for inclusion on the PBS, however they are not yet listed. These include:

  • Sofosbuvir + Ledipasvir for genotype 1
  • Sofosbuvir + Daclatasvir for genotypes 1 and 3
  • Sofosbuvir + Ribavirin for genotype 2
  • Sofosbuvir + Pegylated interferon/ Ribavirin for genotype 1
  • Paritaprevir/r + Ombitasvir + Dasabavir (+/- Ribavirin) for genotype 1

Consumers in Australia can currently access DAAs through a number of mechanisms:

  • purchase the drug without subsidy
  • participate in a clinical trial
  • apply under a compassionate access program (limited places)
  • import drugs into Australia for private use under the Personal Importation Scheme​

ASHM recommends that any individual considering DAA therapy discuss their options with a clinician experienced in HCV management and treatment with the new DAAs.

Patients may approach clinicians to write them a script for DAAs so that they can purchase them overseas or via the internet due to their current high cost in Australia without subsidy. In these circumstances, it is important they understand that it is the patient that is the personal importer. The Doctor should document fully the patient’s request and understanding and that the doctor is supporting the patient to personally import the medicines. More information on this process is discussed below. Doctors should not advertise or promote these methods of acquisition to patients.

Evidence for the effectiveness of DAAs:

The efficacy of DAAs in the treatment of hepatitis C has been widely established in the international literature and is detailed in the EASL and AASLD evidence-based guidelines.

Discussing importation of generic DAAs with patients:

Patients are allowed to import up to 3 months of medication for their own use under the Commonwealth Government’s Personal Importation Scheme. It is important that patients know that the safety and quality of medicines purchased overseas or over the internet cannot be guaranteed. 

It is a legal requirement of this scheme that a patient has a prescription from an Australian registered medical practitioner.

Refer patients to the Hepatitis Australia factsheet Importing Medicines into Australia (May 2015).​

Establishing HCV status:

When a patient requests a script for a generic DAA, it is essential to establish their current HCV status. This should be done using a conventional blood sample and laboratory testing.

Current HCV infection is confirmed when the test results are HCV antibody positive and HCV RNA is positive.

Patient HCV assessment:

Once the presence of chronic HCV (HCV RNA +ve) has been confirmed, it is very important in patient assessment to:

- Establish HCV genotype (as this determines the treatment regimen)

- Determine the degree of liver fibrosis (as this influences treatment choice and duration)

- Determine the presence of comorbidities that may affect treatment (e.g. renal disease)

Patients with cirrhosis need ongoing specialist monitoring for complications, including HCC and oesophageal varices. They also need different treatment combinations and more prolonged treatment.

Drug interactions:

The potential for drug interactions with other medication must be considered when DAAs are prescribed. For up to date drug-drug interaction information, go to: http://www.hep-druginteractions.org/ or download the App: HEP iChart.

Compliance with dosing regimen:

It is essential that patients take the right combination of medications for their HCV genotype and stage of fibrosis. They must also take the medication consistently for a sufficient duration in order to optimise the likelihood of viral clearance (SVR or sustained virological response).

Safe injecting strategies:

Patients should be counselled to use safe injecting practices. This will prevent the acquisition of other blood-borne infections and reinfection with hepatitis C.

Monitoring and side effects:

DAAs are generally very safe. Patients should be monitored according to evidence-based guidelines. The key issues are in initial patient assessment (as discussed above).

Patients will also need post treatment assessment including 2 HCV RNAs (PCR) to determine viral clearance. Note that patients with cirrhosis will need lifelong monitoring.

Accessing DAAs through the Personal Importation Scheme

Patients have a number of options to access DAAs, including their purchase in Australia without subsidy. Patients can also personally import the drugs in person or via mail. Details of how to do this can be obtained on the TGA website. A patient can import up to 3 months supply at the one time into Australia using the Personal Importation Scheme.

Generic drugs can be purchased via a number of websites. These drugs have not been evaluated by the TGA. Generic drugs use alternative trade names and packaging and may be a different colour or shape so you must be sure that the drug being purchased is the correct formulation.

Self-importation has some risks associated with it. You do not have the quality protection provided by drugs evaluated and listed on the ARTG. You need to be careful about the veracity of the website. Supply time may vary and the postage time could be delayed if customs investigates the package. Self-importation is legal, but not routine. Having a valid Australian prescription completed by a registered medical practitioner is essential, and completing all the paper work will facilitate the process but patients should allow up to eight weeks for delivery.

How to order Generic DAAs for HCV online:

ASHM does not endorse any specific websites or products. It is up to the individual personally importing the drugs to locate an appropriate website and test the veracity of the supplier. The following are shown as examples only.

FixHepC is a buyers club http://fixhepc.com/getting-treated/how-to-do-it/buyers-club.html that states it will assist with buying, testing and delivery of hepatitis C drugs.

AIDS Drugs Online http://www.aids-drugs-online.com/ has been used to source low-cost generic versions of HIV medications from various overseas manufacturers and they also stock hepatitis C medications. Please be aware that the brand names used on AIDS Drugs Online are not the same as the brands in Australia. For example:

a. Australian brand name: Sofosbuvir

b. AIDS Drugs Online (ADO) brand name: SOFOSBUVIR / Hepcinat

Online suppliers may be only able to supply one of the HCV drugs needed in a regimen, so patients may need to source medicines from more than one source, e.g. the internet and locally through compassionate patient access schemes.

Helpful links:

TGA Personal Importation Scheme https://www.tga.gov.au/personal-importation-scheme

Fix Hep C – website supplying further information on personal importation http://fixhepc.com/

EASL Recommendations on Treatment of Hepatitis C 2015 http://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/recommendations-on-treatment-of-hepatitis-c-2015

AASLD HCV Guidance: Recommendations for Testing, Managing and Treating Hepatitis C http://www.hcvguidelines.org/full-report-view​

Hepatitis Australia​ http://www.hepatitisaustralia.com/

For further information:

Contact the ASHM office during office hours on 02 8204 0700.

Read 105444 times Last modified on Friday, 16 October 2015 22:30

Copyright © 2015-2017 FixHepC

Back to Top