Australian doctors advice for buying generic sofosbuvir for HepC

1 October 2015. Related: Treatment access, Hepatitis coinfection.

Australian Medical society issues guidelines for personal importation of generic oral hepatitis C drugs including sofosbuvir

Simon Collins, HIV i-Base

On 8 October 2015, the professional association in Australia for doctors and other health workers that specialise in HIV, hepatitis and sexual health (ASHM), issued guidance on the importation of generic HCV drugs. [1]

ASHM is similar to the British HIV Association (BHIVA) in the UK.

This guidance is important as the cost of some medications – notably tenofovir/FTC for PrEP and sofosbuvir and other DAAs (for hepatitis C) – are prohibitively expensive for the NHS to provide widespread access that would meet current medical need.

Australia has similar flexibility to the UK for buying and importing medication online for personal use.

The guidance is printed below in full as a model to aid UK doctors in a similar position.

ASHM 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 evidence-based guidelines produced by EASL and AASLD.

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. For HCV genotype (G) these include:

sofosbuvir + ledipasvir (G1).
sofosbuvir + daclatasvir (G1 and 3).
sofosbuvir + ribavirin (G2).
sofosbuvir + pegylated interferon/ribavirin (G1).
paritaprevir/r + ombitasvir + dasabuvir (+/- ribavirin) (G1).

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

AIDS Drugs Online has been used to source low-cost generic versions of HIV medications from various overseas manufacturers and they also stock hepatitis C medications.
http://www.aids-drugs-online.com

Please be aware that the brand names used on AIDS Drugs Online are not the same as the brands in Australia. For example: Australian brand name sofosbuvir hasw a brand name: sofosbuvir/Hepcinat on AIDS Drugs Online (ADO).

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.

Further information and 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/

comment

The community organisation hepcAsia updates an online resource on generic versions of sofosbuvir that are available in India. [2]

The current price list shows that the 15 generic companies in India selling sofosbuvir (from four different manufacturers) charge $314 to $399 for 28 tablets.

None of these options takes away from the principal that NHS treatment and care in the UK should be available and free to all at the point of care. The NHS should provide PrEP to all those who need it and new hepatitis C drugs to all that need them.

In principle, people in low- and middle-income countries should have access to lower cost medicines and people in high-income countries should pay higher prices. Different prices by country is both reasonable and essential for continued research to generate better medicines that allows for financial benefits after private investment.

The issue of people in the UK accessing generic meds online is not about chasing the cheapest possible treatments but about any chance of access. The ongoing scandal is the level of corporate greed that set prices for immensely effective new hepatitis C treatments that are beyond the ability of any health system to afford. [3]

Although in an ideal world, a system of regulation for setting the price of medications would be tackled as an access issue between the government and the pharmaceutical industry, in the context of pressure for even stronger trade agreement such as TTIP that favour multinational companies, this is unlikely in the near future.

Unlike HIV drugs, an important caveat to using generic HCV formulations is that they have not yet been FDA or WHO prequalilifed, although this is expected soon.

Source:

Australian Society for HIV Medicine (ASHM) advice for HCV clinicians (08 October 2015).
http://www.ashm.org.au/HCV/management-hepc/importation-of-generic-hcv-drugs
hepcasia.com. Updated list of generic manufacturers of sofosbuvir in India plus prices. (10 September 2015).
http://hepcasia.com/2015/09/11/availability-and-pricing-of-generic-sofosbuvir-in-india-updated-10-september-2015
Collins S. Activists protest the price of sofosbuvir: “So-Valdi, So-Expensive” – UK access already rationed. HTB May/June 2014.
https://i-base.info/htb/25884