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Skip Navigation LinksASHM Internet Home > Position Statement: Importation of Generic HCV Drugs

Position Statement: Importation of Generic HCV Drugs

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ASHM supports unrestricted and universal access to Direct Acting Antivirals (DAA) interferon-free treatment regimens for those living with hepatitis C as a way to improve individual and public health outcome

​ASHM supports unrestricted and universal access to Direct Acting Antivirals (DAA) interferon-free treatment regimens for those living with hepatitis C as a way to improve individual and public health outcomes. It is optimal for these drugs to be TGA approved and able to be accessed via the Pharmaceutical Benefits Scheme (PBS).

ASHM recognises that 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. ASHM notes that DAA regimens that are interferon-free have been approved in Australia by the TGA and 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

ASHM recognises that these new treatments can be highly effective with SVR rates greater than 90%, low toxicity, shortened treatment duration, simplified dosing and minimal side effects1. Clinical trials have also demonstrated that the new regimens offer a potential cure for those who previously did not respond well to treatment2, those with co-infection3 or compensated cirrhosis4. However, there are limitations that may affect the availability new treatments, including that:

  • There is currently no subsidisation program such as the Pharmaceutical Benefits Scheme(PBS) to provide affordable access to DAA interferon free treatment regimens for Australianconsumers.

  • Access to DAA interferon-free treatment regimens is available through clinical studies and Patient Access Programs in some Australian States/Territories, but places are limited and not all patients fulfill eligibility criteria.

ASHM supports DAA interferon-free treatment regimens being made available in the Australasian setting as early as possible. ASHM urges caution about importing generic drugs for hepatitis C. However, ASHM recognises that importation of hepatitis C medication is an option for individual
health consumers via the Australian Government’s, Therapeutic Goods Administration (TGA) Personal Importation Scheme.

Medication obtained through this scheme requires a prescription from an Australian registered medical practitioner.

ASHM strongly recommends that consumers seek management and advice from a clinician experienced in the management and treatment of
hepatitis C using Direct Acting Antivirals. It is essential their current HCV infection is confirmed (HCV antibody positive and HCV RNA is positive), in addition to HCV genotype; degree of liver fibrosis; and 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.

Evidence:

ASHM (2015) Importation of Generic HCV Drugs Communique

1. Sievert W, Razavi H, Estes C, Thompson AJ, Zekry A, Roberts S K and Dore GJ (2014) Enhanced antiviral treatment efficacy and uptake in preventing the rising burden of hepatitis C-related liver disease and costs in Australia Journal of Gastroenterology and Hepatology ; 29 (Suppl. 1): 1–9.

2. Lawitz, Eric et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study, The Lancet, Volume 384 , Issue 9956, 1756 – 1765

3. Sulkowski, M.S Management of acute and chronic HCV infection in persons with HIV coinfection, Journal of Hepatology Update: Hepatitis C, Volume 61, Issue 1, Supplement, November 2014, Pages S108–S119

4. ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis, N Engl J Med 2014; 370:1973-1982, May 2014​

Date adopted:

October 2015

Author and review:

Vanessa Towell (A)
Gail Matthews (R)
Ben Cowie (R)

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