Public Release: 

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations

New data indicate that generics are a feasible alternative to support access to direct-acting antiviral treatment for hepatitis C sufferers

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: Data presented today demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure Hepatitis C.

The summary results presented today at The International Liver Congress™ 2016 in Barcelona, Spain, showed high sustained virologic response (SVR) after treatment with generic sofosbuvir, ledipasvir, daclatasvir and ribavirin, confirming clinical efficacy equivalent to outcomes seen in Phase 3 clinical trials of branded combination treatments.

The high costs of branded DAAs prevent access to treatment in many countries.1 Generic DAAs are being mass-produced and are available for less than 1% of the retail price of their branded counterparts. Medication costing $94,000 per person in the US can currently be obtained for less than $1,000 as a generic, and a 12 week course of treatment could be produced for as little as $200 in the future.1

"Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said Dr James Freeman, of GP2U Telehealth, Hobart, Australia and lead author of the study. "At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society."

In this study, people with HCV legally imported low-cost generic treatment to cure their infection. The study included people treated in Australia, USA, UK, Canada, Europe, SE Asia and Africa.

Generic DAAs were first evaluated for quality in Australia, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy. Patients were assessed pre-treatment, during treatment, and then at weeks 4 (SVR4) and 12 (SVR12) following the end of treatment. The objective of the analysis was to assess the efficacy and safety of generic DAAs legally imported for each patient's personal use.

The interim results show that for genotype 1 the overall SVR rate was 95%. Treatment with generic sofosbuvir and ledipsavir led to SVR4 rates of 93% and treatment with generic sofosbuvir and daclatasvir led to SVR4 rates of 97%.

"Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," explained Dr James Freeman.

"There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition," said Professor Laurent Castera, EASL Secretary General.

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.

About EASL

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

For more information, please contact the ILC Press Office at:

Email: ILCpressoffice@ruderfinn.co.uk

Telephone: +44 (0)7841 009 252

Onsite location reference

Late-breaker session, Hall 6.0

Saturday 16 April, 16:00 - 18:00

Presenter: James Freeman, Australia

Abstract: LBO3, High sustained virological response rates using generic Direct Acting Antiviral treatment for Hepatitis c, imported into Australia

Author disclosures of interest

None

References

1 Andrieux-Meyer I, et al. Disparity in market prices for hepatitis C virus direct-acting drugs. The Lancet Global Health. Volume 3, No.11, e676-e677, November 2015.

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