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New data indicate that generics are a feasible alternative to support access to direct-acting antiviral treatment for Hepatitis C (HCV) sufferers
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 (www.easl.eu)
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.
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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
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.
The ILC 2016 app provides full-access to the scientific programme, posters and abstracts, as well as maps of the halls and exhibition area.
Browse the programme by day and filter by specialties, fields or categories in order to locate sessions that match your field of interest.
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Call4Posters® is the preferred poster-printing partner for The International Liver Congress™ 2016.
This service is the simple and most convenient way to print your poster and pick it up on-site in Barcelona. Over 40,000 research professionals have selected Call4Posters™ for their unmatched quality and convenience.
For information on the posters that will be showcased in Barcelona visit the ILC 2016 poster web page.
Print Deadline: Thursday, 7 April 2016 at 17:00 CET.
Rush Deadline: Friday, 8 April 2016 at 17:00 CET (Rush Fee Applies)
The following Early Morning Workshops (EMWs) are already fully booked:
Friday 15 April 2016
Sunday 17 April 2016
Reserve a place now for the remaining EMW sessions to ensure that you have a seat in Barcelona!
This year’s ILC Postgraduate Course, 13 and 14 April, is dedicated to all the key clinical issues relevant to liver tumours and their management. Liver tumours and the management thereof have a major impact on day-to-day hepatology practice.
In recent years, there have been considerable advances in the understanding and clinical management of primary hepatic tumours, both malignant and benign. However, there is still a great deal to do. We still need to unravel many aspects of basic biology, specifically the molecular mechanisms of hepatocarcinogenesis and we need to improve multidisciplinary clinical management.
Get ready for ILC by exploring the PGC ebook now online and downloading your copy.
All 3 sonography courses are already fully booked. If you wish to attend an Early Morning Workshop, pre-registration is required. A fee of EUR 24.20 (21% VAT included) is applied. Only participants registered to ILC 2016 may sign-up for these sessions. Places are limited so book your seat now!