Generic direct-acting antivirals for hepatitis C virus infection Presented at International Liver Congress

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.

Low-cost generic hepatitis C drugs match branded products in viral response
 Keith Alcorn
Generic versions of direct-acting antivirals purchased from China and India by people unable to obtain treatment in their own countries were just as effective and safe as the branded products, a study
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Study shows generics pose safe, economic option for patients with HCV
April 16, 2016
BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological… “In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said
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