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

April 16, 2016, European Association for the Study of the Liver

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 with generic sofosbuvir, ledipasvir, daclatasvir and , confirming clinical efficacy equivalent to outcomes seen in Phase 3 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.

Explore further: New triple drug combination shows promise in hepatitis C infected patients

More information: Reference:

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.

Related Stories

New triple drug combination shows promise in hepatitis C infected patients

April 14, 2016
New data presented today at The International Liver Congress 2016 in Barcelona, Spain, demonstrates a high sustained virologic response (SVR) at 12 weeks from the all-oral combination of sofosbuvir/velpatasvir and experimental ...

New study challenges the concept of treatment failure in hepatitis C

April 16, 2016
Data presented today demonstrate that choosing a different combination of direct-acting antiviral (DAA) treatment for Hepatitis C can eradicate the virus at four weeks in patients who had already failed on previous medication ...

Study demonstrates the potential for a new triple combination treatment for hepatitis C patients

April 14, 2016
A new combination treatment for hepatitis C has potential for patients who were not cured by current treatment options.

High rate of cancer recurrence found in certain hepatitis C patients

April 13, 2016
Data from a new study show that patients with Hepatitis C virus (HCV) taking direct-acting antiviral treatments (DAAs), who have previously fought off hepatocellular carcinoma (HCC), the most common form of liver cancer,1 ...

Researchers to test affordable hepatitis C regimen with Malaysian and Thai governments

April 13, 2016
The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price ...

Differing perspectives on antiviral treatment efficacy in patients co-infected with HIV and HCV

April 13, 2016
Two separate studies presented today at The International Liver Congress 2016 in Barcelona, Spain have offered alternative conclusions regarding the efficacy of direct-acting antivirals (DAAs) among patients co-infected with ...

Recommended for you

Research finds new mechanism that can cause the spread of deadly infection

April 20, 2018
Scientists at the University of Birmingham have discovered a unique mechanism that drives the spread of a deadly infection.

Selection of a pyrethroid metabolic enzyme CYP9K1 by malaria control activities

April 20, 2018
Researchers from LSTM, with partners from a number of international institutions, have shown the rapid selection of a novel P450 enzyme leading to insecticide resistance in a major malaria vector.

Study predicts 2018 flu vaccine will have 20 percent efficacy

April 19, 2018
A Rice University study predicts that this fall's flu vaccine—a new H3N2 formulation for the first time since 2015—will likely have the same reduced efficacy against the dominant circulating strain of influenza A as the ...

Low-cost anti-hookworm drug boosts female farmers' physical fitness

April 19, 2018
Impoverished female farm workers infected with intestinal parasites known as hookworms saw significant improvements in physical fitness when they were treated with a low-cost deworming drug. The benefits were seen even in ...

Zika presents hot spots in brains of chicken embryos

April 19, 2018
Zika prefers certain "hot spots" in the brains of chicken embryos, offering insight into how brain development is affected by the virus.

Super-superbug clones invade Gulf States

April 18, 2018
A new wave of highly antibiotic resistant superbugs has been found in the Middle East Gulf States, discovered by University of Queensland researchers.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.