What role for DNDi in hepatitis C?

BPecoul_3Bernard Pécoul, Executive Director, DNDi
[April 2016]

The barriers to accessing new hepatitis C drugs are a clear illustration of how today’s system of medical innovation is failing to deliver affordable treatments for people in need.

Not that innovation in this field is lagging: with around ten new direct-acting antivirals (DAAs) approved in Europe or the U.S., more than 30 other compounds in clinical development, and over three hundred drug clinical trials underway, drug development for hepatitis C is an extremely exciting field.

DAAs are a real leap forward for patients, offering a radically shortened, highly effective treatment course, with no injections and little side effects. For the first time ever, new DAAs have led many believe that elimination of hepatitis C – which affects up to 150 million people – is now a possibility. But, as been widely reported for the past few years, the vast majority of patients are unable to benefit from these therapeutic breakthroughs.

Hepatitis C activists at the International Liver Congress 2016
Hepatitis C activists at the International Liver Congress 2016

So what should the public health community do to address this complete disconnect between highly successful innovation on the one hand, and unacceptably limited access on the other?

The question of access to medicines and access to medical innovation is up on the political agenda like never before. A special UN High-Level Panel has been created specifically to explore the issue, and the price of medicines could even make it on the agenda of the G7 summit in June.

Hepatitis C medicines, along with drugs to treat cancer, are at the heart of the storm. New treatment regimens combining DAAs cost upwards of $100,000 in the US, and €40,000 in European countries. Health systems in high-income countries are struggling to cope with these expenses, and many are rationing medicines to those most in need.

Middle-income countries such as Brazil, Malaysia and Thailand – home to around 75% of the people living with hepatitis – are worse off still. These patients are largely cut out of the voluntary licensing deals struck by Gilead and Bristol-Myers Squibb with generic manufacturers to lower the price of treatment.

Beyond the question of price, recent drug development in hepatitis C shows how the priorities of medical innovation are skewed away from patients’ needs, and towards areas of greatest commercial reward. Most existing DAAs and the majority of existing R&D efforts target the genotype 1, prevalent in high-income countries, where only 5% of people with HCV live.  They have lower efficacy against other genotypes. As a recent paper released by DNDi argues, research has prioritised genotypes common in these rich markets, and collaborative efforts that could have benefitted patients in poorer markets were shelved.

So what can DNDi do about it?

By focusing on patients’ needs, our ambition is to help foster a public health approach to tackling hepatitis C. Anything else would mean wasting the unprecedented opportunity that DAAs offer: as well as transforming treatment and saving lives, by scaling up treatment we could reduce transmission and stop the disease from spreading. The cornerstone of a public health approach to HCV must be the development of affordable and easy-to-use treatment tools that will, to the greatest extent possible, enable the same regimens to be used for all HCV patients, regardless of genotype, liver disease stage, HIV co-infection, or source of infection.

This objective is at the foundation of DNDi’s new hepatitis C project unveiled earlier this month at the International Liver Conference. Partnerships concluded with the Egyptian pharmaceutical company Pharco and with Presidio, a U.S biotech company, will enable DNDi to test new regimen of sofosbuvir together with ravidasvir, a promising DAA in the development pipeline which has proven effective in genotype 4. We will build on Pharco’s experience in Egypt, a country which has the world’s largest proportion of hepatitis C infected individuals, but has made enormous leaps and bounds in treating these people using affordable DAAs and a public health approach.

Public leadership to improve the standard of hepatitis C care is key, and our project is a strong example of this. The Ministries of Health in Malaysia and Thailand are co-sponsoring clinical trials with DNDi to start shortly in these two countries. Significantly, if the trials are successful, Pharco has agreed to set the commercial price at under $300 per treatment course.  Given the estimated costs of producing most DAAs is low, this price may well fall further, making massive scale-up in affected countries feasible, provided patent barriers can be overcome.

While the close collaboration with two Ministries of Health and with two industry partners builds on our strong history of working with others to deliver tools for neglected diseases, overall the project marks a new direction for DNDi. Having built in the past decade the world’s largest drug development pipeline for the most neglected diseases, hepatitis C was added to DNDi’s portfolio in 2015.  The move came as a part of the adoption of a more flexible, dynamic approach, and in a bid to address the rapidly evolving needs in today’s global health R&D landscape.

Through this new R&D project for HCV, our hope is to deliver a safe, efficacious, affordable, and easy-to-use treatment.  Ultimately, this is about ensuring that today’s neglected populations also get to benefit from the recent progress of science.

 

Dr Bernard Pécoul, Executive Director, DNDi

 

 

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