Greg S. Garrett, Director of Business Development & Alliance Management, DNDi
Since joining DNDi in August 2020, I have been trying to understand what is preventing health systems around the world from ensuring all people living with hepatitis C have access to life-saving treatment. Hepatitis C is unique among infectious diseases: highly effective treatments that cure people completely – direct-acting antivirals – already exist. Yet a mere 13% of people with the disease have had access to the drugs.
Fifty-eight million people are living with hepatitis C, and 800 people die from the disease every day. Accelerating access to DAAs will save lives and create a pathway for halting transmission and eliminating hepatitis C altogether.
I am convinced that one of the major barriers standing between people and their access to a cure is the dearth of effective collaborations between the public and private sectors that bring testing and treatment to scale. Fortunately, we have some successful examples of public-private partnership to learn from – alliances that have delivered innovation, helped drive down costs, and improved access to treatment. We can and must replicate these.
A South-South partnership delivers
One such public-private partnership has led to the development and approval of the drug ravidasvir – an entirely new chemical entity – for use as part of a new combination treatment for hepatitis C. Granted conditional registration by the Malaysian government on 4 June, ravidasvir will be affordable and suitable for people with harder-to-treat forms of hepatitis C and people with HIV coinfection.
Ravidasvir stands out as the very first drug for hepatitis C delivered through South-South collaboration. The public-private partnership that advanced the drug from development to registration was forged five years ago by Pharco Pharmaceuticals[i], Pharmaniaga Berhad of Malaysia, the Malaysian Ministry of Health, and the non-profit R&D organization DNDi.
There is much to learn from this partnership – from the Malaysian Ministry of Health’s leadership and resolve, to middle-income country industry players’ commitment to dedicating vital know-how and resources. Notably, the partnership succeeded without the support of large pharma partners, a demonstration of the burgeoning capacity of stakeholders in low- and middle-income countries (LMICs) to deliver solutions that address priority public health needs.
The secret to success?
Let us start with the private sector and its contributions. Presidio Pharmaceuticals, the originator of ravidasvir, and Pharco Pharmaceuticals of Egypt committed up-front to a pro-access vision, including an equitable licensing scheme to enable rapid scale-up of generic manufacturing. Soon after, Pharco and Pharmaniaga Berhad committed to support the development and scale-up of the active ingredient, manufacture the tablets, complete nearly two dozen toxicology studies to demonstrate safety, and prepare the registration dossier. Pharmaniaga contributed USD 2.2 million to support the registration process.
High prices for DAAs remain a major barrier to treatment scale-up in countries that lack access to more affordable generic DAAs. Putting public health and people’s needs at the top of their agenda, these industry partners committed to affordability from the outset, and to pricing ravidasvir, a novel drug, as close as possible to the price of a generic. Partners also kept R&D expenditure much lower than costs cited for traditional drug development programmes, offering lessons on how to conduct patient-centred R&D efficiently.
Leadership from the public sector has also been critical – particularly the political courage demonstrated by the Malaysian government. Following years of negotiations, Malaysia was unable to secure a price lower than USD 12,000 per 12-week treatment from an originator pharmaceutical company. In order to launch a large-scale ‘test-and-treat’ programme with the potential to reach all people in need, Malaysia issued a government-use compulsory license that enabled it to purchase sofosbuvir, used in combination with ravidasvir, for less than USD 300 per treatment.
With an affordable treatment option in hand, Malaysia embarked on a large-scale screening programme to identify people living with hepatitis C and link patients to treatment while also co-sponsoring clinical trials to prove the safety and efficacy of ravidasvir.
For its part, true to its broker role as ‘conductor of the orchestra’, DNDi worked to bring partners together, focus R&D priorities, and support the STORM-C-1 clinical trial for ravidasvir. Trial results published in The Lancet Gastroenterology & Hepatology in April 2021 showed cure rates of 97%.
Resources and leadership to sustain progress
Moving forward, there is a clear role that governments must play – especially in middle-income countries – in allocating budget and sufficient resources for hepatitis C testing and treatment programmes. There is an onus on pharmaceutical companies to ensure appropriate and affordable pricing for DAAs. And civil society and non-profit organizations will be crucial to bringing stakeholders together in partnership.
At DNDi, we are now working to go further to foster an enabling environment for improved availability of all hepatitis C diagnostics and treatments in LMICs. Our teams are working to grow an industry coalition to help replicate the success of the ravidasvir partnership, and we aim to help broker new public-private partnerships that can design innovative financing mechanisms with countries to bring testing and treatment to scale. Prioritizing new strategic alliances with industry and government partners in LMICs, our aim is to advance the South-South cooperation needed to drive down prices and improve access to all DAAs.
Arguably, we have all the tools we need to bring an end to the hepatitis C epidemic. Delivering them is the challenge, and that requires harnessing public leadership and private sector initiative – for the millions of people still waiting for a cure.
[i] Pharco is a leading pharmaceutical company in Egypt, with a market share of 13%. It produces 500 different generic and over the counter drugs, as well as Hepatitis C treatments including ravidasvir. The Pharco Group is composed of five pharma and two trading companies.
Photo credit: Abang Amirrul Hadi – DNDi