Finding the missing millions” and linking them to treatment remains high on the world’s agenda this World Hepatitis Day. It is an essential part of ensuring that we do indeed have a HepFree Future. Yet, according to the World Health Organization (WHO), among the 325 million[1] people living with hepatitis B and/or C worldwide, too many still have limited access to testing and treatment resulting in over a million hepatitis-related deaths each year.

I was diagnosed with the hepatitis C virus (HCV) in 1995 and resulting liver cirrhosis in 1998. At that time, treatment was long and painful, there was little or no information for patients, and hardly any support. I was one of the fortunate to be fully cured of HCV. Seeing the concerns of others living with hepatitis C, I set up The Hepatitis C Trust in the UK and later went on to be the President of the World Hepatitis Alliance that was established in 2007 where I worked for ten years before joining the Medicines Patent Pool (MPP). The work of the World Hepatitis Alliance changed the course of history and put hepatitis on the map. We worked with patient groups, governments, global health actors, convened meetings and advised on policy and by 2016, every government in the world committed to eliminating viral hepatitis by 2030. That global target is just 10 years away now.

The WHO also stepped up, and in 2014 established the Global Hepatitis Programme which sits in the HIV, Hepatitis and STI department. This milestone coincided with the availability of the first direct-acting antivirals (DAA) for the treatment of HCV along with the recognition that there was much to learn from the HIV experience. In particular, the power of simplified testing and treatment, as well as proven strategies such as voluntary licensing to reduce the cost of treatment, were hard-learnt lessons from the HIV journey that could not be ignored. WHO set out to produce treatment guidelines for managing hepatitis and started to work directly with countries and multiple stakeholders to develop their national programmes of which there are over 80 in country today. As Philippa Easterbrook from the WHO Global Hepatitis Programme said, “Unlike HIV or TB, there is virtually no donor funding (in hepatitis) and working with countries is essential to ensuring efficient and effective access to affordable treatment” (see the full interview with Philippa Easterbrook).

Unitaid also came to the table with their projects in hepatitis C. $50 million of investments later, Unitaid’s work with partners, including Médecins Sans Frontières (MSF); Foundation for Innovative New Diagnostics (FIND); and Coalition Plus, has demonstrated that it is possible to test and treat HCV in resource-limited and decentralised settings. The testing cascade was subsequently simplified, and advocacy on developing in-country hepatitis programmes strengthened (see full Unitaid story by Philippe Duneton, Executive Director a.i.).

Just five years ago, the cost of treatment for HCV remained prohibitive. With no generic competition in sight and the price of a three-month HCV treatment still high, it proved challenging in all countries and in particular for low- and middle-income countries (LMICs) to fund their hepatitis programmes. This is when our organisation, MPP, stepped in. MPP expanded its mandate to hepatitis C in 2015. Gilead had already out-licensed its HCV drug sofosbuvir (SOF). Later in the same year, MPP signed a licence with Bristol-Myers Squibb covering the DAA drug daclatasvir (DAC), and its combinations (e.g. SOF/DAC). The agreement allowed for generic manufacture and supply of the hepatitis C treatment in at least 112 countries that together are home to 65.4% of people living with HCV in LMICs. Mylan was one of the first generic manufacturers to have their product prequalified and developed in record time. “Mylan’s prequalification represents one of the fastest speeds by which any treatment, for any disease, has gone from initial branded approval to the first quality-assured generic – in less than four years,” said Anil Soni, Head of Global Infectious Diseases, Mylan (see full Mylan story).

Today, in most countries, the price of SOF/DAC treatment is under $100, and over 900,000 curative treatments of DAC alone have been supplied through MPP licences since 2016 in 28 countries. In the last few weeks, new evidence from small clinical trials in Iran has shown that this hepatitis C treatment has potential in the treatment of SARS-CoV-2. While this is very encouraging, we must wait for more extensive clinical trials to confirm the efficacy as well as understand the potential supply of SOF/DAC so that no one is left behind.

Since end of 2018, MPP also holds the licence for glecaprevir/pibrentasvir (G/P) from AbbVie that enables quality-assured manufacturers to develop and sell G/P in 96 LMICs. This pan-genotypic regimen shortens treatment duration to just eight weeks and avoids the need for costly genotyping diagnostic tests. As Philippa Easterbrook said, “I think in patients with kidney disease, there is a very unique value of G/P regimen and also in young children less than 12 years”. In December 2019, Mylan became the first generic company to take out the licence, and we hope to encourage others. To this end, MPP will launch another expression of interest shortly and as always, the details will be available on our website. Among our licences for hepatitis C treatments, MPP also holds the licence for ravidasvir from Pharco Pharmaceuticals. Ravidasvir is an investigational DAA with the potential of working across all six major hepatitis C genotypes.

Hepatitis B (HBV) remains a major worldwide concern, as it represents nearly three quarters of the hepatitis disease burden. Unlike for hepatitis C, there is a very cheap, safe and effective vaccine for HBV. Moreover, lifelong affordable treatment for viral suppression is available. Yet too many people, especially in LMICs, are dying of this chronic disease. MPP holds the licence for tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) from Gilead Sciences. These WHO-recommended treatments not only benefit people living with HIV but also people living with chronic HBV. Despite the progress, and the tremendous work of all those working in this space, the coverage gap remains wide and much more needs to be done if we are to meet the global hepatitis goals by 2030. I hope that we can encourage other funders and partners to enter this space.

This World Hepatitis Day 2020, we live through the uncertain times of COVID-19. In the Declaration on the Sustainable Development Goals the world pledged not only not to leave anyone behind but also to endeavour to reach the furthest behind first. People living with viral hepatitis have for too long been left very far behind, partly through an inexplicable global health neglect at the beginning of this century and partly because significant numbers come from vulnerable communities that suffer severe stigma and discrimination. World Hepatitis Day is 10 years old this year and in that time we have made tremendous gains and learned valuable lessons – simplified and extremely cheap, quality treatments, decentralised test & treat approaches, integration of hepatitis services with other health programmes, and much more. In our fight against COVID-19, we must not let that go to waste. And we must continue to fight not to leave anyone behind and to reach the furthest behind first. MPP is also 10 years old this year and we pledge to continue our work to make hepatitis treatments ever more available, accessible and affordable to all those who need them wherever they may be.

[1] Hepatitis, World Health Organization

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