August 1, 2022 — Annually about 1.5 million people are infected by the hepatitis C virus leading to 400,000 deaths globally.
As the Long-Acting Technologies Community Advisory Board (LAT CAB), representing 11 countries, vast civil society networks, and people living with and affected by HCV, malaria, HIV, and tuberculosis across the world, commemorates World Hepatitis Day today, July 28, 2022, and looks towards viral hepatitis elimination in 2030, we are shocked and united in anger about AbbVie’s failure to register Glecaprevir/Pibrentasvir (G/P) in low- and middle-income countries, and the failure of Arene Lifesciences Ltd, Viatris, Remington, and USV, to manufacture and commercialize generic G/P in these countries.
Four years after the Medicines Patent Pool (MPP) and AbbVie came to agreement on a voluntary license authorizing MPP to sublicense G/P to generic manufacturers to ensure commercialization in low- and middle-income countries, generic G/P is not available anywhere. This deprives patients in low- and middle-income countries of a shorter course of treatment, as well as a safer option for patients with advanced kidney disease. Also, many low-income countries have only 1 or 2 generic direct acting antivirals (DAAs) that cure hepatitis C virus (HCV) available on the market keeping treatment costs very high and unaffordable.
Following the MPP AbbVie voluntary license, MPP signed non-exclusive royalty free licenses with 4 generic developers, namely: Arene Lifesciences Ltd, Viatris, Remington, and USV, granting these companies the rights to develop and commercialize generic G/P. To date, none of these companies have developed generic G/P and there are no prospects of it being available throughout 2022.
In 2019 the WHO estimated that 58 million persons were chronically infected and living with HCV, with a disproportionately high burden in low- and middle-income countries. Yet, AbbVie’s market approach since the development of G/P has consisted of registering and commercializing G/P almost exclusively in high-income country markets while completely leaving out people with HCV in low- and middle-income countries.
India and China, which together constitute ¼ of the global HCV burden, are excluded from the MPP AbbVie license on G/P – with India listed as a manufacturer-only country. This unethical approach to licensing has set a terrible precedent for future voluntary licenses, placing India in a terrible position wherein 3 of the 4 generic developers — the Indian based Viatris, Arene Lifesciences, and USV — would manufacture generic G/P primarily for export, while these DAAs are also greatly needed in India. Access to affordable DAAs in India and China is key to meeting the global viral hepatitis elimination goals in 2030.
With the recent WHO updated recommendations on simplified service delivery and diagnostics for HCV, and on HCV treatment in adolescents and children, the demand for pangenotypic generic DAAs has only grown. More generic DAA options are needed to boost competition and further bring down the prices to promote access for the 3.26 million children and adolescents aged 18 years and younger currently estimated to be living with chronic HCV infection globally.
It is critically important for Arene Lifesciences Ltd, Viatris, Remington, and USV as licensed G/P generic developers to immediately manufacture and commercialize these much needed DAAs.
G/P has significant benefits not offered by other formulations: shorter treatment duration for most patients – 8 weeks – as well as proven efficacy for HCV retreatment and against difficult-to-treat subtypes prevalent in some parts of Africa and Asia.
On this World Hepatitis Day, the LAT CAB calls on AbbVie to:
Expand the MPP G/P voluntary license to include marketing and sales in India to avoid the terrible situation where Indian generic developers manufacture and commercialize generic G/P for markets outside India, while people in India are in need of the same medicine;
Immediately register G/P in low- and middle-income countries to allow manufacture and sales of generic formulations, in order to increase competition and reduce prices.
We call on national governments to follow the updated WHO guidelines on treatment of adolescents and children with chronic HCV infection and on simplified service delivery and diagnostics for HCV, and to:
Scale up HCV diagnostics using the simplified diagnostics algorithm, including the use of point-of-care HCV RNA to find the missing millions of people living with HCV who are undiagnosed;
Include HCV case-finding, testing strategies and treatment for adolescents and children in their national guidelines, providing more accurate estimates on the volumes for HCV treatments needed, and providing an incentive and a greater market opportunity for generic manufacturers to develop HCV treatments, hopefully spurring more generic competition, while also enabling governments to negotiate for lower prices through volume procurement;
Incorporate WHO recommendations on HCV reflex testing, treatment decentralization, and task shifting in their national viral hepatitis elimination efforts to find the missing millions of undiagnosed HCV cases, ensure universal access to HCV prevention, testing, treatment and care, and reduce the number of people who are lost to follow-up.
We call on generic G/P developers; Arene Lifesciences Ltd, Viatris, Remington, and USV to:
Speed up the development of generic G/P, and to register and commercialize this treatment in low- and middle-income countries to spur more generic competition and ensure people with difficult-to-treat HCV subtypes and those in need of HCV retreatment have more treatment options.
We call on MPP to:
Immediately engage with Arene Lifesciences Ltd, Viatris, Remington, and USV to understand why generic G/P has not been developed and introduced in low- and middle-income country markets in four years, and to provide a timeline for this to happen in the near future.