Affordable treatment and political commitment are crucial to eliminate hepatitis C globally

It has been nearly 10 years since highly effective, all-oral, direct-acting antiviral (DAA) treatments triggered a revolution in hepatitis C care and treatment. DAAs led to optimism that hepatitis C could be eliminated, and in 2016 WHO set targets to eliminate hepatitis C as a public health threat by 2030. Specifically, WHO called for an 80% reduction in new chronic infections and a 65% reduction in mortality from that reported in 2015.¹ However, many countries are likely to miss these targets,² with the COVID-19 pandemic worsening matters.

Many countries' hepatitis C elimination efforts are lagging because of the cost of DAAs. Although their price has reduced markedly since they first came onto the market (approximately US$1000 per pill) in 2014, treatment remains unaffordable for many people. In high-income countries with strong public health systems or comprehensive insurance programmes, the price of treatment has been negotiated to a cost that enables the population to access care; however, in many other high-income countries, treatment remains unaffordable, presenting a major barrier to scale-up.³ In low-income and middle-income countries (LMICs), voluntary licensing and the Medicine Patent Pool has enabled access to DAAs at less than $60 per treatment course, and, in certain countries, patents for some DAAs have allowed generic manufacturers to set up local production without a license.³ However, as highlighted by Isabelle Andrieux-Meyer and colleagues⁴ in The Lancet Gastroenterology & Hepatology, nearly 50 middle-income countries, estimated to have 43% of the global hepatitis C burden, have been excluded from the license agreements of originator companies for key DAAs, making treatment unaffordable for most of their citizens.

In an effort to address this crucial issue of treatment affordability, Andrieux-Meyer and colleagues⁴ studied the efficacy and safety of ravidasvir plus sofosbuvir in people with chronic hepatitis C. Ravidasvir is a non-structural protein 5A inhibitor supported by the Drugs for Neglected Diseases initiative in the hope of providing an affordable pangenotypic regimen when used in combination with sofosbuvir. STORM-C-1 is the first part of an open-label, single-arm clinical trial with 301 participants in Malaysia and Thailand (98 [33%] with genotype 1a, 27 [9%] with genotype 1b, two [1%] with genotype 2, 158 [52%] with genotype 3, and 16 [5%] with genotype 6), of whom 81 (27%) had compensated cirrhosis, 90 (30%) had HIV co-infection, and 99 (33%) had previous interferon-based treatment. Key findings in this interim analysis were an overall sustained virological response at 12 weeks after treatment (SVR12) of 97%, an SVR12 of 97% in participants with genotype 3 (a subgroup of patients who have lower SVR12 with some regimens), and an SVR of 96% for participants with cirrhosis. SVR12 rates were unaffected by HIV co-infection or previous interferon treatment history.⁴

The outcomes of STORM-C-1 are encouraging. ravidasvir appears to be an affordable option that could help reduce treatment costs, particularly in middle-income countries that are stuck in the middle—ineligible for the licensed generic drugs but unable to afford current pangenotypic regimens.⁵ However, STORM-C-1 had some limitations. It excluded participants who reported current injecting drug use and hepatitis B co-infection; additionally, SVR12 was lower in those with genotype 6, and no participants had genotype 4. Of note, in a previous study from Egypt examining the efficacy of ravidasvir and sofosbuvir with or without ribavirin, participants with genotype 4 HCV infection had high SVR12 rates.⁶

Although the cost of DAA treatment is important, achieving the WHO 2030 elimination targets requires more than affordable treatment. The availability and affordability of diagnostics remains a major barrier to treatment scale-up, particularly in LMICs. In 2020, prices were $1–8 per test for WHO-prequalified HCV antibody rapid diagnostic tests, but many countries cannot purchase rapid diagnostic tests so cheaply.³ Moreover, many health systems require restructuring to meet the needs of individuals who require care; this includes moving care into community settings, supporting task-shifting to reduce reliance on doctors and other highly qualified but few in number medical personnel, and reducing numbers of clinic visits through simplified testing, including point-of-care testing.⁷

Finite resources mean countries must make difficult choices as they work to achieve universal health coverage, a target for 2030 in the UN Sustainable Development Goals.⁸ Countries are advised to identify which interventions to prioritise in their national health benefits package. In making decisions about the composition of health benefits packages, WHO recommends prioritising interventions using three criteria: cost-effectiveness, priority to the worst off, and financial risk protection.⁹ Lowering the cost of treatment through the availability of drugs, such as ravidasvir, is important to improve cost-effectiveness. However, it also requires political commitment to negotiate and address regulatory and intellectual property barriers. An example of such an approach is in Malaysia, where there has been strong political commitment to support public health programmes and to make HCV treatment available and affordable for the population. Pharco (Alexandria, Egypt) has committed to making the ravidasvir and sofosbuvir combination, once approved, available at a price of $300 or less per treatment course,¹⁰ representing a hundredth the cost of the existing originator DAA regimen.

Countries also need high-quality surveillance data to identify which health interventions to prioritise and include in their health benefits package. Absent in many countries, high-quality data about hepatitis C is crucial to enable countries to measure and understand the financial risk associated with the direct and indirect costs of hepatitis C morbidity and mortality. Doing nothing has real but often unrecognised costs. The paucity of data, combined with concern about costs, could prevent many countries from meeting the 2030 hepatitis C elimination targets, despite the demonstrable economic benefits of doing so.⁹