HCV elimination: Importance of investment

Game-changing therapies have made the WHO goal of achieving hepatitis C elimination by 2030 possible, but many countries find themselves fighting an uphill battle, according to experts.

“In 2019 to 2020, WHO estimated there were 50 million persons living with chronic HCV, of whom 1.4 million were persons who inject drugs and 2.3 million were coinfected with HIV. New infections were identified in more than 1.5 million people, with deaths in the range of 0.3 million,” Mark Sulkowski, MD, FAASLD, professor of medicine at Johns Hopkins University, said during a session on viral hepatitis elimination at The Liver Meeting Digital Experience.

Unfortunately, unlike trends seen for malaria, HIV and tuberculosis, mortality due to HCV and hepatitis B have increased in recent years.

“At the current pace, it’s anticipated that morbidity and mortality for HBV and HCV will continue to increase if we don’t begin to apply the tools we have developed for treatment and prevention,” Sulkowski said.

Eye on elimination

The current estimates for the number of infections indicate that HCV remains a major global health challenge, but its negative effects extend beyond the disease itself, according to Margaret Hellard, AM, MBBS, FRACP, FAFPHM, PhD, deputy director at the Burnet Institute and head of hepatitis services in the infectious diseases unit at The Alfred Hospital in Australia.

“As well as deaths, it’s important to think about the broader impact of HCV. It reduces health, well-being and quality of life in individuals and their families and causes liver cirrhosis, liver cancer and other comorbidities,” Hellard said during a presentation at The Liver Meeting Digital Experience. “As well, people with HCV have an internalized and enacted stigma, and there’s discrimination that impacts on their lives. They have reduced social and workforce participation, workforce productivity and personal financial security. It impacts on all aspects of their lives.”

In 2016, the United Nations included combating communicable diseases, including viral hepatitis, among its sustainable development goals and WHO released its proposal for eliminating viral hepatitis as a public health threat by 2030, according to Hellard.

“The organization envisioned a world where transmission is halted and people living with hepatitis had access to effective care and treatment services. In other words, the care continuum is vastly improved, and if we can do that, the anticipation is that we would reduce new infections by 90% and we would reduce mortality by 65%,” Sulkowski said. “This is certainly a very important goal and we have the tools; it is simply a matter of applying those, which of course can be very difficult.”

In 2021, WHO also released the interim guidance for country validation of viral HCV elimination, which set targets for demonstration of elimination, according to Sulkowski. These include reducing incidence of HCV by 80% and mortality by 65% by 2030, as compared with 2015. The organization also set HCV-specific targets for absolute annual incidence (5 or less per 100,000) and annual mortality rate (2 or less per 100,000).

Additionally, WHO set programmatic targets for testing and treatment, with the goal of having more than 90% of people with HCV diagnosed and, of those diagnosed, having more than 80% treated. Prevention targets included reducing unsafe injections, ensuring the blood supply is 100% safe and providing approximately 300 needles, syringes and injection kits to persons who inject drugs.

A ‘non-virtuous cycle’

Although the significant public health burden spurred WHO’s decision to set elimination targets, novel therapies are what made this goal possible, according to Hellard.

“Why is HCV elimination achievable? Simply because direct-acting antivirals were game-changing. We have curative therapies available where people can take a single tablet daily for 8 to 12 weeks and be cured of their infection,” Hellard said. “However, despite the setting of targets and the game changers that make it possible to achieve elimination globally, we are not tracking well.”

In terms of progress, only 15 countries are currently on track to achieve HCV elimination as a public health threat by 2030, according to 2020 data from the Polaris Observatory.

“In my view, a major challenge is the massive lack of funding for the viral hepatitis response. Despite the high number of infections, rising deaths, WHO targets and actually having a cure, HCV does not receive major funding from any of the big global initiatives, such as Global Fund, Gates Foundation and the World Bank’s Global Financing Facility,” Hellard said. “There have been some important admirable exceptions in terms of Unitaid providing support and some ‘leftover’ global fund monies, but overall, very little has been done in terms of global investment in HCV.”

This lack of investment is part of a “non-virtuous cycle,” according to Hellard. Global health funding priorities have been developed over time using a number of reports and programs, but the key driver is whether the disease in question is likely to have a significant economic and development impact on a country and its individuals.

In addition to addressing the public health problem posed by hepatitis, Hellard noted that the U.N.’s 2030 sustainable development goals included universal health coverage. This aims to provide health care and financial protection to all people of a particular country or region by providing a specific package of benefits, with the end goal of providing risk protection, improved health services and broadly helping the country. However, diseases included in these specific health benefits packages are identified through a country’s disease control priorities as well as other more general priorities, according to Hellard.

“Particularly in countries where HCV has a considerable impact, you need to show the extent of this impact of HCV on the country and its health so it is recognized as a priority disease,” Hellard said.

To demonstrate the effect that a disease such as HCV is having on a country, however, data on disease prevalence, incidence, mortality and morbidity and modeling to determine the disease’s broader impact are necessary.

“Funding is needed to collect that data and make that model,” Hellard said. “Testing and treatment costs are falling, so you need to show that it’s cost-effective.”

Community awareness and engagement are also critically important to raise the disease’s profile, which would hopefully lead to politicians and bureaucrats becoming aware of the impact of HCV on the community and support elimination efforts. Once again, however, funding is needed to raise this awareness, Hellard noted.

Improving investment

To address these issues of funding and lack of investment in HCV, countries require commitment and leadership, according to Hellard.

Showing the financial benefits such as cost savings, which was done in a report to the Viral Hepatitis Forum at the 2018 World Innovation Summit for Health, can also be useful in engaging government, Hellard noted.

Moreover, demonstrating success, either in evidence gathering and planning or implementation and integration, is also essential, according to Hellard. Some examples of success include Georgia, the first country in the WHO European region to set clear HCV elimination goals and develop a national plan that had tremendous buy-in from the government; South Africa, which developed one of the first examples of an investment case that combines tools for costing, impact modeling, cost-effectiveness analysis and fiscal space analysis for scaled-up HBV and HCV control scenarios; and Egypt, which experienced significant success with a program that had massive buy-in from the government and political leadership. Australia also has taken a multipronged approach, with a long history of partnerships for approaching the community and harm reduction as well as a risk-sharing agreement with the originator pharmaceutical companies for DAAs, Hellard noted.

Domestic funding is also required to strengthen health systems and finance hepatitis-specific activities and health system costs, according to Hellard.

“We also need to think about it not just for HCV alone but for improving injection and blood safety and harm reduction programs and services as well as strengthening surveillance systems and technology to link patients to care. We need to be innovative,” Hellard said.

This need for innovation applies to financing as well, according to Hellard. Countries should consider blended, pooled or results-based financing, social and development bonds or a dedicated hepatitis fund.

“There are many different ways we could approach this, but overall, investment needs to increase,” Hellard said.

Importantly, the affordability of HCV elimination, such as reduction in treatment costs, also needs to improve in individual countries and regions, Hellard noted.

“We need to look at licensed generics, innovative new treatments, maximize the effectiveness of the public health spending and sharing costs with other strategies, such as the TB, HIV and HBV elimination programs,” Hellard said. “We need to piggyback onto existing infrastructure and we need innovations and efficiencies over time.”

Additionally, Hellard noted that international donor investment is important, especially in resource-limited countries.

Slow progress

Although not all countries are on track to meet the 2030 WHO HCV elimination targets, significant progress has been made, according to Sulkowski.

For example, Iceland’s nationwide TraP Hep C program, which included testing and free access to services, allowed the country to achieve the WHO programmatic goals. Specifically, nearly 95% of people with HCV were diagnosed and more than 90% of those who were diagnosed and linked to care initiated treatment within 3 years, according to data published in The Lancet Gastroenterology and Hepatology.

Similarly, data published in The New England Journal of Medicine showed that Egypt, whose program planned to screen all people aged 18 years and older and provide free treatment to all those with active infection, was particularly successful. They screened approximately 80% of the target population and, by September 2019, 91.8% of the approximately 1.15 million people with viremic infection had started treatment. Additionally, these results led to Egypt dropping from fifth in 2015 to 18th in 2019 on a list of countries with the most viremic infections.

“This is really quite remarkable in terms of progress and needs to be replicated in other settings,” Sulkowski said.

Looking ahead

Despite some significant challenges, HCV elimination is “technically possible,” according to Hellard.

“There have been some great successes, but we need countries and global funders to invest. Countries need to have strategic plans. We need to recognize how the sustainable development goals, universal health coverage and disease control priorities are working,” Hellard said. “We can’t be naive about the system and we need data to show considerable impact of this disease on the community so that it is made a priority disease in countries.”

Furthermore, Hellard noted that the HCV response needs to be integrated within the country’s universal health coverage approaches, where possible, to save money and get it included within the funding mechanisms.

“We need to make viral hepatitis an exemplar disease in terms of the efforts. We need to make it clear to politicians and policymakers that there will be great progress in a few years if governments invest and that they’ll have a win in terms of universal health coverage,” Hellard said. “At the same time, we should never forget we are talking about individuals and their families and friends and their health systems need to work for all people.”

References:

• Olafsson S, et al. Lancet Gastroenterol Hepatol. 2021;doi:10.1016/S2468-1253(21)00137-0.
• Waked I, et al. N Engl J Med. 2020;doi:10.1056/NEJMsr1912628.