Many patients face barriers in accessing treatments for hepatitis C

While highly effective treatments for hepatitis C are available worldwide, many people — especially those living in poorer countries — are not able to access these medications, according to a new study that highlights barriers to care for this liver disease.

Among the 160 nations studied, more than 90% have at least one registered hepatitis C treatment. But access to reimbursed therapies is provided to residents in only two-thirds of these countries, an analysis found.

“Current direct-acting antiviral treatments cure hepatitis C in more than 95 percent of people, revolutionizing the way we manage this condition,” Alison Marshall, PhD, of the University of New South Wales’ Kirby Institute, in Australia, and the study’s first author, said in a university press release. “But there remains a high cost to the treatment in most countries, which has led to a disparate rollout globally, with many countries placing restrictions both on who can access it and who can prescribe it.”

The study, “Direct-acting antiviral therapies for hepatitis C infection: global registration, reimbursement, and restrictions,” was published in The Lancet Gastroenterology and Hepatology.

Hepatitis C spread by contact with bodily fluids, can cause serious liver injury

The hepatitis C virus, known as HCV, is spread by contact with bodily fluids and can cause serious liver injury — including setting the stage for liver cancer. While there isn’t a vaccine for HCV, in recent years a number of highly effective medications, called direct-acting antivirals or DAAs, have become available to treat the virus.

With these powerful tools in the medical arsenal, the World Health Organization has set a goal of eliminating hepatitis C as a global health concern by 2030. Doing so would require diagnosing at least 90% of people with HCV, and treating at least 80% of those diagnosed.

Right now, there aren’t many countries on track to hit these goals.

The situation is made especially challenging, the new study found, because most people with HCV live in low- or middle-income countries that don’t have as many resources to spend on expensive drugs.

“Eliminating viral hepatitis will prevent hundreds of thousands of lives lost to liver cancer and other liver diseases resulting from chronic hepatitis,” said Rachel Halford, CEO of the World Hepatitis Alliance, who was not directly involved in this study.

“As a global hepatitis community, we must collaborate to drive change,” Halford said.

Given that the majority of people living with hepatitis C live in low- and middle-income countries, we need to see much higher numbers of countries providing reimbursement for hepatitis C therapies, especially if we are to meet the World Health Organization target to eliminate hepatitis C as a public health threat by 2030.

To get a global picture of the challenge, the team of researchers conducted analyses of data from 160 countries around the world, including 102 nations classified as low- or middle-income. Specifically, the team sought to assess where DAAs are approved and how easy they are to access.

The results showed that 91% of countries had at least one DAA authorized for use. This rate also was high — at 87% — among low- or middle-income countries. But despite widespread DAA approvals, there were notable discrepancies in policies that affect access to these life-saving medicines.

About two-thirds (68%) of all the countries analyzed, and about half (52%) of low- to middle-income countries provided government reimbursement to help cover the costs of DAAs. This suggests that patients in poorer countries are likely to have a harder time affording treatment, according to the researchers.

“Given that the majority of people living with hepatitis C live in low- and middle-income countries, we need to see much higher numbers of countries providing reimbursement for hepatitis C therapies, especially if we are to meet the World Health Organization target to eliminate hepatitis C as a public health threat by 2030,” Marshall said.

If patients are unable to afford treatment, it poses a risk not only for their own health, but for that of others as well, according to Marshall, who noted that people with untreated HCV are more likely to spread the virus to others.

Over half of countries restrict who can prescribe treatments for hepatitis C

Jason Grebely, PhD, the study’s senior author and a professor at Kirby, noted that, in recent years, “there have been some great initiatives” to lower the costs of treatments for hepatitis C patients. Notable ones have come from the U.S.-based Clinton Health Access Initiative and The Hepatitis Fund, based in Switzerland.

These programs have “helped to facilitate price agreements with generic manufacturers to provide treatments to low- and middle-income countries for $60 USD per treatment course,” Grebely said. “But we need to do more to assist countries to increase access to these lifesaving treatments.”

In other findings, the study showed that more than half of countries (61%) placed restrictions on what kind of healthcare providers are allowed to prescribe DAAs. In practice, this means that patients may not be able to access drugs for hepatitis C unless they can be seen by a specialist, such as an expert in liver disease and/or infectious disease.

“This is a major barrier for marginalized population groups such as people who use or inject drugs — people who are more likely to experience stigma in healthcare settings and avoid attending hospital-based [specialist] centers,” Grebely said.

A handful of countries specifically restricted prescribing DAAs based on factors like drug use. That’s especially concerning, according to Marshall, given that the use of injection drugs is one of the main ways that HCV is spread. With such restrictions, people who most need these treatments for hepatitis C may be explicitly denied access.

“Most people living with hepatitis C globally are marginalized and face multiple challenges to accessing care,” Marshall said. “If cost is a barrier to seeking [a] cure, they are unlikely to seek treatment, which poses risks for their health, as well as for onward transmission.”

Altogether, these findings highlight the need for new policies to remove barriers to treatments for hepatitis C, the researchers concluded. Allowing nonspecialists to prescribe DAAs “is an especially key area for improvement,” the team wrote.

Halford, of the World Hepatitis Alliance, said changes in policy need to come sooner rather than later.

“We hope this research will motivate action from policy makers and healthcare professionals globally, as the urgency to tackle hepatitis cannot be overemphasized,” Halford said.

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