HCV Drug Receives Australian Subsidy as Nation Aims for Zero Infections

Could US leaders in government and health care follow the same route?

The Australian government will subsidize Gilead Sciences' direct-acting antiviral (DAA) drug Epclusa (sofosbuvir/velpatasvir) as the country works to wipe out the hepatitis C virus (HCV).

The action, announced last week, will coincide with the US Food and Drug Administration’s (FDA) approval of updated labeling for Epclusa to include human immunodeficiency virus (HIV) patients.

“The label expansion for Epclusa is especially important for those HIV patients co-infected with genotype 2 or 3 HCV, who previously required more complex and costly regimens,” Mark Snyder, Gilead’s director of public affairs, said.

In Australia, about 230,000 people are living with HCV, according to the Kirby Institute, a global research organization at the University of New South Wales that studies infectious diseases.

Without the government subsidy, Epclusa would cost close to $16,000 per treatment. But because the drug was listed on the country’s Pharmaceutical Benefits Scheme (PBS) on August 1, patients will pay a maximum of about $31 per month, with some spending as little as $5. The PBS provides subsidized prescription drugs to Australian residents and some foreign visitors.

“Epclusa is the first pangenotypic HCV regimen, with the same duration (12 weeks) for all stages of liver disease and genotypes,” Greg Dore, head of the Viral Hepatitis Clinical Research Program at the Kirby Institute in Sydney said. “So it’s very suitable for Australia given involvement of primary care, drug and alcohol service, and prison programs.”

Australia was one of the first countries to subsidize new HCV medicines, making a range of DAAs available starting on March 1, 2016. The nation treated 32,400 patients in 2016, or 14% of the chronic HCV population, Dore said.

“It’s a very good start, but we need to maintain the momentum,” he said.

A recent Kirby report estimated Australia was on track to eliminate HCV by 2026 — four years earlier than the World Health Organization’s goal of ending the virus as a public health problem by 2030.

In the US, the move to update Epclusa’s labeling followed a study of HCV and HIV co-infected patients led by David Wyles, MD, head of the Division of Infectious Disease at the Denver Health Medical Center in Colorado. The research, published March 29 in Clinical Infectious Diseases, showed that 95% of the individuals receiving sofosbuvir-velpatasvir once a day for 12 weeks achieved sustained virologic response.

Dore said Epclusa’s expanded use is not so important for Australia, because all government-supported DAA regimens in the country are approved and funded for those with HIV.

For other nations targeting HCV, Dore provided a handful of pointers. He suggested leaders negotiate DAA prices to reduce budget impact, allow unrestricted access to medicines, involve primary care and other prescriber groups, and include prison-based and alcohol programs — in order to reach marginalized populations.

The study, "Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study," was published online in the journal Clinical Infectious Diseases last month.

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