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Hep C hope comes with a hefty price tag

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Regulators have given approval for a potential cure for hepatitis C amid warnings that the nation faces an explosion in the incidence of serious liver disease without major investment in prevention and treatment programs.

The Therapeutic Goods Administration has approved the use of the antiviral drug Sovaldi as part of a combination antiviral treatment of chronic hepatitis C in adults, raising hopes of improved outcomes for the estimated 233,000 people living with the disease.

But the medicine’s huge price tag – a 12-week course of treatment costs almost $90,000 in the United States – means it will have to be subsidised through the Pharmaceutical Benefits Scheme if it is to be put within financial reach for many patients.

While viral hepatitis has become increasingly common – the Kirby Institute estimates more than half a million Australians now live with either hepatitis B or C – treatment rates are low.

Fewer than 5 per cent of those with hepatitis B receive treatment, and only around 1 per cent of those with chronic hepatitis C.

Hepatitis Australia has warned this threatens to become a major health burden for the country unless urgent action is taken.

Viral hepatitis damages the liver and, without effective treatment, it can lead to liver cirrhosis, cancer and failure – currently around 1000 a year die from hepatitis-related liver cancer, according to the Institute.

“Without urgent investment in rigorous treatment programs, Australia will continue to fail in its efforts to halt escalating rates of serious liver disease due to chronic hepatitis B or C,” Hepatitis Australia said.

There has already been some action on this front.

Earlier this year, the Federal Government allocated almost $22.5 million over four years to fund programs to prevent the spread of sexually transmitted diseases and blood borne viruses including HIV and hepatitis, including $5 million for needle exchange schemes and $4.6 million to boost testing and treatment of hepatitis B.

But Hepatitis Australia said more was needed.

It said hepatitis B and C infections had continued to spiral up despite national strategies aimed at curbing their growth, showing that “Australia needs to redouble its efforts and investment in prevention”.

“We know what works – educating the community on the risks of infection and improving access to hepatitis B vaccinations and needle and syringe programs for vulnerable populations,” the group said. “It’s now time for the investment to make it happen.”

While Hepatitis Australia is urging prevention programs, the TGA’s approval of Sovaldi has boosted hopes of improved treatment.

Pharmaceutical company Gilead Sciences, which manufactures the analogue polymerase inhibitor, claims that a daily dose of Sovaldi can cure hepatitis C in as little as 12 weeks, at least in some cases.

Clinical trials evaluated by the TGA demonstrated that the hepatitis C virus was undetectable in up to 90 per cent of patients 12 weeks after completing therapy.

Professor Gregory Dore, Head of the Kirby Institute’s Viral Hepatitis Clinical Research Program, hailed the drug as “a major advance” in the treatment of hepatitis C because it was able to achieve results more quickly than existing treatments, and with fewer side effects.

But humanitarian organisation Medicins Sans Frontieres has complained that the high cost of the medicine puts it out of the reach of most of the world’s poor.

The medical charity said drugs such as Sovaldi had the potential to revolutionise treatment of hepatitis C, but not at current prices.

Sovaldi, is Gilead’s trade name for sofosbuvir, which in the United States costs $US84,000 ($A90,000) for a 12-week course of treatment – roughly $US1000 a pill. Even in Thailand, its costs $US5000 for a course.

“The price Gilead says it will charge for sofosbuvir in developing countries is still far too high for people to afford,” said MSF Director of Policy and Advocacy Rohit Malpani. “When you’re starting from such an exorbitant price in the US, the price Gilead will offer middle-income countries like Thailand and Indonesia may seem like a good discount, but it will still be too expensive for many of these countries to scale up treatment.”

Adrian Rollins