PBS listing for first pan-genotypic antiviral hep C treatment

liver with hepatitis virus render

Hepatitis Australia has welcomed today’s announcement that a new hepatitis C drug will be listed on the PBS

Epclusa, the first pan-genotypic antiviral, will be PBS listed from 1 August, Health Minister Greg Hunt said today, World Hepatitis Day (July 28).

Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) is a pan-genotypic regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus infection. It is used in combination with ribavirin in patients with cirrhosis.

In clinical trials, 95 to 100% of patients with HCV genotypes 1–6 taking a 12-week course of EPCLUSA achieved sustained viral response rates.

CEO of Hepatitis Australia Helen Tyrrell welcomed the announcement, but said its PBS listing must be matched by a concerted effort to reconnect people living with hepatitis C with clinical care.

“Australians living with hepatitis C now have unprecedented access to curative therapies; however this is only the first step to eliminating hepatitis C as a public health threat in Australia,” Ms Tyrell warned.

“Equipping health care professionals to feel confident engaging their patients in conversations about hepatitis C and the availability of cures must now become a focus,” she said.

“We must also communicate to those living with the condition that a life free from hepatitis C can be a reality.”

Health Minister Greg Hunt told the ABC’s Sabra Lane today that the Government is hoping to eradicate hepatitis C “as quickly as possible”.

Australian researchers have suggested that hepatitis C could be eradicated as early as 2026, Ms Lane said, though the Government target is 2030.

“We’ve set a timeframe, and I’d like to start immediately,” Mr Hunt said.

“This drug, Epclusa, helps the 200,000 Australians who are currently dealing with hep C.

“And this has the potential for a success rate of 90%. I’m hopeful that we can well and truly beat our deadline, but for the first time we have an eradication deadline for hep C. But much more importantly, right now Epclusa will be available.

“That’s the potential for a 90%, not just treatment rate, but a success rate. And that means we can really work towards eradicating and controlling this condition, which can be so hard for so many Australians.”

Professor Alex Thompson, Director, Department of Gastroenterology, St. Vincent’s Hospital, Melbourne and Chair of the Gastroenterological Society of Australia – Australian Liver Association (GESA–ALA), said that he hoped the simplified treatment would encourage people living with hepatitis C, including those living in regional and rural areas, to speak to their doctor about treatment.

“The uniformity and simplicity of dosing with EPCLUSA, combined with the confidence of achieving high SVR rates, will help to achieve the higher treatment rates in community and general practice settings that Australia needs in order to continue its work towards eliminating hepatitis C,” he said.

EPCLUSA is Gilead’s third sofosbuvir-based treatment to be registered in Australia for the treatment of chronic HCV infection, following HARVONI and SOVALDI.

Sofosbuvir-based regimens are recommended by global guidelines across all HCV genotypes and liver disease severities. The World Health Organization added EPCLUSA to its Essential Medicines List on 6 June 2017, as the first combination therapy to treat all six types of hepatitis C.

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