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HCV treatment listing delays
Hepatitis Australia has called on the Federal Government to list new
hepatitis C virus (HCV) medicines on the Pharmaceutical Benefits Scheme
(PBS) without delay.
Responding to the latest round of
Pharmaceutical Benefits Advisory
Committee (PBAC) recommendations,
Hepatitis Australia CEO Helen Tyrrell
said four* groundbreaking curative HCV
therapies had received the green light
for inclusion on the PBS but so far no
listing date had been confirmed.
‘It is a completely unacceptable
situation. Recommendations alone will
not cure anyone. It’s time to act on the
advice of the experts and add these
medicines to the PBS,’ Ms Tyrrell said.
Almost 3,000 Australians with hepatitis C
have progressed to severe liver
disease in the past year according to
surveillance data released by the Kirby
Institute at the University of New South
Wales last month.
Head of the Viral Hepatitis Clinical
Research Program at the Kirby
Institute, Professor Greg Dore, said:
‘ The development of highly curative
all-oral, interferon-free hepatitis C
treatments is one of the major advances
in clinical medicine in recent decades.
‘ These regimens have the capacity to
benefit the vast majority of people with
chronic hepatitis C in Australia, and halt
the escalating burden of advanced
liver disease including liver failure and
‘ These new agents provide physicians
with major advances in treatment
tolerability, simplicity, and options to
cure and manage this disease,’ he said.
Professor Dore said that Australia had
a unique opportunity to be the leader
in moving to interferon-free treatment
of HCV with the introduction of new
Speaking at a media briefing in Sydney
announcing the Therapeutic Goods
Administration (TGA) registration of
Daklinza (daclatasvir), he said there was
potential for community pharmacy to be
involved in dispensing the drug.
The TGA has approved Daklinza,
in combination with other medicinal
products for the treatment of genotypes
1 and 3 of chronic HCV infection in
adults with compensated liver disease
Professor Dore said that the current
HCV standard of care regimens were
prolonged in duration of treatment
(24–48 weeks), administered via
injections, and had substantial
side-effects. People living with
hepatitis C urgently needed better
‘Daklinza is among a new generation
of DAAs to be approved in Australia,
offering clinicians and patients an all-oral
regimen to treat HCV. The availability
of Daklinza, and other oral DAAs, may
potentially lead to a shift in the treatment
of HCV, by allowing us to turn this into
a rare disease within as little as the next
20 years,’ Professor Dore said.
The burden of liver disease and other
morbidities from HCV infection is
significant in Australia, with just under
14,000 cases of compensated cirrhosis
and over 500 liver-related deaths among
people with HCV in a single year.
Ms Tyrrell said liver clinics were
reporting that hundreds of Australians
were deferring treatment and waiting
anxiously for the PBS listing of new
The Kirby Institute surveillance data
shows that the number of Australians
living with hepatitis C-related severe liver
disease more than doubled in 10 years
(from 18,582 to 44,730) , with 2,800 in 2014
alone. Hepatitis C is the leading cause
of liver transplantation in Australia and
accounted for an estimated 690 deaths in
2014 – a 146% increase over 10 years.
Professor Dore said that without a
significant improvement in hepatitis C
treatment rates, Australia would see a
245% increase in rates of liver cancer and
a 230% increase in hepatitis C-related
deaths by 2030.2
1. Kirby Institute Annual Surveillance Report 2015.
2. Razavi H, et al. The present and future disease burden of
hepatitis C virus (HCV) infection with today’s treatment
paradigm. Journal of Viral Hepatitis 2014;21(Suppl.1):34–59.
*In March the PBAC recommended three hepatitis
C medicines for a PBS listing: sofosbuvir (Sovaldi),
ledipasvir/sofosbuvir (Harvoni), and daclatasvir
(Daklinza). The July PBAC meeting recommended
another treatment option: paritaprevir with
ritonavir, ombitasvir and dasabuvir (Viekira Pak with
or without ribavirin).
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