The Therapeutic Goods Administration (TGA) has approved Juluca, the first two-drug, single-pill HIV treatment to be made available in Australia.

Juluca – a combination of dolutegravir and rilpivirine – is the first fixed dose combination of a two-drug regimen for the treatment of HIV in certain adults.

The drug, which is made by ViiV Healthcare, presents an alternative for people living with HIV (PLHIV) who are virologically suppressed to the standard regimen of three or more drugs.

One concern among PLHIV is the development of resistance to certain drugs, as well as the long-term effects of prolonged HIV treatment.

Advancements in anti-retroviral therapy have allowed PLHIV to maintain a life expectancy in line with the general population.

“The TGA approval of the dolutegravir and rilpivirine regimen (Juluca) marks an exciting step forward for PLHIV.

“As more options become available, PLHIV have the opportunity to choose treatments that not only control their HIV long term but ensures they can have a good quality of life over that time too.

“The community welcomes the news that they can now reduce the amount of medicine that is in their body to treat their HIV,” said Robert Mitchell, Vice-President of the National Association of People with HIV Australia (NAPWHA).

“The approval of the first single dose two-drug regimen for HIV challenges the traditional approach of three-drug regimens that have been the standard of care for 20 years,” said Dr Fraser Drummond, ViiV Healthcare’s Australasia Medical Director.

“We are passionate about continuing to optimise management of HIV by providing new treatment options that improve care.

“We are proud of our commitment to this and remain dedicated to continuing to find ways to improve outcomes and quality of life for PLHIV.”

Juluca has now been submitted to the Pharmaceutical Benefits Advisory Committee to determine whether or not it will be listed on the Pharmaceutical Benefits Scheme (PBS).

The drug was already approved in the US in November 2017, where it costs well over $2000 for a month’s supply without insurance, and more recently approved in the EU in May.

Further information about the drug, its applications and side effects can be found on the TGA website.

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