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First two-drug single pill for HIV now approved for use in Australia

MELBOURNE, 23 July 2018: ViiV Healthcare, the global specialist HIV company, today announced that the Therapeutic Goods Administration (TGA) has approved Juluca ( dolutegravir and rilpivirine), the first fixed dose combination of a two-drug regimen for the treatment of adults with human immunodeficiency virus infection type 1 (HIV-1).,[i],[ii]

The approval of a once-daily, single pill two-drug regimen, provides people with HIV (PWHIV) in Australia, who are virologically suppressed, with an effective alternative option to the standard treatment regimen of three or more drugs.[i],[iii]

In Australia, HIV has largely become a chronic and manageable disease, however challenges still remain.[iv],[v]A key issue is the growing ageing population of PWHIV who require life-long medication, for example the average patient who was diagnosed in their 20s from 2008-2010 can now be expected to live to their 78th birthday.[vi] Decades of HIV therapy results in many PWHIV being concerned about the long-term effects of their treatment.[vii]

“The TGA approval of the dolutegravir and rilpivirine regimen (Juluca) marks an exciting step forward for PWHIV. As more options become available, PWHIV 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, National Association of People with HIV Australia.

The dolutegravir and rilpivirine regimen is a once-daily, single pill approved for HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months, with no history of treatment failure and without known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.[i]

“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. At ViiV Healthcare, 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 PWHIV,” said Doctor Fraser Drummond, Medical Director Australasia, ViiV Healthcare.

 

ViiV Healthcare has made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) to ensure that eligible patients will be able to access the treatment via the Pharmaceutical Benefits Scheme (PBS) in the coming months.

 

Minimum PI:

 

Indication: Treatment of HIV-1 infection in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. Contraindications: Known hypersensitivity to dolutegravir or rilpivirine or to any of the FDC excipients. Contraindicated in combination with the following: antiarrhythmic agent dofetilide; anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin; antimycobacterials rifampicin, rifapentine; proton pump inhibitors (such as omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole); glucocorticoid systemic dexamethasone (except as a single dose treatment); St John’s wort (Hypericum perforatum). Clinically significant precautions: Hypersensitivity reactions, immune reactivation syndrome, depressive disorders, opportunistic infections, transmission of infection, monitor for hepatotoxicity, not recommended in severe hepatic impairment, in severe/ end stage renal disease – combination with a strong CYP 3A inhibitor should only be used if benefit outweighs risk, no data in paediatrics , caution in elderly > 65 years old, not recommended in pregnancy (B1), avoid breastfeeding. Clinically significant interactions: See Product Information for full list of interactions. Adverse reactions: Very common: headache , nausea, diarrhoea . Common: Decreased appetite, insomnia, abnormal dreams, depression, anxiety, sleep disorders, dizziness, abdominal pain, vomiting, flatulence, upper abdominal pain, abdominal discomfort, rash, pruritus, fatigue, transaminases increased. Dosage and administration: One tablet once daily with a meal. [Juluca Min PI v1]. For further details, please refer to the full PI.

 

See the full Approved Product Information before prescribing. The full Product Information can be accessed here:

https://www.viivhealthcare.com.au/media/124219/juluca_pi_001_approved-002.pdf


References

 

[i] Juluca® ( dolutegravir and rilpivirine) Australian Approved Product Information. Available at: https://www.viivhealthcare.com.au/media/124219/juluca_pi_001_approved-002.pdf Accessed July 2018.

[ii] Australian Register of Therapeutic Goods. Juluca. Available at: http://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=291356 Accessed July 2018.

[iii] Libre, J. et al. Efficacy, safety, and tolerability of dolutegravir -rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised , non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 3;391(10123):839-849.

[iv] World Health Organisation. Global Update on the health sector response to HIV, 2014. July 2014. Available at: http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1 Accessed July 2018.

[v] Australian Federation of Aids Organisations. HIV in Australia 2018. Available at: https://www.afao.org.au/wp-content/uploads/2017/12/HIV-in-Australia-2018.pdf Accessed July 2018.

[vi] The Antiretroviral Therapy Cohort Collaboration. Survival of HIV-positive patients startingantiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies. Lancet HIV. 2017;4: e349-e356.

[vii] Young B. et al. Patient experience and views on antiretroviral treatment—findings from the Positive Perspectives study. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Poster 1393.

 

 

Date of Preparation: July 2018. Job number: AUS/HIV/0107/18