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First two-drug pill now available for Australians with HIV

First two-drug pill now available for Australians with HIV

Juluca® (dolutegravir and rilpivirine) reimbursed on the PBS in Australia.

MELBOURNE, 29TH November 2018: ViiV Healthcare, the global specialist HIV company,has today announced that Juluca will be reimbursed for Australians onthe Pharmaceutical Benefits Scheme (PBS)for the treatment of adults with Human Immunodeficiency Virus type 1 (HIV-1)who are virologically suppressed.[i],[ii]

In Australia, there is an estimated 27,545 people living with HIV (PWHIV).[iii] Significant progress in treatment has meant that PWHIV in Australia are living longer than ever. In just over 30 years, the number of PWHIV living to over 50 years has increased by more than 40%.3

However, as the population of PWHIV ages, the need for long-term treatment brings new challenges and growing concerns about the health impact of lifelong exposure to antiretroviral therapy (ART).[iv]

Robert Mitchell, National Association of People with HIV Australia (NAPWHA) welcomes this new treatment option for PWHIV:

“The community welcomes this PBS listing of two drug treatment option for people with HIV. No one should be on more medicines than they need for HIV and the National Association of People With HIV Australia believes it remains critically important that Australia continues to have treatments and responses to HIV based on the very latest developments in HIV knowledge, science and technology.”

Dr Norm Roth, Prahran Market Clinic, Melbourne, recognises the desire to address the shifting needs of PWHIV:

“The management of HIV has changed with the advent of new treatments helping people to live long lives. Now we need to focus on ensuring people with HIV maintain viral suppression, alongside achieving a better quality of life. The availability of a two-drug regimen has the potential to alleviate concerns that PWHIV have about the long-term impact of medicines. The reimbursement of Juluca is welcome news for the treatment of HIV.”

Juluca 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 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.1

Dr Fraser Drummond, Medical Director Australasia, ViiV Healthcare, said the reimbursement provides clinicians and patients with a new and effective approach to managing HIV long-term.

“Juluca is the first single-pill two-drug regimen for HIV and the start of a new approach to care that supports the long-term management of HIV. This is a proud milestone for ViiV Healthcare,as we continue to support the HIV community and invest in new treatment options that seekto improve the care and the quality of life for PWHIV in Australia.”

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

[ii] Pharmaceutical Benefits Scheme. Juluca (dolutegravir and rilpivirine) Listing. www.pbs.gov.au/

[iii] Kirby Institute. HIV, viral hepatitis and sexually transmissible infections in Australia, Annual Surveillance Report 2018. Available at: https://kirby.unsw.edu.au/sites/default/files/kirby/report/KI_Annual-Surveillance-Report-2018.pdf. Accessed November 2018.

[iv] ViiV Healthcare. The Positive Perspectives Survey Report 2017. Available at: https://www.viivhealthcare.com/media/125429/positive-perspectives-survey-report-finalcompressed.pdf. Accessed November 2018.

[v] HIV.gov. What Are HIV and AIDS? Available at: https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids. Accessed November 2018.

[vi] World Health Organisation. HIV/AIDS, Online Q&A 2017. Available at: http://www.who.int/features/qa/71/en/. Accessed November 2018.

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

[vii] World Health Organisation. HIV/AID, Key Facts. Available at: http://www.who.int/en/news-room/fact-sheets/detail/hiv-aids. Accessed November 2018.

Date of Preparation: November 2018 | Job number: AUS/HIVP/0004/18j