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New PBS listing of two-drug pill further redefines approach to care for treatment of HIV

MELBOURNE, 27th November 2019: ViiV Healthcare, the global specialist HIV company, today announced that Dovato*(dolutegravir and lamivudine), a new fixed-dose combination, will be reimbursed on the Pharmaceutical Benefits Scheme (PBS) from the 1st December 2019 for treatment-naïve adults and adolescents with human immunodeficiency virus infection type 1 (HIV-1)1,2

In Australia, it is estimated that 27,545 people are living with HIV (2017 data).3 Nearly 1,000 new cases of HIV are diagnosed each year and 11% of people with HIV (PWHIV) in Australia are not yet diagnosed (2017 data).3 Furthermore research shows that many (72%) PWHIV are concerned about the long-term effects of treatment.4 Today’s announcement reflects the commitment made by the Government in the 8th National HIV Strategy5 to support medical advances in the treatment of HIV to improve both short and long-term health outcomes of PWHIV.

Robert Mitchell, NAPWHA spokesperson, welcomes this new treatment option for PWHIV: “The Community welcomes the PBS listing of a new treatment option for PWHIV. The needs of PWHIV have always been important but individual and patient-led care is now more important than ever. Successful management of HIV cannot ignore the importance of maintaining a good quality of life – in Australia, it’s not about just surviving anymore, it’s about thriving. Innovation in treatments responding to the contemporary challenges of PWHIV is always important to our community.”

Professor Mark Boyd, Chair of Medicine, University of Adelaide Medical School, said: “This is the first generation of people being diagnosed with HIV that will have access to a two-drug regimen – representing a paradigm shift in how HIV is managed in Australia. We know that people who begin HIV treatment early in their infection have better health outcomes than those who begin HIV treatment at a later stage.6 Today’s PBS announcement is based on evidence from two large clinical trials which show that HIV can be effectively controlled and sustained with two drugs instead of three – giving people who are diagnosed with HIV and their clinicians a new option of avoiding additional toxicity and potential drug interactions from a third medicine.”

Dovato contains two active ingredients that are used to treat HIV infection: dolutegravir and lamivudine in a single tablet form. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).1

Country Manager at ViiV Healthcare Australia, Mike Graham, said the reimbursement provides clinicians and PWHIV with another long-term treatment option: “At ViiV Healthcare, making HIV a smaller part of peoples’ lives is at the heart of what we do. We deeply believe that no person should take more medicines than they need and so the reimbursement of Dovato on the PBS marks another milestone in our mission to reduce the burden of lifelong medication. For over a decade, our dedication to continued innovation in treatments has been driven by our goal of giving everyone living with HIV the quality of life they deserve, until we live in a world without HIV.”

Dovato Minimum Product Information

PBS Information: This product is listed as a Section 100 item. Refer to PBS Schedule for full authority information.

DOVATO (dolutegravir/lamivudine fixed-dose combination) film-coated tablets.

Indication: Treatment of HIV-1 infection in antiretroviral treatment-naïve adults and adolescents (from 12 years of age weighing at least 40 kg) who have no known or suspected resistance to either antiretroviral component. Contraindications: Known hypersensitivity to dolutegravir or lamivudine or to any of the excipients; in combination with dofetilide or pilsicainide. Clinically significant precautions: Discontinue immediately if signs or symptoms of hypersensitivity develop; administer with caution in presence of risk factors for liver disease – treatment should be suspended if findings suggest lactic acidosis with or without hepatitis; monitor for hepatotoxicity; not recommended for patients with severe hepatic impairment; apply diligence when treating co-infected hepatitis B or C patients; evaluate any inflammatory symptoms due to potential for immune reconstitution syndrome; monitor for opportunistic infections; fat loss or gain have been reported during combination antiretroviral therapy; osteonecrosis has been reported in patients with advanced HIV and/or long-term combination antiretroviral therapy; no data available in children < 12 years or < 40 kg; limited data in patients ≥ 65 years; not recommended if CrCl of < 50 mL/min - dose adjustment of lamivudine required; use in pregnancy – category B3; avoid breastfeeding. Clinically significant interactions: Avoid chronic co-administration of sorbitol-containing medicines; administer 2 hours before or 6 hours after taking calcium, magnesium or iron supplements or alternatively administer with food; administer 2 hours before or 6 hours after polyvalent cation-containing antacids; co-administration with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, tipranavir/ritonavir, rifampicin, carbamazepine, phenobarbital, phenytoin and St John’s wort not recommended; consider dose adjustment of metformin when starting and stopping co-administration of DOVATO; lamivudine not recommended for use in combination with emtricitabine. Adverse effects: Reported in ≥ 3% of subjects in GEMINI-1 and 2: nasopharyngitis, upper respiratory tract infection, pharyngitis, syphilis, influenza, bronchitis, tonsillitis, gonorrhoea, sinusitis, diarrhoea, nausea, abdominal pain, headache, insomnia, back pain, fatigue, influenza-like illness, pyrexia, oropharyngeal pain. Dosage: 1 tablet once daily with or without food. Separate preparations of dolutegravir or lamivudine should be administered in cases where discontinuation or dose adjustments are required. Min PI v1.

Please review Dovato Consumer Medicine Information.

Consumer Medicine Information is available at https://viivhealthcare.com/content/dam/cf-viiv/viiv-healthcare/en_AU/dovato_CMI_au.pdf.

For information on ViiV products or to report an adverse event involving a ViiV product, please contact GSK Medical Information on 1800 499 226. ViiV Healthcare Pty Ltd. Level 3, 436 Johnston Street, Abbotsford VIC 3067. ACN 138 687 448. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. © 2019 ViiV Healthcare group of companies or its licensor.

Dovato® is a registered trademark of the ViiV Healthcare group of companies.

Further information

HIV in Australia

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life.7 There is no cure, however HIV infection has largely become a chronic, manageable condition and the amount of virus in the blood can be reduced to undetectable levels with adherence to treatment.8,9

When a person living with HIV is on effective treatment that lowers the amount of virus in their body to undetectable levels, there is zero risk of passing on HIV to their partners. This is commonly referred to as U=U or undetectable=untransmissible.9

U=U has been recognised by the HIV community since 2016. Based on accumulated research from the early 2000’s, over 450 organisations from more than 65 countries have now endorsed the statement, including the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM).9

The HIV incidence and needs of the HIV population are changing. The HIV population in Australia is ageing, with 46% of PWHIV over 50 years old, prompting concern by many (72%) of PWHIV about the long-term effects of their HIV treatment.3,4

Most recent data from the Kirby Institute shows there were nearly 1,000 new diagnosis of HIV in Australia. There is increased rates of transmission among Aboriginal and Torres Strait Islander people (41% increase between 2013 - 2016) and among heterosexuals (14% increase between 2016 -2017).3

References:

  1. ViiV Healthcare. Our Medicines. Available at: https://www.viivhealthcare.com/en-au/our-medicines/dovato/. Accessed November 2019.
  2. Pharmaceutical Benefits Scheme. Dovato (dolutegravir and lamivudine) Listing. [To be updated: www.pbs.gov.au/]
  3. Kirby Institute. Annual surveillance report 2018. Available at: https://data.kirby.unsw.edu.au/hiv. Accessed November 2019.
  4. ViiV Healthcare. Positive Perspectives. 2017. Available at: https://www.viivhealthcare.com/en-gb/hiv-treatment-and-care/the-positive-perspectives-survey/. Accessed November 2019.
  5. Australian Government Department of Health. Eight National HIV Strategy. 2018-2022. Available at: https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-bbvs-1/$File/HIV-Eight-Nat-Strategy-2018-22.pdf. Accessed November 2019.
  6. Health NSW. HIV Infection Fact Sheet. 2017. Available at: https://www.health.nsw.gov.au/Infectious/factsheets/Pages/HIV-infection.aspx. Accessed November 2019.
  7. 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 2019.
  8. World Aids Day.org.au. Get the facts. Available at: http://www.worldaidsday.org.au/internet/wad/publishing.nsf/Content/get-the-facts-1 Accessed November. 2019.
  9. ASHM. Undetectable = Untransmissable (U=U) Position Statement. Available at: https://www.ashm.org.au/about/what-we-do/position-statements/U-equals-U/. Accessed November 2019.