ViiV Healthcare’s Dovato is the first two-drug single pill that has been EC given approval for the treatment of newly diagnosed people with HIV.
Dovato is a dual therapy single pill comprised of the integrase inhibitor Dolutegravir and the NRTI Lamivudine.
This makes it very similar to another of ViiV’s treatments Triumeq, a more traditional triple therapy, which also includes the NRTI Abacavir.
One of the benefits of this new single pill is, that due to the exclusion of Abacavir, patients will not need to undergo an HLA-B*5701 sensitivity test or be at risk of Abacavir hypersensitivity reactions. This opens up treatments including Dolutegravir and Lamivudine to more people than ever.
Another big benefit is the potential long-term benefits of taking fewer drugs. Two instead of three doesn’t sound like a big deal but if you extrapolate that out over a lifetime the diference is clear to see.
Two drugs, once a day: 14 a week, 60 a month, 730 a year, 7,300 a decade, 36,500 over fifty years.
Three drugs, once a day: 21 a week, 90 a month, 1,095 a year, 10,950 a decade, 54,750 over fifty years.
Over fifty years we could be taking 18,250 more doses of medication, that’s 608 bottles/packets by the way, than we actually need to – and who wants to take more medication than they need?
The go ahead for Dovato from the European Commission was based upon two large studies called GEMINI 1 & GEMINI 2 which followed over 1,400 newly diagnosed people – the studies found Dovato to be non-inferior (as good as) the three-drug regimen it was compared against, and showed good patient acceptance.
Deborah Waterhouse, CEO, ViiV Healthcare, said:
“For many years, the standard of care for people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based 2-drug regimen development programme challenges this, and with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals. Dovato strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV.”
John C. Pottage, Jr, M.D. Chief Scientific and Medical Officer, ViiV Healthcare said:
“The marketing authorisation of Dovato in Europe marks a significant development for people living with HIV. This treatment allows individuals to take a 2-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety profiles of dolutegravir and lamivudine. ViiV Healthcare’s ambition and innovative R&D programme aims to reduce the number of HIV drugs people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to support this aim”
Although Dovato has received marketing authorisation from the European Commission and is now licensed for use in the UK, it will not be available on the NHS until it has undergone a clinical and cost evaluation. The timing of this decision will vary between England, Scotland, Northern Ireland and Wales and can take up to a year. The individual components of Dovato, dolutegravir and lamivudine, are available on the NHS and reimbursed across the whole of the UK.
Dovato is authorised as a complete regimen for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class or lamivudine.
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