A new once-daily single tablet for initial treatment of HIV infection, making combination drug therapy simpler, has been approved for marketing in the EU.
Eviplera, supplied by Gilead Sciences in collaboration with Tibotec Pharmaceuticals, has been approved by the European Commission as a first antiretroviral in adults whose viral load is below 100,000 HIV-1 RNA copies/ml.
The new drug combines Gilead’s Truvada, a fixed-dose combination of the reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil, with Tibotec’s rilpivirine (sold by Janssen-Cilag as Edurant).
“As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical,” said Dr. Mark Nelson, Service Director for the HIV Directorate, Chelsea and Westminster Hospital, London, United Kingdom.
"Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.”
John C. Martin, Chairman and CEO of Gilead Sciences, commented: "Gilead continues to lead the development of single-tablet regimens because we and our partners recognize the ongoing need to simplify HIV therapy. With Eviplera, we are now working with national authorities to ensure the regimen is made available across the EU as quickly as possible.”
Eviplera is the second single-tablet HIV treatment to gain marketing approval in the EU. The first, Atripla, was launched in in 2007 by Gilead in partnership with Bristol-Myers Squibb and MSD.
The authorisation of Eviplera was supported by phase III clinical trials carried out by Tibotec that demonstrated the efficacy and safety of rilpivirine in treatment-naïve HIV-infected adults, and a bioequivalence study carried out by Gilead which showed the single tablet to achieve the same levels of medication in the blood as the three drugs administered separately.
Gilead will lead the manufacturing and commercialisation of Eviplera in the EU, the US, Canada, Brazil, Australia and New Zealand, while Tibotec will be responsible for commercialising rilpivirine as a single agent and can co-detail the single-tablet regimen in these territories.
Tibotec will commercialise the product in Africa, the Middle East, Eastern Europe and Japan.