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news.Janssen R&D Ireland and ViiV Healthcare have entered into a collaboration to develop and commercialize a new single tablet regimen containing Janssen's rilpivirine and ViiV's dolutegravir as the sole active ingredients for maintenance treatment of people with human immunodeficiency virus (HIV).
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Rilpivirine is a non-nucleoside reverse transcriptase inhibitor and is currently being marketed as Edurant, while dolutegravir is an integrase inhibitor marketed as Tivicay.
If successfully developed and approved by regulatory authorities, the treatment could provide an option to HIV patients to switch from a standard three-drug therapy to a two-drug, nucleoside reverse transcriptase inhibitor (NRTI) sparing antiviral regimen.
Janssen worldwide chairman Paul Stoffels said that HIV remains a significant medical challenge.
"We are pleased to collaborate with ViiV Healthcare in pursuing this shift in the HIV treatment paradigm and reaffirm our commitment to collaborate and develop new HIV treatments and fixed-dose regimens," Stoffels said.
Both the firms are expected to start formulation and clinical development for the single tablet regimen in the next few months as well as further investigate development of this drug combination for paediatric use.
Janssen R&D Ireland developed rilpivirine is indicated, in combination with other antiretrovirals, for treatment of HIV-1 in antiretroviral treatment-naive adult patients.
Currently rilpivirine is available in the US and EU as part of a once-daily fixed dose antiretroviral combination with Gilead Sciences’ tenofovir and emtricitabine.
Dolutegravir, available as a 50mg tablet, is indicated for use in combination with other antiretroviral agents to treat HIV-1 in adults and children aged 12 years and older.