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June 12, 2014

Janssen and ViiV Healthcare to develop two-drug single tablet regimen for HIV-1

Janssen R&D Ireland and ViiV Healthcare have announced a collaboration to develop and commercialise 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).

By Mekala ShivaramPrasad

Image

Janssen R&D Ireland and ViiV Healthcare have announced a collaboration to develop and commercialise 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).

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor and is being marketed as Edurant. Dolutegravir is an integrase inhibitor marketed as Tivicay.

If successfully developed and approved by regulatory authorities, this treatment could offer 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."

"This treatment could offer 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 and ViiV Healthcare are expected to begin formulation and clinical development for the single tablet regimen in the next few months. The two companies will further investigate development of this drug combination for paediatric use.

Rilpivirine was developed by Janssen R&D Ireland and is indicated, in combination with other antiretrovirals, for treatment of HIV-1 in antiretroviral treatment-naive adult patients.

Rilpivirine is currently available in the US and EU as part of a once-daily fixed dose antiretroviral combination with Gilead Sciences’ tenofovir and emtricitabine.

Known as Complera (US) or Eviplera, this combination received the US Food and Drug Administration approval in August 2011.

Dolutegravir, available as a 50mg tablet, is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older.


Image: Digital illustration of human immunodeficiency virus. Photo: courtesy of freedigitalphotos.net.

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