injection

ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has formalised its collaboration with Janssen Sciences Ireland UC (Janssen) to develop the first long-acting two-drug HIV injectable regimen.

Under the deal, the companies will focus on the Phase III investigation and commercialisation of the long-acting, injectable formulations of ViiV’s cabotegravir and Janssen’s rilpivirine.

These formulations are being evaluated as an injectable maintenance treatment for patients who have achieved viral suppression.

ViiV Healthcare CEO Dominique Limet said: "As a company committed to innovation in the field of HIV, this agreement with Janssen will enable us to progress the development of the first long-acting, injectable two drug regimen.

"If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three drug therapy."

The companies will start a Phase III programme to evaluate the efficacy, safety and tolerability of the long-acting, two drug injectable regimen this year.

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"If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three drug therapy."

HIV is now considered a chronic manageable condition for most individuals and ViiV is committed to investigating new treatment options that may help to address some of these challenges with the aim of providing healthcare professionals with alternative treatment options for appropriate patients.

In June 2014, the companies agreed to develop and commercialise a single-tablet combining ViiV’s integrase strand transfer inhibitor (INSTI), dolutegravir (Tivicay) and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (EDURANT).

In May last year, the companies initiated a Phase III clinical trial programme to evaluate the safety and efficacy of both medicines as maintenance treatment of HIV-1 infection.

Developed by Janssen, rilpivirine is approved in US and EU as Edurant as a single agent tablet dosed at 25mg taken once a day and is always taken with a meal.


Image: The first long-acting two-drug HIV injectable regimen will include ViiV’s cabotegravir and Janssen’s rilpivirine. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.