Janssen R&D Ireland (Janssen) announced an amendment to its existing agreement with Gilead Sciences, Inc. (Gilead), initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV. This new STR contains a combination of darunavir (Prezista), cobicistat (Tybost), emtricitabine and tenofovir alafenamide (TAF). A number of phase 1 and 2 studies of the new STR have been completed.

Under this amended agreement, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, will be responsible for all manufacturing, registration, distribution and commercialisation of the product worldwide.

If successfully developed and approved by regulatory authorities, this treatment would represent the first protease inhibitor-based STR and thereby continue Janssen's commitment to providing its HIV products in more simplified dosing presentations.

"Janssen has vast experience in developing and making innovative HIV treatments available to patients and we have engaged in several successful collaborations with Gilead. We are proud to be extending our collaboration and leading the development of this darunavir-based single-tablet regimen," says Paul Stoffels, chief scientific officer and Worldwide chairman, Pharmaceuticals, Johnson & Johnson. "Our ultimate goal is to offer new treatment options for people living with HIV. If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen."

In addition to this collaboration, Janssen and Gilead have also expanded a separate agreement initiated in 2009 regarding the approved single-tablet regimen, Complera, marketed as Eviplera in the European Union (EU) (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead's investigational tenofovir alafenamide (TAF), a novel nucleotide reverse transcriptase inhibitor, to replace TDF within Complera/Eviplera. TAF has been shown in clinical trials to have a better renal and bone safety profile than TDF.1 Gilead will be responsible for the development and commercialisation in most countries, while Janssen will lead the commercialisation in select markets.

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.2 It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.

Prezista (darunavir), coadministered with ritonavir (Prezista/r), and with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in ARV treatment-naïve and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with Prezista/r:Treatment history and, when available, genotypic or phenotypic testing should guide the use of Prezista/r. The use of other active agents with Prezista/r is associated with a greater likelihood of treatment response.