Gilead, Janssen expand agreements to develop TAF-based single tablet regimens for HIV treatment

In 2009, both the firms established the original agreement to develop and commercialise Complera, marketed as Eviplera, which combines tenofovir disoproxil fumarate, emtricitabine and rilpivirine in a once-daily tablet.

Subject to approval, Gilead will take the responsibility for the manufacturing, registration, distribution and commercialisation of the regimen in most countries, while Janssen will market the product in around 17 countries.

Gilead intends to begin Phase III trials for emtricitabine/rilpivirine/TAF in the coming months.

Gilead noted that TAF is a nucleotide reverse transcriptase inhibitor that demonstrated high antiviral efficacy at a dose ten times than Viread (tenofovir disoproxil fumarate).

Gilead Sciences research and development executive vice president and chief scientific officer Norbert Bischofberger said: "We believe that TAF’s efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens.

"Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV."

Both the companies have also amended a licensing agreement to develop and commercialise once-daily single tablet regimen for HIV, containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir.

As part of the amended agreement, Janssen will further develop the regimen, and will be responsible for the manufacturing, registration, distribution and commercialisation of the product across the globe, subject to regulatory approval.

Gilead is advancing its own TAF-based single tablet regimen containing elvitegravir, cobicistat, emtricitabine and TAF, in addition to the Janssen agreements.

Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C. Goldsmith.