Janssen R&D Ireland has signed a license agreement with PATH to develop an injectable form of rilpivirine as a potential pre-exposure prophylaxis (PrEP) against HIV infection. It is believed that a long-acting injectable formulation of rilpivirine could address one of the primary challenges in HIV prevention—patient adherence to treatment.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor. Currently, it is commercialized by Janssen for the oral, once daily treatment of HIV-1, in combination with other antiretroviral agents (ARVs), in ARV treatment-naïve adults, and in most countries, in patients with a viral load less than or equal to 100,000 HIV-1RNA copies/mL.

Under the agreement, PATH intends to conduct prophylaxis clinical trials in collaboration with its partners, the HIV Prevention Trials Network and the Division of AIDS at the NIH. Following the completion of the Phase II program, anticipated to begin in 2014, PATH and Janssen will evaluate entering into a late-stage development agreement covering the use of rilpivirine as PrEP for uninfected individuals at high risk of acquiring HIV.

Janssen Therapeutics, partner of Janssen R&D, currently markets three antiretroviral HIV medications. This license agreement with PATH does not impact the commercialization of rilpivirine by Janssen, and does not impact the use of rilpivirine in combination treatments, according to the company.

Funding to PATH for this development program is being provided by the Bill & Melinda Gates Foundation.

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