PATH has entered into a new licensing agreement with pharmaceutical company Janssen R&D Ireland to develop an injectable form of the medicine rilpivirine that could provide a new tool in the fight to stop the spread of HIV.
The agreement paves the way for PATH and our partners to advance the product to phase 2 multisite safety studies in the United States and Africa, with trials anticipated to begin in 2014. The trials will build on the results of ongoing phase 1 work to establish the viability of the drug candidate. Our partners in this work include Janssen, the HIV Prevention Trials Network, and the Division of AIDS at the National Institutes of Health.
An injectable formulation of rilpivirine could become a new pre-exposure prophylaxis (PrEP) intervention against HIV type 1. PrEP is a prevention strategy that involves the use of antiretroviral medications to reduce the risk of HIV infection in healthy uninfected people at risk for acquiring the virus.
Rilpivirine is a highly potent, non-nucleoside reverse transcriptase inhibitor of HIV-1, currently commercialized by Janssen as an oral, once-daily treatment for adults who have not been treated previously with antiretroviral therapy. It is used in combination with other antiretroviral therapies. A long-acting injectable formulation has the potential to address one of the primary challenges in HIV prevention–patient adherence to treatment.
Funding to PATH to establish the viability of an injectable form of PrEP as an intervention for HIV prevention is being provided by the Bill & Melinda Gates Foundation.
Approximately 2 million people die from AIDS each year worldwide, with a disproportionate loss of life in sub-Saharan Africa. Halting the incidence of new infections will require a range of biomedical HIV prevention strategies, including PrEP, microbicides, barrier contraception, and voluntary medical male circumcision, as well as providing treatment to those living with HIV.