Two leading global pharmaceutical companies, London-based ViiV Healthcare and New York-based Pfizer, are joining Irish company Janssen Sciences on a phase III investigation of a possible injectable therapy for the HIV-1 infection.
The study focuses on long-acting, injectable formulations of ViiV's cabotegravir and Janssen's rilpivirine, in a combination indicated for treatment of HIV-infected patients whose virus has been suppressed.
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir. It is a once-daily tablet. Rilpivirine is a once-daily, non-nucleoside reverse transcriptase inhibitor, marketed as a single-dose, 25-miligram, once-daily tablet.
“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,” Dominique Limet, ViiV Healthcare's CEO, said. “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.”
Company officials said the phase III study should begin sometime in mid-2016.
Despite advances in HIV treatment, those living with the infection continue to struggle with such issues as tolerability, safety, dosing schedules, drug interactions and adherence, making the development of new treatment options important.
Patients adhering to the current standard of care for HIV take a combination of at least three oral antiretroviral (ARV) drugs each day: two non-nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI) or integrase strand transfer inhibitor (INSTI).
