Pharma Partners Plan First Long-Acting, Two-Drug Injectable Regimen for HIV Patients

Phase III program to begin in mid 2016

ViiV Healthcare has formalized a collaboration with Janssen Sciences Ireland for the phase III investigation and commercialization of long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Edurant, Janssen) for maintenance therapy of patients with human immunodeficiency virus-1 (HIV-1) infection who have achieved viral suppression.

While HIV infection is now considered a chronic manageable condition for most individuals, remaining treatment challenges continue to affect the lives of people living with the disease; these challenges include tolerability, safety, dosing schedules, drug interactions, and adherence.

As part of the new agreement, ViiV Healthcare and Janssen expect to start a phase III program to evaluate the efficacy, safety, and tolerability of the long-acting, two-drug injectable regimen in mid 2016.

This is the second development agreement between the two companies. In June 2014, they formed a partnership to develop and commercialize a single-tablet combination of ViiV Healthcare’s integrase strand transfer inhibitor dolutegravir (Tivicay) and Janssen’s rilpivirine, a non-nucleoside reverse transcriptase inhibitor. A phase III clinical trial program to evaluate the safety and efficacy of both medications as maintenance treatment of HIV-1 infection began in May 2015. 

Cabotegravir, an analogue of dolutegravir, is being developed by ViiV Healthcare for the treatment and prevention of HIV infection and is being evaluated as a once-daily oral tablet formulation and as a long-acting nanosuspension formulation for intramuscular injection.

Rilpivirine is used for the treatment of HIV‑1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adults with a viral load equal to or less than 100,000 HIV RNA copies/mL. Rilpivirine is approved in the U.S. as a single 25-mg tablet administered once a day with a meal. The product is also available in the U.S. as part of a once-daily fixed-dose antiretroviral combination with tenofovir disoproxil fumarate and emtricitabine (Complera, Gilead Sciences). The most common adverse effects of rilpivirine include depression, headache, insomnia, and rash.

Source: ViiV Healthcare; January 7, 2016.