ViiV Healthcare Launches Phase 3 Program to Evaluate Long-Acting, Injectable HIV Regimen

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of two phase III studies designed to evaluate an investigational long-acting, injectable regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) for the treatment of HIV-1 infection. The two studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), will examine the safety and efficacy of monthly dosing with the two-drug, injectable regimen in both treatment-naïve and treatment-experienced patients.

This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC.

While fixed-dose oral combination therapies have advanced HIV treatment by providing streamlined dosing through reduced pill burden, adherence to therapy continues to be essential to achieving viral suppression, and reducing the emergence of resistance mutations.Therefore, it is important that new HIV treatment modalities, such as long-acting, injectable therapies, are investigated, as they may improve adherence and patient outcomes.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Currently the treatment of HIV involves life-long therapy with multiple antiretrovirals, so it is important that we continue to improve on the durability, safety, tolerability, and convenience of treatment regimens. This phase III programme with long-acting cabotegravir and rilpivirine as a potential HIV treatment regimen is part of ViiV Healthcare’s broader development programme evaluating two-drug treatment regimens and we look forward to seeing results from the ATLAS and FLAIR studies in 2018.”

In FLAIR, treatment-naïve patients will be given a 20-week daily oral dolutegravir/abacavir/lamivudine (Triumeq®) regimen, and will then be randomised to switch to a regimen of long-acting, injectable cabotegravir and rilpivirine, or remain on oral therapy. In ATLAS, treatment-experienced patients with suppressed viral load will be randomised to switch from their existing antiretroviral therapy (ART) to long-acting, injectable formulations of cabotegravir and rilpivirine or remain on oral ART.. Participants will be enrolled from investigative sites across Africa, the Americas, Asia and Europe.

The development of long-acting treatments for HIV forms part of a wider strategy to meet UNAIDS’ ambitious aim of ending the AIDS epidemic by 2030. As adherence to daily oral therapy varies among different populations, it is important to continue to evaluate additional treatment options, including regimens that require less frequent dosing, which may support adherence, and potentially improve patient outcomes.