Phase III FLAIR and ATLAS trials meet primary endpoints in HIV

ViiV Healthcare presented comprehensive 48-week data from the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies of the novel, investigational, long-acting regimen of Edurant + GSK 1265744 (cabotegravir + rilpivirine). These two studies met their primary endpoints, showing that the combination of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine, injected every four weeks, was non-inferior in maintaining viral suppression in adults infected with human immunodeficiency virus type-1 (HIV-1) when compared to a standard of care, daily, oral three-drug regimen.

The global, pivotal, phase III ATLAS study met its primary endpoint, with cabotegravir and rilpivirine demonstrating non-inferiority to an oral three-drug regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, as measured by the proportion of participants with plasma HIV-1 RNA at most 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48 (cabotegravir + rilpivirine: 5/308 [1.6%], current antiretroviral therapy [CAR]. The study found virologic suppression rates (HIV-1 RNA below 50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 285/308 [92.5%], CAR: 294/308 [95.5%]. Confirmed virologic failure (CVF) was infrequent.

The global, pivotal, phase III FLAIR study met its primary endpoint, with cabotegravir and rilpivirine demonstrating non-inferiority to Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), as measured by the proportion of participants with plasma HIV-1 RNA at least 50 c/mL using the FDA Snapshot algorithm at Week 48 (cabotegravir + rilpivirine: 6/283 [2.1%], Triumeq: 7/283 [2.5%], adjusted difference). The study found virologic suppression rates (HIV-1 RNA less than 50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%). CVF was infrequent across both treatment arms. These data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections.