ViiV Healthcare presented data from its ATLAS and FLAIR Phase III trials of its two-drug combo HIV treatment that is injected once a month. The combination was found to be non-inferior to a standard of care, daily oral three-drug combination.
ViiV’s two-drug combo is a combination of its cabotegravir and Janssen, a Johnson & Johnsoncompany’s, Edurant (rilpivirine). The combo is injected every four weeks. The data was presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington.
“With FLAIR and ATLAS, we now have positive results from two pivotal Phase III studies demonstrating that this long-acting, once-monthly injectable regimen has similar efficacy, safety and tolerability to a daily, oral three-drug regimen for the treatment of HIV,” stated John C. Pottage, Jr., ViiV’s chief scientific and medical officer. “We are also encouraged by patient preference data showing that nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy.”
Often, patients prefer oral medications over receiving an injection or infusion, but daily pills sometimes result in compliance problems. In the case of this combination injection, it would, if approved, require patients to visit a clinic or physician once a month for the shot.
ATLAS, which stands for Antiretroviral Therapy as Long-Acting Suppression, had a primary endpoint of showing non-inferiority to an oral three-drug dose of two nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent. The endpoint was met, with virologic suppression rates at Week 48 similar in both treatment arms.
Confirmed virologic failure (CVF) was infrequent, with three patients, about 1 percent of the study group, who received the injection developing resistance to one or both agents. In two of the patients, NNRTI resistance was already present. Two of the three were Russians, and all three had HIV-1 A subtypes, common in Russia, Eastern Europe and East Africa, but seen less commonly in the rest of the world. In the oral CAR group, four patients developed CVF, three from drug resistance mutations.
FLAIR, which stands for First Long-Acting Injectable Regimen, met its primary endpoint, with the two-drug injection showing non-inferiority to ViiV’s Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 48. CVF was infrequent in both arms of the trials. Three receiving the two-drug combo were confirmed virologic failures, all diagnosed with treatment-emergent NNRTI and INSTI resistance. All were from Russia and had HIV-1 subtype A1. Three patients in the Triumeq arm developed CVF with no treatment-emergent resistance observed.
Mitchell Warren, executive director of AVAC, an AIDS advocacy group told WRAL TechWire, “Some people will be thrilled” at the two-drug combo’s convenience.
ViiV is also investigating the two-drug combo in the ATLAS-2M trial, which is evaluating whether it is effective when administered every two months. The company plans to use the data from the FLAIR and ATLAS studies for regulatory submissions.
Another potential benefit of the shot to the pills is privacy. Receiving injections at a clinic provides more privacy than filling a prescription for a HIV medication at a pharmacy, indicated Susan Swindells of the University of Nebraska Medical Center in Omaha. She presented the data at the HIV conference.
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