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Study will investigate injectable ART regimen given just six times per year

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John C. Pottage, Jr.

Researchers began a phase 3 study that will investigate the effectiveness of a two-drug injectable ART regimen for HIV patients that is given just six times per year.

According to a news release, the ATLAS-2M study is designed to demonstrate the noninferior antiviral activity at 48 weeks of a long-acting combination of cabotegravir (ViiV Healthcare) and Edurant (rilpivirine, Janssen Therapeutics) administered every 8 weeks compared with the same regimen given every 4 weeks in adults infected with HIV-1.

Cabotegravir is an investigational integrase strand transfer inhibitor that ViiV is developing to treat and prevent HIV. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in ART-naive patients with viral loads less than or equal to 100,000 copies/mL at the start of therapy. Both drugs have been developed as once-daily oral tablets, as well as being formulated for intramuscular injection.

According to the news release, ATLAS-2M also will assess patient safety and tolerability of the regimen to 96 weeks. Initial results are expected in 2019. Researchers are enrolling approximately 1,020 patients from 13 countries, including the United States.

“HIV treatment regimens that do not require daily dosing could be an important part of making HIV feel like a smaller part of patients’ lives, and with the ATLAS-2M study, we are evaluating the possibility of maintaining viral suppression with six treatments per year of long-acting cabotegravir and long-acting rilpivirine,” John C. Pottage, Jr., MD, chief scientific and medical officer for ViiV Healthcare, said in the news release.

ATLAS-2M is the third phase 3 trial to investigate the two-drug regimen. The results from two previous trials studying the efficacy of cabotegravir and rilpivirine in virally suppressed patients (ATLAS) and treatment-naïve patients (FLAIR) are expected in 2018, according to the news release. Approximately half of the participants for ATLAS-2M will roll over from the ATLAS trial.

Disclosures: Pottage is employed by ViiV Healthcare.