ViiV, Johnson & Johnson's long-acting, injectable HIV regimen given every two months hits main study goal

A Phase III study of the investigational, long-acting, injectable, two-drug regimen of ViiV Healthcare's cabotegravir and Johnson & Johnson's Edurant (rilpivirine) for the treatment of HIV met its primary endpoint, the companies announced Thursday. In the ATLAS-2M trial, cabotegravir and Edurant administered every eight weeks showed similar efficacy compared to every four weeks over a 48-week treatment period.

"We are excited to report…that it is possible to maintain suppression of the HIV virus with an injectable regimen containing two drugs administered every two months," remarked Kimberly Smith, head of global R&D at ViiV. The two-drug regimen, which was submitted for approval earlier this year in the US, Canada and Europe, combines the integrase inhibitor cabotegravir with the non-nucleoside reverse transcriptase inhibitor Edurant.

The trial included 1045 adults living with HIV-1 who were required to be virally suppressed for six months or greater, on first or second regimen, with no prior failure. Subjects were randomised to receive cabotegravir and Edurant administered either every four or eight weeks. The study's primary outcome measure is the proportion of participants with HIV-RNA of at least 50 c/mL at week 48.

"The…study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year," commented Smith, adding "approval of this regimen would mark a significant change in the HIV treatment paradigm." The companies noted that detailed results from the ATLAS-2M study will be presented at an upcoming scientific meeting.

ViiV and Johnson & Johnson are developing the combination of cabotegravir and Edurant under the terms of a 2016 partnership. GlaxoSmithKline, which holds a majority stake in ViiV alongside minority investors Pfizer and Shionogi, previously identified cabotegravir as one of as many as 20 investigational assets that could be submitted for regulatory approval by 2020. 

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