ViiV Healthcare has announced that cabotegravir, an investigational, long-acting, injectable HIV-treatment regimen, has garnered positive study results in a late-stage trial.
The ATLAS-2M study met its primary endpoint, showing similar efficacy of cabotegravir and Janssen’s Edurant (rilpivirine)administered every eight weeks compared to four-week administration.
The the global specialist HIV company submitted a regulatory application to the European Medicines Agency (EMA) in July, based on the global ATLAS and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies, which found that the investigative combo, injected monthly, was as effective as a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.
Kimberly Smith, head of Research & Development at ViiV Healthcare, said that the company are “excited” to report that “for the first time since the AIDS epidemic started more than 30 years ago, our ATLAS-2M study has demonstrated that it is possible to maintain suppression of the HIV virus with an injectable regimen containing two drugs administered every two months.
She continued, “This is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments. The ATLAS-2M 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. Approval of this regimen would mark a significant change in the HIV treatment paradigm.”
Detailed results from the study will be presented at an upcoming scientific meeting.