Every-two-month injections show promise in ATLAS-2M Phase-III study

ViiV Healthcare has presented positive 48-week data from a phase III study showing that their proposed every-two-month regimen of long-acting, injectable cabotegravir and rilpivirine has similar efficacy to once-monthly dosing.

Findings from the ATLAS-2M phase-III study showed that the injectable regimen of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine every two months was as effective and safe as once-monthly administration and preferred by almost all study participants. 

The study was conducted in HIV-1 positive adults who had an suppressed (undetecable) viral load and no resistance to either cabotegravir or rilpivirine.

By Week 48 the study showed that the antiviral activity and safety of the 2 drug regimen (2DR) administered every eight weeks (two months) was non-inferior when compared to its administration every four weeks (monthly).

Non-inferiority was determined by comparing the proportion of participants whose viral load increased beyond 50 copies per mL in each arm. At week 48 the data showed that the two-month arm (9/522 [1.7%]) and one-month arm (5/523 [1.0%]) were similarly effective. 

The study also found that rates of virologic suppression (maintaining an undetectable viral load) were similar, whether the regimen of cabotegravir and rilpivirine was administered every two months (492/522 [94.3%]) or once monthly (489/523 [93.5%]).

Ninety-eight percent (98%) of participants preferred the every-two-month, long-acting treatment over their daily, oral therapy. Patient preference data was measured using a single-item questionnaire at Week 48. 

Turner Overton, M.D., Professor, Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M Primary Investigator, said: 

“ATLAS-2M study participants expressed a clear preference for the two-month treatment option. This preference reinforces the desire for an option of a long-acting treatment. 

“There is a need for more convenient, simplified treatments to help address challenges such as pill burden, pill fatigue, drug and food interactions, and stigma that detrimentally affect adherence for people living with HIV. The results from this study demonstrate the potential for an alternative to traditional daily, oral regimens.”

For further information: https://clinicaltrials.gov/ct2/show/NCT03299049.