Participants in a pair of late-stage trials that investigated the monthly long-acting injectable regimen of cabotegravir and rilpivirine (sold in pill form as Edurant) reported a high level of satisfaction with their treatment, aidsmap reports.
At the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City, Miranda Murray, PhD, of ViiV Healthcare reported findings regarding participant satisfaction with the long-acting regimen in the Phase III ATLAS and FLAIR studies.
ATLAS enrolled 616 people who were on daily oral antiretrovirals and had a fully suppressed viral load. The participants were randomly assigned to stay on their current regimen or to switch to the injectable regimen, given every four weeks following a four-week lead-in period during which they took pill formulations of cabotegravir and rilpivirine.
FLAIR enrolled 556 people starting HIV treatment for the first time. They were switched to Triumeq (dolutegravir/abacavir/lamivudine) to suppress their viral load and then randomized to stay on that single-pill regimen or to switch to monthly long-acting injections of cabotegravir and rilpivirine, following the four-week lead-in of the two drugs given in pill form.
Previous reports indicated that the long-acting regimen was highly effective at suppressing HIV in both studies. Consequently, ViiV applied for Food and Drug Administration approval for the regimen in April; a decision is expected by late 2019 or early 2020.
In ATLAS, the members of the two study arms had similarly high mental and physical health scores both at week 24 and week 48. Those who switched to the long-acting regimen reported a greater improvement in acceptance of their treatment through week 48.
Injection-site reactions were common in both trials but were typically mild to moderate and declined over time. At week 48, 90% of those in ATLAS said these reactions were “totally acceptable” or “very acceptable”, while 86% reported the same range of acceptance about the pain of the injection. Similarly high levels of the FLAIR members reported accepting these outcomes. Four people in ATLAS (1%) discontinued the injectable regimen because of injection-related pain.
Between the two arms of the ATLAS study, those who were randomized to receive the injectable regimen reported a higher level of satisfaction with their treatment during the study than those who remained on their original oral regimen. The injection group had a greater level of improvement in their reported satisfaction when it came to the flexibility and convenience of treatment, the ease of treatment, how well treatment fit into their lifestyle, their willingness to stay on the regimen and their willingness to recommend it to others.
Ninety-seven percent of those receiving the injectable regimen in ATLAS and 99% of those in FLAIR said they preferred the long-acting regimen to pill-based treatment.
Editor’s note: A previous version of this article incorrectly stated that Edurant is the pill form of cabotegravir; it is the pill form of rilpivirine.
To read the aidsmap article, click here.
To read the ATLAS conference abstract, click here.
To read the FLAIR conference abstract, click here.