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Trial evaluates long-acting ART in patients unable to adhere to treatment
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The NIH announced the start of a trial that will evaluate a long-acting injectable ART regimen in patients with poor adherence to standard oral ART.
LATITUDE, which stands for Long-Acting Therapy to Improve Treatment Success in Daily Life, will enroll around 350 participants with documented treatment lapses within the past 18 months and randomly assign them to remain on oral ART or receive injections of long-acting rilpivirine and cabotegravir for 1 year.
Data presented this year at CROI demonstrated that a monthly injection of cabotegravir and rilpivirine is noninferior to a daily three-drug oral regimen to treat HIV and is preferred by most patients.
“Unfortunately, for many people who must take any medication regularly, adherence can be difficult. Effective alternative formulations of antiretrovirals, including long-acting injectables, may help people better adapt to HIV treatment,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said in a news release announcing the new trial.
According to the NIH, study participants will start by taking daily oral ART while getting “individualized adherence and retention support.” Participants who are virally suppressed by week 24 will be randomly assigned to the two study arms. Those assigned to long-acting injectable arm will first begin an oral regimen of rilpivirine and cabotegravir for 4 weeks, followed by injections of those drugs every 4 weeks for 48 weeks.
“After this 52-week period, participants originally randomized to the standard-of-care arm may cross over to long-acting therapy, and participants originally randomized to the long-acting therapy arm may remain on that regimen for an additional year,” NIH said.
Reference:
NIH. News release. https://www.nih.gov/news-events/news-releases/nih-trial-evaluates-long-acting-hiv-medication-unable-adhere-strict-daily-regimens. Accessed May 10, 2019.
Disclosure: Fauci reports no relevant financial disclosures.