The drug, administered six times per year, showed superior efficacy to daily oral PrEP option, in reducing the risk of acquiring HIV
Apretude (cabotegravir extended-release injectable suspension) (Credit: Business Wire.)
ViiV Healthcare, a subsidiary of GlaxoSmithKline (GSK), has secured the US Food and Drug Administration (FDA) approval for Apretude as a pre-exposure prophylaxis (PrEP) option to reduce the risk of acquiring HIV.
Apretude is a long-acting injectable, indicated for adults and adolescents weighing at least 35kg, who are at risk of sexually acquiring HIV.
The indication includes men who have sex with men, along with women and transgender women who have sex with men, who have been tested HIV-1 negative before treatment.
Apretude is an integrase strand transfer inhibitor (INSTI), which works by preventing the HIV DNA from integrating into the genetic material of human immune cells (T-cells).
It is administered as few as six times per year, initiated with two 600mg injections given one month apart, followed by remaining doses for every two months thereafter.
Vocabria (cabotegravir oral tablets) can be used for one month before treatment initiation, to determine patients’ ability to tolerate the drug.
According to ViiV, Apretude is the first and only long-acting injectable PrEP option to show superior to daily oral FTC/TDF in reducing HIV acquisition.
ViiV Healthcare CEO Deborah Waterhouse said: “People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills.
“That’s why ViiV Healthcare is proud that Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.
“With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year. Today’s approval is the latest example of ViiV Healthcare’s commitment to developing long-acting medicines that offer consumers a different choice.”
The US FDA approval is based on results from two multi-centre randomised, double-blind Phase 2b/3 trials, HPTN 083 and HPTN 084.
The trials evaluated the safety and efficacy of Apretude in more than 7,700 participants across 13 countries, compared to Truvada, a once-daily oral HIV PrEP drug.
In the trials, Apretude showed superior results in preventing the acquisition of HIV, compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets.
Based on the independent Data Safety Monitoring Board recommendation, the blinded, randomised arms of both trials were stopped early.
ViiV Healthcare has initiated submissions to other regulatory authorities and is expected to start shipping Apretude to distributors in the US by early 2022.