Two phase III trials are underway with long-acting (LA) formulations of HIV drugs. These trials will explore the safety and effectiveness of LA formulations in people new to HIV treatment (Flair) and in people who are treatment experienced (Atlas). The interim results from these two pivotal studies should be available in the latter half of 2018.
If the results from Flair and Atlas are favourable, the manufacturer of the LA drugs, Viiv Healthcare, will submit a dossier of the data to regulatory authorities. Approval should occur a year later, perhaps in the fall of 2019.
The studies we have reported on have tested LA formulations of HIV drugs as treatment. There are other studies underway in which LA cabotegravir is being tested as a form of HIV prevention. Drugs used for this purpose are called pre-exposure prophylaxis (PrEP). Results from these studies should become available in 2019.
Commenting on Latte-2, Australian researchers have said that injectable ART “might be attractive for some or many people living with HIV.” However, they also underscore that “there will inevitably be a trade-off between the convenience of not having to adhere to oral therapy and the inconvenience and discomfort associated with injectable LA ART.”
There are other issues associated with LA therapies that will affect the deployment of these medicines. For instance, the Australian researchers noted that “healthcare systems are generally not configured to facilitate regular, recurrent injections in a timely way to people who are well. Changing this will take innovation, political will and time.”
Other pharmaceutical companies are closely watching Viiv’s foray into LA formulations. If Viiv’s efforts are financially successful, then it is possible that one or more companies may enter the field of LA therapy for HIV.
Resource: Long-acting therapies—safety and other issues to consider –TreatmentUpdate 214
Boyd MA, Cooper DA. Long-acting injectable ART: the next revolution in HIV? Lancet. 2017 Sep 23;390(10101):1468-1470.
Margolis DA, Gonzales-Garcia J, Stellbrink H-J. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomized, open-label, phase 2b, non-inferiority trial. Lancet.2017 Sep 23;390(10101):1499-1510.
This article by Sean R. Hosein previously appeared at CATIE, here.
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