Long-acting injectable antiretroviral (ARV) therapy appears poised to finally become a reality for people with HIV by the end of 2019. In April, ViiV Healthcare applied to the Food and Drug Administration for approval of a long-acting injectable formulation of Janssen’s rilpivirine (sold in daily pill form as Edurant) and ViiV’s cabotegravir. The regimen is injected into the muscle every four weeks and requires a clinic visit.
Two late-stage trials including more than 1,100 HIV-positive participants found that 48 weeks of the long-acting regimen suppressed HIV as effectively as a standard daily oral triple-ARV combination in people starting treatment for the virus for the first time or switching from a standard oral regimen.
Meanwhile, the National Institutes of Health (NIH) has launched a trial of the injectable regimen for those who have not adhered well to daily oral treatment. The study will randomize half of an expected 350 such individuals to receive the injectable regimen; after one year, it will compare their rate of viral suppression with that of people who were randomized to stay on daily oral treatment.
“There are a considerable number of people who are on antiretrovirals and are adequately suppressing their viremia who do not want to have to take a pill every single day for a number of reasons,” says Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a division of the NIH. “They don’t like to be reminded every single day of the year that if they don’t take this pill, their virus is going to come back. That is really a very strong psychological issue. Having trouble taking a pill every day might be an actual manifestation of this issue.”