The agency’s approval follows trial results demonstrating the superior efficacy of the cabotegravir long-acting injectable to a daily oral PrEP option in reducing the risk of infection.
The FDA has approved the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option (Apretude, ViiV Healthcare) to reduce the risk of acquiring HIV-1 in adolescents and adults.
Following clinical trial results assessing the cabotegravir long-acting injectable in men who have sex with men, as well as women and transgender women who have sex with men, the FDA has approved the injectable PrEP for use in patients weighing at least 35 kg following a negative HIV-1 test result.
The injection can be administered as few as 6 times per year at an initial dose of a single 600-mg (3-ml) injection. This initial injection dose should be given 1 month apart for 2 consecutive months. Following the second initiation dose, clinical research demonstrated that the recommended continuation injection dose is a single 600-mg (3-ml) injection given every 2 months. To assess a patient’s tolerability of the injection, cabotegravir oral tablets (Vocabria; ViiV Healthcare) can be given for approximately 1 month before the initial injection dose.
“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the U.S., may want options beyond daily oral pills,” Deborah Waterhouse, CEO, ViiV Healthcare, said in a statement. “Apretude was studied in 1 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.”
The approval from the FDA was based on data from both the HPTN 083 and HPTN 084 international phase 2b/3 clinical trials, which evaluated the efficacy and safety of cabotegravir long-acting for PrEP in HIV-negative cisgender women, transgender men, and men who have sex with men, as these populations have an increased likelihood of contracting HIV.
During the clinical trials, investigators assessed the cabotegravir long-acting injectable in 7700 participants at sites in 13 countries. Both trials were active-controlled, double-blind, multicenter, randomized trials, but the blinded, randomized portions of the trials were stopped early by an independent data safety monitoring board following results showing the superior efficacy and safety of cabotegravir long-acting injectable to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets in the prevention of HIV acquisition.
In the HPTN 083 trial, investigators observed that participants who were administered cabotegravir long-acting injectable showed a 69% lower incidence of HIV compared with those taking FTC/TDF tablets. In HPTN 084, investigators saw a 90% lower incidence rate of HIV acquisition compared with patients administered the FTC/TDF tablets.
During the trials, the most common adverse events (AEs) observed by investigators among patients on the cabotegravir long-acting injectable were abdominal pain, back pain, decreased appetite, diarrhea, dizziness, fatigue, flatulence, headaches, injection site reactions, myalgia, nausea, pyrexia, rash, sleep disorders, somnolence, upper-respiratory-trace infection, and vomiting. In 6% of participants in the HPTN 083 trial and 1% of participants in the HPTN 084 trial, AEs led to discontinuation of the injectable treatment.
In the HPTN 083 trial, investigators looked to assess the efficacy and safety of the injectable in a diverse population that represents the patients most likely to receive the treatment. In the trial sites conducted in the United States, participants included men and transgender women who have sex with men of the Black and Latinx communities. These populations were important to include in the clinical trial, as they are historically disproportionately affected by the HIV epidemic. These populations continue to experience the greatest percentage of new HIV diagnoses.
In the HPTN 084 trial, participants included in the study were cisgender women from sub-Saharan Africa. These participants were important to include, as women from this region bear a disproportionate burden of the HIV epidemic. Additionally, this population may be twice as at risk of acquiring HIV as their male counterparts.
“We have the tools to end the HIV epidemic through the implementation of effective antiretroviral treatment and HIV prevention. PrEP has played a vital role in protecting people from acquiring HIV,” Richard Elion, MD, director of research at Washington Health Institute, said in the statement.
“With the availability of cabotegravir long-acting for PrEP as an injection every 2 months to prevent HIV, people now have an important new option besides daily medication,” he said. “This long-acting medication offers more options for prevention, and now providers and patients will be empowered by choices and the ability to choose the approach that is optimal for each individual.”
ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention. ViiV Healthcare. News release. December 20, 2021. Accessed December 22, 2021. https://www.businesswire.com/news/home/20211220005863/en