FDA Approves Long-Acting, Injectable Cabotegravir to Prevent HIV

The FDA this week approved cabotegravir (Apretude), the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.

ViiV Healthcare said this week that the FDA approved cabotegravir (Apretude), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1.

The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of and who have a negative HIV-1 test before starting the therapy.

The medicine was studied in men who have sex with men, as well as women and transgender women who have sex with men, who were at increased risk of sexually acquiring HIV.

The injectable is given as few as 6 times per year and is initiated with a single 600 mg (3-ml) injection given 1 month apart for 2 consecutive months. After the second injection, the recommended course is a single 600 mg (3-ml) injection given every 2 months.

Oral cabotegravir tablets (Vocabria) may be given for approximately 1 month before the first injection to assess the tolerability of the medicine.

Approval is based on the results from 2 international phase 2b/3 multicenter, randomized, double-blind, active-controlled trials, HPTN 083 and HPTN 084.

The trials included more than 7700 participants across 13 countries and the blinded, randomized portions of both trials were stopped early by an independent Data Safety Monitoring Board after cabotegravir was shown to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets in preventing HIV.

Clinical trial participants who received long-acting cabotegravir experienced a 69% lower incidence of HIV compared to FTC/TDF tablets in HPTN 083 and a 90% lower incidence of HIV compared to FTC/TDF tablets in HPTN 084.

The most common adverse reactions (all grades) observed in at least 1% of clinical trial participants were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

Adverse events led to discontinuation in 6% of participants in HPTN 083 and 1% of participants in HPTN 084.

Viiv, majority owned by GlaxoSmithKline, said the trial participants were diverse: in HPTN 083, US participants were inclusive of the Black/African American and Latinx communities of men and transgender women, who are disproportionately affected by the HIV epidemic and comprise the greatest percentage of new HIV diagnoses.

In HPTN 084, all participants were cisgender women from sub-Saharan Africa, where women carry bear a disproportionate HIV burden and may be twice as likely to acquire HIV as their male counterparts.