2021-12-22| Trials & Approvals

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

by Arvind C. Shekhar
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The US Food and Drug Administration (FDA) has approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. The approval for Apretude was granted to Viiv Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK) with Pfizer and Shionogi Limited as shareholders.


HIV and the Need for Pre-exposure Prophylaxis


Pre-exposure Prophylaxis or PrEP represents an effective tool to reduce new cases of HIV, which in addition to successful HIV antiretroviral treatment, will help efforts to end the HIV epidemic.

Apretude whose generic name is “cabotegravir extended- release injectable suspension” is  for use in at-risk adults and adolescents weighing at least 35 kilograms to reduce the risk of sexually acquired HIV. 

Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. Previously, the only PrEP medications that have been approved were pills required to be taken daily, such as Truvada and Descovy. 

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” he said in a statement

Related Article: A Digital Solution Tracks Pill Adherence with 98% Accuracy

Clinical Trials and Apretude


The US FDA’s approval is based on the results from two randomised, double-blind, active-controlled trials, comprising more than 7,700 participants across 13 countries which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men.

In Trial 1, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada. Participants of Trial 1 in the US, were inclusive of the Black/African American and Latinx communities of men and transgender women who have sex with men, who are disproportionately affected by the HIV epidemic and comprise the greatest percentage of new HIV diagnoses. The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.

In Trial 2, all 3,224 participants were cisgender women from sub-Saharan Africa as women in this region bear a disproportionate burden of the HIV epidemic and are twice as likely to acquire HIV as their male counterparts. These participants received either Apretude or Truvada similar to those in Trial 1. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

The most common side effects observed in the clinical trial participants receiving Apretude were injection site reactions, diarrhoea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. 

The US FDA in its statement said Apretude must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. 


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