FDA Approves HIV Prevention Drug As Shot

On Monday, the U.S. Food and Drug Administration (FDA) approved the first injection drug for HIV pre-exposure prevention. 

The FDA approved use of the drug Apretude “(cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.”

The drug is first carried out as two injections given with one month of separation, and every two months afterwards. People can either start by getting the Apretude injection or take the oral drug cabotegravir (Vocabria) for four weeks to see how they do with the medication.

The FDA explained the trials that were carried out: 

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

…

In Trial 1, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada. 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, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

It added, “Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. … Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.”

The FDA noted that the drug administer every two months instead of a daily pill medication is an “Important Tool in [the] Effort to End the HIV Epidemic.”

NBC News reported that “[w]hile gains have been made in PrEP use over the past several years, only 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed the treatment last year, according to the Centers for Disease Control and Prevention. The CDC estimates that as of 2019, there were approximately 285,000 people using PrEP, the vast majority of them gay and bisexual men.”

“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., who is the 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.”

The Hill reported, “Approximately 1.7 million new HIV cases are identified every year. Those who get infected with HIV while taking Apretude are instructed to transition to an HIV treatment regimen.”

In an announcement, ViiV Healthcare said it “will begin shipping Apretude to wholesalers and specialty distributors in the U.S. in early 2022. ViiV Healthcare has initiated submissions to other regulatory authorities. Apretude has not been approved or licensed anywhere outside of the U.S. for use in HIV prevention.”

Per the company’s website, “ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline […] and Pfizer […] dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV.”

Americans have become more familiarized with the FDA over the course of the last several years as the process for getting treatments and vaccines approved has been brought to light through the coronavirus pandemic. 

This week, a Tuesday report from Bloomberg stated that the U.S. Food and Drug Administration could authorize use of COVID-19 pills by Pfizer and Merck as early as this week. 

Some have started to consider the FDA and CDC as political tools, perhaps contributing to the apparent rise of distrust in American institutions. 

Last week, the FDA removed restrictions from the distribution of the abortion pill, allowing it to be given out in different settings rather than the method by which it

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