- Federal regulators approved a new, injectable form of HIV prevention that may improve adherence to the drug regimen compared to the currently available daily pill.
- Experts say that adherence is a major obstacle for people using this type of medication, and an injectable drug that is taken every 2 months could significantly improve adherence.
- They also say that the new drug could change the course of the HIV prevention by decreasing new cases of the condition worldwide.
Officials at the Food and Drug Administration (FDA) have announced the approval of the first injectable, HIV preexposure prophylaxis (PrEP) drug.
The drug is called Apretude and it’s taken every 2 months to reduce the chance of sexually acquired HIV.
“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 Dr. Debra Birnkrant, the director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, in a statement.
Birnkrant emphasized that the drug will be critical to addressing the HIV epidemic. It may help individuals who could have a higher chance of contracting HIV and groups where adherence to a daily medication is challenging or not a realistic option.
Approval based on two trials
Apretude’s effectiveness and safety were evaluated in two randomized, double-blind, clinical trials (RCT) that compared the injectable drug to Truvada — a once daily PrEP medication.
The first trial included men who have sex with men without using a barrier method and who don’t live with HIV. The trial also included transgender women who have sex with men without using a barrier method and who don’t live with HIV.
The second trial evaluated HIV-negative, cisgender women with potentially higher chances of contracting HIV.
The first trial reported that participants who took Apretude experienced a nearly 70 percent reduced chance of contracting HIV when compared to people taking Truvada.
The second trial found Apretude reduced the chance of contracting HIV by 90 percent compared to people who took Truvada.
Researchers also reported that Apretude had a higher incidence of side effects than Truvada, including injection site reactions, headache, fatigue, fever, muscle pain, back pain, and rash.
Apretude and HIV-positive people
The FDA included a boxed warning with Apretude to not use the drug without a confirmed negative HIV test.
“It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the chance of developing drug resistance,” FDA officials said in their statement.
According to the agency, drug-resistant HIV variants have been identified in people with undiagnosed HIV when using Apretude.
FDA officials also cautioned that people who contract HIV while taking Apretude must transition to a complete HIV treatment regimen.
Apretude labeling will also include warnings and precautions regarding “hypersensitivity reactions, hepatotoxicity (liver damage), and depressive disorders.”
What is PrEP?
Dr. David Rosenthal, DO, an allergy and immunology specialist at Northwell Health in Great Neck, New York, has advocated for PrEP medications since shortly before FDA approval of the preventive treatment in 2012.
‘PrEP is really, in the bigger picture, a preventative modality that prevents you from getting HIV by taking medication before you’re exposed to HIV,” he told Healthline.
According to Rosenthal, PrEP is intended to protect anyone who has a higher chance than average of contracting HIV.
“Typically, that might be men who are sexually active with men, sexually active transgender women, people who use intravenous drugs, and individuals that have sexually transmitted infections,” he said.
Adherence to treatment is a challenge
Rosenthal noted that one of the great challenges with people taking daily medication for PrEP is that they forget to take the medication or don’t want to take the medication because it’s too hard for them to remember.
“The advantage of [Apretude] is that it’s a medication that you can take only once every 2 months at your doctor’s office and that’s a way to make sure you don’t need to take medication on a daily basis,” he said.
Rosenthal said this schedule improves medication adherence because the doctor’s appointment is one that more people attend, “whereas more people forget taking medications at home.”
“In the two clinical trials that were done, both of them show superiority to taking oral daily PrEP by taking the injectable PrEP, largely due to medication adherence and follow through,” said Rosenthal.
Time will tell
According to Rosenthal, we still need to wait in a “real world model” to determine if people are really going to make sure they come to their doctor on a timely basis as they’re supposed to, to get a dose of injectable PrEP every 2 months.
“The HIV epidemic is really continuing to increase,” he said. “We’ve had more ongoing cases year after year, until we really started introducing PrEP into the fabric.”
Rosenthal is also confident that Apretude is “going to change the course of the entire epidemic” by decreasing cases of new HIV and bringing down the overall numbers of cases in the United States and worldwide.