For immediate release:

Today, the U.S. Food and Drug Administration has Apretude (Cabotegravir Sustained Release) for use in adults and adolescents at risk of at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce sexual risk. Approved Suspension for Sex Injection) Acquired HIV. Apretude is first given as two starting injections at 1-month intervals and then every 2 months. Patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for 4 weeks to assess tolerance to the drug.

“Today’s approval adds an important tool for ending the HIV epidemic by providing the first option to prevent HIV without taking daily tablets,” the FDA’s antiviral. Dr. Debra Birnkrant, director of the antiviral department of the Virus Center, said. Drug evaluation and research. “This injection is given every two months and is important for combating the HIV epidemic in the United States. It is a big challenge or realistic for high-risk individuals and daily medication compliance. It also includes helping specific groups that are not options. “

According to the US Centers for Disease Control and Prevention I got a remarkable profit Increased use of PrEP for HIV prevention in the United States and preliminary data show that in 2020, about 25% of the 1.2 million people recommended for PrEP were prescribed, compared to about 3% in 2015. did. For improvement. PrEP requires a high level of compliance Certain high-risk individuals and groups, such as young men who are effective and have sex with men, are less likely to stick to daily dosing. Other interpersonal factors such as substance use disorders, depression, poverty, and efforts to hide medication can also affect medication compliance. The availability of long-acting, injectable PrEP options is expected to improve PrEP uptake and compliance in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV was evaluated in two randomized, double-blind trials comparing Apretude with Truvada, a once-daily oral drug for HIV PrEP. Study 1 included men who were not infected with HIV and transgender women who had sex with men and behaved at high risk of HIV transmission. Study 2 included uninfected cisgender females at risk of becoming infected with HIV.

Participants taking Apretude received cabotegravir (oral, 30 mg tablets) and placebo daily for up to 5 weeks, followed by injections of Apretude 600 mg daily in the first and second months, followed by daily every two months. I took a placebo tablet and started the test.

Participants who took torubada started the study with oral tolvada and placebo daily for up to 5 weeks, followed by oral tolvada and placebo daily in the 1st and 2nd months, and every 2 months thereafter. I had an intramuscular injection.

In Study 1, 4,566 cisgender men and transgender women having sex with men received either Apretude or Truvada. The study measured the HIV prevalence of study participants who took cabotegravir daily and then received apretude injections every two months compared to daily oral torbada. The study showed that participants who took Appletude had a 69% lower risk of becoming infected with HIV than those who took Torubada.

In Study 2, 3,224 cisgender females received either Apretude or Truvada. The study measured the HIV prevalence of participants who received oral cabotegravir and injections of Appletude compared to those who received torubada orally. The study showed that participants who took Appletude had a 90% lower risk of becoming infected with HIV than those who took Torubada.

Side effects that occur more frequently in participants receiving Appletude compared to participants receiving Tolvada in either study include injection site reactions, headache, fever (fever), malaise, and low back pain. Includes, muscle aches and rashes.

Apretude contains a boxed warning not to use this drug unless the HIV test is confirmed to be negative. To reduce the risk of developing drug resistance, it should only be prescribed to individuals who are confirmed to be HIV negative immediately before starting the drug and before each injection. Drug-resistant HIV variants have been identified in people who have not been diagnosed with HIV using Apretude for HIV PrEeP. Individuals infected with HIV while undergoing PrEP Apretude should move to a complete HIV treatment regimen. The drug label also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver disorders), and depressive disorders.

Apretude Priority review When Breakthrough therapy specify. The FDA has given Viiv approval for Apretude.

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