The Top 10 Things You Need to Know About Apretude – The New Monthly HIV Prevention Injection

The FDA recently approved the first long-acting injectable drug called Apretude for HIV pre-exposure prophylaxis or PrEP. Apretude provides an exciting new option for reducing the risk of HIV beyond just daily oral pills. As the manufacturer Viiv prepares for the commercial launch of Apretude in early 2022, here are the top 10 things Americans should know about this groundbreaking new HIV prevention medication.

Warning: Taking any medicine without doctor’s advice is life threatening. Consult a certified doctor before taking any medicine.

1. What is Apretude and what is it used for?

Apretude is the brand name for the long-acting injectable medication called cabotegravir. Apretude was approved by the FDA in December 2021 to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 77 lbs. Apretude acts as PrEP, which stands for pre-exposure prophylaxis. PrEP is when HIV-negative people take antiretroviral medications like Apretude to prevent acquisition of HIV through sexual contact or injection drug use. By maintaining protective drug levels constantly in the body, Apretude gives a highly effective yet infrequent dosing option for HIV prevention.

2. How does Apretude work compared to daily PrEP pills?

Those already familiar with Truvada or Descovy for daily PrEP may wonder how Apretude differs. While daily oral PrEP requires taking a pill every day to maintain drug levels, Apretude is injected into muscles every 2 months. This longer-acting formulation allows consistent distribution of the antiretroviral drug cabotegravir throughout those 8 weeks. Clinical trials showed plasma levels of cabotegravir remained high and effective for preventing HIV acquisition between doses. Not needing a daily pill likely improves adherence for many compared to the strict schedule of oral PrEP.

3. How effective is Apretude at preventing HIV compared to daily pills?

Two large global clinical trials directly compared the efficacy of Apretude injections every 2 months against daily oral Truvada. In men and transgender women who have sex with men, Apretude provided 69% reduced risk of HIV infection versus Truvada. For cisgender women, the reduction was a remarkable 90% with Apretude over Truvada. This unmatched level of protection from an injection every other month could tremendously impact the HIV epidemic in high-risk populations with challenges taking a daily prevention medication consistently.

4. When can someone start taking Apretude? What are the age limits?

Apretude is approved for use in at-risk individuals weighing at least 77 lbs, including both adults and adolescents. There is no upper age limit. The drug’s package insert does note safety and efficacy have not been established in pediatric patients younger than 12 years old or weighing less than 77 lbs. When initiating Apretude, patients start with 4 weeks of daily oral cabotegravir tablets to assess tolerability before receiving the intramuscular injections.

5. How much does Apretude cost and will insurance cover it?

As the first long-acting injectable PrEP medication, the manufacturer Viiv has not yet announced Apretude’s official list price. However, advocates estimate its cost will likely be comparable to the current annual price of oral PrEP drugs like Truvada which range from $20,000-22,000 without insurance. Most major private health insurers have committed to covering Apretude with low to no out-of-pocket costs similar to other PrEP. Gilead also offers assistance programs to provide Truvada PrEP free to uninsured. It’s hoped these programs will expand to include support for those needing financial assistance accessing Apretude as well.

6. What are potential side effects of Apretude?

The most common side effects reported in Apretude clinical trials included injection site reactions, headache, fatigue, back pain, and fever. Serious systemic hypersensitivity reactions were rare. As with other antiretroviral drugs, there is also a boxed warning for potential liver damage. Like oral PrEP, potential psychiatric side effects including depression were also reported. However, rates of side effects did not meaningfully differ from those taking oral Truvada daily instead of Apretude injections during clinical studies.

7. How safe is it long term to be on Apretude injections every 2 months?

The safety of long-term Apretude use is still unknown since the approval is relatively new. However, the pharmacokinetic profile data submitted to the FDA reassuringly showed no accumulation of the active drug cabotegravir in tissues over time with repeated bi-monthly dosing. No safety signals emerged even among trial participants who received Apretude for well over a year. As more real-world experience is gained with Apretude beyond clinical trials, long-term safety monitoring will continue to evaluate any risks over 5-10 years of ongoing use.

8. Who is Apretude best suited for compared to daily oral PrEP?

Apretude is ideally suited for those who struggle adhering to a daily PrEP prevention pill schedule due to forgetfulness, active substance use disorders, mental health issues or attempts to conceal taking medication. Young men who have sex with men, particularly those with multiple partners, often face the highest adherence challenges. trans women, sex workers or individuals in serodiscordant partnerships where an infected partner’s viral load isn’t fully suppressed may also benefit most from Apretude’s infrequent dosing schedule.

9. How does someone access and get prescribed Apretude injections?

Apretude will require a prescription from a healthcare provider. Individuals should speak to their primary doctor, an infectious disease specialist or visit their local HIV/STI testing clinic to be evaluated for PrEP with Apretude. Getting prescribed involves confirming an initial undetectable HIV status, routine STI screening, discussing potential side effects and providing consent. The first two Apretude doses are administered by a provider at month one and two, while later doses can potentially be self-injected at home if preferred after training.

10. What’s the future potential for even longer-acting options like Apretude?

As the first injectable PrEP, Apretude’s approval marks an exciting new chapter in HIV prevention technology. Already some research is evaluating whether an Apretude injection could potentially be extended even longer, like every 3-4 months. And other companies are working on developing different long-acting implants, gels or even an oral drug that could maintain protection for months at a time. If proven safe and effective, these novel extended-duration platforms beyond just an injection could transform HIV prevention by requiring protection from as little as a single application every 6-12 months. Excitingly, continued PrEP innovation is bringing us ever closer to new HIV prevention options matching peoples’ real-world needs and circumstances.

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Conclusion

In conclusion, the FDA approval of the new HIV PrEP injection Apretude provides hope in the effort to end new HIV transmissions through an accessible option beyond daily pills. As Apretude becomes commercially available in early 2022, expect to hear apretude marketing campaigns, learn more about apretude copays and insurance coverage details, and hopefully apretude helps get us closer to an AIDS-free generation.