What do I need to know about Pre-Exposure Prophylaxis (PREP) and the injectable version?

From the Guidelines

Pre-Exposure Prophylaxis (PrEP) is a highly effective HIV prevention method for people at risk of HIV infection, and the injectable version, called Apretude (cabotegravir), is recommended as a convenient alternative to daily pills, with a regimen of two initiation injections one month apart, followed by maintenance injections every two months thereafter, as supported by the most recent evidence from 1. The most common form of PrEP is a daily oral medication, typically Truvada (emtricitabine/tenofovir disoproxil fumarate) or Descovy (emtricitabine/tenofovir alafenamide), which can reduce HIV transmission risk by more than 99% when taken consistently. Before starting any form of PrEP, you'll need HIV testing to confirm you're HIV-negative, as well as kidney function tests and screenings for other sexually transmitted infections, as recommended by 1 and 1. While on PrEP, regular follow-up visits (every 3 months) are necessary to test for HIV and monitor for side effects, with additional testing for sexually transmitted infections and kidney function, as outlined in 1. Common side effects of oral PrEP include nausea, headache, and fatigue, which typically resolve within the first month, and injectable PrEP may cause injection site reactions like pain or swelling, as noted in 1. PrEP only protects against HIV, not other sexually transmitted infections or pregnancy, so additional prevention methods are recommended, and it works by maintaining sufficient levels of antiretroviral medication in the bloodstream and genital/rectal tissues to prevent HIV from establishing infection if exposure occurs, essentially creating a protective barrier against the virus. Key considerations for the use of PrEP include the importance of adherence to the prescribed regimen, regular monitoring for side effects and HIV infection, and the need for additional prevention methods to protect against other sexually transmitted infections and pregnancy, as emphasized in 1, 1, and 1. Overall, PrEP is a highly effective and recommended method for preventing HIV infection in individuals at risk, and the injectable version offers a convenient alternative to daily oral medication, as supported by the evidence from 1.

Some key points to consider when using PrEP include:

• The importance of regular HIV testing and monitoring for side effects, as recommended by 1
• The need for additional prevention methods to protect against other sexually transmitted infections and pregnancy, as noted in 1
• The potential for drug interactions between PrEP and other medications, as discussed in 1
• The importance of adherence to the prescribed regimen to ensure maximum effectiveness, as emphasized in 1 and 1
• The potential for side effects, such as nausea, headache, and fatigue, and the need for regular monitoring, as noted in 1 and 1.

It is essential to consult with a healthcare provider to determine the best course of treatment and to discuss any concerns or questions about PrEP, as recommended by 1 and 1. By following the recommended guidelines and adhering to the prescribed regimen, individuals can effectively reduce their risk of HIV infection and protect their health, as supported by the evidence from 1.

In terms of the injectable version of PrEP, it is essential to follow the recommended regimen of two initiation injections one month apart, followed by maintenance injections every two months thereafter, as outlined in 1 and 1. Additionally, regular monitoring for side effects and HIV infection is crucial, as well as the need for additional prevention methods to protect against other sexually transmitted infections and pregnancy, as noted in 1 and 1. Overall, the injectable version of PrEP offers a convenient and effective alternative to daily oral medication, and individuals should consult with a healthcare provider to determine the best course of treatment, as recommended by 1 and 1.

Some key recommendations for the use of PrEP include:

• PrEP is recommended for individuals at risk for HIV infection, as supported by the evidence from 1 and 1
• The injectable version of PrEP is recommended as a convenient alternative to daily pills, with a regimen of two initiation injections one month apart, followed by maintenance injections every two months thereafter, as outlined in 1 and 1
• Regular HIV testing and monitoring for side effects are necessary while on PrEP, as recommended by 1
• Additional prevention methods are recommended to protect against other sexually transmitted infections and pregnancy, as noted in 1
• Adherence to the prescribed regimen is crucial to ensure maximum effectiveness, as emphasized in 1 and 1.

By following these recommendations and consulting with a healthcare provider, individuals can effectively reduce their risk of HIV infection and protect their health, as supported by the evidence from 1.

From the FDA Drug Label

Individuals must be tested for HIV-1 infection prior to initiating VOCABRIA and APRETUDE for HIV-1 PrEP, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection Oral lead-in may be used to assess the tolerability of cabotegravir prior to the initiation of APRETUDE The recommended oral daily dose is one 30-mg tablet of VOCABRIA for approximately 1 month (at least 28 days). If an individual plans to miss a scheduled injection of APRETUDE by more than 7 days, take daily oral VOCABRIA to replace one every-2-month injection visit.

To use Pre-Exposure Prophylaxis (PREP) and the injectable version, you need to know the following key points:

• HIV-1 screening is required before initiating VOCABRIA and APRETUDE for HIV-1 PrEP, and with each subsequent injection of APRETUDE.
• An oral lead-in dose of cabotegravir may be used to assess tolerability before starting the injectable version.
• The recommended oral daily dose is one 30-mg tablet of VOCABRIA for at least 28 days.
• If a scheduled injection of APRETUDE is missed by more than 7 days, daily oral VOCABRIA can be taken to replace one every-2-month injection visit 2.

From the Research

Overview of Pre-Exposure Prophylaxis (PREP)

• Pre-Exposure Prophylaxis (PREP) is a medication regimen taken by individuals who are HIV-negative to prevent HIV infection.
• The most commonly used PREP regimen is a daily oral pill that contains tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) 3, 4, 5, 6.

Injectable Version of PREP

• A long-acting injectable version of PREP, called cabotegravir, has been approved by the U.S. Food and Drug Administration (FDA) for use in individuals at high risk of HIV infection 3, 4, 5.
• The injectable version is administered every 8 weeks and has been shown to be effective in preventing HIV infection in clinical trials 3, 4, 5.
• The injectable version has a lower risk of HIV infection compared to the oral version, with a hazard ratio of 0.22 (95% CI: 0.08-0.59, p < 0.01) 3.
• The injectable version also has a lower risk of decreased creatinine clearance compared to the oral version, with a relative risk of 0.96 (95% CI: 0.93-0.99, p < 0.01) 3.

Efficacy and Safety of PREP

• PREP has been shown to be effective in preventing HIV infection in individuals at high risk, with a relative risk of 0.46 (95% CI: 0.33-0.66) compared to placebo or no PREP 5, 6.
• The efficacy of PREP is highly dependent on adherence, with greater adherence associated with greater efficacy 5, 6.
• PREP is generally well-tolerated, but can cause renal and gastrointestinal adverse events, which are usually mild and reversible 5, 6.

Values and Preferences of PREP Users

• A systematic review of values and preferences among populations that might benefit from PREP found that awareness of PREP was low, but once participants were presented with information about PREP, the majority said they would consider using it 7.
• Concerns about safety, side effects, cost, and effectiveness were the most frequently cited barriers to use 7.
• Healthcare providers would consider prescribing PREP, but need more information before doing so 7.