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What is PrEP?

Pre-Exposure Prophylaxis (PrEP) is the use of HIV medication by someone who is HIV-negative, in advance of a potential exposure to HIV, with the aim of preventing HIV infection. When taken daily, PrEP can significantly decrease the likelihood of an HIV infection occurring.

The medication most commonly used as PrEP is emtricitabine/tenofovir disoproxil fumarate (TDF/FTC). Originally manufactured by Gilead Sciences under the brand name Truvada, Health Canada has recently approved several generic versions of TDF/FTC as well.

How does PrEP work?

PrEP prevents HIV infection by preventing the virus from making copies of itself, limiting the ability of HIV to spread from cell to cell. Because of this, it is much more difficult for the virus to multiply and establish an infection within the body.

For PrEP to stop this replication from occurring, there must be adequate concentration of the drug in the body when the virus first enters. Therefore, PrEP should be taken daily as prescribed to generate sufficient levels of the drug within the blood and in tissues which are most likely to come into contact with the virus, such as rectal and genital tissues.

The time taken to reach these levels is not certain, however there are estimates for how long (or how many doses) it can take PrEP to reach maximum drug concentration levels within certain tissues.

  • Seven doses to reach maximum drug concentration in rectal tissues (for receptive anal sex).

  • Twenty doses to reach maximum concentration in vaginal (or frontal) tissues (for receptive vaginal or frontal sex).

  • Twenty doses to reach maximum concentration as it relates to preventing HIV infection through injection drug use.

  • There is insufficient data to establish exactly when maximum concentration is reached in penile tissues (for insertive anal or vaginal/frontal sex).

Proof that PrEP Works

Several studies have demonstrated that PrEP is a highly effective method of reducing the risk of HIV infection amongst men who have sex with men (MSM), transgender women, heterosexual men and women, and people who inject drugs.

The iPrEx clinical trial conducted in 2010 showed that when PrEP is taken daily, there is a 92% reduction in the risk of HIV infection amongst MSM and transgender women. These findings prompted additional open-label studies (PROUD & IPERGAY) which both reported a relative risk reduction of 86%. Together these studies confirmed that PrEP is as effective as traditional HIV prevention options like condoms.

The efficacy of PrEP has also been studied in heterosexual populations with a high risk of HIV exposure. The PARTNERS trial, conducted with heterosexual serodiscordant couples, showed PrEP to be highly effective, reducing the risk of HIV infection by 90% when there were detectable levels of TDF/FTC in the blood.

It is important to note the reference to “detectable” levels of PrEP in the blood. A common theme amongst PrEP studies is that the level of HIV risk reduction individuals experienced was directly related to drug adherence, or how often they took the drug. Those who took the drug daily (or at a high adherence of 4-7 pills/week) experienced a higher risk reduction than those who took the pill less frequently.

Because of this it is important that PrEP is taken as prescribed to ensure maximum HIV prevention benefit. Fortunately, as the benefits of PrEP have become more well-known, recent demonstration projects and real-world PrEP use data has indicated very high levels of adherence amongst populations at an elevated risk of HIV infection.

[Note: Although PrEP has been demonstrated to be nearly 100% effective at preventing HIV infection amongst those who take the medication daily as prescribed, there have been a handful of HIV infections amongst individuals demonstrated to be highly adherent to PrEP. Most of these occurrences are related to a rare circumstance wherein the strain of HIV someone is infected with is resistant to the drugs present in PrEP (TDF/FTC). More information on that here]

What about Side Effects?

Although PrEP is generally well tolerated, some users have reported side effects. These include:

  • Nausea and headache

  • Reduced bone mineral density

  • Impaired kidney function

 

Some people experience mild symptoms when starting PrEP, with <10% reporting nausea within the first month – known as “start-up syndrome.” After the first month, these symptoms generally disappear and are not experienced at higher rates than amongst people taking a placebo.

 

Clinical trials also demonstrated that PrEP can have an impact on the bone density and kidney function of some users. Decreases in bone density were minor (~1%) and were not associated with an increased likelihood of bone fractures. Increases in the amount of serum creatinine, a molecule normally filtered by the kidneys, has also been reported as a side effect in up to 2% of HIV-negative individuals taking PrEP. Although this is a mild side effect that generally requires no intervention, it may be more severe in individuals with pre-existing kidney conditions.

 

Healthcare providers should monitor patients for these side effects while on PrEP. Fortunately, these side effects are not generally long-term and usually resolve themselves after an individual stops taking PrEP .