What is PrEP?
PrEP stands for Pre-Exposure Prophylaxis. PrEP is an HIV prevention strategy that uses anti-HIV medications to fight HIV in people who do not have HIV to reduce the risk of HIV. HPTN 083-01 is testing the safety and acceptability of long-acting injectable cabotegravir for PrEP, which is not currently approved for use among adolescents. There are currently only two drugs approved for PrEP by the U.S. Food and Drug Administration (FDA) and both are single pills taken as prescribed that contain two anti-HIV drugs:
- emtricitabine and tenofovir disoproxil fumarate, sold under the brand name Truvada®
- emtricitabine and tenofovir alafenamide, sold under the brand name Descovy®
Truvada is approved for PrEP for all adults and adolescents at risk of HIV. Descovy is approved for HIV prevention in adult and adolescent cisgender men and transgender women but has not been studied in other populations.
What is Truvada for PrEP?
Truvada is a daily oral pill for PrEP that contains two anti-HIV medications: emtricitabine (FTC) and tenofovir (TDF). Truvada works by preventing HIV from making copies of itself. This means that if you are exposed to HIV and you have been taking Truvada every day, the virus is more likely to die before multiplying in your body. Studies have shown that Truvada reduces the risk of acquiring HIV from sex by over 90 percent when taken as prescribed. Truvada for PrEP is safe. Most people taking Truvada do not have any serious side effects from the medicine.
For more information about Truvada for PrEP visit truvada.com.
What is Descovy for PrEP?
Descovy is a daily oral pill for PrEP that was recently approved by the U.S FDA for use among men who have sex with men and transgender women. Descovy is similar to Truvada but uses a different form of tenofovir called tenofovir alafenamide (TAF) instead of TDF. Descovy is as effective as Truvada in preventing cisgender men and transgender women from acquiring HIV. In the U.S., Descovy may be used for HIV prevention by cisgender men and transgender women.
For more information about Descovy for PrEP visit descovy.com/prep.
What is long-acting cabotegravir for PrEP?
Long-acting injectable cabotegravir (CAB LA) is a medication for PrEP that is currently being studied in HPTN 083 and HPTN 084 to see if it works to prevent HIV. CAB for PrEP is a single injection given every eight weeks. Two forms of CAB are being used in HPTN studies: a pill that is taken daily by mouth for five weeks only (known as oral CAB) and a long-acting injectable (CAB LA), received in clinic every eight weeks. Since cabotegravir can remain in the body for up to a year or more in some people, the pill is taken for five weeks first to make sure there are no reactions to cabotegravir before an injection is given.
Is injectable CAB safe?
Studies conducted so far in adults have shown CAB to be safe. Safety will continue to be assessed among adults in HPTN 083 and HPTN 084 as well as among adolescents in HPTN 083-01 and HPTN 084-01.
Can injectable CAB protect participants from getting infected with HIV?
Results from the HPTN 083 study released at the AIDS 2020: Virtual conference in July showed that a PrEP regimen containing CAB LA was superior to oral Truvada for the prevention of HIV acquisition in 4570 cisgender men and transgender women enrolled in HPTN 083. More information about HPTN 083 is available at giveprepashot.org or hptn.org/research/studies/hptn083.
Participants in HPTN 083 were put into one of two groups by chance (like the flip of a coin):
- Group A:Real CAB drug and Truvada placebo (injection that has real CAB and pill that does not have real TDF/FTC)
- Group B: CAB placebo and real Truvada (injections that do not have real CAB and pill that has real TDF/FTC)
In HPTN 083, both CAB LA and Truvada were safe, well tolerated, and very good at preventing new HIV infections. The HPTN 083 study found that people who got the CAB LA shots had 2/3 less new HIV infections than people who got daily Truvada pills.
We do not know if CAB can protect adult cisgender women from acquiring HIV. The HPTN 084 (LIFE) study is looking at the safety and efficacy of CAB in adult cisgender women and will continue to be a rigorously conducted study and collect data about CAB LA in cisgender women. More information about HPTN 084 is available at 084life.org or hptn.org/research/studies/hptn084.
What do the HPTN 083 results mean for HPTN 083-01?
We are not changing how we are doing HPTN 083-01 because we still need to see if the CAB LA shots are safe and acceptable among youth. We need to find this out if we want CAB LA shots to be approved for use by youth. So, all people in HPTN 083-01 will receive CAB LA shots. This is good news now that we know CAB LA works to prevent HIV infection. HPTN 083-01 and HPTN 084-01 will not show us if CAB works for PrEP among adolescents but will show us if CAB LA shots are safe and acceptable in young people.