Pre-exposure prophylaxis, or PrEP, is a way for people who do not have HIV to help prevent HIV infection by taking a pill every day. When used consistently, PrEP has been shown to greatly reduce the risk of HIV infection in people who are at substantial risk.
PrEP is a powerful HIV prevention tool, and can be combined with condoms and other prevention methods to provide even greater protection than when used alone. People who use PrEP must commit to taking the drug daily and seeing their health care provider every 3 months for HIV testing and other follow-up.
What is PrEP?
PrEP is short for PrE-Exposure Prophylaxis. It is medicine that can prevent people who may be at-risk for HIV from getting HIV. PrEP can come in two forms: oral medication or an injectable.
Truvada was the first drug approved for use as PrEP for both men and women by the Food & Drug Administration in 2012. In 2019, a second drug, Descovy, was approved by the FDA for use by men. In 2021, the FDA approved of the first ever PrEP injection, called Apretude.
All forms of PrEP are highly effective when taken as prescribed.
CDC, HIV Basics, PrEP. October 2019.
FDA, FDA Approves Second Drug to Prevent HIV Infection as Part of Ongoing Efforts to End the HIV Epidemic. October 2019.
Oral PrEP – Truvada vs. Descovy
Truvada:
- Approved for ALL genders
- Approved and studied on people who inject drugs.
- Can be taken daily, or as needed if taken based on correct 2-1-1 dosing schedule.
- A generic version is available, and some insurance companies prefer it because it’s cheaper than brand-named Truvada.
- Side effects:
- Headache (7%) and/or abdominal discomfort (3%).
- Small decrease in kidney function, which can improve upon discontinuation. If this is an issue, your provider may recommend Descovy or Apretude.
- Slight decrease in bone density, but no increased fractures.
Descovy:
- Only approved for gay & bisexual cisgender men and transgender women.
- Not approved for people assigned female at birth who are at risk for HIV through receptive vaginal sex.
- Must be taken daily, no as-needed method has been studied.
- No generic version available.
- Safe to take with existing kidney issues or a strong family history of kidney disease.
- Side effects:
- Abdominal discomfort and headaches.
- Small increase in cholesterol.
- Slight increase in body weight, but no different than the average yearly amount of weight gain.
- May cause worsening of Hepatitis B.
What is On-demand PrEP?
- On-demand PrEP has only been studied with Truvada and is not approved by the FDA.
- Only been studied and recommended for cisgender men and transgender women.
- Has not been studied on people assigned female at birth and people who inject drugs.
- On-demand PrEP may be recommended for men who:
- Experience bouts of sexual inactivity.
- Have impaired kidney function.
- Don’t always use a condom.
- 2-1-1 dosing schedule:
- Take 2 pills 2-24 hours before sex (closer to 24 is ideal).
- Continue taking one pill every 24 hours for as long as individual is having sexual encounters.
- Once a person stops having encounters, take 2 final doses 24 hours apart.
- If sex occurs again during this interval, the daily dosing should continue with 1 tablet taken daily until 48 hours has passed since last encounter.
What about PrEP Injection – Apretude?
- Apretude injections may be appropriate for:
- People with significant renal disease.
- Those who have had difficult adherence to oral PrEP.
- Those who prefer injections and labs every 2-months over a daily pill.
HIV.gov, https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis/. January 2022
FDA, https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic. October 2019
FDA, https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention. December 2021
How Effective is PrEP
PrEP pills, Truvada and Descovy can reduce the risk of HIV through sex by about 99% when taken as prescribed. It can prevent HIV through injection drug use by about 74% when taken as prescribed.
For injectable PrEP, please see the clinical studies on the Apretude website, listed at the link down below.
While PrEP is highly effective in preventing HIV, it does not protect against other Sexually Transmitted Diseases (STDs).
CDC, https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html. June 2022
Apretude website, https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF#page=36. February 2023
How quickly does PrEP start working?
For receptive anal sex (bottoming), PrEP pills reach maximum protection from HIV after 7 days of daily use.
For receptive vaginal sex and injection drug use, PrEP pills reach maximum protection at about 21 days of daily use.
No data is available for insertive anal sex (topping) or insertive vaginal sex.
We don’t know how long it takes for the PrEP injection to reach maximum protection from sex. To research all information available, please refer to the Apretude website.
CDC, https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html. June 2022
Apretude website, https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF#page=36. February 2023
Once I start PrEP, can I stop?
For oral PrEP medication, you can go on and off PrEP at different times in your life, but should do so under the guidance of a health care provider. If you do not take PrEP as prescribed, there may not be enough medicine in your bloodstream to block the virus.
Before restarting oral PrEP medication, you will need to get tested again for HIV and renew your prescription.
For the PrEP injection, it’s important to come in for injections and HIV testing every 2 months. To research all information available, please refer to the Apretude website.
CDC, https://www.cdc.gov/hiv/basics/prep/continuing-prep.html. June 2022
Apretude website, https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF#page=36. February 2023
Who is PrEP for?
PrEP can help protect you if you don’t have HIV and any of the following apply to you:
- You have had anal or vaginal sex in the pasty six months and you:
- Have a sexual partner with HIV (especially if the partner has an unknown or detectable viral load).
- Don’t always use a condom consistently.
- Have been diagnosed with a STD in the past 6 months.
- You inject drugs and you:
- Have an injection partner with HIV.
- Share needles, syringes, or other drug injection equipment (for example, cookers).
- You have been prescribed PEP (Post-Exposure Prophylaxis) and you:
- Have used multiple courses of PEP.
PrEP is for anyone who wants added protection against HIV. Your health care provider can help you decide if PrEP is a good fit for you. You may still choose to take PrEP, even if the behaviors listed above don’t apply to you.
If you are considering getting pregnant and concerned about HIV, talk to your health care provider about PrEP. PrEP may be an option to help protect you and your baby from getting HIV while you try to get pregnant, during pregnancy, or breastfeeding.
CDC, https://www.cdc.gov/hiv/basics/prep/prep-decision.html. July 2022
How much does PrEP cost?
Oral PrEP medication is covered by all insurance plans, including Medicaid and Medicare. If you do not have insurance, or have insurance but need help with out-of-pocket costs, there are financial assistance programs that may be able to help.
Injectable PrEP medication is covered by most insurance plans, including Medicaid and Medicare. If you have insurance but need help with out-of-pocket costs, there is an Apretude Savings Program that can help you with these costs. Please refer to the Apretude website for further information. There are currently no programs available for full coverage of the PrEP injection for those with no insurance.
Ready, Set, PrEP, https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program. March 2022
Gilead Advancing Access, https://www.gileadadvancingaccess.com. 2023
Apretude Savings Program, https://apretude.com/apretude-cost. December 2022
How do I get PrEP?
Any medical professional can prescribe medications. Even if a provider doesn’t prescribe PrEP in particular, they can send a referral to the appropriate location. Look for a provider nearest to you!
What about condoms?
PrEP provides protection from HIV, but does not protect against other Sexually Transmitted Diseases (STDs). Condoms are an easily accessible, highly effective means of preventing the sexual transmission of HIV. Condoms are also the only method of protection that prevents both pregnancy and disease. To be effective, condoms must be used correctly and consistently.
For more information about using external condoms (sometimes called a male condom) and an internal condom (sometimes called a female condom), please refer to the CDC website.
CDC, https://www.cdc.gov/hiv/basics/hiv-prevention/condoms.html. May 2021
What is PEP?
PEP is short for Post-Exposure Prophylaxis. It is a medication to be taken in emergency situations to protect against HIV after exposure. It is not intended to be used as a substitute for regular HIV prevention. If you are at an ongoing risk for HIV, ask your health care provider about PrEP.
PEP must be taken within 72 hours of possible HIV exposure. If you are prescribed PEP, you will need to take it daily for 28 days.
Talk immediately to your health care provider, an emergency room provider, or urgent care provider about PEP if you think you may have been exposed to HIV:
- During sex (for example, if the condom broke).
- Through sharing needles, syringes, or other equipment to inject drugs (for example, cookers).
- You have been sexually assaulted.
CDC, https://www.cdc.gov/hiv/basics/pep/about-pep.html. July 2022
I don’t have insurance, can I still get PrEP?
If you don’t have insurance, there are resources available that can help pay for PrEP.
These resources are only for PrEP pills: Truvada & Descovy. Currently, there are no options yet for the PrEP injection, Apretude.
One source is the U.S. Department of Health and Human Services’ Ready, Set, PrEP Program that provides PrEP at no cost for people who do not have insurance coverage. For more information, and to apply for the program, visit www.getyourprep.com or call 855-447-8410. No proof of income is required.
Another is Gilead’s Advancing Access Program. To see if you are eligible for the program provided by the Truvada & Descovy for PrEP manufacturer, call 855-330-5479. Eligibility is based on income.
What about payment assistance for PrEP?
There are various sources of payment assistance for PrEP for people with and without insurance coverage.
For oral PrEP – Truvada and Descovy:
If you don’t have insurance, options are available to get oral PrEP medications. The U.S. Department of Health and Human Services’ Ready, Set, PrEP Program provides PrEP at no cost. For more information and to apply for the program, visit www.getyourprep.com or call 855-447-8410.
In addition, depending on your income, you may be eligible to get PrEP at no cost as part of a program offered by Truvada and Descovy’s manufacturer. Gilead’s Advancing Access Program may also be available to those on Medicare who don’t have Part D prescription drug coverage. To determine if you are eligible, your medical provider needs to submit an application. For more information, call 855-330-5479.
For those with insurance who need help with copay and deductible costs, Gilead’s Co-Pay Coupon provides up to $7,200 per year, with no monthly limit, to cover out-of-pocket expenses for PrEP, including copays, coinsurance, and deductibles. The program does not restrict benefits based on income. However, it is not available for those on Medicaid, Medicare Part D or any other government prescription drug programs. For more information, call 800-226-2056.
Another option for people who get their PrEP covered by insurance, including Medicare, is the Patient Advocate Foundation, which provides up to $7,500 per year to help pay for costs related to the prescription. Approval is based on your income. If you earn less than 400 percent of the federal poverty level (or about $49,960 for an individual with no dependents) you may qualify for this program. For more information go to www.patientadvocatefoundation.com or call 866-512-3861 and select option 1.
For Injectable PrEP, Apretude:
Talk to your provider or health care office about the Apretude Savings Program. If eligible, you may pay as little as a $0 copay. For more information, call 844-588-3288 or visit www.viivconnect.com. This program is only available for people with insurance. Currently, there is no financial assistance programs to receive the injection for people with no insurance.
What is the Ready, Set, PrEP program?
The Ready, Set, PrEP Program is a new program by the U.S. Department of Health and Human Services that makes PrEP available at no cost for people without insurance. To receive PrEP through this program, you must test negative for HIV, have a valid prescription for PrEP, and not have prescription drug coverage.
If you receive PrEP through the Ready, Set, PrEP Program, you will not have to pay for the medicine. The costs of clinic visits and lab test costs may vary depending on your income.
Click here for more information about Ready, Set, PrEP. To apply for the program, visit GetYourPrEP.com or call (855) 447-8410.
Does Medicaid cover PrEP? What about Medicare?
Yes. Both Medicaid, as well as Medicare, should cover PrEP.
Depending on what state you live in, Medicaid may require your physician to obtain a pre-approval for PrEP before you fill your prescription.
If you are on Medicare but do not have Part D prescription drug coverage, you may be able to receive PrEP for free from its manufacturer if you have a low income. You may also be eligible for co-pay assistance if you are on Medicare.