Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Health Equity Forum Podcast

Health Equity Forum Podcast

                        Toward Improving Race and Ethnicity Data in Health Care (RAISE)
          What You Need to Know about FDA’s Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions Home
          For Consumers
          Minority Health and Health Equity
          Health Equity Forum Podcast
          PrEP and PEP for HIV Prevention in Older AdultsHealth Equity Forum Podcast PrEP and PEP for HIV Prevention in Older Adults
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListen (MP3, 27MB)
 In this episode, we'll be talking about the use of medication regimens known as PrEP and PEP as part of HIV prevention strategies for older adults with Dr. Debra Birnkrant, MD, Director, Division of Antivirals, Center for Drugs Evaluation and Research (CDER).

Health Equity Forum Podcast: Episode 5 - Transcript

**RADM Araojo:**Hello, and welcome to The Health Equity Forum Podcast, hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA. In this episode, we'll be talking about the use of medication regimens known as PrEP and PEP as part of HIV prevention strategies for older adults.

HIV is not only a disease of young people. According to the most recent data from 2018, almost 1 in 6 new diagnoses of HIV were in people age 50 and over. African Americans and Hispanics/Latinos had the highest HIV incidence among this group. Like everyone else, older adults can acquire HIV from having unprotected sex with someone living with HIV, through contact with HIV infected blood, or by sharing needles with the person living with HIV. For those at high risk of HIV infection through sex or injection drug use, PrEP and PEP are medication regimens that can greatly reduce their risk of transmission. In 2019, the US Department of Health and Human Services embarked upon a bold initiative called Ending The HIV Epidemic in The United States. This initiative aims to reduce the number of new HIV infections in the United States by 75% by 2025, and then by at least 90% by 2030 for an estimated 250,000 total HIV infections averted.

Both younger and older Americans alike are at risk of HIV infection. So it's important for everyone to be aware of how to protect themselves. To talk about the use of PrEP and PEP for HIV prevention among older adults. I'd like to welcome Dr. Debra Birnkrant, Director of the Division of Antivirals and the Center for Drug Evaluation and Research at FDA. Welcome Dr. Birnkrant.

**Dr. Debra Birnkrant:**Thank you for having me Rear Admiral Araojo.

**RADM Araojo:** Dr. Birnkrant, what is your role as the Director of the Division of Antivirals? And can you describe the work of your division?

**Dr. Debra Birnkrant:**Our division is part of the Office of Infectious Diseases in the Center for Drug Evaluation and Research at FDA. We review all applications for antiviral drug products.

**RADM Araojo****:** Why don't we start by providing listeners a brief explanation of what HIV is?

**Dr. Debra Birnkrant:**Sure. HIV stands for Human Immunodeficiency Virus. It's a retrovirus that infects immune cells and impairs the body's ability to protect itself against other infections or cancer. If left untreated, HIV usually progresses to AIDS, which stands for Acquired Immune Deficiency Syndrome. AIDS is a devastating, life-threatening condition that causes serious damage to the body's immune system. There is no cure for HIV, but progress in the treatment and prevention of HIV has advanced significantly since AIDS was first documented in 1981. We now have medications to treat HIV called Antiretroviral Therapy or A-R-T. These work to decrease the amount of HIV in the body, which helps prevent the damage that can be caused by HIV and keep HIV infection from progressing to AIDS. People living with HIV can live longer, healthier lives when they maintain their antiretroviral treatment regimen.

**RADM Araojo:** Why is HIV prevention important for older adults?

**Dr. Debra Birnkrant:** Well, although we've come a long way, HIV is still a major public health problem. Over 1 million Americans are living with HIV and nearly half of those are age 50 and over. This may be attributable to the fact that people with HIV are living longer, thanks to Antiretroviral Therapy. But we also have a significant number of new diagnoses of HIV in older adults. This may be because older adults don't perceive themselves to be at high risk for HIV infection, as it has historically been viewed as a disease of young people. But if they are staying sexually active and engaging in high risk sexual activities or injection drug use, older adults have the same risk for becoming infected with HIV as their younger peers.

For instance, when consistently and correctly used, condoms are highly effective in preventing HIV infection due to sex. However, some post-menopausal women may not feel the need to use a condom with their male partners because they know they cannot become pregnant. Also, some older adults may not be as aware of the risk factors for HIV or how to protect themselves as younger people if they are new to the dating scene, because of a divorce or death of a longtime partner.

So older adults are still vulnerable to HIV infection. And unfortunately, HIV testing rates among adults over 50 are very low. Older adults should get tested to know their HIV status if they are sexually active, outside the monogamous relationship or inject drugs, even if they have no symptoms. Some older adults notice symptoms of HIV, but don't get tested as they assume common symptoms like fatigue and weight loss are part of the aging process. When it's not caught early, HIV infection can progress further and be more difficult to treat. There's also the issue of stigma associated with HIV and AIDS that may be stronger in older generations. Stigma negatively affects a person's quality of life, their self-image, and their ability to adopt healthy behaviors. So even though older adults may visit with their healthcare providers more often, they may be uncomfortable discussing their sex lives. And, if a healthcare provider doesn't routinely ask their older patients about these risk factors, high risk patients may remain unaware of the need to get tested for HIV and prevention options like PrEP and PEP.

**RADM Araojo:** And what is PrEP and PEP?

**Dr, Debra Birnkrant:** PrEP and PEP are medications that HIV negative people can take to prevent HIV infection. PrEP stands for Pre-exposure Prophylaxis. Right now, PrEP is a pill you take every day before possible exposure to HIV to prevent you from getting HIV from unprotected sex. PEP, which stands for Post-exposure Prophylaxis is a series of pills you take for emergency prevention of HIV after a single high risk exposure. Some situations that would warrant the use of PEP are unprotected sex with someone who is HIV positive or who's HIV status is unknown. Sexual assault and sharing needles, or using other equipment to inject drugs with someone who may have HIV.

**RADM Araojo:** Okay. So let's focus on PrEP first. Can you tell us more about its use?

**Dr. Debra Birnkrant:** Currently approved PrEP options are a combination antiretroviral medications consisting of tenofovir and emtricitabine, that are commonly used to stop HIV from replicating and people who are already infected. However, if taken daily in people who are HIV negative, the presence of these medicines in the bloodstream can usually stop the virus from establishing itself in the body and spreading following an HIV exposure. So the individual remains HIV negative. It's not a vaccine though. Vaccines train the body's immune system to fight off viruses for years. PrEP only works if you take it every day to keep enough of the medication in your bloodstream to block the virus. There are a couple of different medications approved for PrEP on the market right now. The difference has to do with the type of tenofovir included in the medication. It is important to discuss with your healthcare provider about which PrEP medication is right for you.

**RADM Araojo:** Who should consider using PrEP?

**Dr. Debra Birnkrant:** PrEP is for individuals who have been tested and found to be HIV negative, but who may be at substantial risk of becoming infected through sex. The types of sexual activities that are at highest risk are anal and vaginal sex. If you are HIV negative, but have engaged in anal or vaginal sex in the past six months and your sexual partner is living with HIV or is at risk of HIV infection because they have sex with multiple partners for instance, PrEP may benefit you. People who have sexually transmitted diseases are also more likely to get HIV. So consider PrEP if you have been diagnosed with a sexually transmitted disease in the past six months, or do not regularly use condoms.

RADM Araojo: And how effective is PrEP?

**Dr. Debra Birnkrant:** Studies show that PrEP lowers the chances of getting HIV from sex by about 99% when taken daily. While we do not know for sure how long you need to take PrEP before you reach maximal protection, the CDC recommends you should take PrEP for about seven days to reach maximum protection from HIV infection if you have anal sex and for 21 days for maximum protection, if you have vaginal sex.

**RADM Araojo:** That's a significant reduction in risk. How can someone obtain PrEP?

**Dr. Debra Birnkrant:** Well, you will need a prescription from your healthcare provider. There is also an online tool called preplocator.org that you can use to find a healthcare provider in your area who can prescribe PrEP. Your provider will want you to come in for an appointment to discuss your risk of HIV infection. If they agree that you are a good candidate for PrEP, they'll want to conduct a general physical exam and do an HIV test to make sure you are HIV negative. You will also be tested to see if your kidneys and liver are functioning well. Then once you are prescribed PrEP, be prepared for regular follow up appointments so your healthcare provider can monitor how your body is reacting to PrEP and check your HIV status to make sure you remain HIV negative.

**RADM Araojo:** Let's talk about PEP. When should a person start taking PEP?

**Dr. Debra Birnkrant:** PEP should be taken within three days of a possible exposure to HIV. The sooner PEP is started after a possible HIV exposure, the better. Keep in mind that PEP is for a single, one-time HIV exposure. It shouldn't be used in place of other HIV prevention methods, by people who may be exposed to HIV repeatedly.

**RADM Araojo:** And how effective is PEP?

**Dr. Debra Birnkrant:** Well like PrEP, PEP is also a combination of antiretroviral drugs that can help prevent HIV from spreading in the body if taken within the 72 hour window from the time of exposure. While taking PEP, it's important to keep using other HIV prevention methods such as condoms. Once started, the use of a PEP regimen is 28 days. It's believed to be more than 80% effective as long as a patient completes the full course by taking the medication every day and avoids additional exposures to HIV.

**RADM Araojo:** And how can someone obtain PEP?

**Dr. Debra Birnkrant:** Talk to your healthcare provider, an emergency room doctor, or an urgent healthcare provider about PEP right away if you think you've been exposed to HIV. They'll determine your level of risk and whether a prescription for PEP makes sense for you.

**RADM Araojo:** Are there any side effects for PrEP or PEP consumers should know about?

**Dr. Debra Birnkrant:** The most common side effects observed with PrEP and PEP are mild to moderate gastrointestinal effects like nausea or upset stomach, fatigue or headache. These side effects usually go away over time and most people don't have to change or stop taking their medication.

**RADM Araojo:** What kinds of questions should older adults ask their healthcare provider when discussing the use of PrEP or PEP for HIV prevention?

**Dr. Debra Birnkrant:** Well, it's always important to discuss any other medications you are taking with your healthcare provider before starting a new prescription, particularly for older adults who may be taking multiple medications each day. And don't forget to discuss over the counter medications like herbs, vitamins, supplements, and any other drugs you may take to avoid any potential interactions with PrEP or PEP. Likewise, ask your healthcare provider whether PrEP or PEP is a good choice for you considering any current medical conditions you may have. And some other good questions to ask are how to manage my side effects, should you experience them, how to remind yourself to take your medication each day, and what to do if you miss a dose. Also, keep in mind that while PEP has given for a limited duration of 28 days, PrEP should be taken for as long as you remain at risk of HIV. However, PrEP doesn't have to be a lifelong treatment. Discuss with your doctor if you feel your risk of HIV has changed and whether it is safe to stop PrEP. Do not stop PEP or PrEP without first discussing with your doctor.

**RADM Araojo:** Can you talk more about the possible side effects of long-term PrEP use?

**Dr. Debra Birnkrant:** Tenofovir, one of the main ingredients of currently approved PrEP is associated with a small risk of decreased kidney function and or bone density loss. You might also experience some minor weight changes and changes to your blood cholesterol levels, depending on which PrEP medication you are prescribed. Your doctor will need to determine if you're a good candidate for PrEP based on your lab test results and medical history. And will monitor you for these potential issues while you remain on PrEP.

**RADM Araojo:** Where can consumers get more information or resources?

**Dr. Debra Birnkrant:** They can visit hiv.gov for more information on HIV prevention options. This is where you'll find the HIV services locator I mentioned earlier, preplocator.org. Another good resource is the CDCs campaign, Let's Stop HIV Together, aimed at stopping HIV stigma and promoting HIV testing, prevention and treatment.

**RADM Araojo:** And finally, is there anything else you would like our listeners to know?

**Dr. Debra Birnkrant:** I want to emphasize that neither PrEP nor PEP is a cure for HIV or AIDS, and neither is 100% effective at preventing HIV infection. They also don't work against other sexually transmitted diseases. To get the most protection during sex while using PrEP or PEP, always use a condom. It's a good idea to talk with your doctor and learn about safer sex practices, no matter what your age. And avoid sharing needles or any other equipment use to inject drugs. Always use new sterile needles for injection. The best way for us to reduce the spread of HIV is through routine screening, get tested to know your HIV status and ask your partners to do the same. You may also be at higher risk if you or your partner had a blood transfusion between 1978 and 1985 in the United States, or a blood transfusion in a developing country at any time. If you have ever been diagnosed with or treated for hepatitis or tuberculosis, your risk of HIV may be higher as well.

**RADM Araojo:** Dr. Birnkrant, thank you so much for joining me today to discuss PrEP and PEP use among older adults for HIV prevention and for sharing such valuable information with our listeners.

**Dr. Debra Birnkrant:** Thanks for having me.

**RADM Araojo:** For more information about the Health Equity Forum Podcast series, visit our website at www.fda.gov/healthequity. While you're there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @FDAHealthEquity. Remember, together we can create a world where health equity is a reality for all.

[end of transcript]

                                                                                  Content current as of:
      08/27/2021Health Equity Forum Podcast

          
                        RAISE
          What You Need to Know about FDA’s Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop