Pre-Exposure Prophylaxis (PrEP)
This factsheet summarizes CDC’s 2021 update to the Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—A Clinical Practice Guideline. The updates in this version of the guideline give health care providers the latest information on prescribing pre-exposure prophylaxis (PrEP) for HIV prevention to their patients and increasing PrEP use by people who could benefit from it.
Dr. Demetre Daskalakis, Director of CDC’s Division of HIV Prevention, and Dr. Dawn Smith, Medical Officer with DHP’s HIV Research Branch, host a webinar about Pre-Exposure Prophylaxis (PrEP) for HIV prevention. The webinar covers:
- The state of HIV in the United States
- The role of PrEP in the Ending the HIV Epidemic in the U.S. initiative
- Challenges to implementing PrEP in the U.S.
- An overview of the new PrEP Guideline
- Future opportunities and resources
Following the presentation, Drs. Daskalakis and Smith answer attendee questions.
Please note: The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
What is PrEP?
PrEP is short for pre-exposure prophylaxis. It is the use of antiretroviral medication to prevent HIV infection. PrEP is used by people without HIV who may be exposed to HIV through sex or injection drug use.
The US Food and Drug Administration (FDA) has approved three medications for use as PrEP, which are listed below. Two consist of a combination of drugs in a single oral tablet taken daily. The third medication is a medicine given by injection every 2 months.
- Emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (F/TDF – brand name Truvada® or generic equivalent).
- Emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (F/TAF – brand name Descovy®).
- Cabotegravir (CAB) 600 mg injection (brand name Apretude®).
These medications are approved to prevent HIV infection in adults and adolescents weighing at least 35 kg (77 lb) as follows:
- Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use.
- Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex. F/TAF has not yet been studied for HIV prevention for people assigned female at birth who could get HIV through receptive vaginal sex.
- Injectable PrEP with CAB is recommended to prevent HIV infection among all people at risk through sex. It may be especially useful for people who have problems taking oral PrEP as prescribed, who prefer getting a shot every 2 months instead of taking oral PrEP, or who have serious kidney disease that prevents use of oral PrEP medications.
PrEP should be considered part of a comprehensive prevention plan that includes a discussion about adherence to PrEP, condom use to prevent getting other sexually transmitted infections (STIs), and other risk-reduction methods.
What are the guidelines for prescribing PrEP?
The Centers for Disease Control and Prevention (CDC) has published comprehensive guidelines for prescribing PrEP in A Clinical Practice Guideline for PrEP [PDF – 1.6 MB], including a Clinical Providers’ Supplement for PrEP [PDF – 809 KB].
The Clinical Providers’ Supplement for PrEP [PDF – 809 KB] contains additional tools for health care providers providing PrEP, such as patient/provider checklists; patient information sheets; provider information sheets; HIV risk screening assessments for gay, bisexual, and other men who have sex with men (collectively referred to as MSM) and people who inject drugs; supplemental counseling information; billing codes; and practice quality measures. Health care providers who have questions about PrEP or would like advice about prescribing PrEP or HIV testing should consult the National Clinicians Consultation Center PrEPline at 1-855-448-7737 (9:00 AM – 8:00 PM EST).
The US Preventive Services Task Force has given oral PrEP a grade A recommendation. This grade indicates that their review found high certainty that the net benefit of this service is substantial. For more information, view the full recommendation rationale at USPSTF.
Who can prescribe PrEP?
Any licensed prescriber can prescribe PrEP. The provider does not have to specialize in infectious diseases or HIV medicine. PrEP is a primary care preventive service that should be offered by any prescriber who cares for people without HIV.
To whom should I offer PrEP?
Providers should tell all their sexually active patients about PrEP and how it can protect them from getting HIV. Telling all sexually active patients about PrEP will increase the number of people who know about PrEP and may also help patients overcome embarrassment or stigma that may prevent them from telling their health care provider about behaviors that put them at risk for getting HIV.[4-9] Providers should prescribe PrEP to anyone who asks for it, including sexually active adults and adolescents who do not report behaviors that put them at risk for getting HIV.
Whether or not a patient asks for PrEP, it is important to take a sexual and substance use history. This information is essential to understand each patient’s risk of getting HIV, if PrEP might be right for them, and what other risk-reduction services should be offered. Providers can use the following flowcharts to assess patients before offering PrEP.
Assessing Indications for PrEP in Sexually Active People
Assessing Indications for PrEP in People Who Inject Drugs
How is PrEP prescribed?
Oral PrEP is FDA approved to be taken once daily by mouth.[10,11]
Cabotegravir for PrEP is FDA approved as an intramuscular injection in the buttocks initiated as a first injection followed by a second injection 1 month after the first and then continued with an injection every 2 months thereafter. A 4-week lead-in period of 30 mg daily oral CAB prior to the first injection is optional for patients who are worried about side effects.
For patient information about PrEP, access the Clinical Providers’ Supplement for PrEP [PDF – 809 KB], Section 3: Medication Information Sheets.
What is the evidence base for PrEP?
Multiple studies have demonstrated that PrEP is highly effective when taken as prescribed.
|Transmission Route||Effectiveness Estimate||Interpretation|
|Sexual||~99%||Very high levels of adherence to PrEP provide maximum effectiveness.|
|Injection drug use||74% – 84%||These estimates are based on tenofovir alone and not necessarily when taken daily. The effectiveness may be greater for the two-drug oral therapy and if used daily.|
Summaries of clinical trials showing the efficacy and safety of both oral and injectable PrEP are included in A Clinical Practice Guideline for PrEP [PDF – 1.6 MB].
How important is adherence to PrEP?
To be effective, PrEP requires high levels of adherence.
Oral PrEP. When taken as prescribed, oral PrEP is extremely effective in preventing HIV. A few cases of HIV infection have been reported among MSM whose high adherence to PrEP was verified. These rare cases show that the risk of HIV when oral PrEP is taken as prescribed is extremely low.
Based on existing research, oral PrEP reaches maximum drug levels associated with protection from HIV for receptive anal sex at about 7 days of daily use. For receptive vaginal sex and injection drug use, oral PrEP reaches maximum drug levels at up to about 21 days of daily use.
Health care providers can prescribe F/TDF off-label using “2-1-1” dosing for adult MSM. This is also known as event-driven, intermittent, or on-demand PrEP. When using 2-1-1 dosing, the patient takes F/TDF doses based on when they plan to have sex: two pills 2–24 hours before sex, one pill 24 hours after the first two-pill dose, and one pill 48 hours after the first two-pill dose.
Off-label 2-1-1 dosing can be prescribed to MSM who meet the following criteria:
- Request non-daily dosing.
- Have sex infrequently (e.g., less often than once a week).
- Can anticipate sex (or delay sex) to permit the first two-pill dose at least 2 hours prior to sex.
2-1-1 dosing should not be prescribed for MSM who might have problems adhering to a complex dosing regimen (e.g., adolescents, patients with an active substance use disorder). Note that 2-1-1 dosing is not approved by the FDA and is not recommended by CDC. CAB injections may be appropriate for people who have problems taking oral PrEP as prescribed.
Injectable PrEP. Returning for bimonthly injections is necessary to maintain protective levels of medication. In trials, HIV infections have occurred among people who delayed receiving their injections for several months. There are no available data for CAB to estimate how long it takes to reach maximal drug levels associated with protection against HIV acquisition.
Is PrEP safe?
Yes. PrEP has not caused serious short- or medium-term safety concerns.[14-17] F/TDF as PrEP is considered generally safe for people who are pregnant and breastfeeding. If a patient who is or may become pregnant has concerns, the health care provider should discuss those concerns with the patient. Then, the provider and patient can decide together if the risk of getting HIV through sex or injection drug use is high enough to use PrEP, knowing that pregnancy is associated with an increased risk of HIV acquisition.
Oral PrEP. Because F/TDF and F/TAF are eliminated by the kidneys, oral PrEP should only be used in patients without significant kidney impairment (see Kidney Function, below). It should be co-administered with care in patients taking other drugs eliminated by the kidneys (e.g., acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, and high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs]). Drugs that decrease kidney function may also increase serum concentrations of tenofovir or emtricitabine.[10,11] Instead of oral PrEP, CAB injections are recommended for people who have severe kidney disease with estimated creatinine clearance (eCrCl) <30 mL/min.
Injectable PrEP. In clinical trials, injection site reactions (e.g., pain, tenderness, local skin swelling) were frequently reported following CAB injections. Patients should be informed that these reactions are common, are generally mild or moderate, and do not last long.
Who should not be prescribed oral PrEP?
- People with HIV. Health care providers must confirm that patients are HIV-negative before starting PrEP. Excluding people with acute HIV infection is critically important so that they do not develop drug-resistant HIV because they took PrEP medication while in the early stages of HIV infection. F/TDF and F/TAF are appropriate parts of a regimen to treat HIV but must be combined with additional antiretrovirals to provide effective treatment.
- People with severe kidney impairment. Before prescribing oral PrEP, providers should confirm that each patient’s estimated creatinine clearance is high enough, using the Cockcroft-Gault formula:
- ≥60 mL/minute for F/TDF or F/TAF.
- ≥30 mL/minute for F/TAF.
Who should not be prescribed 2-1-1 dosing of oral PrEP?
- People other than adult MSM. The 2-1-1 dosing method has only been studied in adult MSM.
- People with active hepatitis B (HBV) infection. Episodic F/TDF exposure can cause hepatic flares in people with active HBV infection and should be avoided.
Who should not be prescribed PrEP injections?
- People with HIV. Health care providers must confirm that patients are HIV-negative before starting PrEP. Excluding people with acute HIV infection is critically important so that they do not develop drug-resistant HIV because they took PrEP medication while in the early stages of HIV infection. CAB must be combined with other antiretroviral medication to provide effective treatment for people with HIV.
- People with sensitivity to CAB. CAB should not be given to people with a history of hypersensitivity reaction to CAB.
What baseline assessment is required for individuals beginning PrEP?
HIV testing is required to confirm that patients do not have HIV infection when they start taking PrEP. Required testing differs for people who have or do not have recent antiretroviral PrEP or post-exposure prophylaxis (PEP) use. Recent use is defined as taking oral PrEP in the last 3 months or receiving a CAB injection in the last 12 months.
For patients who are starting or restarting PrEP after a long stop, test using an HIV antigen/antibody test (a laboratory-based test is preferred).
For patients who are taking or have recently taken PrEP, test using an HIV antigen/antibody test and a qualitative (or quantitative) HIV-1 RNA test.
If a patient has a negative antigen/antibody test and an undetectable HIV-1 RNA test (if applicable) confirming they do not have HIV, PrEP can be prescribed. However, if a patient has both a positive antigen/antibody test and a detectable HIV-1 RNA test confirming that they have HIV, link that patient to HIV care and treatment. If results are discordant or ambiguous, a new blood specimen should be obtained for retesting, and PrEP should not be prescribed until true HIV status is confirmed. For assistance with ambiguous HIV test results, contact the PrEPline (1-855-448-7737) to get advice and find a laboratory that can do specialized testing.
The required HIV testing can be done by one of two methods:
- Drawing blood, sending it to a laboratory for testing, and getting the results before prescribing or continuing PrEP.
- Administering a rapid, point-of-care, FDA-approved fingerstick HIV antigen/antibody blood test and drawing blood to send for laboratory testing. PrEP can be prescribed or continued based on a negative rapid antigen/antibody test result while awaiting laboratory test results.
Oral rapid tests should not be used to screen for HIV infection when considering offering or continuing PrEP because they are less sensitive than blood tests and may not detect recent HIV infection. A listing of FDA-approved HIV tests, specimen requirements, and time to detection of HIV infection is available at our laboratory testing page.
Since PrEP is indicated for people at risk of getting HIV, health care providers should suspect acute HIV infection in patients who were recently exposed. Providers should ask all PrEP candidates with a negative or indeterminate result on an HIV test about whether they have experienced any signs or symptoms of viral infection in the preceding month or on the day of evaluation.
For a patient with signs/symptoms of acute HIV infection within the prior 4 weeks, the following options are suggested:
- Test the patient with a combination antigen/antibody assay. Ideally, use a laboratory-based method. If a point-of-care antigen/antibody test is used and is non-reactive (negative), PrEP can be started while waiting for confirmatory laboratory test results.
- Test the patient’s HIV-1 RNA. If the patient has a measurable viral load that is <200 copies/mL, they may have HIV or a false-positive test result. PrEP should be deferred while testing is repeated on a new blood specimen. If the viral load is below the level of detection of the assay for the second blood specimen, and the patient has no signs/symptoms on that day, the first HIV-1 RNA test result was a false positive. The patient is considered to not have HIV, and PrEP can be started.
Tests to screen for chlamydia, gonorrhea, and syphilis are recommended for all sexually active adults before starting oral or injectable PrEP.
Oral PrEP. For patients taking F/TDF or F/TAF as PrEP, assess kidney function before starting PrEP.
When used as PrEP, tenofovir can cause decreases in kidney function that are generally small, usually remain within the normal range, and are of no known clinical significance.[20,21] These small decreases typically return to earlier levels when the patient stops taking the medication.[10,11] Occasional cases of acute kidney failure, including Fanconi’s syndrome, have occurred.[22-29] Therefore, all patients considered for oral PrEP must have their kidney function assessed at PrEP initiation and periodically thereafter so that oral PrEP can be stopped, if necessary.
Kidney function should be assessed by using the Cockcroft-Gault formula with the patient’s serum creatinine value to calculate an eCrCl. F/TDF is approved for use in people with eCrCl >60 mL/min. F/TAF is approved for use in people with eCrCl <60 mL/min but ≥30 mL/min. Either F/TDF or F/TAF can be used when eCrCl >60 mL/min. 
Injectable PrEP. For patients taking CAB, kidney assessments are not needed.
Hepatitis B (HBV) Serology
Emtricitabine and tenofovir can be used to treat active HBV infection. However, in people with active HBV, stopping these medicines can result in a rebound of HBV replication leading to liver damage. HBV infection is not a contraindication to PrEP, but all people considered for PrEP with F/TDF or F/TAF must be screened for HBV. Patients with active HBV infection should be educated about the risks of stopping oral PrEP without appropriate follow up so that if they stop using oral PrEP, their liver function can be closely monitored for reactivation of HBV replication that could cause liver damage.
For patients taking F/TAF as PrEP, assess cholesterol and triglyceride levels before starting PrEP.
What additional support and ongoing assessments are required for patients on oral PrEP?
Prescribe PrEP as part of a combination prevention plan. At minimum, while patients are on oral PrEP, CDC guidelines recommend that health care providers:
|Provide the following services:|
|At least every 3 months:||
|At least every 6 months:||
|At least every 12 months:||
What if a patient wants to discontinue oral PrEP?
How to safely discontinue and restart daily PrEP use should be discussed with patients both when starting PrEP and when discontinuing PrEP. Protection from HIV infection will wane over 7-10 days after ceasing daily oral PrEP use. Because some patients have acquired HIV soon after stopping PrEP, providers should assess ongoing risk for HIV and discuss other prevention methods if HIV exposure is anticipated, including nonoccupational PEP.
What additional support and ongoing assessments are required for patients taking injectable PrEP?
Prescribe PrEP as part of a combination prevention plan. At minimum, while patients are on injectable PrEP, CDC guidelines recommend that health care providers:
|Provide the following services:|
|At visit 1 month after initial injection (month 1, second injection):||
|At each bimonthly visit (beginning with the third injection [month 3]):||
|At least every 4 months (every other injection visit, beginning with the third injection [month 3]):||
|At least every 6 months (beginning with the fifth injection [month 7]):||
|At least every 12 months (after the first injection):||
What if a patient wants to discontinue injectable PrEP?
CAB levels slowly wane over many months after injections are discontinued. At some point during this “tail” phase, CAB levels will fall below a protective threshold and persist for some time at nonprotective levels (for more information, see page 53 of the Guideline). For these reasons, patients discontinuing CAB injections who may be at ongoing risk should be provided with another highly effective HIV prevention method during the months following their last injection. Clinicians should:
- Counsel patients about the risk of developing drug-resistant HIV during declining CAB levels (the “tail period”) after CAB injections are stopped or when injections are missed.
- Assess ongoing risk for HIV exposure and prescribe daily oral PrEP within 8 weeks after the last CAB injection or other prevention methods if HIV exposure is anticipated, including nonoccupational PEP.
- Continue follow-up visits quarterly for 12 months.
- Conduct antigen/antibody and HIV-1 RNA tests at each quarterly follow-up visit after stopping CAB injections.
How can HIV status be confirmed if a PrEP patient has ambiguous HIV test results at a follow-up visit?
If a patient has unclear HIV test results at a follow-up visit, providers can follow these steps to confirm the patient’s true HIV status:
- Wait 5-7 days and then draw a new blood specimen for repeat laboratory HIV testing using both an HIV antigen/antibody test and an HIV-1 RNA assay.
- If the repeat testing results show the patient has HIV, link the patient to HIV care and treatment. If the repeat testing results confirm that the patient does not have HIV, PrEP can be continued.
- If the results are still ambiguous, contact the PrEPline (1-855-448-7737) to get further testing advice and for linkage to a laboratory that can do specialized testing to confirm their HIV status.
While HIV status is being confirmed, providers have the following antiretroviral management options:
For patients using oral PrEP:
- Continue oral PrEP medication: Because PrEP is highly effective, it is unlikely that a patient who takes PrEP medication as prescribed will get HIV. If the patient does get HIV, continuing PrEP offers some level of viral suppression but may select for drug resistance (particularly M184v). If this occurs, there are well-tolerated and highly effective treatment regimens available.
- Prescribe a third drug as PEP for 28 days: This option provides a fully suppressive treatment regimen without the need to diagnose the patient with HIV, which can be difficult to undo if further testing shows the patient does not have HIV. If the patient is found to have HIV, this regimen can be considered early antiretroviral initiation and be continued. This option is especially applicable for patients who may not have taken their daily oral PrEP medication as prescribed.
- Stop oral PrEP medication for 1–2 weeks: If the patient has HIV, briefly stopping PrEP allows time for HIV replication to occur and increases the likelihood that an HIV test will detect the virus, if it is present. Note that stopping oral PrEP will leave the patient with less protection from HIV because oral PrEP levels wane over 7–10 days after the medication is stopped.
For patients using CAB injections:
- Pause CAB injections until testing shows that the patient does not have HIV.
- During the 1–2 weeks needed for additional HIV testing to determine HIV status, CAB is likely to remain at protective levels.
- If the patient has HIV, start HIV treatment immediately.
- If the patient does not have HIV, resume CAB injections every 2 months.
How will my patients pay for PrEP medication, clinical visits, and lab tests?
Most insurance plans and state Medicaid programs cover oral PrEP. Prior authorization may be required.
Uninsured patients can be assisted to apply for Medicaid or Affordable Care Act (ACA) marketplace insurance programs if they are eligible. To assist patients in choosing an ACA plan for PrEP coverage, visit NASTAD.
Assistance for oral PrEP. Various programs are available to help patients pay for oral PrEP medication, co-pays, and clinical visits and lab costs.
Ready, Set, PrEP makes PrEP medication available at no cost to patients without HIV who have a prescription but no insurance coverage for PrEP medication, regardless of income. To learn more, call toll-free 1-855-447-8410 or visit Ready, Set, PrEP.
The Gilead Sciences Advancing Access program offers eligible patients assistance with medication costs. For more information, visit Gilead’s Advancing Access.
Additionally, some states have their own PrEP assistance programs. Some cover medication, some cover clinical visit and lab costs, and some cover both. To learn more, visit NASTAD.
Assistance for injectable PrEP. ViiVConnect offers a medication assistance program to help patients pay for CAB injections. For more information, visit ViiVConnect.
How should a patient who acquires HIV infection while taking PrEP be managed?
Once additional laboratory tests have confirmed infection, the following steps should be taken:
- Initiate treatment or refer for comprehensive HIV care.
- Counsel the patient about how to prevent HIV transmission to others and to improve their own health.
- Report the new HIV infection to the local health department.
To learn more about HIV treatment, visit: https://www.cdc.gov/hiv/clinicians/treatment/.
How do I provide PrEP by telehealth services?
The recent expansion of telehealth visits to replace some or all in-clinic visits has led to adaptations for the provision of PrEP. These adaptations can include the following procedures:
- Providers may conduct PrEP screening, initiation, or follow-up visits by phone or web-based consult with patients.
- Regular HIV testing should be continued for patient safety. Lab-only visits for HIV testing and other indicated tests for the provision of PrEP are strongly preferred. If lab-only visits are not possible, CDC recommends considering two additional options:
- Some laboratories (such as Molecular Testing LabsTM) have validated protocols for testing home-collected samples for the panel of tests required for patients starting or continuing PrEP. This type of laboratory test is sensitive enough to detect recent HIV infection.
- Only in situations where no laboratory or clinic visits are possible (e.g., local emergencies or lock-downs), patients may conduct self-testing using an oral swab-based test. This type of HIV test is usually not recommended for PrEP patients because it may not detect recent HIV infection in people taking PrEP medications.
- Once HIV-negative status is confirmed, if prescribing oral PrEP, providers can consider writing a prescription for a 90-day supply of medication rather than a 30-day supply with two refills. This will help patients minimize trips to the pharmacy and facilitate oral PrEP adherence.
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