PrEP OVERVIEW

PrEP (Pre-Exposure Prophylaxis) is an FDA-approved, once-daily oral medication for people who are HIV negative. The use of PrEP has been recommended by the Centers for Disease Control and Prevention for those who are at risk of getting HIV. If taken as prescribed, PrEP is over 90% effective in preventing HIV. 1

PrEP can make a big difference in the lives of those who use it, inspiring peace of mind and confidence. A patient’s choice to take PrEP can also be an empowering decision leading to safer sex and the ability to take control of his/her overall health and wellness.

If you are a healthcare provider in Colorado who is interested in incorporating PrEP in your practice, the Colorado Dept. of Public Health & Environment offers free Public Health Detailing. Please inquire about detailing by calling 1-844-367-7075 ext. 3, or by completing a Detailing Request Form.

 

TABLE OF CONTENTS

  1. PrEP Quick Facts
  2. PrEP In Your Practice
  3. HIV Epidemiology
  4. PrEP Prescribing Guidelines
  5. Post-Exposure Prophylaxis (nPEP)
  6. Frequently Asked Questions
  7. Financial Assistance For Patients
  8. Sexual Health
  9. Provider Resources, Guidelines, and Print Materials
  10. References

PrEP Quick Facts

  • PrEP is a once-daily pill for people who are HIV negative that can help prevent HIV transmission.
  • PrEP can reduce the risk of HIV by more than 90%.1
  • PrEP is safe. No significant health effects have been observed among individuals who have taken PrEP for up to five years.2
  • PrEP was FDA approved in 2012 as the fixed-dose antiretroviral medication Truvada®.

Who may benefit from PrEP?

  • Men who have sex with men (MSM)
  • People who inject drugs
  • Anyone with a partner with or at risk for HIV
  • Transgender individuals

PrEP In Your Practice

  1. Prescribing PrEP is not difficult. As with many other prescriptions, labs are checked regularly, possible side effects are reviewed at follow-up visits, and conversations are open between patient and provider. There are no special trainings or certifications needed to prescribe Truvada for PrEP.
  2. PrEP is effective in preventing HIV. When taken daily, studies demonstrate that Truvada for PrEP reduces risk of HIV by more than 92%. Truvada was approved for PrEP by the FDA in 2012, and the US Public Health Service and the CDC issued clinical guidelines for PrEP in 2014.1
  3. HIV is still being diagnosed in Colorado. For the past five years, the rate of new diagnoses of HIV in Colorado has remained steadily between 325 and 400 each year.3 That’s about one case every single day.
  4. You have the best connection to HIV negative patients who may be interested in PrEP. If you are a primary care provider (PCP), many patients will already be comfortable with you and prefer seeing you rather than having to see a specialist.
  5. Get creative with scheduling. Patients are seen every three months for labs, counseling, and STI/HIV testing, but many of these visits can be completed by other staff, with provider review and consultation when necessary.
  6. Side effects are minimal and manageable. About 10% of patients experience GI symptoms or fatigue, and these symptoms typically resolve within a few weeks. Kidney function is monitored every six months with a simple serum creatinine test.2
  7. Your patients can afford PrEP. Many insurance companies cover Truvada for PrEP including Health First Colorado (Colorado’s Medicaid Program).
  8. Drug resistance has been extremely rare. To date, there have been four cases of reported PrEP failure, with two of those attributed to drug-resistant virus. Because PrEP is not adequate treatment for HIV, patients should be tested and documented as HIV negative before starting PrEP and every three months thereafter.4, 5, 16
  9. You have the chance to make a huge difference for your patients. This is a new era in HIV prevention. For patients interested in PrEP, this can be a game-changer in decreasing the anxiety and stigma they may feel around their sexuality and their health.
  10. You have the opportunity to help stop the spread of HIV. Combined with effective viral suppression available for people living with HIV, PrEP as an additional prevention tool can truly get all of us closer to a world without HIV.

HIV Epidemiology

Despite falling rates of new HIV diagnoses throughout the US, rates are remaining fairly constant in Colorado.3 Providers now have an additional tool to help prevent HIV in your patients who might be at risk. You can contribute to decreasing new diagnoses of HIV in Colorado and can help improve the odds for people of color.

HIV in Colorado

  • Prevalence: Around 12,300 Coloradans aged ≥ 13 years are living with HIV (including about 9% who are undiagnosed) according to the CDC’s HIV Surveillance Supplemental Report (2014).6
  • Incidence: Over the past five years, between 325 and 400 new HIV diagnoses have been made each year in Colorado.3 In combination with viral load suppression in people living with HIV and other options for risk reduction, PrEP can help limit the spread of HIV.
  • Based on CDC data, there are approximately 39,700 men ages 18-59 who have had sex with men within the last 12 months living in Colorado.7 The CDC’s model estimates that 24.7% of those individuals (about 9,800) would benefit from PrEP.8

Health disparities and HIV

  • In 2015, African Americans accounted for 45% of HIV diagnoses, though they comprise 12% of the US population. According to the US pharmacy PrEP survey (January 2012 through September 2015), Caucasians made up 74% of all those who filled Truvada PrEP prescriptions, with Hispanics (12%), African-Americans (10%) and Asians (4%) accounting for much smaller proportions. Further, the proportion of African Americans who started PrEP actually dropped, from 12% in 2012 to 10% in 2015.9
  • People under age 25 account for 20% of new diagnoses overall, with 80% of them being young gay/bi men and more than half of those being black. However, only around 8% of people who started PrEP were younger than 25 years with similar breakdowns across all racial/ethnic groups.9
  • From 2011 to 2015, Colorado rates of new HIV diagnoses (per 100,000) were 30.3 for African Americans, 9.7 for Hispanics and 8.9 for American Indian/Alaskan Natives compared with 5.0 for non-Hispanic Caucasians. In other words, rates of new HIV diagnoses were six times higher in African Americans and nearly twice as high in Hispanic and American Indian/Alaskan Native populations than in Caucasians.3 While three-quarters of Caucasians and nearly two-thirds of Hispanics in Colorado have heard of PrEP, only one in three African Americans have ever heard of it, according to the American Men’s Internet Survey (Denver 2014).10

PrEP Prescribing Guidelines

Prescribing PrEP and following a patient taking PrEP with quarterly labs is well within the scope of most primary care practices. Many physicians, advanced practice nurses and physician assistants have already successfully incorporated PrEP into their practice. It is not unlike regular check-ins for a patient on medication for hypertension or diabetes.

Key Messages

  • Take a sexual history to identify patients who might benefit from PrEP.
  • Talk about PrEP as one method for preventing HIV.
  • Test for HIV. Only begin PrEP after confirming that the patient is HIV negative.
  • Follow up with patients every three months for HIV/STD testing and PrEP prescription refill.

Baseline Assessment (PrEP prescribed within seven days of documented negative HIV test)

  • Screen for symptoms of acute HIV (fever, fatigue, myalgia/arthralgia, rash, headache, pharyngitis, cervical adenopathy, night sweats, diarrhea)
  • HIV test: 4th generation Ag/Ab preferred; 3rd generation if 4th is not available (plus HIV viral load if concern for acute HIV)
  • STI screening: gonorrhea & Chlamydia NAAT [urine or vagina, rectum, pharynx], syphilis screen(Rectal swabs can be self-collected)
  • Serum creatinine (contraindicated if CrCl < 60ml/min)
  • Pregnancy test*
  • Hepatitis B Surface Antigen (HBsAg)*
  • Hepatitis C Antibody*

* Not a contraindication, but follow-up indicated if positive

Follow-up assessment every three months

  • HIV test
  • Serum creatinine, every six months
  • Screen for symptoms of acute HIV
  • Hepatitis C Antibody, every 12 months
  • STI screening
  • Pregnancy test, as appropriate

Side effects and potential risks:2 PrEP is generally well tolerated. About 10% of patients experience nausea and fatigue in the first month of treatment. This typically resolves after three to four weeks. Other adverse effects experienced can include:

  • Decline in renal function: Consider more frequent monitoring in patients with risk factors for kidney disease.
  • Decrease in bone mineral density: Use caution in prescribing PrEP to those with osteoporosis or a history of pathologic fracture. Consider baseline DXA for patients with a history of or who are at risk for osteoporosis.

Patient counseling

  • Daily dosing is recommended though imperfect yet regular adherence can still provide significant protection for men who have sex with men. Intermittent dosing is not currently recommended.1
  • PrEP reaches maximum protection in the blood after approximately 20 days of daily oral dosing, in rectal tissue at approximately seven days, and in cervicovaginal tissues at approximately 20 days.11
  • Combining prevention strategies, such as condoms plus PrEP, provides the greatest protection from HIV and other STIs. Reinforce the need for HIV and STI testing every three months for optimal sexual health.
  • Identify and address barriers to medication adherence.

What if my patient has a positive HIV test on PrEP?

  • Discontinue PrEP immediately to avoid potential development of HIV drug resistance.
  • Determine the last time PrEP was taken and the patient’s recent habit of taking PrEP.
  • Ensure establishment with HIV primary care for prompt initiation of a fully active ARV treatment regimen and counseling/support services.
  • Report any new HIV diagnosis to the Colorado Department of Public Health & Environment: 303-692-2694.

POST-EXPOSURE PROPHYLAXIS (nPEP)

When a patient presents ≤ 72 hours after a potential non-occupational exposure that presents a substantial risk for HIV acquisition, providers should consider nPEP (also known simply as PEP). PEP is recommended when the source of the body fluids is known to be HIV-positive and the reported exposure presents a substantial risk for transmission. If the HIV infection status of the source of the body fluids is unknown, determination should be made on a case-by-case basis. PEP is a 28-day regimen that can then be transitioned easily to PrEP if desired.12

If potential HIV exposure < 72 hours: consider nPEP (non-occupational post-exposure prophylaxis)

Perform HIV test: 4th generation Ag/Ab preferred; 3rd generation if 4th not available. If rapid HIV blood test results are unavailable, and nPEP is otherwise indicated, it should be initiated without delay and can be discontinued if the patient is later determined to have HIV infection already or the source is determined not to have HIV infection.

Frequently Asked Questions

Do you have questions about PrEP? If so, you are not alone. Find answers to commonly asked questions below.

What is PrEP?

Pre-exposure prophylaxis (PrEP) is daily oral antiretroviral therapy used to reduce the risk of acquiring HIV infection in HIV-negative adults. In contrast to HIV treatment regimens that typically consist of three or four agents, PrEP is a once-daily, fixed-dose combination of two antiretrovirals. Currently the only FDA-approved drug is Truvada, a combination of tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200mg. In 2014, the US Public Health Service and the Centers for Disease Control and Prevention issued clinical guidelines for using PrEP to prevent HIV in the United States.1

Why should Colorado healthcare providers care about PrEP?

Over the past five years, between 325 and 400 new HIV diagnoses have been made each year in Colorado.3 In combination with viral load suppression in people living with HIV and other options for risk reduction, PrEP can help limit the spread of HIV. Primary care providers (PCPs) typically don’t treat HIV in patients; the disease usually is managed by infectious disease physicians. However, managing PrEP in HIV-negative patients gives PCPs an opportunity to play an active and vital role in preventing HIV. Discussing PrEP can strengthen relationships with patients at high risk for HIV, and it can alleviate the burden of HIV-negative patients who need to seek PrEP care from infectious disease specialists.

Your role: HIV still exists in Colorado. Primary care providers can improve access to HIV prevention with PrEP.

How effective is PrEP?

PrEP is safe and highly effective. Multiple trials have shown that when taken correctly, PrEP can decrease HIV risk by as much as 92% in adults. These trials, including the iPrEx study13 of men who have sex with men (MSM) and the Partners PrEP study14 of serodiscordant heterosexual couples, are detailed in the CDC’s clinical guidelines.

The take home: When taken daily, PrEP can reduce the risk of acquiring HIV by 92%.

How safe is PrEP?

PrEP is generally well tolerated. Nausea and fatigue in the first month of treatment were only reported in about 10% of patients in early studies, and these side effects typically resolved after three to four weeks. Only two of 100 patients permanently discontinued PrEP due to side effects.2, 13 In the US MSM Safety Trial2, the TDF component was associated with a small decrease in bone mineral density (one percent decrease at the femoral neck and 0.8% decrease for total hip) but was not associated with reported bone fractures at any anatomical site. When used for HIV-1 treatment, TDF is known to cause small decreases in glomerular filtration, but no evidence of clinically significant elevations in serum creatinine were noted in Partners PrEP14, and no grade ≥3 creatinine elevations were seen in the US MSM Safety Trial.2

Side-effects summary: GI symptoms can be seen in about 10% of patients and usually subside after the first month. Bone mineral density can be followed in patients with other risk factors, and creatinine clearance should be followed every six months.

Can my patients afford PrEP?

In Colorado, there are many financial resources for patients who want to receive PrEP. Health First Colorado (Colorado’s Medicaid Program) and many private health insurers cover PrEP. Patients who are uninsured or underinsured may be able to take advantage of manufacturer copay and drug-cost assistance programs or get help from Colorado’s Public Health Intervention Program (PHIP).

The good news: Most patients can get help paying for PrEP.

What about drug resistance and ongoing testing?

More than 80,000 US residents had filled at least one PrEP prescription by the end of 2015.15 To date, there have been four reports of PrEP failing when taken as prescribed: two due to a drug-resistant virus,4 one unrelated to viral resistance, and one still under investigation.5, 16 Because PrEP is not adequate treatment for HIV, patients should be tested and documented as HIV negative before starting PrEP. Patients on PrEP should be tested at least every three months so that those who become infected do not continue taking an insufficient treatment regimen.

Bottom line: Drug resistance has been rare, but patients should be tested regularly for HIV infection while taking PrEP.

Who might benefit from PrEP?

PrEP is recommended as one prevention option for sexually active adult MSM, transgender individuals, and heterosexually active adult men and women who are at substantial risk of acquiring HIV. PrEP also should also be discussed with men and women whose partners are living with HIV. Populations who may benefit from PrEP include the following:

  • • MSM and transgender individuals with a history of sexually transmitted infections (STIs), condomless anal intercourse, substance use and/or multiple sex partners
  • • Women who have sex with MSM
  • • Anyone with a partner living with HIV
  • • People who inject drugs
  • • People who exchange sex for something of value

In short: Any adult who is at substantial risk of acquiring HIV could be a candidate for PrEP1.

Where can my patients get help?

The Colorado Department of Public Health and Environment (CDPHE) launched a campaign in early 2017 to update and inform people about PrEP as one option to decrease the risk of acquiring HIV. CDPHE helps patients access financial assistance for PrEP and find a provider if needed, and provides resources on PrEP and sexual health. CDPHE also works with several community-based organizations to provide navigation and retention services supporting PrEP and sexual health.

Where can I get help?

CDPHE offers free Public Health Detailing (education and guideline updates) to Colorado providers to help you incorporate sexual health conversations and PrEP into your practice in a way that is cost efficient, time effective and of the most benefit to your patients.

Providers are busy, and new evidence-based data is being generated rapidly. Detailing can provide summarized data, pocket-sized clinical guidelines, printed information for patients and providers, and billing and coding assistance. A Detailer can meet with you one-on-one to assess your needs and help you incorporate HIV prevention into your practice.

A Detailer can also speak at practice meetings or conferences on the basics of PrEP, HIV prevention, working with men who have sex with men (MSM) and transgender individuals, taking a sexual history, and extragenital STI testing. Please inquire about detailing by emailing deborah.monaghan@state.co.us or by calling 303-692-2767 or 1-844-367-7075, ext. 3.

The references below also provide a wealth of information and include the 2014 Clinical Practice Guidelines from the US Public Health Service and the CDC.

Financial Assistance For Patients

Health First Colorado (Colorado’s Medicaid Program) and most insurance plans pay for PrEP.

Additional assistance for uninsured or underinsured patients is available through the following:

Sexual Health

Taking a sexual history provides important insight into your patients’ health, establishes individual risk of HIV and other sexually transmitted infections (STIs), and guides STI screening of all exposed anatomical sites. This dialogue can also create a safe environment for patient questions and risk-reduction counseling.

Start by letting your patient know that you ask all of your patients these questions, and they are free to decide not to answer any questions they choose.

Take a sexual history from all patients and utilize “The Five P’s” for guidance and sample questions:

The Five P’s of Sexual Health

  • Partners: Number and gender of partners over a given time
    • In the past 12 months, how many sexual partners have you had? Men? Women? Both? Transgender?
  • Practices: Types of sexual practices: oral, vaginal, anal
    • In the past 12 months, have you had vaginal sex? Oral sex? Anal sex?
    • For men who have sex with men—Are you the receptive partner (“the bottom”), insertive partner (“the top”) or both?
  • Protection from STIs: Use of condoms and other risk reduction methods
    • What methods do you use to keep yourself from getting an STI (or STD)?
    • If condom use is one of your methods, in which situations are you more or less likely to use a condom?
  • Past History of STIs: Establish risk of repeat infections, HIV status, hepatitis risk and prior STI treatments
    • Have you even been diagnosed with an STI (HIV, herpes, gonorrhea, chlamydia, syphilis, HPV or trichomoniasis)? If so, when?
    • Have you had any recurring symptoms or diagnosis?
    • Have you or any of your partners been diagnosed with HIV or hepatitis C?
    • When was your last HIV test?
  • Prevention of Pregnancy: Desire for pregnancy and use of prevention methods
    • Are you trying to conceive or father a child? Do you want to avoid pregnancy?
    • Are you using contraception or practicing any form of birth control?
    • Do you need any information on birth control or a referral?

The more comfortable you become taking a sexual history, the more comfortable your patients will be sharing with you.

Best practices for obtaining a sexual history

  • Ensure a safe patient environment
  • Assure confidentiality
  • Be nonjudgmental
  • Be sensitive and matter-of-fact
  • Avoid assumptions
  • Thank the patient for being open and honest
  • Praise any protective efforts

Download our STI Screening and Treatment Charts and other provider resources in the section below.

Provider Resources & Guidelines

For questions regarding HIV and PrEP:

  • Call CDPHE’s Physician Detailer at 303-692-2767 or 1-844-367-7075 ext. 3
  • Contact the National Clinician Consultation Center at 855-448-7737 or visit nccc.ucsf.edu for HIV, PrEP and PEP questions.
  • CDC PrEP Guidelines
  • CDC PEP Guidelines
  • Visit Proud to be PrEPPED for Colorado-specific PrEP information and resources for patients: FAQs, financial info, finding a provider, videos and testimonials.

Download our provider resources:

CDPHE offers free Public Health Detailing (education and guideline updates) to Colorado providers to help you incorporate sexual health conversations and PrEP into your practice in a way that is cost-efficient, time-effective, and of the most benefit to your patients.

Providers are busy, and new evidence-based data is being generated rapidly. Detailing can provide summarized data, pocket-sized clinical guidelines, printed information for patients and providers, and billing and coding assistance. A Detailer can meet with you one-on-one to assess your needs and help you incorporate HIV prevention into your practice.

A Detailer can also speak at practice meetings or conferences on the basics of PrEP, HIV prevention, working with men who have sex with men (MSM) and transgender individuals, taking a sexual history, and extragenital STI testing. Please inquire about detailing by calling 1-844-367-7075 ext. 3, or by completing a Detailing Request Form.