by Sonali Kulkarni, MD, MPH
Medical Director, Division of HIV and STD Programs
County of Los Angeles Department of Public Health
Leo Moore, MD, MSHPM
Robert Wood Johnson Clinical Scholars Program
University of California Los Angeles
This week the President released a budget that includes a $20 million pilot program to increase access to PrEP, an effective treatment that prevents transmission of HIV. Even prior to this federal recognition of a promising program, LA County has been at the forefront of expanding access to this life-saving intervention.
Los Angeles County has continued to see gradual declines in the annual number of new HIV cases over the past few years. Unfortunately, we still have approximately 1,800 County residents who are newly diagnosed with HIV every year.
But there is some good news. One of the most exciting recent developments in the field of public health has been the advent of HIV pre-exposure prophylaxis, or PrEP. PrEP is a daily pill taken by individuals who are HIV-negative before they are potentially exposed to HIV and has been shown to reduce the risk of HIV infection by up to 99% when taken consistently. The only FDA-approved drug for PrEP at this time is Truvada® (a combination of tenofovir/emtricitabine) taken once daily.
While consumer knowledge about PrEP in certain high risk groups has recently increased, many health care providers still lack adequate knowledge about PrEP to maximize its potential to reduce new HIV infections in LA County.
To help health care providers get “PrEPared for PrEP” the Department of Public Health’s Division of HIV and STD Programs (DHSP) recommends providers use the following five key steps:
1. Familiarize Yourself with PrEP Guidelines.
In 2014, the CDC released the PrEP Clinical Practice Guidelines to equip providers with comprehensive information for the use of PrEP to reduce the risk of acquiring HIV infection in high-risk adults. These guidelines include, among other topics, an overview of clinical trials, indications for use, goals of PrEP therapy, screening labs, and special considerations for PrEP use.
The guidelines are very thorough and will likely serve as a future reference in your care for patients on PrEP, so it’s good practice to review them prior to discussing PrEP with your patients. In clinical practice, we’ve found that patients have many questions about PrEP during the initial conversation, such as “How does it work?”, “What are the side effects?”, and “Do I have to use condoms with this medication?”, and this document will help you prepare to address their questions.
2. Assess Your Patient’s Risk for HIV.
You’ll never know if your patients are at risk for HIV unless you ask them about their sexual history.
Use the “Five P’s” of sexual history: Partners, Practices, Protection from STDs, Past History of STDs, and Prevention of Pregnancy. (For a quick refresher, see CDC’s Guide to Taking a Sexual History. ) Our comfort level as health care providers in asking sexual health questions can influence how comfortable our patients feel disclosing information about their sexual practices.
Based on the local epidemiology of new HIV cases, DHSP asks health care providers to consider PrEP for the following groups:
- Persons with an HIV-positive sex partner
- Men who have sex with other men and transgender persons who
- Engage in unprotected sex with partners of unknown HIV status
- Have a history of an STD (syphilis, gonorrhea, chlamydia) in the past year
- Have multiple sexual partners of unknown HIV status
- Individuals with other behaviors that elevate their HIV risk: history of transactional sex (i.e. sex for money, drugs, housing); use of shared injection equipment (i.e. needles for hormones in transgender women or for drugs in injection drug users); and use of stimulant drugs associated with high risk sexual behaviors, such as methamphetamine.
3. Discuss PrEP with your patient.
If your patient is in one of the above risk groups, talk with him or her about PrEP. Based on our experience, the following are key talking points to help your patient understand how PrEP works:
- What is PrEP? – Daily medication used to prevent HIV infection by “building armor around the fighter cells in your body to keep them from becoming infected by HIV, the virus that causes AIDS.”
- Adherence – Explain that only studies of daily dosing have proven the efficacy of PrEP. Explain that adherence is associated with how well the drug protects against HIV. If taken daily, as prescribed, the medication is up to 99% effective in preventing HIV acquisition.
- Side effects – Most common side effects include nausea or bloating, which usually improves after the first few weeks. Most patients can tolerate this if they are warned about it in advance. Another much less common side effect is mild worsening of kidney function (decreased creatinine clearance), which usually normalizes after discontinuation of the medication.
- Condoms– Condoms are still very important. Inform your patient that PrEP does not protect against STDs and that the best form of protection for these is condoms. Cases of chlamydia, gonorrhea, and syphilis (primary, secondary, and congenital) have all increased for the first time since 2006, which further highlights the importance of encouraging concurrent condom and PrEP use. If a patient reports decreased or no condom use after starting PrEP, this is not a reason to withhold the medication. Instead continue PrEP due to his or her elevated risk and continue to screen for STDs and provide education.
- Signs of acute HIV infection – Inform patients of signs of acute HIV infection such as a flu- or mono-like illness, fever, or diarrhea. They should return to the office as soon as possible if these symptoms develop.
4. Complete Screening Labs & Review Medical Contraindications.
Screen patients for HIV, STDs (using urine GC/CT, pharyngeal GC and/or rectal GC/CT testing based on reported sexual behavior), Hepatitis B and Hepatitis C, kidney dysfunction, and pregnancy (if applicable).
Screening patients for HIV involves assessing them for symptoms of acute HIV as well as testing them for HIV. Advances in laboratory HIV testing mean that most large laboratories offer 4th generation testing, which can detect acute HIV. If patients who started on PrEP seroconvert, there is a risk that the HIV virus can become resistant to the two drugs used in PrEP because it does not constitute a complete treatment regimen for someone infected with HIV. Fortunately, this has been shown to be extremely rare. DHSP recommends informing patients to return to care immediately to undergo repeat HIV testing if they develop symptoms concerning for acute HIV infection.
5. Start PrEP and Follow Up!
Once you identify a patient at elevated risk for HIV, make every attempt to expedite this process and initiate PrEP as soon as possible. Epidemiological data show that certain high-risk groups, such as black MSM, participate in less risky sexual behaviors in comparison to other racial groups but are at increased risk of HIV infection with every sexual encounter due to the prevalence of HIV among this racial sub-group. Therefore, these groups are at highest risk of seroconverting between office visits if initiation is delayed.
After initiating PrEP, patients should return in 1 month to assess for side effects and adherence and then every three months for repeat HIV, STD, and kidney function testing.
Helping Patients Stay on PrEP
It’s important to inform your patients that PrEP can be affordable. For patients on Medi-Cal, access should be easiest as there is a carve-out for PrEP, so medical provider can prescribe it without the need for additional approvals. For patients seeking health insurance through Covered California, the Bronze plan provides poor coverage for PrEP so patients should consider alternate plans Private insurance and costs under Affordable Care Act insurance plans will vary, but there are Medication Assistance Programs sponsored by Gilead Sciences (the manufacturer of Truvada) that will significantly decrease out-of-pocket costs for those who qualify, including those who are uninsured or not eligible for health insurance.
Two county public health STD clinics have started offering PrEP and additional public health funded safety net PrEP clinics will be opening in 2016 and will be able to serve uninsured residents.
After hearing the facts about PrEP from a medical provider, patients may want to learn about the real-life experiences of others who have actually taken the medication. Project Inform, a national HIV and Hepatitis C advocacy group, has developed concise educational videos with narratives delivered by patients. These videos provide the patient perspective as well as basic information about PrEP that can serve as reinforcement of the facts provided during the patient visit.
For additional information, visit our dedicated PrEP website, getprepla.com.
- Grant RM, Lama JR, Anderson PL, et al.Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587-2599.
- Baeten JM, Donnell D, Ndase P, et al.Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399-410.
- Thigpen MC, Kebaabetswe PM, Paxton LA, et al.Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367:423-434.
- Choopanya K, Martin M, Suntharasamai P, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. 2013; 381(9883), 2083-90.