The CDC recommends that physicians offer pre-exposure prophylaxis (PrEP), a once-daily tablet containing emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada), to patients at high risk of acquiring HIV infection. According to the CDC, determining whether a patient is an appropriate candidate for PrEP(www.cdc.gov) begins with a detailed sexual history and screening for illicit drug use as a routine part of primary care.
Jeffrey Kirchner, D.O., AAHIVS
It is often difficult to initiate dialogue about an individual's sexual behaviors and to accurately gauge the patient's risk. In this article, I will describe the case of a 34-year-old gay man who visits his family physician for a physical examination.
The patient, Michael, reports being in good health with no medical concerns. He is in a stable relationship with his male partner of four years, but occasionally engages in sex with other men. Michael tells the physician that he and his partner have an open relationship. He sometimes uses condoms but does not do so consistently; it's usually only when he's with someone he does not know very well.
Michael reports that about six months ago, he was treated for a sexually transmitted infection (STI) at an urgent care center with "a shot and four pills." He did not receive any followup testing after the treatment. His last HIV test was about one year before this physical exam, and he does not know when his regular partner was last tested.
His physician orders a fourth generation HIV antibody/antigen, STI screening tests and a basic metabolic panel (BMP). One week later, Michael returns to the office to discuss his results. HIV and STI results are negative, and his BMP is normal. The physician asks him whether he would consider starting PrEP for HIV prevention.
When to Initiate PrEP
According to CDC guidelines, PrEP is recommended for men and women who are HIV-negative but who have a substantial risk for HIV infection. PrEP is indicated for the following three categories of patients:
1. Any adult man without acute or established HIV infection who
- has had any male sex partners in the past six months;
- is not in a monogamous partnership with a recently tested HIV-negative man;
AND (at least one of the following)
- has had any anal sex without condoms (receptive or insertive) in the past six months;
- has had a bacterial STI (syphilis, gonorrhea or chlamydia) diagnosed or reported in the past six months.
2. Any adult without acute or established HIV infection who
- has had sex with an opposite sex partner in the past six months;
- is not in a monogamous partnership with a recently tested HIV-negative partner;
AND (at least one of the following)
- is a man who has sex with both women and men (behaviorally bisexual);
- infrequently uses condoms during sex with one or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (people who inject drugs or have bisexual male partners);
- is in an ongoing relationship with an HIV-positive partner;
- has had a bacterial STI (syphilis, gonorrhea, or chlamydia) diagnosed or reported in the past six months.
3. Any adult without acute or established HIV infection who
- has injected any drug not prescribed by a clinician in the past six months;
AND (at least one of the following)
- has shared injection or drug preparation equipment in the past six months;
- has a risk of HIV acquisition based on sexual behavior.
Michael is a candidate for PrEP as a gay man who does not consistently use condoms and is not in a monogamous relationship. He was treated for an STI about six months before visiting his physician, but his history of infection indicates behaviors that place him at high risk for contracting HIV infection. Lastly, Michael does not know the HIV status of his regular partner and only assumes he is negative.
People at Risk for HIV in the United States
This case is not unique. The CDC estimates that about 1.2 million people(www.cdc.gov) in the United States engage in sexual or injection drug-use behaviors that place them at substantial risk of acquiring HIV infection. Like our patient, about 70 percent of those people are men who have sex with men.(www.croiconference.org) In these individuals, oral PrEP, when used consistently, can reduce the risk of acquiring HIV infection by more than 90 percent.(www.cdc.gov)
In a study of adults in California, no new HIV infections occurred among 657 patients who were prescribed PrEP;(www.ncbi.nlm.nih.gov) however, 187 patients (28 percent) developed at least one or more STIs during a mean 7.2 month duration of taking PrEP. This finding supports the impression that many individuals will continue to engage in high-risk behaviors but will not contract HIV infection while on PrEP. Moreover, linking patients to care enables appropriate diagnosis and treatment of other STIs. This study also confirmed the finding of "risk compensation" -- no change in risk behaviors or a tendency to be less cautious when there is a perception of lower risk.
Providing Risk Reduction Counseling and Introducing PrEP
PrEP should be prescribed as part of a comprehensive HIV prevention strategy. In our patient, implementing that strategy begins with an open discussion of his current sexual practices and ways to reduce HIV infection risk.(www.cdc.gov) These include consistent use of condoms and, ideally, knowing the HIV status of his sexual partners. Creating a dialogue that extends beyond the physician and patient to include the patient's sexual partners helps create cooperation between all parties at risk. Sexual behaviors and prevention decision-making are complex and should be evaluated and discussed in the context of each individual's sexual health goals.
After taking steps to minimize HIV exposure through behavioral changes, the patient can be introduced to the benefits of PrEP as a safeguard against future HIV infection. The patient should be reminded that they may still become infected with HIV if they engage in risky behaviors without appropriate protection, and that condoms, although an effective mechanical barrier against contracting HIV infection, are not 100 percent protective.
Initiating PrEP and Monitoring Patients
Before initiating PrEP, several baseline laboratory tests should be performed to exclude contraindications for its use. (See Table 1)
|Table 1: Baseline Evaluations Before Starting PrEP|
HIV testing and documentation of results are required to confirm that patients do not have HIV infection when they start taking pre-exposure prophylaxis (PrEP) medications.
In addition, care providers should
After PrEP is initiated, the patient should ideally have followup visits every three months to confirm continued HIV-negative status and to monitor side effects and treatment adherence. (See Table 2)
|Table 2: Protocol for Followup of PrEP Patient 1|
|Six-month (or less) Followup|
Addressing Patient Barriers to the Use of PrEP
Like many patients, Michael may have concerns that taking PrEP will make people think he is irresponsible or promiscuous.(ajph.aphapublications.org) Patients who share this belief may downplay their need for PrEP. Providers should help patients overcome their resistance to treatment by listening, educating and being supportive. Accordingly, our patient should be reassured in a nonjudgmental way that many people have more than one sexual partner, but that this places them at increased risk of acquiring HIV infection. He should also be reminded that although HIV disease is treatable, it remains a lifelong chronic condition that can seriously compromise his health and shorten his life expectancy. Prevention is the best treatment.
PrEP is covered by most health insurance plans and state Medicaid programs. Paying for PrEP can be challenging for the uninsured, as the current retail cost is about $1,700 per month. If patients are uninsured, they may be eligible for help with PrEP coverage from drug manufacturers or patient advocacy foundations. Patients can seek additional information about payment assistance from the CDC.(www.cdc.gov)
Primary care physicians are in the best position to help reduce the number of new HIV infections in the United States. Daily use of PrEP is safe and highly effective in preventing HIV infection in patients at risk. Because most people without HIV infection receive health care in primary care settings, these clinicians are optimally positioned to identify patients who are candidates for PrEP and to prescribe it to those who are willing to take it. Following these PrEP protocols is well within the scope and expertise of family physicians, pediatricians, general internists, gynecologists and advanced practice professionals.
Family physician Jeffrey Kirchner, D.O., AAHIVS, is medical director for Lancaster General Health Physicians Comprehensive Care in Lancaster, Pa., and provides HIV/AIDS medical care.
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