A Highly Effective Primary Prevention Strategy
The Medical Care Criteria Committee (MCCC) of the New York State Department of Health (NYSDOH) AIDS Institute recently released guidelines on preexposure prophylaxis (PrEP), PrEP to Prevent HIV Acquisition. This clinically focused guideline for the administration and management of PrEP for prevention of HIV infection supports New York State's End the Epidemic (ETE) initiative, a three-point plan set forth by Governor Cuomo in 2014 to end the AIDS epidemic in New York State. ETE aims to decrease the number of new HIV infections to 750 (from an estimated 3000) by 2020, and HIV prevalence will be reduced for the first time ever in New York State. The plan focuses on three key actions:
Identifying people with HIV infection who have not received a diagnosis and linking them to HIV care;
Linking and retaining people diagnosed with HIV to healthcare to maximize virus suppression so that they remain healthy and do not transmit the virus; and
Facilitating access to PrEP for people at high risk of acquiring HIV to prevent infections.
PrEP is a highly effective primary prevention strategy for individuals at increased risk for HIV acquisition. The NYSDOH AIDS Institute guideline committee recommends PrEP as part of a comprehensive HIV prevention strategy that includes counseling on safer sex and safer injection practices. PrEP consists of a daily tablet of combined tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada for PrEP™). The significant effectiveness of PrEP in reducing HIV acquisition has been demonstrated in clinical trials and through implementation in the clinical setting.[1,2,3,4,5,6,7]
Guideline-Based Approach to Implementing PrEP in Clinical Practice
The NYSDOH AIDS Institute PrEP guideline takes a step-by-step approach to implementing PrEP in clinical practice, starting with guidance on screening to identify candidates for PrEP. Several checklists are provided for clinicians; these include pre-prescription evaluation, patient education, and PrEP management, all of which are available in printable pocket guides as well. The guideline is written for a broad range of clinicians, including primary care practitioners and specialists in infectious diseases, general internal medicine, pediatrics/adolescent medicine, family medicine, and gynecology/obstetrics. In short, it is designed for use by all care providers who have the opportunity to address sexual health and HIV prevention with their patients. The PrEP Guideline is a tool for all clinicians to understand the benefits, use, and management of PrEP; to educate their patients; and to help their patients protect themselves from HIV infection.
Candidates for PrEP
When used as prescribed, PrEP is > 90% effective in reducing risk acquired through sexual activity, and > 70% effective in reducing risk acquired through injection drug use.[1,3,6] PrEP use has been rising steadily over the past 4 years, but PrEP awareness and uptake are not aligned with need. In the United States, 44% of new HIV infections occur among black people, but 70% of PrEP users are white and only 10% are black. There is a critical need to increase the use of PrEP among individuals who stand to benefit from it the most. Early adopters and those willing to seek out PrEP providers are likely to obtain PrEP from HIV care providers and to be adherent with PrEP. Expanding the use of PrEP beyond early adopters will challenge clinicians to identify those who are more reluctant, may not recognize their risk, may have barriers to considering and obtaining PrEP, or may not know about this HIV prevention method.
As the PrEP Guideline states, populations at highest risk for HIV acquisition should be prioritized for outreach and access to ensure that they are aware of PrEP and its benefits. These populations include transgender women, men who have sex with men (MSM), and people who inject drugs. PrEP is appropriate as well for the partner of a person with HIV infection who is not virally suppressed or whose level of viral suppression is not known. Clinicians should also offer PrEP to individuals who have, or whose partners may have, multiple or anonymous sex partners; are involved in commercial sex work or other forms of transactional sex; use mood-altering drugs (eg, alcohol, cocaine, methamphetamine, ecstasy); or who use nonoccupational postexposure HIV prophylaxis (nPEP) one or more times and engage in ongoing high-risk behavior.
Healthcare providers have an important role to play in raising awareness and acceptance of PrEP among those at high risk of acquiring HIV, including young black MSM. The Centers for Disease Control and Prevention (CDC) reports that in 2015, people aged 13-24 years accounted for approximately 22% of all new HIV diagnoses in the United States, and most (79%) of those new diagnoses were made in gay and bisexual men of color. PrEP is currently indicated for adults > 18 years of age. Its use in individuals younger than age 18 year is considered off-label. The guideline notes that "since licensed for treatment of HIV in adolescents, TDF/FTC has been used without evidence of increased toxicity in this population. Off-label use of TDF/FTC as part of a nPEP regimen is recommended for adolescents aged 13 to 18 years to prevent HIV infection after a high-risk exposure. The CDC and the IAS-USA [International Antiviral Society-USA] have extended the indication for TDF/FTC to include PrEP for adolescents at high risk for HIV infection."[10,11]
PrEP as an Integral Component of Sexual Health
PrEP is central to the sexual health of people who are at risk of acquiring HIV, but stigma may prevent its use. A nationwide online survey found that 18% of 2926 MSM were not using PrEP but knew about it, and were concerned about their healthcare provider's reaction to a request for PrEP. This finding underscores the importance of discussing sexual activity and history to ensure that patients' sexual health is given the same attention as their physical and mental health. The PrEP guideline encourages providers to speak candidly with patients about sexual activity and practices and to avoid a judgmental or prudish approach. Providers who discuss sexual health and well-being with their patients are providing an important service. Resources are available to help providers build skills and comfort, such as the CDC's guide Taking a Sexual History.
PrEP as a Harm-Reduction Approach
PrEP is based on a harm-reduction approach similar to the highly successful approach of making sterile needles and needle exchange programs available for injection drug users. A recommendation for PrEP focuses on mitigating some deleterious consequences for patients and their partners. Therefore, the NYSDOH AIDS Institute PrEP guideline encourages healthcare providers to screen patients to identify those at ongoing high risk for HIV acquisition who would most benefit from use of PrEP as part of a comprehensive prevention plan.
The Effect of PrEP on Rates of Other Sexually Transmitted Infections
Because PrEP users are engaged in ongoing clinical care, there are more opportunities to provide risk-reduction counseling and sexually transmitted infection (STI) screening and treatment. The MCCC recommends that PrEP users at the highest risk for HIV acquisition be tested for bacterial STIs at least once every 3 months (at all sites of exposure: oral/pharyngeal, urethral, vaginal, and/or anal), even if they are asymptomatic, as part of PrEP care. Screening individuals for STIs at 3-month visits to renew PrEP prescriptions, rather than only when symptoms are present, increases the chance that STIs will be diagnosed and treated. The majority of STIs among PrEP users are identified through routine screening, rather than testing driven by symptomatic presentation.
Because PrEP does not offer protection against STIs other than HIV, if condoms are not used, an increase in other STIs may occur. Studies have demonstrated that STI rates after PrEP was started remained at the same level or increased.[2,15,16] High STI rates among PrEP users validates that the appropriate risk population is being reached. It should be noted that rates of STIs among MSM were increasing before the uptake of PrEP use; therefore, engagement in ongoing clinical care offered through the comprehensive delivery of services as outlined in the PrEP guideline may lead to a reduction in STIs among the highest risk populations. Strategies to reduce STIs among PrEP users include frequent screening from all exposure sites, prompt treatment of identified STIs and after reported recent exposure, risk-reduction counseling, and delivery of partner services (including expedited partner therapy for chlamydia; engagement in PrEP; and STI, HIV, and hepatitis screening and treatment).
It's Up to Clinicians
A comprehensive prevention plan for PrEP will include counseling and education about adherence to PrEP, health screenings and vaccines, ongoing laboratory monitoring and STI screening, and education about risk-reducing strategies and signs of acute HIV infection. Other PrEP drug formulations may evolve over time, but the basic principles of adherence and frequent screening for HIV and STIs will remain part of any PrEP protocol.
Clinicians should partner with other healthcare providers within or outside of their organizations to provide necessary services, including subspecialty care, mental health and substance use treatment, case management, navigation and linkage services, housing assistance, and income/benefits assessments. Most insurance plans cover PrEP. Moreover, individuals covered through insurances that require copays by beneficiaries are often eligible to receive copay assistance from drug manufacturers, grants, or other drug assistance programs. However, the biggest impediment to the widespread adoption of PrEP in high-risk individuals is the reluctance of healthcare providers to consider its use as a highly effective HIV prevention strategy, educate patients about its efficacy, and prescribe and monitor its use.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Get Comfortable With HIV PrEP in Primary Care - Medscape - Mar 01, 2018.