Are Health Care Providers PrEPared?

September 24, 2014


By Nathan King

Faculty Reviewed

Doctors are known to be some of the worst patients, and from personal experience I predict that medical students are not too far behind. That’s why when I finally found the time to take a proactive step in maintaining my good health, the last thing I hoped to run into were barriers, but that’s exactly what I hit. To my surprise, it was not at the hands of insurance companies, overbooked doctors, or the general bureaucracy of the medical system; it stemmed from ignorance on the part of the health care professionals. Ignorance as in a lack of knowledge, and in this case, the subject was pre-exposure prophylaxis of HIV, more commonly known as PrEP.

The combination of emtricitabine and tenofovir (Truvada; Gilead Sciences, Foster City, California) was first approved for use as PrEP by the FDA in 2012 after the landmark iPrEx study found it to be effective in preventing HIV infection in seronegative individuals. [1] Thus, I was taken aback when I asked a provider if she prescribed the medication, and after first having to explain to her what it is, got the response, “Why do you need it? Are you planning to travel to a developing country soon?” My jaw dropped. I attempted to salvage the conversion by explaining the indications a little more, but was met with uncomfortable resistance, and I was urged to ask someone else at a follow-up visit. Weeks later I transferred my care to a primary care physician located at a renowned academic medical center in Manhattan, and again I asked the same question. Though this time the response was less uninformed and pejorative, the practitioner stated that she had never prescribed that medication and did not feel comfortable doing so. Her solution was to offer me a referral to an infectious disease specialist.

My first thought: the last time I spoke with an infectious disease specialist I was consulting them for a patient with severe neutropenia who had spiked a fever with a blood culture growing gram-positive cocci. My second and third revolved around the lack of time and money I had to see an outside specialist for what I understood to be routine preventive care. I then began to get frustrated with the many obstacles I had faced. Should primary care providers be responsible for prescribing PrEP and, if so, are they effectively prepared to do so?

In order to begin answering this question, a burden of proof for the treatment itself must be met: is PrEP something that should even be recommended? The landmark PrEP study by Grant and colleagues, “Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men,” appeared in the New England Journal of Medicine in December 2010.[1] The study followed 2499 seronegative men who have sex with men (MSMs) for a median of 1.2 years and found an overall reduction in HIV infection of 44% using an intention-to-treat analysis and a 90% reduction when corrected for laboratory-tested medication adherence (by-protocol analysis).[1] This and other studies led the FDA to approve Truvada for use as PrEP in July 2012, following early advocacy by the CDC.[3] This was groundbreaking news: the first time that any medication was approved for preventing HIV. Naturally, skepticism arose. People asked the following, legitimate questions:

Is Truvada truly effective?

Who warrants treatment with PrEP?

Will this medication encourage unsafe sex practices? [3]

Since the initial study, several other publications have shown similar reductions in HIV seroconversion with the use of PrEP, including studies of heterosexual serodiscordant couples.[4] Most recently, a study that followed a large percentage of the participants in the original iPrEx study was published and presented at the 2014 World Aids Conference. Of the 1600 participants, all followed for 17 months, no one who took the pill more than four times per week seroconverted.[5] Moreover, this study also supported the original study’s findings that, in those taking PrEP compared to placebo, self-reported condom use did not decrease, number of sexual partners did not increase, and STI testing revealed no increase in syphilis or herpes infections, a more objective measure of risk-taking behavior.[1,5] This aggregation of promising data supporting the effectiveness and potential of PrEP led the World Health Organization (WHO) to make an official statement on July 11, 2014, advocating that all men who have sex with men consider using PrEP as further protection against HIV infection.[6]

The question of why MSMs are being singled out for the use of this treatment warrants attention and further highlights the potential implications of PrEP. A recent research letter published in JAMA analyzed HIV infection rates in the US from 2002 to 2011. On first glance, the results are encouraging, reporting a 33.2% reduction in the rate of new infections within the 9-year span.[7] However, the details paint a different picture. Although the rates of infection attributed to heterosexual contact or injection drug use significantly declined, the rates of infection from male-to-male sexual contact significantly increased. MSMs aged 13-24 bore most of the brunt, with an overall increase in infection rate of 132.5%.[7] In New York City, this was accompanied by increasing rates of gonorrhea infection as well as outbreaks of meningitis. This discrepancy, in addition to data that show that MSMs already carry the majority of the HIV burden within the US, identifies MSMs as the most vulnerable population in terms of HIV infection. Moreover, it shows that current measures, including widespread advocacy of condom use, are not working. Therefore, it is this population that is most likely to benefit from additional, innovative measures of HIV prevention such as PrEP.

Unfortunately, when comparing the promise of PrEP with its actual usage, the numbers don’t seem to line up. Although exact statistics are hard to come by, anecdotal data suggest that the use of Truvada has not taken off within the LGBT community. For instance, in 2013, Whitman-Walker Health, a large LGBT-serving clinic in Washington DC whose patients mostly consist of African-American gay or bisexual men, reported that only 90 of their 3000 HIV-negative patients (3%) had started PrEP. Another well-known HIV advocate reported to Out.com magazine that one of the largest national health insurers reportedly covered just over 300 prescriptions for PrEP in 2013.[7] While tangible evidence to support these specific claims is lacking, numerous similar reports from LGBT advocates and health care providers alike suggest that a small minority of MSMs are using PrEP.

There are many explanations for the lack of uptake within the LGBT community. Gilead itself admits to relying on LGBT health organizations for public relations purposes as it worries about the backlash it may receive upon advertising the medication.[3] Moreover, there have been reports of a general stigma within the LGBT community that labels people taking the medication as highly promiscuous, leading to the pejorative term “Truvada-whore.” However, one study conducted in NYC points to another possible explanation: misunderstanding. The study surveyed 629 MSMs in three different NYC sex clubs, and found that when asked, 78% of men identified themselves as not being candidates for PrEP based on their perceived risk, despite the fact that over 80% met eligibility criteria.[8,9] All three of the potential obstacles for increasing the usage of PrEP as addressed above highlight one important trait among individuals who could potentially benefit from treatment: ignorance.

Ironically, this ignorance is not unlike the ignorance of the practitioners I encountered. The difference, however, is in the responsibility of these two populations, patients and practitioners, in becoming informed. It is convenient to place the onus on patients to take care of their health needs, especially when these needs relate to a specific characteristic of the patient that places them in the minority, such as race, ethnicity, or sexual orientation. However, as a medical student, I am taught and expected to know what antihypertensive is preferred in African Americans, what genetic disorders are more necessary to screen for in the Ashkenazi Jewish population, and in what circumstances a Jehovah’s Witness can refuse life-saving treatments. Why then, do I feel such a heavy burden to advocate for the appropriate preventive measure to lower my risk of becoming infected with HIV?

The answer again is ignorance: practitioners are not well informed about PrEP or equipped to promote its usage. Reasons range from the novelty of the treatment to the reluctance of providers to discuss gay sex, both of which probably contribute to the overall problem. Regardless, it is unacceptable. Primary care providers, gatekeepers of preventive health, have the responsibility to oversee their patient’s medical well being. One cannot force an obese hyperlipidemic patient to diet and exercise any more than one can force an MSM to practice safe sex, yet the former is almost automatically prescribed a statin, while the latter is often left to fend for himself. Additionally, history shows that information and conversation breeds normalization, as was the case with contraceptives, multiple medical and surgical therapies, and even AIDS itself. It is likely that as practitioners become more aware, informed, and upfront about PrEP, the stigma around it will diminish. Yet, as of now, how can we expect the LGBT community to embrace a treatment that the medical community has been too reluctant to embrace itself?

It is imperative that all health care professionals, especially those on the front line serving as primary care providers, educate themselves about PrEP. It is their responsibility to inform patients of this option, to carry out its management, and to help the community at large fight the HIV epidemic. Thus, I encourage every health care professional to ask, the next time someone comes to your office who could benefit from further HIV prevention, will you be PrEPared?

Appendix

Recommended Indications for PrEP Use by MSM [9]

Commentary by Dr. Richard Greene

The conversation about PrEP so far has been focused on “Should we or shouldn’t we?” However, there are now data establishing that indeed we should, and recommendations to do so. In 2011, the Institute of Medicine produced a report on LGBT health [10] stating that the greatest health disparities facing LGBT patients are lack of evidence-based information and lack of provider knowledge about the evidence that exists to care for this community. In my clinic and my personal life as a gay primary care physician, I hear stories at least once a week of patients who have asked for PrEP who have been dismissed or told they do not need it, when in fact they are excellent candidates. In NYC, as many as 1 in 5 young MSM have HIV. For 30 years, we have been recommending the use of condoms for all sex, but this has been ineffective in stopping the spread of HIV in this country. Here we have both data and clear recommendations from the CDC and WHO for use of PrEP in a high-risk population, and it behooves providers to be aware of the intervention and able to provide it. Isn’t it time we educate ourselves and offer our patients the full arsenal of protection they deserve?

By Nathan King is a 2nd year medical student at NYU School of Medicine

Reviewed with a Commentary by Richard Greene, MD, Medicine, NYU Langone Medical Center

Image courtesy of Wikimedia Commons

References

1. 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(27):2587–2599. http://www.nejm.org/doi/full/10.1056/NEJMoa1011205

2. Centers for Disease Control and Prevention. CDC Statement on FDA approval of drug for HIV prevention. http://www.cdc.gov/nchhstp/newsroom/FDA-ApprovesDrugStatement.html Published July 16, 2012. Accessed July 23, 2014.

3. Murphy T. Is this the new condom? Out. September 9, 2013. http://www.out.com/news-opinion/2013/09/09/hiv-prevention-new-condom-truvada-pill-prep?page=full Accessed July 23, 2014.

4. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. http://www.nejm.org/doi/full/10.1056/NEJMoa1108524

5. CBS/AP website. HIV pill Truvada shows more promise against infection. http://www.cbsnews.com/news/hiv-pill-truvada-shows-more-promise-to-prevent-infection/  Published July 22, 2014.  Accessed July 23, 2014.

6. World Health Organization. HIV/AIDS: Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV. Recommendations for use in the context of demonstration projects. http://www.who.int/hiv/pub/guidance_prep/en/ Published July 2014.  Accessed July 23, 2014.

7. Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States. JAMA. 2014;312(4):432-434.

8. AIDSMeds website. Gay men at risk may not see themselves as prep candidates. July 1, 2014. http://www.aidsmeds.com/articles/MSM_candidacy_PrEP_1667_25848.shtml Accessed July 23, 2014.

9. Centers for Disease Control and Prevention website. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014. A clinical practice guideline. http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf Accessed September 13, 2014

10. Canadian Women’s Health Network. Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps Opportunities Board on the Health of Select Populations. The health of lesbian, gay, bisexual, and transgender (LGBT) people: building a foundation for better understanding. http://www.iom.edu/~/media/Files/Report%20Files/2011/The-Health-of-Lesbian-Gay-Bisexual-and-TransgenderPeople/ LGBT%20Health%202011%20Report%20Brief.pdf Published 2011.  Accessed August 5, 2014.