A Preemptive Weapon
By Joey Berlin Texas Medicine November 2016

PrEP Treatment to Prevent HIV Promising if Physicians Can Identify High-Risk Minority Patients

Public Health Feature — November 2016

By Joey Berlin
Reporter

Tex Med. 2016;112(11):39-41.

The questions can be hard for physicians to ask. They can be personal, and they can be awkward for a patient to answer. But answers to sensitive questions are necessary to determine whether patients' sexual behavior or drug use puts them at high risk for contracting HIV. If they are at increased risk, treatment may drastically curb that risk.

That's why family physician Cynthia Brinson, MD, strives to get all the information she needs, including uncomfortable-but-pertinent details on sexual behavior, when assessing patients for the Austin PrEP Access Project (APAP). The volunteer clinic provides HIV pre-exposure prophylaxis (PrEP) to patients susceptible to the virus that causes AIDS.

To know whether PrEP treatment is indicated for a particular patient, physician and patient may have to set aside assumptions Dr. Brinson says they often have about each other.

"I've heard many patients say, 'I don't want to talk to my physician because they wouldn't approve of what I'm doing,' whether that's true or not," Dr. Brinson said. "And the physicians are making assumptions by saying, 'I've known my patient a long time, and they're in a monogamous relationship.' I think when we make assumptions about the people we know, we're not really seeing people in the full context of a life."

In the roughly three decades since AIDS first became the United States' biggest public health scare, hysteria over the disease and HIV has largely disappeared. The virus itself, however, persists, especially in Texas, where Texas Department of State Health Services (DSHS) figures show more than 82,000 people were living with HIV at the end of 2015. 

PrEP, which includes a daily pill that can prevent the contraction of HIV, offers an inroad to keep that number from increasing. But the 2012 news of U.S. Food and Drug Administration (FDA) approval of PrEP drug treatment didn't reach every corner of Texas or the nation, and many people at high risk don't know it exists, let alone how accessible it can be. APAP and other PrEP clinics around the state are working to change that.

"If this [were] the '80s or '90s, people would be burning our doors down," Dr. Brinson said. "But people are lining up around the block to get it; I have to say that that's true, so some of the people who need it know it. But not enough of the people who need it know it."

At press time, the Texas Medical Association's Committee on Child and Adolescent Health and Committee on Infectious Diseases were preparing a report on PrEP.

Access and Effectiveness

Patients interested in beginning PrEP must take an HIV test before starting it, according to U.S. Centers for Disease Control and Prevention (CDC) guidelines, and continue getting tested every three months while on the drug.

For most high-risk activities, including vaginal sex, injection drug use, and insertive anal sex, PrEP reaches maximum protection after about 20 days of daily use, according to CDC. For receptive anal sex, the drug reaches maximum protection after about a week of use.

CDC says possible side effects from PrEP, such as nausea, generally subside over time, and PrEP hasn't yielded any observed serious or life-threatening side effects.

The only FDA-approved PrEP drug on the market is Truvada, a combination of two antiretroviral drugs in one pill. FDA approved Truvada as an HIV treatment in 2004 before approving it for PrEP four years ago for patients aged 18 and older. CDC says some clinical studies have evaluated stand-alone use of tenofovir, one of the antiretroviral drugs in Truvada, but tenofovir by itself isn't approved for PrEP.

Large clinical trials showed consistent PrEP use reduces the risk of getting HIV from sex by more than 90 percent and reduces the risk of getting it from drug injections by more than 70 percent, according to CDC.

Federal guidelines recommend practitioners consider PrEP for people who are HIV-negative but at substantial risk for infection. (See "Guidance for PrEP Use.") Those at substantial risk for contracting HIV by sexual transmission include people who are not in a mutually monogamous relationship with a partner who recently tested HIV negative, and are also:  

• Gay or bisexual and have had anal sex without a condom or have been diagnosed with a sexually transmitted disease (STD) in the past six months; or
• Heterosexual people who don't regularly use condoms during sex with partners of unknown HIV status, when those partners themselves are at substantial risk for becoming infected.

 The substantial-risk group also includes people who have injected illicit drugs in the past six months and have shared their injection equipment or been in drug treatment for injected drug use during that time. This fact sheet includes the guidelines. 

John Carlo, MD, chair of TMA's Council on Socioeconomics, says effective PrEP treatment entails a comprehensive program, which includes testing for other sexually transmitted infections and treating any STIs the patient may have; monitoring potential side effects; and making sure the patient is continuing to maintain non-risky practices. Dr. Carlo is the chief executive officer of AIDS Arms, a nonprofit that works to combat HIV and AIDS in the greater Dallas area.

"There's a lot of diagnostic workup at the beginning to make sure that things are ready to go, and then there's an ongoing maintenance that's required," Dr. Carlo said. "Generally, you'll see your doctor every three to six months for the first couple of years."

Physicians say for insured adults, cost hasn't been a major obstacle in obtaining PrEP care. Many insurance plans, including Medicaid, cover Truvada, although preauthorization and copays may apply. Gilead, the company that manufactures the drug, offers a medication assistance program for eligible HIV-negative adults who don't have access to PrEP, such as low-income adults with no insurance. Dr. Brinson says APAP has had great success at getting its patients on PrEP. Gilead provides copay cards, she says, and grants are usually available for people with high deductibles.

"We've had very few patients who fell outside of the criteria, and most of the people who have fallen outside of being able to get PrEP are people who make more than $75,000 a year and have not accessed some sort of Obamacare," she said. "All of the other patients, we've been able to access PrEP for them at no cost."

But PrEP isn't FDA-approved for patients younger than 18, leaving insured minors without access; their use of Truvada would be considered off-label. Without insurance, PrEP costs about $1,500 per month.

"That's the trouble that our minors run into, is that we have this population who … may need this, and they're having high-risk sex, high-risk behaviors during sex. But they can't access the medication unless it's given to them free through a clinic," said Houston adolescent medicine fellow M. Brett Cooper, MD, a member of TMA's Committee on Child and Adolescent Health.

He said in September that a clinical trial geared toward earning FDA approval for Truvada for minors had completed, and data from that study should be published within a year.

Hard Questions, Apprehensions

Obstetrician-gynecologist Catherine Eppes, MD, an assistant professor at Baylor College of Medicine who works with high-risk women at a Houston infectious disease pregnancy clinic, says physicians assessing a patient's risk for HIV may not always ask the right questions for a number of reasons. She says the demands involved in a clinic visit and discomfort with taking a sexual history and discussing details of sexual relationships are factors. At the clinic, Dr. Eppes often sees women interested in contraception who are HIV-negative but who have an HIV-positive partner.

"I think, most importantly, we are probably not as thorough in asking about sexual history or contacts. For example, not only asking a patient about their medical problems, but their sexual partner, if they are HIV-positive or -negative," Dr. Eppes said. 

Dr. Brinson says it's important for physicians to set aside what they think they know and ask the questions they need to ask. For example, physicians who know a patient is married or assume the patient is in a monogamous relationship might be less likely to ask about the patient's sexual habits to properly assess his or her risk. 

She says when she tries to assess a patient's risk factors for HIV, she avoids asking leading questions.

"I'll ask patients if they're involved with anyone sexually. And if they say no, I might ask them, 'Well, if you were to be involved with someone sexually, would that be a male, a female, or both?' and let the patient take it from there," she said.

"Then I might ask them if they were having sexual relations with someone, what kind of sexual relations they were having, in more specific detail; I just let the patient tell me. And if they appeared a little bit shy, I might bring up some sexual activities to try to make them feel a little more comfortable, in more descriptive terms."

Dr. Cooper says merely asking patients if they're sexually active isn't gleaning enough information.

"For the adults right now, you're missing out on that 18–29 [group] if you're not asking, 'What gender are your sexual partners? Are you having sex under the influence of substances, whether that's drugs [or] alcohol? How many partners are you having?' That's where CDC recommendations for putting people on it [PrEP] come into play, is your behaviors," he said.

Austin OB-Gyn Geoff Erwin, MD, says it's also good for physicians to assess a patient's emotional, spiritual, and financial needs to get an idea of their HIV risk, noting "people are complicated creatures."

"Unless you ask those kind of questions, you're going to possibly be treating less than the whole issue," he said. "Certainly, addressing the sexual aspects is one thing, and you can get there that way. But sometimes you have to go around the corner to get to the issues. You can ask not only about their physical [feelings], their sexuality, you have to ask about their emotional feelings; you have to ask about the spiritual issues; you have to ask about financial issues because it all interplays. I think … when we see articles that are written in journals, it seems like they're leaving that part of it out. … Medicine is certainly medicine, but it's also an art."

Some physicians may struggle with prescribing PrEP because of a feeling that it serves as an enabling influence. Dr. Carlo says he saw some hesitancy to use PrEP when it first became available because of concerns it would lead to more high-risk behavior, such as reduced condom use.

"Early studies have shown that's not the case. Actually, condom use can increase in PrEP patients because you're bringing them in the office more, you're engaging in an open and frank discussion about sexual risk, and you are educating your patients on what precautions should be made," he said. "You're empowering people to take more awareness about safe sex, so this concern is diminishing, opening up opportunities for organizations and governmental entities to be more involved."

High-Risk Groups

DSHS' 2015 Texas HIV Surveillance Report, released last July, counted 82,745 Texans living with HIV through the end of last year. (See "HIV in Texas by the Numbers.") On top of that, 2012 CDC figures estimate 18,000 Texans made up the state's undiagnosed HIV population.

Overall, Texas' HIV diagnosis rates have remained stable in recent years, according to DSHS data. Texas had 16.3 diagnoses of HIV per 100,000 people in 2015, virtually unchanged from the 16.8 figure of 2011. But the numbers also show an elevated risk among certain demographic groups.

African-Americans make up about 12 percent of the Texas population, according to the U.S. Census Bureau, but DSHS statistics show African-Americans accounted for nearly 37 percent of the state's 2015 HIV diagnoses. Caucasians accounted for 21 percent of diagnoses. The Hispanic population accounted for 38 percent of HIV diagnoses, about in line with the overall Hispanic population. 

African-American males accounted for one-third of the HIV diagnoses among all Texas men in 2015, while African-American women made up 54 percent of the female diagnoses.

Young African-Americans, both adolescents and younger adults, are particularly at risk. African-Americans aged 15–19 accounted for more than half of all 2015 Texas diagnoses in that age range, and 42 percent of the diagnoses for those aged 20–24 were for African-Americans. Nearly three times as many African-American men aged 20–24 were diagnosed with HIV compared with Caucasian men.

Among categories of transmission, male-to-male sexual contact is the most common way to transmit HIV, accounting for 70 percent of all 2015 Texas diagnoses. Heterosexual contact caused 21 percent, and intravenous drug use accounted for about 5 percent. Another transmission category combining people who engage in male-to-male sexual contact and intravenous drug use accounted for 3 percent.

Dr. Cooper says medicine is trying to identify outreach efforts for some of the at-risk portions of the population. He says minorities tend to underuse many of the available services, and the highest diagnosis rates show up in African-American men having sex with men. 

A CDC analysis released in February 2015 found that if current HIV diagnosis rates persist, about 50 percent of African-American men who have sex with men (MSM) will be diagnosed with HIV during their lifetime, and about one-quarter of Latino MSM will be diagnosed.

"The theory behind it is that there's a lot more stigma in the minority communities around [men] having sex with men, whether you identify as gay or not," Dr. Cooper said. "Then if you show up at a clinic for PrEP, people will look around and be like, 'I know this person, I know [that] person.'"

Austin pediatric infectious disease specialist Don Murphey, MD, says he has noticed an upswing the past several years in HIV-infected minors.

"What I have seen is a few mostly minority teenage boys who were going out and having sex with men, maybe hooking up using these apps on the phone like Tinder … meeting up in the park with people they don't necessarily know, [having] multiple partners, high-risk sex," Dr. Murphey said. "These young kids don't really remember the '80s and '90s with the HIV epidemic, and I don't think they understand the real risk very well."

Mission: Eradicate

The potential PrEP has to slash HIV diagnosis rates is encouraging for physicians who come in contact with these at-risk populations.

"Meeting these kids, they are nice, normal kids who are taking great risk but don't realize it. I think a lot of them would be motivated to take preventive medicine if they understood the risks and benefits," Dr. Murphey said. "Some of them, I think if they knew they could take medicine and avoid acquiring HIV infection, they would do it."

PrEP clinics can be found in Texas' major cities, including APAP and Legacy Community Health in Houston. DSHS' PrEP webpage has additional resources. But Dr. Brinson says the treatment is "sort of still a new phenomenon" in the Lone Star State. 

She says eradication of HIV is possible, and the goal of APAP is to see no new infections in Austin by 2020. The major stumbling blocks to high-risk patients accessing PrEP, she says, are awareness and patient trust. Dr. Brinson says while PrEP has been successful in gay white communities, the clinic has trouble reaching into the communities it would like to reach, such as Hispanics, African-Americans, and the underserved.

"We must do something to stop this continual infection rate," she said.

Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.

SIDEBAR

HIV in Texas by the Numbers

82,745
People living with HIV in Texas in 2015

4,486
Number of HIV diagnoses in 2015

6
Texas' HIV diagnosis ranking among U.S. adults and adolescents in 2014

36.9%
Patients diagnosed with HIV in Texas in 2015 who are African-American 

70%
New HIV cases in Texas attributed to male-to-male sexual contact in 2015

Sources: Texas Department of State Health Services, 2015 Texas HIV Surveillance Report; State HIV ranking for 2014 from U.S. Centers for Disease Control and Prevention

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SIDEBAR

Guidance for PrEP Use

These are risk factors and clinical eligibility guidelines physicians can use to detect a substantial risk for acquiring HIV infection, according to the U.S. Centers for Disease Control and Prevention:

Risk Factors  

• For men who have sex with men or for heterosexual men and women:
  • Sexual partner with HIV,
  • Recent bacterial sexually transmitted disease,
  • High number of sex partners,
  • History of inconsistent or no condom use, and
  • Commercial sex work. 
   
• For heterosexual men and women: living in an area with high HIV prevalence or being part of a sexual network at high risk.
• For injection drug users:
  • HIV-positive injecting partner,
  • Sharing injection equipment, and
  • Recent drug treatment (but currently injecting).  

Clinical Eligibility Guidelines  

• Documented negative HIV test before prescription of pre-exposure prophylaxis (PrEP),
• No signs or symptoms of an acute HIV infection,
• Normal renal function and no contraindicated medications, and
• Documented hepatitis B virus infection and vaccination status. 

Source: U.S. Centers for Disease Control and Prevention, Pre-Exposure Prophylaxis for HIV Prevention fact sheet