What physicians need to know about Truvada, the HIV prevention drug

In May, the Centers for Disease Control and Prevention endorsed the drug Truvada as a safe and effective way to reduce the risk of HIV acquisition in adults. Although the Food and Drug Administration approved Truvada for HIV prevention in July 2012, many physicians have been reluctant to prescribe it. One study found that fewer than 10% of infectious disease specialists had prescribed the drug, though nearly three-quarters supported its use, reported Clinical Infectious Diseases.

In that study, physicians expressed concern that HIV-negative patients might not take the pill daily as directed, which could lead to the virus becoming resistant to Truvada, an antiretroviral drug that is often used in combination with another medication to combat HIV in infected patients. Physicians also cited lack of knowledge about Truvada and worries about irresponsible sexual activity as reasons for not prescribing the drug.

Despite these misgivings, Truvada reduces the likelihood of HIV infection in sexually active high-risk populations. By being open to prescribing the drug and carefully screening and counseling patients, physicians can help ensure Truvada’s safe and appropriate use, says general internist and pediatrician Henry Ng, MD, MPH.

“Truvada isn’t for everybody,” says Dr. Ng, the clinical director of LGBT health care at MetroHealth Medical Center in Cleveland. “But it can be a very useful tool to prevent HIV transmission.”

PrEP primer

Truvada is the first pharmaceutical pre-exposure prophylaxis (PrEP) approved by the FDA to prevent HIV infection. The CDC recommends daily oral PrEP as a prevention option for sexually active HIV-negative men who have sex with men (MSM) and heterosexual men and women who are at “substantial risk” due to one or more the following factors:

• an HIV-positive sex partner.
• a high number of sex partners.
• a history of inconsistent or no condom use.
• a recent bacterial sexually transmitted infection.
• involvement in commercial sex work.

The CDC also recommends PrEP as a prevention option for HIV-negative injection drug users who have an HIV-positive injecting partner or who share injection equipment.

Several studies, including a 2010 National Institutes of Health-funded clinical trial of MSM, have shown that when taken as directed, PrEP significantly reduces the likelihood of contracting HIV among individuals in high-risk populations.

Approximately 50,000 individuals become newly infected with HIV each year in the United States—a statistic that has been consistent for the past decade, according to the CDC. Truvada for PrEP has yet to noticeably reduce HIV incidence.

Even after the release of the CDC guidelines, some physicians are hesitant to prescribe PrEP for sexually active gay men unless they are in serodiscordant monogamous relationships (in which one partner has HIV and the other doesn’t), contends New York City AIDS activist Christopher Glazek, who takes Truvada to prevent HIV.

“I have a friend who had to threaten to sue his doctor to get a prescription,” says Glazek, who wrote about PrEP for The New Yorker last year. “The doctor told him, ‘I’m not going to write a prescription for you because you’re not in a serodiscordant relationship.’

“My friend said, ‘That’s not what the CDC says. It’s for anyone at risk. I am at risk, and I want it.’ When the doctor still refused, my friend said, ‘That’s fine. But if I get infected in the next year, I’m going to sue you for malpractice.’ At that point, the doctor quickly got out his prescription pad.”

Clinicians who feel more comfortable prescribing Truvada to prevent HIV say they still exercise caution because of the risks associated with noncompliance, the drug’s potential side effects and the possibility that users will develop a false sense of security.

David V. Condoluci, DO, an infectious disease specialist in Vorhees, N.J., has prescribed Truvada for PrEP to patients from all walks of life, but he doesn’t do so heedlessly.

“You’ve got to make sure that you start by properly counseling the patient about risk reduction,” he says. “Truvada, if taken daily, will protect against HIV, but it won’t prevent other sexually transmitted diseases, such as gonorrhea, herpes and condyloma. All of those are very contagious and very serious at times.”

Before he prescribes PrEP, Dr. Condoluci will have a conversation with the patient about responsibility. Depending on the individual, he may urge more consistent condom usage or discourage promiscuity.

“Having said that, we don’t want more HIV out there,” Dr. Condoluci says. “We have to be realistic about the fact that from adolescence on, people are having sexual relations. Some people are in monogamous relationships, and some are not. We try not to be judgmental.”

Physicians need to be sensitive when questioning and counseling patients about their sexual behavior, Dr. Ng says.

“Avoid labeling behaviors as ‘risky,’ ” he says. “We’re trying to provide an opportunity for people to have healthy expression of sexuality and minimize the transmission of HIV.

“In health care, we’ve gotten good at pathologizing an important way that human beings express their feelings and their attraction for one another.”

Taking precautions

Used alone, Truvada for PrEP is insufficient to treat HIV in infected patients. Therefore, physicians must make sure that patients are HIV-negative before prescribing PrEP.

“Someone might come in who thinks they are HIV-negative and ask for PrEP. But it would be dangerous to give them PrEP without being sure that they don’t have HIV,” says Travis Sherer, PA-C, the program manager of the Lenox Hill Retroviral Disease Center in New York City.

Another contraindication for prescribing PrEP is the likelihood of poor adherence, Sherer points out. The 2010 NIH-funded study showed a 50% HIV risk reduction among subjects who self-reported at least 50% compliance with the daily pill protocol and a 73% risk reduction among those reporting at least 90% compliance.

An ongoing extension of this study has shown more dramatic results: nearly 100% risk reduction in those who take four or more pills a week (as measured by blood detection of the drug), reported The Lancet Infectious Diseases in July.

“Although different studies have different numbers, PrEP’s effectiveness universally has to do with adherence,” says Sherer.

To size up someone’s likelihood of complying with the PrEP protocol, Sherer relies heavily on instinct, trusting his own observations of the patient’s punctuality and reliability. “It’s rare that you would start somebody on PrEP the day they come in asking for it because you’ve got to rule out HIV, you’ve got to rule out other STDs, and you have to get some lab work done,” he notes. “These patients need to come back a time or two after they see you before they can get the prescription.

“How good patients are at keeping those appointments is an excellent barometer of how adherent they will be on PrEP.”

Truvada may cause kidney problems over time, so physicians must assess a patient’s renal function before and while prescribing Truvada. The patient should have another renal function test three months after starting the medication and every six months after that, according to the CDC. Any kidney dysfunction is reversible, however, if the patient stops taking Truvada.

Dr. Condoluci prescribes 90 days’ worth of Truvada at a time and requires his PrEP patients to come to his clinic for monitoring every three months, as the CDC recommends: for HIV testing, side-effect assessment, and medication-adherence counseling, as well as a kidney function test every other visit. He also tests to see whether female patients of childbearing age are pregnant, a major contraindication for PrEP.

“Although the drug is not for everyone, most people can be on Truvada for years without any serious side effects,” Dr. Condoluci says.

Overcoming barriers

Truvada for PrEP costs more than $1,100 a month, but many insurance plans cover the drug. Gilead, the drug’s manufacturer, offers financial assistance to uninsured and underinsured low-income patients. Still, the drug’s high price is a barrier to many economically disadvantaged individuals at high risk for HIV who would benefit from the drug.

Although total HIV incidence has remained stable for a decade, increases have occurred within specific populations. From 2008 to 2010, HIV incidence, or the number of new cases, rose 22% among adolescent and young adult men who have sex with men (aged 13 to 24 years), with the greatest number of new infections occurring in African-American men, according to the CDC.

“The messages that have been used about reducing risks haven’t been working that well, especially with young MSM of color, a population in which we’ve seen HIV infection rates increase,” Dr. Ng says. “It’s pointless to just stick to the status quo and tell people to use condoms and negotiate and abstain and wait. That didn’t work before. Why would anyone think that it would work now?

“If I have a young MSM of color, and he tells me that he’s sexually active and does this, that and the other thing, my job is to begin having a conversation. ‘Do you think you can take a medication every day?’ I would ask. ‘There is a medicine that can help you.’ “

After blood tests assure him of the patient’s health and suitability for Truvada, Dr. Ng will say, “Let’s put you on PrEP. I’ll see you in three months—sooner if you’d like. We’ll see how you’re doing and how you’re feeling.”

If the patient can’t keep to the schedule or has an adverse reaction, Dr. Ng may discontinue prescribing Truvada for that individual.

Avoid shaming, advocates say

Glazek, the AIDS activist, says he doesn’t understand why some physicians worry that gay men on PrEP will stop using condoms. Doctors should understand that many gay men don’t consistently use them to begin with. One in 6 MSM use condoms 100% of the time, according to a 2013 CDC estimate.

On the other hand, he notes, having multiple sex partners is a huge risk factor for HIV and other STDs. “But there is no evidence that being on Truvada increases your number of sexual partners,” says Glazek, who is the founder of the Yale AIDS Memorial Project.

Glazek likens the shaming that sometimes occurs when physicians advise patients about Truvada to the medical community’s reaction when the birth control pill first became available in the 1960s. “Initially, some physicians would only prescribe the pill to married women,” he says. “People had this fear that birth control would create these promiscuous young harlots.

“Did birth control make people use condoms less? Probably yes. Did it cause big increases in the number of sexual partners? I’m pretty sure the answer is no.”

Similarly, Dr. Ng takes issue with arguments that someone who uses Truvada for PrEP but doesn’t wear condoms is self-harming and not responsible.

“I fail to see how a person who is willing to take a medication every day and have HIV and other types of laboratory blood testing and see a health care professional every three months could be considered irresponsible morally, ethically or sexually,” Dr. Ng says. “Being on PrEP is at least just as responsible as wearing a condom.

“PrEP is just one of many tools that we can use to negotiate with our patients and work with them to decrease HIV.”