A new preventive pill meant to stop the spread of HIV has created a conundrum for gay men and the doctors who treat them. Public health organizations have recommended that HIV-negative men who have sex with other men consider taking the pill, called Truvada, every day to keep from getting infected with the sexually transmitted virus.
But there are important caveats: Gay men who are in monogamous relationships may not need a medication that, while considered safe, isn’t without any risks or side effects. For those who have trouble remembering to take a pill every day, the drug could actually pose more risks than benefits.
Such issues have led to a mixed reception for the HIV prevention pill also referred to as pre-exposure prophylaxis (PrEP).
Truvada for HIV prevention was approved by the US Food and Drug Administration two years ago to prevent the infection in people at high risk for contracting the sexually transmitted virus such as men having sex with men, intravenous drug users, or those having sex with infected partners. Last May, the Centers for Disease Control and Prevention recommended Truvada — the only pill approved so far for PrEP — as “one prevention option” for those at high-risk for contracting HIV. The World Health Organization issued a stronger endorsement in July, urging all gay men to take Truvada even if they use condoms.
Public health organizations have largely focused on gay men for Truvada usage because they represent the biggest group of new HIV infections in the United States. A 2013 CDC study suggests that only one in six gay men use condoms every time they have sex with a new partner. In 2010, 28,500 American men contracted HIV from having sex with other men, according to the latest data from the CDC. That compares to 12,450 new infections that occurred from heterosexual sex or intravenous drug use in both men and women.
Jason Roush , 40, is among those who have decided against taking the drug, despite the recommendations.
“I worry about potential toxicity,” said Roush, an Emerson College instructor who is gay and uses condoms consistently. “I don’t want to put any medication into my body unless it’s something I absolutely have to take.”
But for others, taking the pill is a welcome choice.
“I would say there’s growing awareness in the gay community about PrEP,” said Carl Sciortino, executive director of the AIDS Action Committee of Massachusetts. “People are beginning to ask questions and to realize that this could be an option for them.”
Erik Hamilton, 36, said he has been taking the pill every day for the past six months.
“My husband and I are in an open relationship, and although we used condoms with others, we decided we didn’t want to take any chances,” said Hamilton, a Lowell resident and office manager. Now, Hamilton added, he occasionally skips condoms when having sex with men he meets online, relying on the pill for protection against HIV.
It’s difficult to determine how many high-risk individuals have decided to follow the recommendations to take the drug. Gilead, manufacturer of Truvada, reported that 2,319 Americans started taking Truvada for PrEP in 2012 through September 2013, the most recent data available from 55 percent of pharmacies nationwide. That number includes women with HIV-infected partners who are taking the drug as well as gay men.
Manufacturer-sponsored clinical trials of Truvada conducted to gain FDA approval found that it reduced the risk of HIV infection by 42 percent compared to a placebo in nearly 2,500 men or transgender women who had sex with men and didn’t consistently use a condom. Infection risk was reduced by 75 percent in more than 4,700 heterosexual couples in which one partner was HIV positive and the other was not and was given Truvada instead of a placebo.
Side effects like nausea, diarrhea, and abdominal pain were uncommon and usually temporary, and serious adverse events were extremely rare, according to the FDA.
Unlike condoms, Truvada won’t protect against other sexually transmitted diseases, though a July study conducted in African men found that the pill lowered the risk of contracting genital herpes by about 30 percent.
Dr. Brian Bakofen, a primary care physician at Fenway Health, has prescribed Truvada to 45 patients so far, but has declined to prescribe the drug to a handful of men who have asked for a prescription. “I won’t prescribe it if I suspect a patient won’t take it every day,” Bakofen said, because of the increased risk of developing a Truvada-resistant HIV infection.
Approved in 2004 to treat HIV infections, Truvada is routinely prescribed along with two other anti-retroviral drugs to more than one million Americans who are infected with the virus. Because it is well tolerated and has few long-term side effects, doctors prefer to prescribe it as a first-line treatment, Bakofen said, before turning to older, and potentially more toxic medications.
But there are other considerations for would-be users of the drug.
Some of Bakofen’s 800 patients who would be eligible for the prevention pill have declined to take it, he said, because of the stigma of promiscuity that surrounds it. Others aren’t having sex outside of a monogamous relationship — or aren’t having much sex at all. Given all of these nuances, Bakofen prefers an individual approach when deciding whether PrEP is the right choice for a patient.
The drug’s cost could also be a deterrent. Insurance plans in Massachusetts typically cover Truvada for prevention as well as treatment, according to Bakofen, but some patients face copays of $50 per month. While that’s far less than the $10,000 to $13,000 annual cost for the drug without any coverage, $600 annually may still be too expensive for some.
Dawn Fukuda, director of the State Health Department’s Office of HIV/AIDS, said potential Truvada users need to be aware that the prevention regimen isn’t as simple as popping a pill.
They need to be tested for HIV before taking the drug — often twice over two weeks to ensure any early infections are detected — and they need to have repeat tests every three months. Doctors should also perform regular blood tests to check for kidney and liver problems which can, in rare cases, occur from the drug. “The PrEP protocol requires careful monitoring and sexual health counseling,” Fukada said, which is why it’s so important that people receive a prescription from doctors who fully understand the benefits and downsides of the prevention pill.
If used correctly, Truvada could continue the dramatic decline in the state’s HIV incidence: Massachusetts has had a 41 percent drop in new HIV infections from 2000 to 2013, partly due to the passage of the 2006 state health law. “High access to HIV medications has had a huge prevention impact,” Fukada said.
Infectious disease experts agree that the success of PrEP to stop the spread of HIV will likely depend on the reliability of patients who take it. In a July study published in the journal Lancet, researchers found that slightly more than half of 793 patients who chose to take Truvada were still taking it consistently after 12 weeks.
In a review of PrEP studies involving thousands of patients, “HIV infections and the emergence of resistance were extremely uncommon and almost always seen in those who didn’t take PrEP regularly,” said study co-author Dr. Kenneth Mayer, medical research director at Fenway Health. As with birth control pills, he added, the efficacy of PrEP depends on taking the pill at the same time every day.
Patrick Buzzell said he’s been faithfully taking Truvada for the past two years every day at 8 p.m. “I try to bring the pill with me if I know I’m not going to be home until later at night,” said the 37-year-old who recently moved to Manhattan from Boston. “I take blood pressure medication, so I’m used to taking pills.”
Hamilton said he sets at alarm on his phone to remind himself to take a dose at lunch time. “I’ve never forgotten,” he added.
Newer formulations of PrEP using different drugs with different delivery systems could soon offer alternative options for those who don’t want to take a daily pill — like a monthly injection or implant that delivers the drug continuous. “We’re at where hormonal contraception was at 50 years ago,” Mayer said. “Truvada is just the first generation of PrEP.”