Health providers slowly embrace drug Truvada to prevent HIV

Go to Source

 

When Adam Zeboski started using the HIV drug Truvada in November 2012, he was HIV-free himself, but in a relationship with a man who had been infected.

 

He was taking one Truvada pill a day for prevention, or PrEP – the breezy term for pre-exposure prophylaxis. Multiple international studies had shown that daily use of Truvada could nearly eliminate the risk of contracting HIV.

 

But PrEP wasn’t something most of Zeboski’s friends talked about, and even fewer admitted taking. Even in progressive San Francisco, “there was a lot of disapproval,” Zeboski said.

 

“People were talking about how PrEP would turn you into a slut,” said Zeboski, 26, who is an HIV testing counselor with the San Francisco AIDS Foundation.

 

The negativity came from gay men and their friends and families, from doctors and other health care providers, and even from advocacy groups that wouldn’t fully endorse Truvada for prevention.

 

And that’s part of the reason why, two years after the drug was approved by the U.S. Food and Drug Administration for prevention, and more than four years after studies showed it to be effective, very few people are actually using PrEP.

 

But that may be about to change. Last month, the U.S. Centers for Disease Control and Prevention released the first recommendations for who should consider the drug, focusing on groups of people at highest risk of contracting HIV. The recommendations would apply to roughly half a million people in the United States – a radical jump from the 2,000 or so currently taking PrEP.

Providers coming around

The recommendations could be a game-changer, HIV specialists say. A prevention therapy that’s been slow to catch on may finally have its toehold.

 

“Health care providers already are starting to come around,” said Dr. Robert Grant, a UCSF professor and chief medical officer of the San Francisco AIDS Foundation who led the international clinical trials demonstrating that Truvada worked for prevention. “They’re actually providing PrEP rather than trying to talk patients out of it. And people are asking about it in an intentional way – they’re saying, ‘I want PrEP, it’s something I can use.’ ”

 

In San Francisco, more efforts to increase use are under way. San Francisco is one of three places in the country conducting demonstration projects on practical uses of PrEP in the community. Three hundred men and transgender women have joined the San Francisco project.

 

Kaiser San Francisco has built up a program to make it easier for uninfected members to see an expert and get a Truvada prescription. At San Francisco General Hospital, health care providers who run the HIV clinic, called Ward 86, will spend the next 12 months developing a program to offer PrEP, which would be their first foray into treating people who aren’t infected.

 

San Francisco public health experts, who have announced aggressive plans to end the spread of HIV entirely, see Truvada as a key tool in their efforts.

 

“PrEP is going to be one cornerstone of our initiative,” said Dr. Susan Buchbinder, director of HIV research for the San Francisco Department of Public Health. “It’s a really remarkable tool that we need to finally roll out so people can actually use it.”

 

Truvada, which has been used to treat HIV infection since 2002, is a single tablet that combines the drugs emtricitabine and tenofovir disoproxil fumarate. It is made by Gilead Sciences in Foster City and costs about $13,000 a year, whether it’s used for HIV treatment or prevention.

Infection risk plummets

Studies have found that for men who have sex with men, the drug taken daily can cut the risk of HIV infection by 90 percent. Truvada also is effective for women as well as for transgender men and women, but the studies involving those groups have been smaller. Most of the efforts toward increasing use of PrEP have focused on men.

 

Adherence to the daily regimen is key. Research has shown that missing two or three doses a week still offers protection, but it’s unclear just how much and probably varies from person to person.

 

Side effects appear to be minimal. Most people report no side effects, and about 10 percent of users say they have some gastrointestinal discomfort for the first few weeks after starting. A smaller percentage of users can suffer more serious signs of drug toxicity and will need to stop taking the drug.

 

But the biggest barriers to wide acceptance of PrEP haven’t been questions of efficacy or side effects. Doctors and other health care providers have been slow to embrace PrEP, HIV specialists say. Plus, Gilead hasn’t put much effort into marketing Truvada for prevention.

 

“Our approach at Kaiser is PrEP is a very responsible way to address your sexual health,” said Dr. Brad Hare, former head of Ward 86 who is now director of HIV care and prevention at Kaiser San Francisco. “But it is a serious intervention. These are expensive drugs that need to be used responsibly.” And then there’s the stigma.

 

In San Francisco’s gay community and among health care providers, PrEP largely has been considered acceptable for specific situations – long-term, monogamous couples in which one person was HIV-positive, for example – but not for men who were at risk for HIV because they weren’t using condoms.

‘Less to worry about’

About two years ago, rumors began circulating of men using Truvada as a “party drug” – popping a few pills before a night of clubbing or a wild weekend in hopes that would be enough to provide some protection. And though there’s little evidence that such use has ever been prevalent, it fed into the idea of “slut-shaming” that tagged people who were using PrEP, Zeboski said.

 

In February, he designed a T-shirt with “Truvada whore” printed across the front, as his way of addressing the stigma of PrEP head-on.

 

“At one point I had an epiphany, like, ‘Oh, my gosh, it has to be me talking about it.’ I just have to disclose everything about myself,” Zeboski said. “I felt really motivated to put myself out there and get more involved in activism and movement around promoting Truvada.

 

“Taking PrEP has really changed my life,” he added. “Sex is just so much more fun and less stressful. There’s a lot less to worry about now.”

 

The most prominent voice against widespread use of PrEP has been Michael Weinstein, president of the AIDS Healthcare Foundation. He argues that PrEP is a potentially dangerous tool, warning that adherence could be tricky.

Adherence a hurdle

It’s not known whether people will be willing or able to take Truvada every day, Weinstein said. People who forget a day or two a week may be unknowingly putting themselves at greater risk of becoming infected, he said. Truvada also doesn’t protect people from other sexually transmitted diseases, so if they’re skipping condoms, they still risk a gonorrhea or syphilis infection.

 

“People who talk about this, they say it’s 90 percent effective. But they really minimize the issues around adherence,” Weinstein said. He added that the fact that doctors have been the biggest barrier to widespread acceptance of Truvada is telling.

 

“The bottom line is that if doctors believed in PrEP, they would be prescribing it,” he said.

 

His concerns are shared by many of those who endorse PrEP, but they argue that those problems can be, and often already are, addressed.

 

Still, supporters of the drug acknowledge that widespread usage and acceptance of it is going to be a challenge.

 

Prescribing Truvada is no simple thing – it requires an initial HIV test, plus follow-ups at least every three months to test for HIV and other sexually transmitted infections and to make sure patients aren’t showing signs of drug toxicity, which could cause organ damage.

 

Many general practitioners are unfamiliar with Truvada and may still view it as a highly toxic drug that requires special care and handling – something best prescribed only by HIV doctors, said Grant with the San Francisco AIDS Foundation. Overcoming their long-held reservations about Truvada will take time and education.

Overcoming costs

Cost of the drug is an issue too. So far, insurers have seemed inclined to cover the cost of Truvada as prevention, and Gilead will provide it at a discounted price or for free to people who want it and can’t afford it.

 

Still, the cost is intimidating, and the price tag wraps back around to the stigma of PrEP – condoms, after all, are a lot cheaper than a daily drug, and they aren’t toxic.

 

“But it’s not helpful to tell someone who’s not using condoms that they should use condoms,” Grant said. “They already know they should be using condoms.”

 

Buchbinder said someday, she’d like to see patients and doctors comparing Truvada to the use of statins in lowering cholesterol and preventing heart disease.

 

“You hear people say, ‘Why do people need a pill? We know how to prevent HIV with condoms,’ ” Buchbinder said. “With statins, we encourage people to eat better and exercise, but we don’t say we’re not going to give it to you unless you promise to not eat any ice cream. It’s the same with HIV prevention.

 

“But there’s a certain moral concern people raise around PrEP,” she said. “That doesn’t exist around other preventive strategies.”

 

Comments are closed.