Not quite – Truvada helps prevent HIV, but doesn’t replace condom use

By : Steve Blanchard
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Suddenly, Truvada is getting a lot of attention. But that’s not because it’s a new drug. It’s because new studies have shown the HIV drug helps inhibit the transmission of HIV, meaning it can help reduce infection in those who are negative.

In a controlled study with strict adherence by participants, Truvada was nearly 96% effective in reducing HIV transmission rates. However, another study shows that healthy gay men who use condoms can lower their risk of becoming infected up to 42%. That second study incorporates real-world factors like forgetting to take the medication, not using condoms and other factors.

Surprisingly, many doctors aren’t even aware of Truvada as a PrEP.

“That’s the sad part,” says Saul Leon, a Certified Clinical Research Coordinator with the Orlando Immunology Center. “It’s a lack of education. Guidelines on prescribing Truvada were released by the Centers for Disease Control in May. As doctors and providers become more familiar with these guidelines, they’ll be more willing to release the medication to their patients.”

Fortunately for Lance T. of Tampa Bay, his doctor was well aware of the medication, and when he visited his doctor, he made sure he had the information he needed to ask the right questions.

“I saw articles posted on Facebook by friends and researched what the benefits were and what the side effects might be,” says Lance, who asked to remain anonymous for this story. “After about a year I went to my doctor, who has a lot of gay and lesbian patients. He strongly suggests his patients get on Truvada if insurance will pay for it.”

The pill is extremely expensive and can cost close to $14,000 a year. Without insurance, a 30-day dose runs close to $1,400. Luckily for Lance, his co-pay is only about $100, and participates in a co-pay assistance program through Gilead Sciences, the company that makes the drug.

“My insurance covers most of it and Gilead takes care of the co-pay, so there’s no direct cost to me,” Lance explains. “Otherwise, there’s no way I could afford it.”

Unfortunately, there are no immediate plans to release a generic, less-expensive form of Truvada in the United States until at least 2017, according to Leon. There are several programs available to help with the cost, such as the one Lance participates in. Leon suggests downloading the assistant forms from the Truvada website.

How it works
It’s important to remember that Truvada is not a new drug, explains Lorraine Langlois, CEO of Metro Wellness and Community Centers in Tampa Bay. In fact, it’s been around for years and has been used in the protocol, or lineup of drugs, for HIV-positive patients for years.

“But new studies have shown that it helps prevent transmission, which has boosted its appearance in the headlines,” Langlois says.

According to the Food and Drug Administration, Truvada gained its approval as PrEP due to two large clinical studies. In one study, 2,500 HIV-negative MSM from Latin America, Thailand, and the U.S. took either Truvada or a placebo pill once a day. The study found that Truvada reduced the risk of HIV by 44%. But many people assigned to Truvada missed doses or never took it at all. In people who took it consistently, the reduction was 73%. It’s estimated that people who took two doses a week reduced their risk by 76%. Taking four or more doses a week might have reduced risk by over 95%—but these are only estimates.

The Partners PrEP Study enrolled over 4,700 couples in Uganda and Kenya, with one negative and one positive partner. Those who were negative took Truvada, Viread or a placebo. Viread reduced infections by 67% and Truvada by 75%. In people who were found to have drug in their systems, Viread reduced infections by 86% and Truvada by 90%.

“Truvada is actually a combination of two HIV medications,” Leon explains. “What they do is inhibit HIV’s ability to reproduce and gives the immune system a better chance of killing the virus.”

Leon says that although it only takes one encounter to get infected with HIV, it’s more likely to become positive after multiple encounters with the virus.

“When you provide the medication and it’s in the system, it can get in contact with the virus and prevent it’s reproduction,” Leon explains. “It then allows the immune system to kill it and remove it from the body.”

Like most medications, the side effects of Truvada vary by patient. However, the most common side effects are a build-up of acid in the blood and serious liver problems.

A tool in the HIV arsenal
According to William Harper, executive director of the AIDS Service Association of Pinellas, many doctors want more information on Truvada or aren’t comfortable with
prescribing it as a PrEP.

“Many doctors don’t like the liability of it,” Harper says. “Many fear they will prescribe it to a young guy who suddenly thinks, ‘Hey, I don’t have to use a condom!’ But it’s like other medications. You have to use it stringently. If you miss a dose or a few doses, you’ve got a lull in your system and your susceptible and you could get infected.”

Lance said his doctor was very clear that condom use is still required to protect against HIV infection, even while he’s on Truvada.

“This is just a supplement to practicing safe sex and help you in case something happens,” Lance says. “He even suggests I still get tested for HIV, but to do it annually rather than every three months. That’s kind of unusual. I agreed to that since the instances of infection are so small.”

Lance doesn’t see the use of Truvada and condoms as redundant. In fact, he says that since he’s been on Truvada, he’s had encounters with other men where a condom has broken.

“I don’t freak out anymore,” Lance says. “Condoms have broken and there are incidents where I haven’t practiced safe sex. It used to be, ‘Oh my God, oh my God, I need to go get tested right away!’ Now I don’t freak out and don’t rush to get tested. There’s a sense of relief.”

Leon says that Truvada has a half-life of seven days, meaning the medication is still in the system for a week after the pill is taken. However, it is still recommended that the pill is taken daily for maximum protection.

“If someone forgets to take it for a day, it’s kind of okay,” Leon says. “The problem is when they forget multiple times in the same week. We have to educate people.”
The best way to look at Truvada, according to Harper, is as a way to make safe sex even safer.

“It’s another tool in your toolbox of safer sex options,” Harper says. “It raises your ability to stay negative by another level. But for God’s sake, if your insurance won’t cover it, how can you afford it?”

Truvada as a PrEP, or prevention tool, falls into a different category with the Centers for Disease Control and insurance companies, according to Priya Rajkumar, VP of Metro Wellness.

“When an HIV medication becomes a prevention tool, it falls into a whole different category and that affects whether funding is available to pay for it,” Rajkumar explains. “There’s more money for care than for prevention.”

Still more to learn
Harper adds that Truvada is by no means the Holy Grail of HIV prevention. But it does give hope to someday eradicating the disease or at least bringing infection rates way down.

“We’re happy about it,” Harper says of Truvada. “It shows to be effective, but not all of the research is in yet.”

Langlois says she’s happy about Truvada as well and see is as a step forward. She is concerned, however, that those at risk of infection—especially gay men—will miss the details and only read the headlines.

“The problem is the information and the cost. I also have not heard where Truvada can be paid through a government program yet,” Langlois says. “We’re actually very lucky in the HIV/gay community. There is a law of government funding for HIV, but it’s not enough. It’s very costly and it’s a political issue.”

According to Leon, there is truth to the rumor that a version of Truvada could become a once-a-month medication, but the research is still out on that study.

“In Europe there’s a study on a monthly injection that’s an inhibitor—it’s another class of HIV medication,” Leon explains. “That medication prevents HIV from entering the cell, but that’s still ongoing research.”

The ultimate goal in research, of course, is to find a vaccination that could eradicate HIV. Unfortunately, Leon doesn’t expect that major headline news for at least a decade, if not longer.

“The vaccine is going to take awhile,” he says. “A recent study found the current vaccination isn’t effective, so it’s set us back another 15 years or so.”

But Truvada is a step in the right direction for those who are able to obtain it. But there’s a stigma related to Truvada use.

Adding to the stigma
Lance is very careful about who he tells about his Truvada regimen. He has no trouble remembering to take it each morning since he takes vitamins and other supplements as well. But if word gets out that he takes the HIV prevention pill, his reputation could take a hit.

“I’ve told maybe three or four friends that I’m on it, and they’re okay with that,” Lance says. “But I’m afraid to tell everyone in the world because there is a perception that if you’re on Truvada, you’re a whore.”

That’s exactly what happened when the birth control pill was released in 1961.

“It took a few years to get over that stigma,” Lance recalls. “But eventually it was seen as a medical option, nothing more.”

The term “Truvada Whore” is making its way through the LGBT community. In fact, a group enjoying St. Pete Pride in June were spotted wearing shirts with that phrase on it. It may have been a way of advertising the pharmaceutical. But that doesn’t make it acceptable, Harper says.

“I think it’s an abhorrent term,” Harper says. “I know that it was probably meant as tongue in cheek to be cutesy. ButI don’t think it’s cute or something that should be laughed at or taken lightly. It’s not cool to add another stigma to a disease that has enough stigma on top of it.”

And the stigma in Tampa Bay is higher than in other places, Langlois believes.

“It’s tough getting people to come to education things and getting people to know their status,” Langlois says. “It’s a dated way of looking at the world.”

It also makes it difficult to recruit educators and participants for support groups, Rajkumar adds.

“By coming to a group, they are disclosing their status and they don’t want their friends to know they are positive,” Rajkumar says. “Even if it’s a generic group discussion about sex and relationships. They’re terrified of getting that stigma.”

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