BY STEVE ROTHAUS, srothaus@MiamiHerald.com
When the U.S. government this week approved a drug to prevent HIV infection, some called it a turning point in the fight against AIDS.
“This is a watershed moment for both U.S. and global HIV prevention efforts,” said Mitchell Warren, executive director of AVAC, Global Advocacy for HIV Prevention.
One Truvada pill a day, along with safer sex practices, could reduce the risk of infection 42 percent among male partners and 75 percent in opposite-sex pairs, according to the U.S. Food and Drug Administration.
But using Truvada daily comes with a $1,200 monthly price tag and possible side effects — including diarrhea, kidney and bone damage — and some South Florida AIDS activists say the costs outweigh the benefits.
“I wouldn’t want to take the risk of this medication,” said Stacy Hyde, vice president of Broward House, which provides care and support for people with HIV. “Condoms are available everywhere for free. Why put your body through that? And there are so many other STDs — Truvada is not going to protect you from hepatitis C, gonorrhea, syphilis or herpes.”
In 2004, the FDA approved Truvada by Gilead Sciences as an effective treatment for those already infected with HIV. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.
Studies began in 2010 showing that the drug had potential to help prevent people from contracting HIV in the first place. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year, another study found that Truvada reduced by 75 percent the rate at which an HIV-infected person in a heterosexual relationship passed the virus to his or her partner.
Each year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, according to FDA Commissioner Margaret A. Hamburg. “New treatments as well as prevention methods are needed to fight the HIV epidemic in this country,” she said in a news release.
Many AIDS activists cheered when the FDA this week OK’d using Truvada for pre-exposure prophylaxis (PrEP). “It really marks a new era in HIV prevention,” said James Loduca, vice president of the San Francisco AIDS Foundation.
The lifetime cost of treating one person diagnosed with HIV infection has been estimated at more than $600,000. The cost of using Truvada is about $14,000 a year.
"It is expensive, but on the other hand it’s far cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of the Johns Hopkins University School of Medicine.
Gilead Sciences stresses that Truvada must be used with condoms. “You must practice safer sex at all times and do not have any kind of sex without protection,” according to the Gilead website.
Safer sex has been the mantra practically since the beginning of the AIDS epidemic more than 30 years ago. So why use Truvada, with its risks and expense?
“It’s just one more layer of protection,” said Hyde, whose Fort Lauderdale agency sees 5,000 clients a year.
“This doesn’t replace safe sex. Safe sex includes condoms and not having impaired judgment,” said Raben, a South Miami physician. “Not having drugs and alcohol driving the engine.”
Raben said preventive use of Truvada would most benefit “discordant couples,” in which one partner is HIV positive and the other negative.
The pill could also benefit someone who doesn’t know or trust his or her partner’s HIV status, said Dale Penn, a Miami AIDS activist.
“I do know someone who was in a monogamous relationship. They both tested negative, both tested negative again six months later. Three years later one of the partners became very ill, was taken to the hospital and died within a week of [AIDS-related] pneumocystis.
Penn said anyone contemplating preventive use of Truvada should speak with “their trusted physician, weigh the pros and cons, financially and medically, and then reach an informed decision whether it’s right for them.”
Gilead requires that patients taking Truvada be tested for HIV every three months, along with checkups for other STDs.
Raben believes that’s a big plus in the 31-year fight against HIV. “It may encourage some people to get tested, now that they know they have something to take if they’re negative,” she said.
“How good are young people about taking their medication?” he says, especially if the drug is preventive and not medically necessary. “How many people who do not have to take something like me to stay alive remember to take their medication every day?”
If an HIV patient skips or misses repeated doses, the virus will likely replicate and could develop a resistance to Truvada, rendering it ineffective, according to Raben.
Garner also worries that people taking Truvada will not use condoms. “As soon as someone thinks they’re protected from HIV, condoms are going to go out the window. I don’t care if you’re gay, straight or bi.”
He questions the wisdom of long-term use of Truvada.
“This is a newer drug and we still don’t know the long-term side effects. Nobody’s been on this more than 10 or 12 years,” Garner said.
Truvada costs about $1,200 a month. Most health Insurance plans cover the medication for treatment of HIV/AIDS. It’s unclear whether Medicaid or private insurance will cover it to prevent HIV transmission.
Heywood was diagnosed with HIV in 2007 and has used Truvada for exactly a year.
“It does come with a lot of potential side effects. There are the minor side effects, which I happen to be suffering,” he said. “It makes it difficult to go to sleep and when you do go to sleep you have some really bizarre dreams. I also have gastrointestinal disturbances. ... The other unintended consequence from these drugs: the weight gain. I’ve gained almost 35 pounds.”
The most serious side effects are less common and include acid buildup in blood that can cause weakness, muscle pain, fast or irregular heartbeat; liver problems including enlargement that cause jaundice; bone thinning and kidney problems. More common side effects include diarrhea, dizziness, nausea, headache, fatigue, abnormal dreams, sleeping problems, rash and depression.
Still, Heywood stays on Truvada. A month after he started taking the drug, the AIDS virus became undetectable in his body.
“For me, as somebody living with HIV, it’s a choice of combating the virus or dying from the virus,” Heywood said.
He’s not sure he’d use the drug if he was HIV negative. “This would be a very tantalizing thing for me to look at. But I’m also anal retentive about the drugs I put in my body.”
In addition to using condoms, Heywood advocates that people adopt other forms of safer sex, including “traditional hugging and cuddling and mutual masturbation.”
“Communicating and understanding what your needs are, and how you’re going to get them to keep you and your partner safe,” he said. “Monogamy is the most effective risk reduction.”
This report was supplemented with material from The Associated Press.