In a Bangkok go-go bar, a prostitute in a transparent miniskirt who goes by the name “Joy” said she’s ready to benefit from one of the biggest scientific breakthroughs in the 30-year fight against AIDS.
The 23-year-old sex worker says she’d like the chance to use Gilead Sciences Inc. (GILD:US)’s pill Truvada to help protect her from becoming one of the 530,000 people in Thailand with HIV.
“I am scared,” she said, during a break at the bar. “I want to find a husband. If it works, I’ll take it.”
Truvada, a staple of treatment for patients with HIV, was approved today in the U.S. to lessen the risk of infection in healthy people by as much as 94 percent when taken regularly. As researchers struggle to develop an AIDS vaccine, having a daily pill to block the virus could be a crucial interim step to rein in the disease. Yet rather than celebrating Truvada’s effectiveness, global health planners are now facing a difficult moment of soul searching over how to allocate limited resources.
“On the surface it’s something amazing, you can prevent HIV with a pill,” said Kevin Robert Frost, chief executive officer of amfAR, The Foundation for AIDS Research. “But then you start to dig deeper and it gets really complicated. When I get to the question of who pays for this I am completely dumbfounded. In developing countries, most of them can’t afford to give pills to those who are HIV positive.”
The human immunodeficiency virus, which can cripple the body’s immune system if left untreated, killed 1.8 million people in 2010. Of the estimated 15 million who needed treatment, just 6.6 million in low- and middle-income countries received the cocktail of drugs that can prolong lives and lower the virus to undetectable levels, according to UNAIDS, the UN’s program on HIV/AIDS. To get the drugs to those already infected would cost $6 billion on top of the $16 billion spent fighting the virus last year, UNAIDS said.
This weekend, more than 20,000 activists and researchers will gather in Washington for the first International AIDS Conference to be held in the U.S. in 22 years. Much of the focus of the weeklong conference will be on preventing the more than 7,000 HIV infections a day worldwide, and discussion will center on how to put the latest breakthroughs, including Truvada, into action in the regions where they are most needed.
Francois Venter, deputy executive director at the Wits Reproductive Health and HIV Institute in Johannesburg, said he was “blown away” when researchers reported in 2010 that Truvada cut the risk of healthy people contracting the virus. Since then, though, he said he has been able to prescribe it as a preventative to only a few patients who can afford the $480-a- year cost. In South Africa, where almost 1 in 3 people live on less than $2 a day, the drug is out of reach for most, he said.
“In a general epidemic like ours, we need interventions that can be used by the general population,” said Venter, who works in South Africa where 5.6 million people are infected. “I don’t know how you practically could do that.”
In the U.S., where the median household income is more than $51,000 a year and the majority of people have health insurance, the U.S Food and Drug Administration cleared marketing of the drug for prevention as well as treatment. The FDA said Truvada should be used along with other safe sex practices, like condoms and counseling, and only in people confirmed to be HIV negative who are at high risk of getting the virus.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret Hamburg in a statement. “New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
At the Fenway Institute in Boston, doctors have been studying the drug in gay men and gearing up for U.S. approval, Ken Mayer, the center’s medical director, said earlier. About 50,000 people are newly infected with HIV yearly in the U.S., according to the Centers for Disease Control and Prevention in Atlanta.
“There are people I take care of who are very high risk,” Mayer said. “I do think this could be very effective in protecting them from getting infected.”
To do the same in Africa and Asia, though, could cost billions of dollars.
In South Africa, where about 1 in 6 adults ages 15 to 49 are infected, Venter said the entire population is at risk. Even at the lowest price for the drug, $100 a year, it would cost billions to give it to the 45 million people uninfected people in the country.
“Huge chunks of Africa and Asia don’t have money to pay for drugs for people already infected,” Venter said. “To put prevention ahead of treatment isn’t ethically responsible, and it doesn’t make sense from a financial viewpoint.”
Timothy Hallett, a researcher at Imperial College London, said that in countries with a high incident rate, doctors would have to treat at least 50 to 100 people to prevent one infection.
In Kisumu, Kenya, where 1 in 10 adults are infected, Hallett and Imperial College researcher Ide Cremin found it would cost $14,000 to $20,000 to prevent one infection, assuming that half of all high-risk individuals were given Truvada.
Under that scenario, 13 percent of infections would be averted over 10 years, he said.
“You can’t get away from the fact that these drugs are quite expensive and there are all sorts of costs that go along with it,” Hallett said in a telephone interview. The cost and complexity of simply administering the drug to millions of people would be difficult, he said.
Gilead sells Truvada in the least-developed countries at no profit and has given the rights to sell the drug to Indian generic makers to help lower the price in 112 countries, said Cara Miller, a spokeswoman for the Foster City, California-based company, the world’s leading (GILD:US) maker of HIV drugs.
The treatment sells for as little as $8 a month in some low-income countries, she said by e-mail.
Even if there were suddenly billions of dollars available to supply Truvada, the drug won’t be a panacea, said Michel Alary, a professor at Universite Laval in Quebec.
Some people won’t remember to take it every day, which is necessary for it to be most effective. Irregular use of the drug could result in HIV infection and foster development of resistant strains of the virus, according to Alary.
Alary worries users may get a false sense of security if they don’t understand the pill’s properties. If people cut back on condom use without taking the pill daily, reducing its protection, there could be a spike in infections, he said. He wants governments to continue focusing the bulk of their prevention efforts on condoms, for now.
“For me, it isn’t a magic bullet,” he said. “I don’t think it should be a priority intervention. I think the priority for preventing HIV among sex workers is to carry on with strong condom promotion.”
While “Joy,” the Bangkok bar worker, said she wouldn’t have a problem remembering to take Truvada regularly if it was available, daily use would be difficult for “Din” a 37-year- old male prostitute who also works in that city.
Both workers asked that their full names not be used because of the stigma attached to prostitution in Thailand.
The man was involved in a study to see if sex workers would be willing to take a daily pill or gel used before intercourse for prevention. The study, which used a placebo rather than an active drug, was conducted by the Thai Red Cross, which provided access to him in a telephone interview.
Din has been working in the sex trade for eight years, since coming to Bangkok from the northern province of Udon Thani, he said. He said he struggles to remember to take the pill daily and didn’t like carrying it for fear someone would see it and misunderstand its use.
“I know the pill is good for HIV protection, but it isn’t so convenient because I have to take it every day,” said the man, who doesn’t have AIDS and always uses a condom.
The World Health Organization plans to issue guidelines recommending the use of Truvada as prevention for men who have sex with men and couples where one partner is known to be infected. The agency isn’t recommending use in sex workers yet because it doesn’t have enough data showing it will benefit that group and that sex workers will take it regularly, said Gottfried Hirnschall, director of the WHO’s HIV department.
Concerns about cost and usage aren’t discouraging Anthony Fauci, director of the National Institute of Allergy and Infectious Disease in Bethesda, Maryland, from trying to find a way to use Truvada for prevention in the poorest countries.
Fauci said he heard similar fears a decade ago about the U.S. President’s Emergency Plan for AIDS Relief, which provides AIDS treatments to 3.9 million people. With a lot of work, those issues were surmountable, he said.
“There is always going to be skepticism,” he said in a telephone interview. “I’ve been through things before where people said it was impossible, I’m not Pollyannaish about it, but I am optimistic.”
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