Scientists Debate on NPR

Hi Friends and family,

Below is a link to an online audio interview (or text below) that was on NPR this week. The focus is on microbicides, but they do mention PrEP (antiretroviral prevention) which is the study that I am working on. There are some important issues that are brought up that will no doubt be debated heavily over the next few years. MTN (Microbicide Trial Network) has been doing clinical trials using a gel that women can apply that would prevent them from becoming HIV positive (where we are using a pill with our PrEP study).

Hope you enjoy it- let me know if you have any questions.

Hugs,

Meighan

GLOBAL HEALTH
Scientists Debate HIV Prevention Products
by Brenda Wilson
http://www.npr.org/templates/story/story.php?storyId=101631646

Audio online at
javascript:NPR.Player.openPlayer(101631646,%20101642018,%20null,%20NPR.Playe
r.Action.PLAY_NOW,%20NPR.Player.Type.STORY,%20'0')

Morning Edition, March 10, 2009 · For years now, scientists have tried to
find a product that would give women in developing countries more control in
protecting themselves against sexually transmitted HIV. They have yet to
find a universally effective and safe method.

A recent study presented at the Conference on Retroviruses and Opportunistic
Infections in Montreal highlighted the dilemmas in this field < a gel to
prevent HIV worked in 30 percent of the women who tried it. Many scientists
have dismissed those results because there was a 1-in-10 chance that the
effect was due to chance. Others who had great expectations riding on the
findings were encouraged.

Still, Tachi Yamada, director of global health policy for the Bill and
Melinda Gates Foundation, was concerned that the results were presented as
promising.

"To me, it was very unfortunate," says Yamada. "In fact, there should be a
little bit of concern that this is now the fifth or sixth trial that came
out statistically insignificant."

Scientists say the negative results could have been predicted. In at least
two previous clinical studies, the women who were given the vaginal gels
containing spermicides faced an increased likelihood of becoming infected
with HIV. The PRO 2000 used in this study contained compounds similar to
those used in other studies that provided no protective effect.

To understand why so much effort is invested in finding a product that women
in developing countries can use independently, researcher Sharon Hillier at
the University of Pittsburgh School of Medicine says you have to put
yourself in the mind of a 19-year-old Zambian woman who just got married.

She needs to have children because her value as a woman is very much
associated with her ability to have a baby, and she needs to breast-feed,
Hillier explains. She also needs to have sex with her husband, but if she
asks him to use condoms, he will think she has been unfaithful or that she
doesn't trust him. He might even beat her up, Hillier says.

As a result, that young Zambian woman needs something that she can use,
possibly without her husband knowing it, that will allow her to stay
uninfected.

Lorie Heise of the Global Campaign for Microbicides acknowledges that the
results were statistically insignificant, but she wasn't entirely
disappointed. She has even greater hopes in the next generation of
microbicide, which will contain lower doses of anti-AIDS drugs to block the
virus.

Perhaps the most promising aspect of this study, Heise says, is that more
than 80 percent of the women reported that they used the gel consistently,
even knowing that they may have simply gotten a placebo that did not contain
PRO 2000. And most of the women stayed with the study for two years < to
Heise a sure sign that women in developing countries will use a microbicide
if one is found to be effective against HIV. After all, she adds, gels are
sexier than condoms.

"We spend enormous sums in the United States to buy sexual lubricants to
make sex more fun," Heise says. "It's a selling point we shouldn't
underestimate S Even in parts of the world like Africa where that practice
hasn't been as common, people are liking the gels."

She notes that the gel appeared to be more effective among the highest level
of users < those who used it almost every time. These findings were based
largely on self-reports, and not everyone is convinced that similar
participation could be achieved under real-world conditions, where the women
are not counseled once a month as they were in this study. Yamada, for one,
is not quite convinced a microbicide could be found that would work reliably
enough that women would use it.

Yamada imagines a woman trying to maintain confidentiality about her sexual
life with her husband. He thinks that using microbicides in small villages
and towns in Africa would make it difficult to maintain privacy.

"[The microbicides] come in a paper packet, and there's a plastic
applicator, and you have to apply the plastic applicator presumably around
the sex act," Yamada says. And then you have to dispose of the packet.

"So what happens if it gets put out around your hut, and then everybody in
the village knows you had sex and that you suspect your husband has HIV,"
Yamada explains.

He has higher hopes for another prevention method < the pre-exposure pill,
or PrEP < that involves an uninfected person using an anti-AIDS drug. Some
of the compounds being studied are longer-acting, so they could be taken
once a day or once a month to block infection. Heise says the pills would
create a separate set of challenges for a woman in Africa. If it turns out
that someone else, such as her husband, were infected with HIV, the wife
might be forced to share the medicines.

Only people who don't face the same risk as women in developing countries
would quibble over what prevention method was used, says Hillier of the
University of Pittsburgh. "Almost all the women I've talked to in this
[study], told me their aunts had died, their brothers had died of HIV."

Hillier says the women were emphatic, "They didn't care if it was a pill or
a gel or a diaphragm, they wanted something to help protect them from HIV."

Scientists like microbiologist John Moore at Weill Cornell Medical College
is concerned about both gels and pills since they are now adding to them the
same drugs that are used to treat HIV. He says that we should proceed more
cautiously because of the risk of undermining the effectiveness of the
drugs.

"The use of antiretrovirals for prevention could create the spread of
resistant variants that compromise treatment programs."

This happened with nevirapine, which has proven effective in preventing the
transmission of HIV from mother to child. The problem is that nevirapine, a
relatively inexpensive drug used in drug combination treatments widely used
in developing countries, can't be used by mothers who developed resistance
when they took it to protect their newborns against HIV. That would leave
poor women with fewer treatment options.

There needs to be one coordinating body to establish guidelines for this
kind of research, according to Moore. As it is, he says, too many different
researchers and organizations are chasing concepts that are too similar,
making the same mistakes that were made in HIV vaccine research.

"Before hurrying off in a certain direction," Moore says, "you need to know
that you're heading off in the right direction, and there are times when the
vaccine and the microbicide fields S have almost acted like they're racing
to be the first lemmings off the cliff."

In response to these criticisms, Hillier and other members of the Alliance
for Microbicide Development say they are working to create greater
coordination and to pursue the best scientific leads. What they cannot do is
wait, they say, because the need is too great.