Indevus’ sex gel shows first AIDS protection in women (update1)
By John Lauerman (Bloomberg) 9 February 2009: A vaginal gel made by Indevus Pharmaceuticals Inc. showed first signs that such a product might protect women from the AIDS virus.
http://www.bloomberg.com/apps/news?pid=20601087&sid=aEGcHw8JQkYU&refer=home
Women who used the gel were 30 percent less likely to become infected
with the virus than those using no gel or an unmedicated product, said
Salim Abdool Karim, a Columbia University researcher who presented the
study today at an AIDS meeting in Montreal. While the finding didn’t
pass a test for statistical significance, it should spur further
examination of Lexington, Massachusetts-based Indevus’s product, he
said.
After years of frustration, prevention researchers said they’re making
headway reducing 2.7 million annual new infections with the AIDS virus.
Other studies presented today at the AIDS conference suggested that
gels or pills containing Gilead Sciences Inc.’s drugs, now used to
treat people already infected, might also protect against the
virus.
“It’s very exciting that PRO 2000 might have a positive effect,” said
Karim, referring to the Indevus gel, in an interview at the Conference
on Retroviruses and Opportunistic Infections. “Now we need a trial
that’s big enough to show whether this is a statistically significant
effect.”
Another study of PRO 2000 is being conducted by the London- based
Medical Research Council. The study includes about 9,500 women, three
times the size of Karim’s study.
High Drama
“A positive signal from this trial increases the anticipation of those
from the next,” said Mitchell Warren, executive director of the AIDS
Vaccine Advocacy Coalition in New York. “There’s a lot riding on
it.”
Sexual gels, called microbicides, are key to preventing the human
immunodeficiency virus, or HIV, in African women, Karim said. The women
are often infected by their husbands or steady sexual partners, said
Karim, who is also pro vice-chancellor of the University of KwaZulu
Natal in South Africa.
“I have nothing to offer a woman who asks me how to prevent HIV,” he
said. “I can’t tell her to be faithful, because she is. I can’t tell
her to be abstinent or use condoms, because she wants to have her
husband’s children.”
Most new cases of HIV are spread through sexual intercourse or contact
with infected blood or tissue, according to UNAIDS, the New York-based
agency that coordinates the United Nations’ response to the disease.
While condoms can block contact with infected semen and blood, many
couples and sex workers don’t use them consistently, Warren said.
Microbicides in gels have an advantage because they can be applied
discreetly and allow intimate contact, Warren said.
Dashed Hopes
Previous failures of gels, pills and other products have hurt hopes for
preventing the spread of HIV in Africa. Karim, who has been working
with microbicides for 15 years, was part of a team of researchers
testing a spermicide called nonoxynol-9 in women. He was shocked when
the trial was stopped early in 2000 because the gel raised women’s risk
of infection.
Indevus’s product contains a negatively charged molecule. Researchers
believe the charge attracts positively charged portions of HIV,
preventing the virus from infecting cells, Karim said.
Another vaginal product, BufferGel from ReProtect Inc. in Baltimore,
was tested in the same study. It had no effect on HIV transmission,
Karim said at a press conference today.
U.S. government research presented at the conference also suggested
that Gilead’s Viread and Truvada, used in gels or in oral pills, might
prevent the spread of HIV, said scientists studying a monkey equivalent
of the disease.
Monkey AIDS
In one test, animals treated with a gel containing Viread were
completely protected from SHIV, an animal version of the AIDS virus,
U.S. Centers for Disease Control and Prevention scientists said today
at the conference in Montreal. The single- drug gel was just as
protective as a gel containing two-drug Truvada, said Walid Heneine,
laboratory chief of CDC’s division of HIV/AIDS prevention, who led the
study.
“This is very promising, although we’re waiting for the results of
human trials to see if they correlate with animal studies,” Heneine
said in an interview.
The second trial measured how oral doses of Truvada, a combination of
two Gilead drugs, would affect monkeys exposed to HIV through the
rectum.
Almost all untreated monkeys were quickly infected after being exposed
to the virus twice. Two doses of Truvada, one before and another after
rectal exposure, protected most monkeys from infection, said Gerardo
Garcia-Lerma, a CDC senior scientist in the HIV/AIDS prevention
division.
Pre-Sex Drug
The study also suggests that people might be able to use the drugs when
they know they’re going to have sex, rather than daily. A gel or pill
containing Gilead’s drugs that people could use before sex might slow
the spread of the disease, which now infects about 32 million people,
most of them in Africa, AVAC’s Warren said.
“It’s very exciting,” he said in an interview. “Like any animal
research we need to see if it correlates with human experimentation.
We’ve certainly seen in the vaccine field that we mustn’t be too
optimistic that we’ll see the same results in people.”
At least seven human studies are now looking at whether giving
high-risk people oral doses of Gilead’s Viread or Truvada can safely
prevent transmission.
“It’s important to support the ongoing and planned prevention studies,
particularly given the impact of HIV in developing countries,” said Amy
Flood, a Gilead spokeswoman, in an e-mail. Gilead is providing its
drugs free of charge for these trials, she said.

