UN and WHO warmly welcome results of study on use of vaginal gel
before sexual intercourse
Sarah Boseley, health editor
Tuesday July 20 2010
The Guardian
http://www.guardian.co.uk/world/2010/jul/19/aids-infection-risk-women-halved-gel-study
Scientists held out the hope of a breakthrough in the prevention of
HIV/Aids today with the results of a study showing that a vaginal gel
used by women before sexual intercourse halved the numbers who became
infected.
Scientists have been hunting for years for something that will allow
women to protect themselves, and the excitement of Aids campaigners
will be hard to contain, even though further research is needed to
confirm the findings.
Women fall victim to HIV/Aids in disproportionately large numbers ?
60% of new infections in Africa are among women. Many in the poorest
countries have little education and suffer from very low status, so
are unable to negotiate safe sex, using a condom, with their partner.
"We are giving hope to women," said Michel Sidib?, executive director
of Unaids, the United Nations programme on Aids, as the trial results
emerged. "For the first time we have seen results for a woman-
initiated and controlled HIV prevention option. If confirmed, a
microbicide will be a powerful option for the prevention revolution
and help us break the trajectory of the Aids epidemic."
The director general of the World Health Organisation (WHO), Margaret
Chan, also immediately congratulated the scientists. If their results
were confirmed by further tests, "WHO will work with countries and
partners to accelerate access to these products," she said.
A number of large microbicide trials have been run, but all have
failed. The success of this one (run in South Africa where one in
three young women aged 20 to 34 is living with HIV) is attributed to
the use of an anti-retroviral drug called tenofovir ? of the sort used
to treat Aids ? in gel form.
The study, called Caprisa 004, was conducted by the Centre for the
Aids Programme of Research at the University of KwaZulu Natal in South
Africa. The researchers recruited 889 women between 18 and 40 who were
HIV-negative, sexually active and at risk of becoming infected.
Half were given vaginal applicators filled with gel containing 1%
tenofovir. The others got something that looked the same but was
inactive. Until the end of the trial, nobody knew who was in each
group. The women were asked to insert a first dose of gel 12 hours
before sexual intercourse and a second dose as soon as possible
afterwards, within 12 hours. All were given counselling on avoiding
HIV infection and a free supply of condoms.
At the end of a year, the researchers discovered that the gel had
halved the numbers of women becoming infected with HIV. After two and
a half years, the numbers had dropped, but there were still 39% fewer
infections in those women using it. The drop in the numbers
protected, they believe, is caused by some women tending to use it
inconsistently as time went on, not knowing whether it was in fact
having any effect.
The excitement of the researchers was clear in a teleconference before
publication. "Picture a young woman in a rural community in South
Africa who walks through my clinic doors asking me what I have to
protect her from getting infected," said Dr Quarraisha Abdool Karim,
one of the authors of the paper. "Her partner is a migrant worker and
refuses to wear a condom and she is not sure of his faithfulness in
this relationship.
"From being able to tell her for years that I have nothing, I can now
offer her 1% tenofovir gel, which offers her 39% protection and, if
she is highly attuned to this gel [uses it consistently], it offers
her 54% protection."
Warren Mitchell, executive director of Avac, an Aids vaccine
campaigning group, said it was "a historic day for HIV prevention
research". The results demanded immediate action in South Africa and
around the world, he said. "We believe that the most responsible plan
of action now is to quickly and efficiently articulate the sequence of
steps necessary for confirmation and follow-up of these results, while
also aggressively planning for potential roll-out of a licensable
product."
Another piece of good news is that the gel appeared to cause few side-
effects. There is still work to do before the gel goes through to
being manufactured.
But the WHO is committed to help and all agencies will do their best
to speed it to women who need it, perhaps within two years, the
researchers said.
guardian.co.uk Copyright (c) Guardian News and Media Limited. 2010
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