AIDS breakthrough: Vaginal gel helps prevent infection

[Guest guest]

MILWAUKEE: For the first time, a vaginal gel has proved capable of blocking the

AIDS virus: It cut in half a woman's chances of getting HIV from an infected

partner in a study in South Africa. Scientists called it a breakthrough in the

long quest for a tool to help women whose partners won't use condoms.

The results need to be confirmed in another study, and that level of

protection is probably not enough to win approval of the microbicide gel in

countries like the United States, researchers say. But they are optimistic it

can be improved.

" We are giving hope to women, " who account for most new HIV infections, said

Michel Sidibe in a statement. He is executive director of the World Health

Organization's UNAIDS program. A gel could " help us break the trajectory of the

AIDS epidemic, " he said.

And Dr. Fauci of the US National Institutes of Health said, " It's the

first time we've ever seen any microbicide give a positive result " that

scientists agree is true evidence of protection.

The gel, spiked with the AIDS drug tenofovir, cut the risk of HIV infection by

50 percent after one year of use and 39 percent after 2 1/2 years, compared to a

gel that contained no medicine.

To be licensed in the US, a gel or cream to prevent HIV infection may need to be

at least 80 percent effective, Fauci said. That might be achieved by adding more

tenofovir or getting women to use it more consistently. In the study, women used

the gel only 60 percent of the time; those who used it more often had higher

rates of protection.

The gel also cut in half the chances of getting HSV-2, the herpes virus that

causes genital warts. That's important because other sexually spread diseases

raise the risk of catching HIV.

Even partial protection is a huge victory that could be a boon not just in poor

countries but for couples anywhere when one partner has HIV and the other does

not, said Dr. Salim Abdool Karim, the South African researcher who led the

study. In the US, nearly a third of new infections each year are among

heterosexuals, he noted.

Countries may come to different decisions about whether a gel that offers this

amount of protection should be licensed. In South Africa, where one in three

girls is infected with HIV by age 20, this gel could prevent 1.3 million

infections and 826,000 deaths over the next two decades, he calculated.

He will present results of the study Tuesday at the International AIDS

Conference in Vienna. The research was published online Monday by the

journal Science.

" We now have a product that potentially can alter the epidemic trends ... and

save millions of lives, " said Dr. Quarraisha Abdool Karim, the lead researcher's

wife and associate director of the South African program that led the testing.

It's the second big advance in less than a year on the prevention front. Last

fall, scientists reported that an experimental vaccine cut the risk of HIV

infection by about 30 percent. Research is under way to try to improve it.

If further study shows the gel to be safe and effective, WHO will work to speed

access to it, said its director-general, Dr. Margaret Chan.

The gel is in limited supply; it's not a commercial product, and was made for

this and another ongoing study from drug donated by California-based Gilead

Sciences Inc., which sells tenofovir in pill form as Viread. If further study

proves the gel effective, a full-scale production system would need to be geared

up to make it.

The study tested the gel in 889 heterosexual women in and near Durban, South

Africa. Researchers had no information on the women's partners, but the women

were heterosexual and, in general, not in a high-risk group, such as

prostitutes.

Half of the women were given the microbicide and the others, a dummy gel. Women

were told to use it 12 hours before sex and as soon as possible within 12 hours

afterward.

At the study's end, there were 38 HIV infections among the microbicide group

versus 60 in the others.

The gel seemed safe -- only mild diarrhea was slightly more common among those

using it. Surveys showed that the vast majority of women found it easy to use

and said their partners didn't mind it. And 99 percent of the women said they

would use the gel if they knew for sure that it prevented HIV.

This shows that new studies testing the gel's effectiveness without a

placebo group should immediately be launched, said Salim Abdool Karim. The only

other study testing the gel now compares it to placebo and will take a couple

more years to complete.

The study was sponsored by the Centre for the AIDS Programme of Research in

South Africa, or CAPRISA; Family Health International; CONRAD, an AIDS research

effort based at Eastern Virginia Medical School; and the US Agency for

International Development, or USAID.

Gilead has licensed the rights to produce the gel, royalty-free, to CONRAD and

the International Partnership on Microbicides for the 95 poorest countries in

the world, said Dr. Jaffe, president of the Gilead Foundation, the

company's philanthropic arm.

The biggest cost of the gel is the plastic applicator -- about 32 cents, which

hopefully would be lower when mass-produced, researchers said.

Warren, head of the AIDS Vaccine Advocacy Coalition, a nonprofit group

that works on HIV prevention tools, said the study shows a preventive gel is

possible.

" We can now say with great certainty that the concept has been proved. And that

in itself is a day for celebration, " he said.

http://timesofindia.indiatimes.com/world/us/AIDS-breakthrough-Vaginal-gel-helps-\

prevent-infection/articleshow/6189333.cms

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Regards

Tarunima Sen

e-mail: <tarunimasen@...>