AIDS breakthrough: Gel helps prevent infection

[Miss Philicia]

AIDS breakthrough: Gel helps prevent infection
By MARILYNN MARCHIONE
The Associated Press
Monday, July 19, 2010; 2:15 PM

-- Researchers are reporting a breakthrough against AIDS. A vaginal gel containing an AIDS drug cut in half a woman's chances of getting HIV from an infected partner.

The results need to be confirmed, and scientists disagree about whether this amount of protection is enough to justify using the gel now. But it is the first hope of protection for women if their partners refuse to use condoms.

Results of the South African study are being presented at the International AIDS Conference in Vienna and were published online Monday by the journal Science.

"It's the first time we've ever seen any microbicide give a positive result that you could say was statistically significant," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

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.

In the study, women used the gel only 60 percent of the time; those who used it more often had higher rates of protection, and researchers said this is the key to improving effectiveness, not changing the gel.

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

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 the AIDS virus and the other does not, said Dr. Salim Abdool Karim, the South African researcher who led the study. In the U.S., nearly a third of new infections each year are among heterosexuals, he noted.

The gel is in limited supply; it was made for this and another ongoing study from a drug donated by California-based Gilead Sciences Inc., which sells tenofovir in pill form as Viread.

The study tested it in 889 heterosexual women in and near Durban, South Africa. Half 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.

[Ann]

Very good news. It sounds like they've gone to an antiretroviral approach rather than a microbial approach.

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

What? I wonder if this is a mis-quote or mis-print or what. It's HPV that causes warts, not herpes.

[max123]

AIDS breakthrough: Gel helps prevent infection
By MARILYNN MARCHIONE
The Associated Press
Monday, July 19, 2010; 2:15 PM

-- Researchers are reporting a breakthrough against AIDS. A vaginal gel containing an AIDS drug cut in half a woman's chances of getting HIV from an infected partner.

The results need to be confirmed, and scientists disagree about whether this amount of protection is enough to justify using the gel now. But it is the first hope of protection for women if their partners refuse to use condoms.

Results of the South African study are being presented at the International AIDS Conference in Vienna and were published online Monday by the journal Science.

"It's the first time we've ever seen any microbicide give a positive result that you could say was statistically significant," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

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.

In the study, women used the gel only 60 percent of the time; those who used it more often had higher rates of protection, and researchers said this is the key to improving effectiveness, not changing the gel.

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

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 the AIDS virus and the other does not, said Dr. Salim Abdool Karim, the South African researcher who led the study. In the U.S., nearly a third of new infections each year are among heterosexuals, he noted.

The gel is in limited supply; it was made for this and another ongoing study from a drug donated by California-based Gilead Sciences Inc., which sells tenofovir in pill form as Viread.

The study tested it in 889 heterosexual women in and near Durban, South Africa. Half 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.

astroglide plus 

[Joe K]

Here's a more detailed article and another very interesting study using cash payments as prevention.

New York Times

Studies Offer 2 Paths to Cut H.I.V. Rate for African Women
By CELIA W. DUGGER

VULINDLELA, South Africa — With an AIDS vaccine still out of reach, two rigorous new studies have found different ways to sharply cut H.I.V. infections among women and schoolgirls, who make up a majority of the newly infected in sub-Saharan Africa.

After two decades in which researchers searched fruitlessly for an effective vaginal microbicide to block H.I.V., South African scientists working in two AIDS-devastated communities of South Africa, one rural and one urban, say they have finally found something that shows real promise.

Women who used a vaginal microbicidal gel containing an antiretroviral medication widely used to treat AIDS, tenofovir, were 39 percent less likely overall to contract H.I.V. than those who used a placebo. Those who used the gel most regularly reduced their odds of infection 54 percent, according to a two-and-a-half year study of 889 women by Caprisa, a Durban-based AIDS research center.

Broader trials are needed to confirm the results, and it will most likely be years before the product is publicly available, but if produced on a large scale the gel would cost less than 25 cents per application, the lead investigators estimated.

Bruce Walker, a Harvard Medical School professor who was not involved in the study, said a cheer erupted when researchers unveiled their findings to a small group of scientists last month in Durban. “This is the first time that there’s been a tool that women can use to protect themselves from becoming infected,” he said. “It’s a game changer.”

In Vienna, where the biannual meeting of the International AIDS Society just opened, leaders of the global fight against AIDS said they found the results of the microbicide trial very impressive.

"This is very encouraging," said Dr. Michel Sidibe, executive director of Unaids, the United Nations AIDS-fighting agency. "It can be controlled by women, and put in 12 hours earlier, and that is empowering. They do not have to ask the man for permission to use it. And the cost of the gel is not high."

In another piece of progress against AIDS, a separate, large study in Malawi sponsored by the World Bank, and made public on Sunday, found that if poor schoolgirls and their families received small monthly cash payments, the girls had sex later, less often and with fewer partners.

A year and a half after the program started, they were less than half as likely to be infected with the AIDS or herpes viruses as girls whose families got no payments. The likelihood that the girls would turn to older men for sex, gifts and cash declined as the size of the payments from the program rose, suggesting the central role of extreme poverty in sexual choices.

“Maybe we can combine these behavioral and biomedical interventions,” said Tim Farley, a scientist with the World Health Organization involved in H.I.V. prevention research. “We need to pursue both avenues.”

At a time of intensifying competition for global health dollars, when the number of people who contract H.I.V. is outstripping those put on treatment each year, pressure is mounting on African countries and donors to focus more heavily on prevention. Male circumcision is one method proven to at least halve a man’s odds of H.I.V. infection.

Scientists say the success of the $18 million microbicide trial, largely paid for by the United .States Agency for International Development, and the study on cash payments offer hope to girls and women in Africa, who have higher rates of H.I.V. infection than their male counterparts and often less power in relationships to protect themselves.

There have been other signs of progress. A new Unaids study found that H.I.V. prevalence among young people had declined by more than 25 percent in 15 of the 21 countries most affected by AIDS. In eight countries, the agency found evidence of positive changes in sexual behavior among the young, for example delaying having sex, having fewer partners and increasing use of condoms.

In the $400,000 trial in Malawi, 3,800 teenage girls and young women, ages 13 to 22, were randomly assigned to two groups. Half the girls received no cash payments. The parents of the other half were paid $4 to $10 a month, while those girls themselves got $1 to $5 a month.

After 18 months, the H.I.V. prevalence among the girls who got the cash was 1.2 percent, compared to 3 percent for the others. “The program empowered these girls to make better choices,” said Berk Ozler, a senior economist with the World Bank’s Development Research Group.

While cash programs are already spreading in Africa, the antiretroviral gel will take longer, according to the husband-and-wife team of epidemiologists who led the study. They are Dr. Salim Abdool Karim, Caprisa’s director, and Dr. Quarraisha Abdool Karim, associate scientific director.

“I would be very sad if we had to sit around a table three years from now and we don’t have the confirmation and regulations in place,” he said. She noted that “For women, it certainly is a turning point.”

Here in South Africa, where 5.7 million people are H.I.V.-positive, more than in any other nation, the government is eager to move forward. “As soon as we’re confident it’s a safe and effective product, we should do our best to get it out,” said Derek Hanekom, the country’s deputy minister of science and technology.

The women who participated in the study — in the city of Durban and in the rural community of Vulindlela, in the rolling hills of KwaZulu-Natal — used a the gel up to 12 hours before and after sex. Usually their partners were not aware of it. Tissue biopsies found levels of tenofovir that were 1,000 times higher than they would have been in the blood if the drug had been taken by pill, the team said.

The success follows years of disappointing results in trials of other microbicides that were found to be ineffective, or even to raise a woman’s risk of H.I.V. infection. There are currently other trials under way that use tenofovir in gel and pill forms.

Gilead Sciences, the California-based biopharmaceutical company that developed tenofovir, donated 65 pounds of the active ingredient for the study. It has also relinquished any claim to royalties on the gel if it is distributed in Africa and poor countries in other parts of the world.

Dr. Howard Jaffe, president of the Gilead Foundation, the company’s charitable arm, said Dr. Salim Abdool Karim — nicknamed Slim — pitched the microbicide idea to company scientists in 2004, to initial reluctance.

“Slim is nothing if not charismatic, passionate and intelligent and we thought, ‘It needs to be studied, it will be studied and this may be the best time to do it,’ ” Dr. Jaffe said.

In Vulindlela, women have a desperate need for a way to protect themselves. H.I.V. testing of pregnant women in the area has found that one in 10 is already H.I.V.-positive by 16; half are infected by 24.

Before antiretroviral treatment became available here, the graveyards were crowded every weekend with funeralgoers. Fewer people are dying now, but many young women are still getting infected.

Xoliswa Mthethwa, 26, who was part of the study, said she told her boyfriend about the gel and he was very supportive. If it worked, she said, “I’d be the first person to go buy it.”

Donald G. McNeil Jr. contributed reporting from Vienna.

[WillyWump]

This is great stuff.

But a logistics issue pops up in my head...I'm assuming the women have to apply just before each encounter and that efficacy wears off at some point shortly thereafter and since the target group is women in poorer countries such as Africa, what are the logistics going to be to be certain each women has a box full of applications at all times??

But yes, this is great news. Love hearing it.

-Will

[tednlou2]

I saw this on the evening news tonight.  I was just so happy to see HIV/AIDS get talked about on the news not to mention the gel.

http://www.msnbc.msn.com/id/3032619/ns/nightly_news/#38315546

[Ann]

I have to wonder if this would work the other way around as well - an infected person could use the gel to stop them from transmitting the virus.

I also want to know if they've looked at whether or not it works for anal sex.

[skeebo1969]

    Very interesting, and from what I gather they were able to achieve a 39% success rate by using just one drug (Viread).  It makes me wonder if something more effective can be made in the near future by using other combinations instead.  Also, I am surprised the article makes no mention of it's use for those serodiscordant couples trying to conceive, although I do understand what the intent of the correlational study was - efforts to stop the spread of course.

   I will admit though, the statistic of 39% really makes me wonder how much of this success was purely by chance.  In any event, the results are definitely promising.

   

[Tim Horn]

    Very interesting, and from what I gather they were able to achieve a 39% success rate by using just one drug (Viread).  It makes me wonder if something more effective can be made in the near future by using other combinations instead.  Also, I am surprised the article makes no mention of it's use for those serodiscordant couples trying to conceive, although I do understand what the intent of the correlational study was - efforts to stop the spread of course.

   I will admit though, the statistic of 39% really makes me wonder how much of this success was purely by chance.  In any event, the results are definitely promising.

  

A microbicide employing both tenofovir and emtricitabine -- essentially, Truvada in a gel -- is currently being explored. The data being discussed here (we also covered it in slightly more detail), as significant as they are, are merely proof of concept -- a much larger study, ultimately using the tenofovir/emtricitabine gel, is needed before this approach revolutionizes biomedical prevention efforts.

No, the 39 percent was not due to chance -- the analysis presented earlier today in Vienna specifically found a statistically significant difference between the two groups (i.e., the difference was too great to have occurred by chance). After 30 months of follow-up, the HIV incidence in the tenofovir group was 5.6%, compared with 9.1% in the control group, which is a major difference, epidemiologically speaking.

What's more, the 39 percent efficacy rate reflected the average -- among women who were highly adherent to the protocol instructions (meaning they used the gel 80 percent of the time), the efficacy rate was 54 percent.

Of course, what happens in a clinical trial tends to be the "best case scenario" -- all too often, efficacy in the real world, whether it be a prevention or treatment strategy, tends to diminish.  In turn, ongoing studies will need to understand what works, and what doesn't, when it comes to microbicides -- and to explore combination agents -- to ensure the best possible results in the real world once an agent becomes available.

At the end of the day, after 11 years of microbicide research, it's nice to see that we're finally (and very much) on the right track.

Tim

[Jody]

 Possible AIDS breakthroughs?
Sarah Coffey
Jul 20th 2010 at 6:00AM

U.S. researchers have discovered two powerful antibodies that can neutralize more than 90% of all known strains of the HIV virus in the lab, according to new research by National Institutes of Health scientists. And another new study has possibly discovered a vaginal gel that can block transmission of the AIDS virus by half.

In the first study, the antibodies, known as VRCO1 and VRCO2, prevent most HIV strains from infecting human cells, a potential breakthrough for advancing HIV vaccine design, and antibody therapy for other diseases.

The study is published in the July 9 issue of Science.

"The discovery of these exceptionally broadly neutralizing antibodies to HIV and the structural analysis that explains how they work are exciting advances that will accelerate our efforts to find a preventive HIV vaccine for global use," said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health.

"In addition, the technique the teams used to find the new antibodies represents a novel strategy that could be applied to vaccine design for many other infectious diseases," Fauci stressed in a statement.

At the end of 2006, around 1.1 million people in the U.S. were living with an HIV infection, according to the Centers for Disease Control and Prevention. Globally, the number of people getting treatment for AIDS has increased twelve-fold since 2003, according to Aids2010.org.
The gel in the second study contains the AIDS drug tenofovir was tested over two years on women in South Africa and needs follow-up tests.
Source


Tags: AIDS, aids2010.org, cure for AIDS, health, vaccine



Read more: http://www.walletpop.com/blog/2010/07/20/aids-breakthrough/#ixzz0uFm9zTNV

[emeraldize]

I have to wonder if this would work the other way around as well - an infected person could use the gel to stop them from transmitting the virus.

I also want to know if they've looked at whether or not it works for anal sex.

Ann:
Yes, microbicides for use during anal sex are being explored/developed, however, because of the difference in tissue of the rectum vs the vagina tissue it is expected to be two different products rather than a universal one. And, yes, the notion of using it as a preventative by an infected person has certainly been discussed, but the focus at present is on vaginal protection of uninfected women and rectal protection of men and women.
Em

[Tim Horn]

There is an education and advocacy group, International Rectal Microbicide Advocates (IRMA), focusing specifically on this very issue.

At present, rectal microbicides are still in the safety phase of development. One study has been completed and another was started last year.

[newt]

This is a start, a good one, and damn better than the vaccine results to date.

But, in terms of women negotiating safer sex, there are serious logistical hurdles, like where do you privately store the corn cob size applicators exactly? and behaviourally, as it stands, a before and after dose is possibly more complicated than condoms.

But, got me out the deckchair this did

- matt

[Tim Horn]

But, in terms of women negotiating safer sex, there are serious logistical hurdles, like where do you privately store the corn cob size applicators exactly? and behaviourally, as it stands, a before and after dose is possibly more complicated than condoms.

Indeed. The all-around efficacy of the microbicide at the 12-month follow-up mark actually exceeded 50 percent, but dropped to 39 percent by month 30. This was likely due to adherence fatigue -- a situation that continues to plague condom-based strategies as well.