An Interview with Professor Salim Abdool Karim about VOICE Trial Setbacks

viaAllAfrica, interview with Professor Salim Abdool Karim

Professor Salim Abdool Karim, director of the Centre for the AIDS Program of Research in South Africa (Caprisa) at the University of KwaZulu-Natal and Columbia University in the United States, spoke to AllAfrica's Julie Frederikse about the unexpected halt of a study into tenofovir vaginal gel. This followed a finding that the microbicide failed to prevent HIV transmission, in contrast to the positive result in a previous study conducted by his Caprisa team.

What happened when you heard the findings of the new study that contradicted your results?

We were surprised and very disappointed. We know that science doesn't always give you the answers you want and hope for, but when you look at the totality of the evidence, we know that there's still pretty strong evidence, whether from the laboratory or in monkeys or in humans, that tenofovir gel is effective in preventing HIV. This is rationale for why the Caprisa and Voice (Vaginal and Oral Interventions to Control the Epidemic) studies were conducted in the first instance. So now we need to understand why the Voice trial produced a different result.

Is this a big setback to Caprisa's research?

The Voice trial is an important result. We now need to understand it. It doesn't take us completely off track - it's a temporary setback - and understanding this result would put us in a better position to move forward again. Science grows not only from success, it also grows from failure.

Has the suspension of this study demoralised your team?

That's the nature of science. In a series of studies, it is seldom that every study shows the same thing. But we'll stay on track, and try and understand why the Voice result is different. Whether the women in the study were not using the gel correctly, or there were other underlying problems, we don't know yet. It's too early to tell.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

No time to give up on microbicides

via allAfrica.com, by Julie Frederikse

Africans tracking the worldwide HIV epidemic have not found much to celebrate since Aids began ravaging the continent 30 years ago, but researchers are optimistic that they are learning as much from their failures as their successes.

Sub-Saharan Africa still carries the biggest burden of HIV worldwide, and while there has been a significant improvement in access to antiretroviral treatment in recent years, scientists searching for a gel or vaccine that can prevent HIV infection ride a rollercoaster of hope and disappointment.

Take the case of a husband and wife team from the University of KwaZulu-Natal in South Africa. Professors Salim Karim and Quarraisha Abdool Karim head up a research unit that has been at the forefront of clinical trials to find a safe and effective microbicide to protect women from HIV.

In July 2010, delegates at the last World Aids conference gave the couple a standing ovation when they announced the results of one of the most promising studies on HIV prevention to date. Their team at the Centre for the Aids Program of Research in South Africa (Caprisa), showed that a vaginal gel called tenofovir was able to reduce sexual transmission of the virus by 39 percent overall and 54 percent in women who used it consistently.
But the euphoria over this breakthrough has dissolved into disappointment, with the unexpected finding of a wider sub-Saharan African study that the microbicidal gel, when prescribed daily, does not prevent HIV infections. This has led to the suspension of tenofovir in the Vaginal and Oral Interventions to Control the Epidemic (Voice) trial.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

ARV gel almost ready to roll out

via the Daily News, by Liz Clarke

In the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Building the momentum to prevent HIV in MSM

Via The Lancet, by Thomas J Coates.

Larry Kramer, on accepting the Tony Award last month from the Theatre Guild-American Theatrical Society for The Normal Heart as Best Revival of a Play said: “To gay people everywhere, whom I love so dearly…we are a very special people, an exceptional people, and…our day will come.” My day came in 1982 when I secured an Assistant Professorship in the Department of Medicine at the University of California, San Francisco. I set about establishing a behavioural medicine clinic fully integrated into general medicine practices, researching chronic disease prevention, and teaching interns and residents about psychological issues. One guest speaker, a social worker, led a discussion with the residents about the special medical needs of gay men. He was dead a month later from what later became known as AIDS.

The “special and exceptional people” cited by Kramer had lived through the 1970s and fought for human rights in the USA. That was followed in 1981 with the scourge of AIDS that could have knocked the wind out of the gay community. Instead, the community rallied and used its skills and talents to advocate for resources to develop community-based systems of care and prevention, and to ensure that human rights were not trampled.

Unleashing that energy and skill to build a global movement to improve HIV prevention and care services for men who have sex with men (MSM) is long overdue. Momentum is building and Chris Beyrer and co-authors make an important contribution. The Global HIV Epidemics among Men Who Have Sex with Men documents the extent of the HIV epidemic and outlines what needs to happen to ensure that everything possible is being done to prevent and treat HIV infection in MSM worldwide.

This volume documents the need in terms of the numbers, but also addresses the scenarios in which HIV epidemics among MSM exist in low-income and middle-income countries. The first scenario they describe, characterising the HIV epidemic in most of Latin America, is one in which MSM are the predominant exposure mode for HIV infection in the population. In these countries MSM are ten to over 100 times more likely to have HIV than the general population. By contrast, eastern Europe and central Asia have the highest rates of HIV among injection drug users (IDUs), but MSM are still several times more likely to have HIV than the general population. A different scenario is found in sub-Saharan Africa where HIV is widespread among heterosexuals, but even in these contexts MSM can have two to 20 times higher prevalence of HIV than the general population estimates. South, southeast, and northeast Asia are characterised by epidemics that have equal contributions from MSM, IDUs, and heterosexuals, although MSM are still at least ten times more likely to have HIV than the general population.

The needs come not only from the numbers. Beyrer and his co-authors document well the lack of prevention technologies focused on male-to-male transmission. They note that much effort has been expended on encouraging voluntary HIV counselling, testing, and behavioural interventions to decrease rates of unprotected anal intercourse by encouraging less risky sexual behaviours. Although important, such strategies are probably insufficient to produce immediate or lasting change in HIV transmission. Male circumcision may be effective for reducing acquisition of HIV through anal intercourse but we will never know for sure because of the challenges of conducting a trial to prove efficacy. Antiretroviral-based prophylactic approaches provide the best opportunity for managing HIV among MSM. In the wake of the IPREX, CAPRISA 004, and HPTN 052 trials, it is now time to accelerate efforts to determine if similar benefits can be obtained with rectal use of these or similar compounds. In some countries, like Peru where the epidemic is concentrated in MSM, providing universal access to care with MSM-sensitive services could actually change the overall trajectory of disease spread.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Anti-AIDS Gel Also Boosts Sexual Pleasure

Via Times of India.

 South African scientists, who launched a 24-month trial to confirm the efficacy of a microbicide gel that would reduce the risk of women getting HIV, have found an unexpected spin-off – it also boosts sexual pleasure.

Wits professor Helen Rees, of the university's reproductive health and HIV institute, said the R300m trial would involve about 2,200 sexually active women at seven locations countrywide.

The Tenofovir gel study - known as Follow-on African Consortium for Tenofovir Studies (Facts) study - would be a follow-up to the Caprisa 004 study, which showed that a highly consistent use of the microbicide by women resulted in a 59 per cent reduction in the risk of HIV infection.

Rees said during a previous study involving another gel - that proved unsuccessful in the fight against HIV - participants had noted the gel improved their sexual pleasure.

"One of the big messages we got, was many women said 'We liked this', News24.com quoted her as saying. 

 

Read the rest here. 

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Before and After CAPRISA: What does it mean for rectal microbicides?

Let the Sun Shine In

From Positively Aware, by Jim Pickett (IRMA Chair)

Excerpt:

While the rectal microbicide field has gained significant momentum, more focus and resources are necessary. In 2010, 7.2 million U.S. dollars are being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011-2014, to $10 million per year and must increase further to $44 million in the years 2015-2020 to ensure a minimum of candidate products are moving through the research pipeline into late stage testing for effectiveness.

Advocates are optimistic that the CAPRISA proof of concept will also be translated into more financial and creative energy being put into rectal microbicide development. With five new infections for every two individuals beginning treatment, it’s absolutely imperative we find new ways to prevent HIV for individuals at risk, gay and straight, women and men. As these new methods become available, it is also of paramount importance that people who are already using condoms correctly and consistently continue doing so.

We won’t treat our way out of this global epidemic. As of this writing, over 3,400 individuals in the U.S. bide their time on AIDS Drug Assistance Program waiting lists in nine states. The new National AIDS Strategy focuses on three pillars to attack the domestic epidemic, one of which is access to care and treatment. Can we ensure this happens? Those waiting lists are made up of people who can’t wait.

Read the rest

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

If We Can Make it There... New York Times Goes Rectal!

New Lines of Attack in H.I.V. Prevention
via New York Times, by Donald G. McNeil, Jr.

[McNeil gets things a little confused overall in this article, sometime a bit fuzzy on the facts, but this has to be the most the New York Times has ever written on rectal microbicides, beyond the one word - "rectal." This is pretty major - the rectal agenda has made the Times!]

Rectal excerpt:

Because 95 percent of gay American men and 40 percent of heterosexual American women have had anal sex at least once during their lifetimes, according to surveys, rectal versions of the gel are being developed. Tests of new, less viscous formulations that are less likely to draw water into the rectum, making use unpleasant, will begin soon, said Dr. Ian McGowan, another leader of microbicide trials at the University of Pittsburgh’s medical school.

Gay and bisexual black and Hispanic men, who are now the highest AIDS risk groups in the United States, will be recruited soon in Boston, Pittsburgh and Puerto Rico to see if they find the gels acceptable, he said.

But first it is crucial to make sure gels don’t inflame the rectal lining, which is more fragile than the vagina’s. Since H.I.V. zeros in on activated immune cells, inflammation increases infection risk. Brief tests of irritation and acceptability will be done on people advised to remain celibate during the tests, he added. Larger trials, in which thousands of men and women regularly practicing anal sex are given gel or placebo will not begin for two to three more years.

“The rectal microbicide field is about 10 years behind the vaginal one,” Dr. McGowan said.

That is partly due to misconceptions.

“When you mention rectal microbicides, a lot of people say ‘Oh, come on,’ because they think you have to protect the whole colon, and it’s meters long,” Dr. McGowan said. In fact, researchers believe protecting only the last six to eight inches will suffice.

A 2008 British study showed that rectal tenofovir gel was very protective in monkeys that were then given anal doses of the virus that causes simian AIDS.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

FDA to Fast Track 1% Tenofovir (Press Release)

Press Release from CONRAD

October 25, 2010, Arlington, VA - - The U.S. Food and Drug Administration (FDA) held an end-of-Phase II meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a microbicide product recently found to be effective at  reducing the rate of HIV and herpes infection in women when used before and after sex.

The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.

Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.

A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.

During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.

In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s “Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.

CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.

In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.

New AIDS microbicide has huge potential, but needs funding

via ONE, by Todd Summers

At the big International AIDS Conference in Vienna a few weeks back, there was wide coverage of positive trial results for a new microbicide –- a gel that women can use to reduce their risk of getting infected with HIV.

Giving women a prevention tool that they can use to protect themselves from the virus is critical. Right now, they have to depend on men to use condoms or other methods — and you can see how well that’s going.

The next step in moving the microbicide forward is to conduct confirmatory studies to validate this first one. This ensures that the study wasn’t somehow flawed, and that the product is safe and predictable. Unfortunately, the New York Times reported over the weekend that donors are dragging their feet in funding these studies.

This just cannot be accepted. We need the U.S. and other rich countries to put forward the relatively modest amounts needed to conduct the validation trials to put them on the fast track for completion.

These investments in prevention technology make huge public health and financial sense, helping ensure that we meet the treatment needs of those already living with HIV.

As Melinda Gates said in a great speech four years ago (at the International AIDS Conference in Toronto), “No matter where she lives, who she is, or what she does — a woman should never need her partner’s permission to save her own life.”

A microbicide is the best hope we have — until there’s a vaccine, of course -– of giving women some control over their own HIV risk. So, let’s get these studies going.

Source.

UNAIDS, WHO Meeting: Follow-Up Studies Of ARV-Containing Microbicide Gel Must Start Soon

via Kaiser Family Foundation

Experts gathered at a joint meeting of UNAIDS and the WHO last week called for two additional clinical trials to test the effectiveness and safety of a microbicide vaginal gel containing the antiretroviral tenofovir, which previous studies have shown reduces the risk of HIV transmission in women who used it before and after sex by 39 percent, PANA/Afrique en ligne reports (9/5).

"The results of the first trial of the tenofovir-based gel, [conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA)] … announced in July at the XVIII International AIDS Conference in Vienna, must be confirmed before the product can be made available for general use," U.N. News Centre reports.

The follow-up trials will build off of "[t]he CAPRISA study [which] was conducted in South Africa with women aged 18 to 40 years who used the gel once during the 12 hours before sex and once during the 12 hours after sex," the news service continues. One of the two trials, which will also be held in South Africa, will test the effectiveness of the microbicide in "sexually active 16- and 17-year-olds in settings where HIV incidence is high," according to the U.N. News Centre.

"The other study will be conducted in other African countries and examine if a different dosing schedule is safe and effective. It will test if a single application of the gel before sex, or failing that immediately after, is equally effective and safe as the original two-dose regimen," the news service adds (9/3).

According to VOA News, "The first trials are likely to get under way early next year. The next phase of the research is estimated to cost $100 million." The article includes comments by UNAIDS Chief Scientific Adviser Catherine Hankins (Schlein. 9/3).

Pharma Times, also reporting on the meeting, writes, "An ongoing trial being conducted by the Microbicides Trial Network, which is evaluating the same gel used daily, will generate additional data on safety and product use. Research in the communities where the CAPRISA 004 trial was carried out will look at how to best promote, distribute and monitor gel use through existing family planning facilities." The news service continues, "While participants at the meeting in Johannesburg agreed on research priorities for the tenofovir gel, concerns were expressed over the limited funding committed so far to carry forward the next phase of research" (Mansell, 9/7).

The New York Times reports that "about $58 million of the $100 million needed for follow-up research has been pledged, according to UNAIDS." The newspaper explores the perception that donor nations are rethinking their commitments because of "shifting global health priorities and tight finances," and how "[e]xperts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment." The article includes quotes from Stefano Bertozzi of the Bill & Melinda Gates Foundation, Nomfundo Eland of Treatment Action Campaign, Hankins of UNAIDS, and Mead Over of Center for Global Development (Dugger, 9/3).

Source.

Microbicide hits snag: It's about the money honey

via New York Times, by Celia Dugger


When scientists celebrated the announcement in July that a vaginal microbicide had finally been found that significantly reduced H.I.V. infections in women, there was still a prosaic — though essential — piece of the puzzle missing: money.

Donors have not committed enough money for even one of the two studies needed to confirm a promising South African trial of the microbicide and get it into women’s hands. Only about $58 million of the $100 million needed for follow-up research has been pledged, according to Unaids, the United Nations AIDS agency. Experts say shifting global health priorities and tight finances in the West are making it hard to raise the rest.

Advocates say any delay could be deadly. Most of the 22 million people infected with H.I.V. in sub-Saharan Africa are women, and about a million women on the continent are infected each year. If subsequent studies find the gel effective, women could use it to protect themselves even when men refuse to use condoms.

Read the rest.

Communities debate microbicide results in South Africa

via PlusNews

The recent release of positive results from a microbicide trial in South Africa have kick-started discussions between scientists, activists and community workers about the quickest and most responsible way of getting a product into women's hands.

The trial by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) found that a vaginal gel containing tenofovir, an antiretroviral (ARV) drug, was 39 percent effective at reducing women's risk of contracting HIV during sex.

In other parts of the world, such results might not be cause for celebration, but in South Africa, and particularly in hard-hit KwaZulu-Natal Province, where the trial was conducted, even such partial effectiveness could prevent 1.3 million new HIV infections over the next two decades and avert over 800,000 deaths, according to mathematical modelling.

"The discomfort we all have is that if this [product] is working, shouldn't we be pushing its use as quickly as possible?" said Prof Helen Rees (pictured), director of the Reproductive Health and HIV Research Unit (RHRU) of Witwatersrand University, at a meeting about the CAPRISA trial results in Johannesburg.

Read the rest.

New York Times Examines Questions Left Unanswered By Microbicide Trial

Via Kaiser Daily Global Health Policy Report

The New York Times examines a set of questions raised by news out of the International AIDS Conference-AIDS 2010 last week that a microbicide gel containing the antiretroviral (ARV) tenofovir used by women before and after sex helped reduce their risk of HIV infection by 39 percent.

"After more than a dozen microbicide failures, [the news of the trial] was a huge relief …," the newspaper writes, before noting researchers' questions regarding the amount of testing needed before the drug could win approval from regulators, the cost of the drug for poor countries and the potential for tenofovir-resistance from using the microbicide gel.

According to the newspaper, "The price of a dose could fall below that of a condom because the applicators are just molded plastic and, without patents restrictions, 'the Chinese could make them for half a penny,' [Principal investigator Salim Abdool Karim, professor of epidemiology at the University of KwaZulu-Natal in South Africa and Columbia University] said." Other questions, such as how to improve drug efficacy, would be dependent on what researchers find in future clinical trials. "A complex multination trial of several methods, including microbicide, is due to end in 2013, but a rapid new one may be designed as quickly as possible. … Globally, more than a million women a year die of AIDS, so speed is important," the newspaper writes.

The article explores still more questions raised by the trial – such as the viability of the microbicide gel offering protection against HIV transmission for gay men – and includes comments by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Kevin Fenton, director of the AIDS division of the CDC; Catherine Hankins, chief scientific adviser for UNAIDS; as well as a microbicide researcher and HIV/AIDS advocate (McNeil, 7/26).

For more click here.

The CAPRISA 004 by Ida Jooste (“Gabi’s Gift”)

The top news story of the Vienna 2010 AIDS conference was the encouraging results from the CAPRISA 004 study, showing that a tenofovir microbicide gel provided 39% protection against HIV.

In 2007 Gabi Nxele volunteered to be a participant in the study to test the efficacy of the gel for the prevention of HIV infection in women. This is the story of Gabi's Gift - from rural South Africa for all the women of the world.

CAPRISA microbicide results explained on You Tube

Positive Results from a Microbicide Trial - an overview of media coverage

The HIV prevention world is abuzz with excitement following news of the first clinical evidence that a vaginal gel - known as a microbicide - can help to prevent sexual transmission of HIV infection.

A study by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) found that a vaginal gel containing the antiretroviral (ARV) drug tenofovir was 39 percent effective in reducing a woman's HIV risk when used for about three-quarters of sex acts and 54 percent effective when used more consistently. It also halved the incidence of genital herpes infections.

“Tenofovir gel could fill an important HIV prevention gap by empowering women who are unable to successfully negotiate mutual faithfulness or condom use with their male partners,” said Quarraisha Abdool Karim, one of the lead investigators of the study and associate director of Caprisa. “This new technology has the potential to alter the course of the HIV epidemic, especially in southern Africa where young women bear the brunt of this devastating disease.”

To learn more visit the following stories:
 
Scientific American: Vaginal gel shows effectiveness in preventing HIV in women
Science Express: At Last, Vaginal Gel Scores Victory Against HIV and Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women
New York Times: Study Offers Two Paths To Cut H.IV. Rate For African Women
Wall Street Journal Online: Gel Cuts AIDS, Herpes Risk For Women
Financial Times Online: HIV Infections Halved By Gel Treatment
Associated Press: Anti-AIDS Gel Helps Prevent Infection, Study Finds
Reuters: AIDS Gel With Gilead Drug Protects Women In Study and FACTBOX - Trial Shows An AIDS Gel Can Protect Women
Agence France-Presse: Major Step Seen In Quest For Anti-HIV Vaginal Gel
Aidsmap: Tenofovir-Based Microbicide Gel Reduces Risk of Infection for Women by 39%
BBC: Scientists Say Vaginal Gel Cuts HIV-Infections By Half
Washington Post: Vaginal Gel Cuts Risk Of HIV Infection, Study Shows
US News & World Report: Vaginal Gel Cuts Risk Of HIV Infection, Study Shows
The Guardian: HIV infection risk for women halved by gel – study and HIV breakthrough as scientists discover new vaccine to prevent infection
All Africa: Finally, Positive Results From a Microbicide Trial
CBS News: Anti-AIDS Gel Halves Infection Risk, Study Finds
Mail and Guardian: Aids infection risk for women halved by gel, says study
BuaNews: Study On Risk-Reducing Gel Welcomed

HIV Prevention Science Scores a Victory – The Gel Works!

IRMA media release
IRMA Presses for Intensified Rectal Microbicide Research

Quarraisha Abdool Karim (left) and Salim Abdool Karim, 

co-principal investigators of the CAPRISA 004 trial.

Vienna, Austria July 19, 2010 – Today at the XVIII International AIDS Conference in Vienna, Austria, members of the International Rectal Microbicide Advocates (IRMA) and thousands of other HIV advocates and scientists cheered a long-awaited, much anticipated success in the quest for new HIV prevention technologies. Researchers announced that a vaginal gel has been shown to significantly reduce a woman’s risk of being infected with HIV and genital herpes.

These game-changing results of the safety and effectiveness study of an antiretroviral microbicide gel were reported by the Centre for the AIDS Programme of Research in South Africa (CAPRISA).

The microbicide gel that CAPRISA studied contained 1% tenofovir—an antiretroviral drug commonly used to treat people living with HIV—and was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during vaginal intercourse and 51% effective in preventing genital herpes infections among the women in the trial. These protective effects increased as the use of tenofovir increased, so that women who used the gel in more than 80% of their sex acts during the trial had a 54% reduction in HIV infections. If and when other studies of tenofovir gel confirm these results, widespread use of the gel, at this level of protection, could prevent millions of new HIV infections over the next two decades. Tenofovir is also being studied as a form of oral pre-exposure prophylaxis.

 “The positive results from the CAPRISA 004 study represent a very significant milestone in HIV prevention research and they increase optimism that we can develop safe and effective antiretroviral rectal microbicides,” said University of Pittsburgh’s Dr. Ian McGowan, IRMA Scientific Vice-Chair and co-principal investigator of the Microbicide Trials Network. “Phase I rectal safety studies with tenofovir are ongoing and these efforts need to be intensified to help us move forward to rectal microbicide effectiveness studies as quickly as possible,” he said.

As with vaginal microbicides, safe and effective rectal microbicides are urgently needed by millions of people. Anal intercourse is a common human sexual behavior, practiced by approximately 5 – 10% of the world’s general population, including heterosexual women and men, gay men, and other men who have sex with men (MSM). Because an act of unprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission compared to unprotected vaginal intercourse, it is likely that unprotected anal intercourse is a significant driver in the global HIV epidemic.

“Certainly, for gay men and other MSM across the world, unprotected anal intercourse is the chief cause of HIV infection,” said IRMA Chair Jim Pickett. “But the world has largely ignored gay men, and anal intercourse. Gay men and other MSM are under-represented in most national AIDS strategies, in epidemiology, surveillance, and in research, if they show up at all. They have been woefully underserved by prevention, care, treatment and support services. “Similarly,” he continued, “there is a paucity of data regarding anal intercourse – homosexual and heterosexual – due to politics, stigma, criminalization, and outright denial.”

Globally, gay men and other MSM are 19 times more likely to be HIV infected compared to the general population. These disproportionate rates extend to Africa, where the epidemic is often characterized as “heterosexual.” In Uganda for instance, HIV rates among gay men and other MSM are just above 40% compared to 5% for men of reproductive age. In South Africa, where the global AIDS pandemic is most severe, the HIV rates between gay men/MSM and men of reproductive age are almost the same – both hovering around 15%.

Comparing gay men and other MSM to both males and females of reproductive age, gay men and MSM are 1.3 times more likely to be HIV-infected in Eastern Europe, 3.8 times more likely in Africa, 18.7 times more likely in Asia, and 33.3 times more likely in the Americas. Data released by the U.S. Centers for Disease Control and Prevention in early 2010 revealed that gay men/MSM  in the United States are 44 times more likely to be HIV-positive than other men, and 40 times more likely to be HIV-positive than women.

“The bottom line is, for the men and women who engage in anal intercourse, condoms work quite well to prevent HIV,” said Pickett, “but many people do not use them, or are simply unable to use them due to a number of issues including power dynamics in sexual relationships, stigma, and a serious lack of availability. According to the Global HIV Prevention Working Group, only 9% of individuals at risk for HIV infection had access to condoms in 2008. Condom-compatible lubricants are also in dangerously short supply.”

While the rectal microbicide field has gained significant momentum, more focus and resources are needed. In 2010, U.S. $7.2 million is being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011 – 2014, to U.S. $10 million/year and must increase further to U.S. $44 million (a six-fold increase) in the years 2015 – 2020 to ensure a minimum of candidate products are moving through the research pipeline into late stage testing for effectiveness.

“We are optimistic that the CAPRISA results will not only accelerate the development of safe and effective vaginal microbicides, but that this proof of concept will also be translated into more financial and creative energy into rectal microbicide development,” said Pickett. “With five new infections for every two individuals beginning treatment, it’s absolutely imperative we find new ways to prevent HIV for individuals at risk, gay and straight, women and men.”

***** Click here for the article in Science - Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women 

DSMB recommends tenofovir gel trial continue

A Data and Safety Monitoring Board (DSMB) held a scheduled review of the CAPRISA 004 Tenofovir Gel Phase IIb trial on 27 July 2009.

This microbicide trial is assessing the safety and effectiveness of 1% tenofovir gel to prevent HIV infection in women in South Africa. It is a collaborative effort between the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal in Durban, South Africa, Family Health International, and CONRAD. The study is funded by USAID and the South Africa Department of Science and Technology through LIFElab in South Africa.

The DSMB congratulated the study team on trial conduct and recommended that the study continue.

Source: Professor Salim Abdool Karim, Director: CAPRISA, Durban, South Africa