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.