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.]

NIH researchers show how anti-HIV drug acts to block herpes virus

via Infotech

"The findings explain the results of a recent clinical trial showing that the anti-HIV drug tenofovir, when it is formulated as a vaginal gel, could reduce the risk of herpes simplex virus (HSV) infections -- as well as HIV infections -- in women.

Tenofovir taken orally had been demonstrated to inhibit reproduction of HIV, but had not been known to block the genital herpes virus.

"HIV infection is closely associated with herpes viral infection. When people with genital herpes are exposed to HIV, they are more likely to become infected than are people who do not carry the herpes virus," said Leonid Margolis, Ph.D., head of the Section on Intercellular Interactions at NICHD and one of the authors of the study. "Human tissues convert tenofovir to a form that suppresses HIV. We found that this form of tenofovir also suppresses HSV. This discovery may help to identify drugs to treat the two viruses even more effectively." Discoveries leading to new uses for previously approved drugs have the potential to save millions of dollars, Dr. Margolis said. New drugs typically undergo years of testing for safety and effectiveness before they are approved for patients. Finding new uses for an approved drug increases the value of the initial investment in testing, because most of the testing has previously been completed."

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.]

The Pharmacokinetics of Tenofovir Following Intravaginal and Intrarectal Administration of Tenofovir Gel to Rhesus Macaques

via AAC Accepts, by Jeremy Nuttall, Angela Kashuba, Ruili Wang, Nicole White, Philip Allen, Jeffrey Roberts, and Joseph Romano

Abstract

Tenofovir gel (1%) is being developed as a microbicide for the prevention of HIV infection, and has been shown to reduce transmission to women by 39%. The gel also prevents infection in macaques when applied intravaginally or intrarectally prior to challenge with SHIV, but very little pharmacokinetic information in macaques is available to help extrapolate the data to humans, and thus inform future development activities. We have determined the pharmacokinetics of tenofovir in macaques following intravaginal and intrarectal administration of 0.2, 1 and 5% gels. Plasma and vaginal and rectal fluid samples were collected up to 24 hours after dosing, and at 24 hours post dosing biopsies were taken from the vaginal wall, cervix and rectum. Following vaginal and rectal administration, tenofovir rapidly distributed to the matrices distal to the site of administration. In all matrices, exposure increased with increasing dose, and with the 1% and 5% formulations, concentrations remained detectable in most animals 24 h after dosing. At all doses, concentrations at the dosing site were typically 1-2 logs higher than in the opposite compartment, and 4-5 logs higher than in plasma. Exposure in vaginal fluid after vaginal dosing was 58-82% lower than in rectal fluid after rectal dosing, but plasma exposure was 1-2-fold greater after vaginal dosing than after rectal dosing. These data suggest that a tenofovir-based microbicide may have the potential to protect when exposure is via vaginal or anal intercourse, regardless of whether the microbicide is applied vaginally or rectally.



[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.]

First Phase 1 Double-Blind, Placebo-Controlled, Randomized Rectal Microbicide Trial Using UC781 Gel with a Novel Index of Ex Vivo Efficacy

via PLoS ONE, by Peter A. Anton, Terry Saunders, Julie Elliott, Elena Khanukhova, Robert Dennis, Amy Adler, Galen Cortina, Karen Tanner, John Boscardin, William G. Cumberland, Ying Zhou, Ana Ventuneac, Alex Carballo-Diéguez, Lorna Rabe, Timothy McCormick, Henry Gabelnick, Christine Mauck, Ian McGowan

Objectives:

Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels. A first-in-Phase 1 assessment of preliminary pharmacodynamics was included by measuring changes in ex vivo HIV-1 suppression in rectal biopsy tissue after exposure to product in vivo.

Methods:

HIV-1 seronegative, sexually-abstinent men and women (N = 36) were randomized in a double-blind, placebo-controlled trial comparing UC781 gel at two concentrations (0.1%, 0.25%) with placebo gel (1:1:1). Baseline, single-dose exposure and a separate, 7-day at-home dosing were assessed. Safety and acceptability were primary endpoints. Changes in colorectal mucosal markers and UC781 plasma drug levels were secondary endpoints; ex vivo biopsy infectibility was an ancillary endpoint.

Results:

All 36 subjects enrolled completed the 7–14 week trial (100% retention) including 3 flexible sigmoidoscopies, each with 28 biopsies (14 at 10 cm; 14 at 30 cm). There were 81 Grade 1 adverse events (AEs) and 8 Grade 2; no Grade 3, 4 or procedure-related AEs were reported. Acceptability was high, including likelihood of future use. No changes in mucosal immunoinflammatory markers were identified. Plasma levels of UC781 were not detected. Ex vivo infection of biopsies using two titers of HIV-1BaL showed marked suppression of p24 in tissues exposed in vivo to 0.25% UC781; strong trends of suppression were seen with the lower 0.1% UC781 concentration.

Conclusions:

Single and 7-day topical rectal exposure to both concentrations of UC781 were safe with no significant AEs, high acceptability, no detected plasma drug levels and no significant mucosal changes. Ex vivo biopsy infections demonstrated marked suppression of HIV infectibility, identifying a potential early biomarker of efficacy. (Registered at ClinicalTrials.gov; #NCT00408538)

Read a more detailed description of the study 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.]

New Microbicide May Block Virus From Infecting Cells

via The University of Utah U News Center

University of Utah researchers have discovered a new class of compounds that stick to the sugary coating of the AIDS virus and inhibit it from infecting cells – an early step toward a new treatment to prevent sexual transmission of the virus.

Development and laboratory testing of the potential new microbicide to prevent human immunodeficiency virus infection is outlined in a study set for online publication by Friday in the journal Molecular Pharmaceutics.

Despite years of research, there is only one effective microbicide to prevent sexual transmission of HIV, which causes AIDS, or acquired immune deficiency syndrome. Microbicide development has focused on gels and other treatments that would be applied vaginally by women, particularly in Africa and other developing regions.

To establish infection, HIV must first enter the cells of a host organism and then take control of the cells’ replication machinery to make copies of itself. Those HIV copies in turn infect other cells. These two steps of the HIV life cycle, known as viral entry and viral replication, each provide a potential target for anti-AIDS medicines.

“Most of the anti-HIV drugs in clinical trials target the machinery involved in viral replication,” says the study’s senior author, Patrick F. Kiser, associate professor of bioengineering and adjunct associate professor of pharmaceutics and pharmaceutical chemistry at the University of Utah.

“There is a gap in the HIV treatment pipeline for cost-effective and mass-producible viral entry inhibitors that can inactivate the virus before it has a chance to interact with target cells,” he says.

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.]

2012 International Microbicides Conference (M2012) in Sydney, Australia

The next International Microbicides Conference will be held in Sydney, Australia from April 15-18th, 2012!

Registration
Registration is not yet open, but to submit an expression of interest, please click here. By submitting this, you will be contacted as soon as official registration opens!

Abstract Submission
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines.  Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. Click here for more information and details about uploading your abstract.

Scholarships
Scholarships are available to attend the 2012 International Microbicides Conference (M2012) in Sydney, Australia.

Scholarships will be offered in four categories that have distinct criteria:
1. Research
2. Community
3. Government Official/Public Health Policy
4. Media (Further details to come - Media scholarships will open 23 September)

Scholarship applications are due 5:00 pm AEST on Thursday 17 November 2011.  Click here for more details about scholarships and to apply.

For any other information about M2012 please go to microbicides2012.org.

[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.]

Sexual Pleasure is Key for Successful Microbicides

via WeNews, by Amy Littlefield

Participants in Kate Morrow's [IRMA Steering Committee Member] recent study may not have felt like they were fighting the global HIV epidemic.

In fact, what they were literally feeling were gels of various consistencies inside their vaginas.

The women in Morrow's Project LINK answered questions after handling the gels, inserting them vaginally, walking around and simulating intercourse with a fake phallus. Did the gel leak out? Did it inhibit the experience . . . or did they actually enjoy it?

Morrow has developed a set of scales to show the range of sensations and experiences women reported. Her goal now is to connect those sensations to data about which gels women would use to prevent HIV. Do they prefer gels that are smooth, thin or thick like hair gel? The answers to those questions could help lead to a microbicide that women will tolerate--and perhaps even enjoy.

For decades, women's health advocates have known that women need a way to protect themselves from HIV that is not dependent on a male partner. Vaginal microbicide gels are among an array of options--including pills, rectal microbicides and vaginal rings--that may one day help. Advocates hope microbicides could even be combined with birth control and help prevent other sexually-transmitted illnesses.

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.]

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Investment in HIV Prevention Research

A report released yesterday by HIV Vaccines and Microbicides Resource Tracking Working Group at the IAS conference in Rome "found that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision.":

"2010 has been a year of retrospection, a time for looking back over the 30 years since the first published report of the mysterious illness that would come to be known as AIDS. As sobering as this anniversary has been, it has also been a time for some optimism and calls to end the epidemic. These calls may not be simply wishful thinking, fueled as they have been by promising research results over the past two years in vaccines, microbicides, pre-exposure prophylaxis using antiretrovirals (PrEP), and antiretroviral treatment as prevention—results that have energized the entire HIV prevention field.

The first good news came at the end of 2009, when researchers in the RV 144 Thai vaccine trial reported that a vaccine combination had reduced risk of infection by 31 percent—the first clinical evidence that a preventive AIDS vaccine would be possible. Then, in July 2010, the CAPRISA 004 trial team announced its findings–that use of 1% tenofovir (TDF, also known as Viread®) vaginal gel reduced women’s risk of HIV infection by 39 percent—providing the first proof that a microbicide would be possible. This news was followed in November 2010 by the announcement from the iPrEx trial team that daily oral tenofovir/emtricitabine (TDF/FTC, also known as Truvada®) had reduced risk of HIV infection by an estimated 44 percent overall in men who have sex with men (MSM) and transgender women, and proved for the first time that HIV prevention using PrEP would be possible. And finally, in early 2011, the HIV Prevention Trials Network (HPTN) 052 trial established that use of antiretroviral therapy (ART) by HIV-positive individuals reduced transmission to their partners"

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

[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.]

Microbicide Trials Network Statement On The Partners PrEP Study And The CDC's TDF2 Study: VOICE Study Will Continue

Via Medical News Today.

Researchers from two major HIV prevention trials announced favorable results of an approach called oral pre-exposure prophylaxis, or PrEP. One of these trials, the Partners PrEP Study, has provided the strongest evidence yet of PrEP's effectiveness.

Information from both studies will need to be fully evaluated before it can be determined what impact they will have on another major trial that is ongoing. Investigators for VOICE - Vaginal and Oral Interventions to Control the Epidemic, and the study's sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), hope to complete their evaluation as soon as possible. In the meantime, the five-arm study involving more than 5,000 women in sub-Saharan Africa will continue as currently designed.

PrEP involves the use of antiretroviral (ARV) drugs commonly used in the treatment of HIV by individuals who are not infected. In the Partners PrEP Study, researchers from the University of Washington and their collaborators in Uganda and Kenya, evaluated the safety and effectiveness of daily use of two ARVs - tenofovir and Truvada®, the brand name for a tablet combining tenofovir and emtricitabine - among men and women in a discordant relationship with a partner who is HIV-positive. The study enrolled 4,758 serodiscordant couples.

There were 62 percent fewer HIV infections among participants assigned to take the ARV tenofovir daily compared to participants who took a placebo tablet, and 73 percent fewer infections among those who took Truvada. In statistical terms, the results leave little doubt they are not due to chance. However, the study was not able to say whether Truvada or tenofovir works better than the other in preventing HIV.

The results came to light during a review conducted by Partner PrEP's independent Data Safety and Monitoring Board (DSMB) just a few days ago, on July 10. The DSMB found the results so compelling that it recommended that it stop testing in the placebo group. The research team will be making arrangements so that participants who had been randomly assigned to take a placebo tablet can instead receive one of the study's active study products. Participants in the other two groups will continue to be followed.

In the second study, a smaller trial that involved 1,200 heterosexual men and women in Botswana, researchers from the U.S. Centers for Disease Control and Prevention (CDC) found that 62.6 percent fewer HIV infections had occurred in the group of participants assigned to take Truvada than in the placebo group. The CDC team will be reporting more details about the findings of the study, known as TDF2, at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome next week.
 
Both sets of results bolster the findings of iPrEx, which late last year provided the first evidence that oral PrEP can help prevent HIV. iPrEx found Truvada - together with a comprehensive HIV prevention package - was safe and 44 (43.8) percent more effective than a placebo tablet for protecting against HIV in men who have sex with men. The two studies' favorable results also raise more questions about what happened with FEM-PrEP. Two months ago, researchers announced the trial would be stopping earlier than planned because an interim review of the study's progress by its data monitoring committee determined that even if the study were to continue, it would not be able to conclude whether or not Truvada is effective in its population of women. The study team is still collecting data. A final report is not expected until late this year or early 2012.

Few conclusions can be drawn from the CDC study concerning the effectiveness of Truvada specifically in women. And although Partners PrEP found tenofovir and Truvada worked well for both men and women, the study provides more information about how these drugs can protect heterosexual men from getting infected than it does about how these drugs can protect women from getting infected from a partner with HIV. That's because in most of the 4,758 couples enrolled (62 percent) it was the male who was the uninfected partner.

VOICE involves 5,029 women from Uganda, South Africa and Zimbabwe. VOICE is testing not only daily use of an ARV tablet - Truvada or tenofovir, but also a vaginal microbicide containing tenofovir in gel form. VOICE is the only trial evaluating both a tablet and a gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women may prefer.
 
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.]

Slide Presentations from MTN's 2011 Annual Meeting

The 2011 Annual Meeting of the Microbicide Trials Network was held in Washington, DC this past March.

Very informative plenary presentations occurred on the two main days of the meeting. The MTN and all the presenters have graciously provided access to their slide sets. Below are links to each of them. Please take advantage of this great set of resources.

Presentations from Plenary Sessions on Monday, March 28, 2011
DIEFFENBACH: Challenges and Opportunities in HIV Prevention
FENTON: Enhancing HIV/STI Prevention for MSM in the United States
HILLIER: Welcome and MTN State of the Network
HUMES: Engaging African American MSM in Research
MCGOWAN: MTN Response to the US Domestic Agenda
MGODI: Where are we going after effectiveness studies?
MILLETT: The U.S. National HIV/AIDS Strategy
STANTON: Update on the Status of USAID’s HIV/AIDS Microbicides Program
Presentations from Plenary Sessions on Tuesday, March 29, 2011
BANGSBERG: PREP Adherence Measurement
CELUM: Adherence & Effectiveness: Lessons from CAPRISA 004, iPrEx & Partners PrEP (& HSV-HIV Trials)
GORBACH: Integration of Behavioral Science in the MTN
HENDRIX: MTN-001Phase 2 Adherence and Pharmacokinetic Study of Oral and Vaginal Preparationsof Tenofovir
HILLIER: MTN Annual Meeting Awards and Closing Remarks
MCGOWAN: Microbicides 2012
ROMANO: The Microbicide Pipeline:A Critical Review

[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.]

Forecasters agree PrEP/microbicides could cut HIV infections in South Africa

via Aidsmap, by Gus Cairns

Several presentations at the Eighteenth Conference on Retroviruses and Opportunistic Infections this week used mathematical modelling to forecast the impact of adopting oral pre-exposure prophlyaxis (PrEP) or a topical microbicide in a high-prevalence country, added to HIV treatment or on its own. Three used South Africa as a model, while one analysed how PrEP might affect a serodiscordant couple.

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.]

CHAARM Program Newsletter - Issue Number 1, 2011

This newsletter contains information about the CHAARM project, main activities executed and results achieved in these 12 months activity as well as researchers’ interviews to give a deeper overview of single laboratories tasks.

CHAARM - Combined Highly Active Anti-Retroviral Microbicides project is large scale collaborative project co-funded by the European Commission under the 7th Framework Programme (FP7). The main objective of this project is to develop combinations of new and existing microbicides that will be designed to be specifically targeted agents, which can be applied topically to reduce transmission of HIV during sexual intercourse.

The content of the newsletter is the result of all CHAARM project partners’ efforts under the coordination of the communication partner together with the project coordinator. This newsletter is published once per year and is sent out via email to a number of interested stakeholders but it is also available on the website.



[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.]

The 10 Stories to Follow as HIV/AIDS Enters Its Fourth Decade

via Colorlines, by Ramon Johnson

Thirty years into the HIV/AIDS epidemic, and after decades of research disappointments, 2010 saw major breakthroughs that put scientific advances such as microbicides, pre-exposure prophylaxis (PrEP) and vaccines within reach and created a favorable environment for other prevention and treatment efforts. In fact, some experts predict that over the next year, some of these discoveries could change the trajectory of the AIDS epidemic.

So what comes next? Colorlines will be covering the HIV epidemic closely throughout this year, in which the epidemic plunges into its fourth decade. Here, we examine 10 major HIV stories of 2010—and how experts expect them to unfold during 2011.

1. Microbicides March Toward the Market

Could applying a gel to the vagina or rectum one day prevent HIV? Scientists hope so. Last year, South African researchers reported breakthroughs in microbicide research. They found that inserting a vaginal-gel version of an antiretroviral medicine called tenofovir (prescribed in pill form as Viread) could reduce HIV incidence in women by 39 percent—and up to 54 percent in the most careful users.

What to watch: Never have scientists been closer to identifying a viable microbicide than they are today. Next steps include confirming these results. Some experts believe that a microbicide for women could be on the market by 2014. Efforts to develop a rectal microbicide are also under way; however, vaginal and rectal tissue are very different from each other, so this research may take significantly longer***.

Read the rest.

***Note - Rectal microbicide research is indeed a bit behind compared to vaginal microbicides - but it is moving forward nonetheless. There are small trials underway now with sites in Pittsburgh, Boston, San Juan and Birmingham!

Learn more about rectal microbicide research and advocacy at the home of IRMA - International Rectal Microbicide Advocates. 

[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.]

USAID Meeting on Microbicides

Over the past year, new technologies have been proven including a microbicide gel that could help prevent HIV transmission in women. On November 29th, 2010, USAID Administrator Raj Shah convened a high-level meeting of global health professionals, experts, and policy makers at USAID headquarter.




Related:

Goosby, Emanuel Address Progress, Potential Roadblocks Ahead For Introduction Of Microbicides In Developing Countries



[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.]

The 411 on microbicides

via ONE, by Todd Summers

There’s exciting news coming from researchers working on HIV prevention technologies about a gel that women can use that reduces significantly their risk of acquiring HIV from vaginal intercourse. Called a microbicide, it’s particularly exciting because it offers women more control over HIV prevention –- and this is important because AIDS impacts girls and women disproportionately (I blogged about this earlier, but it’s so exciting, I’m doing it again!)

Yesterday, I had a chance to attend a workshop at the US Agency for International Development hosted by its administrator Dr. Raj Shah (disclosure: I worked with Raj at the Gates Foundation and he’s a friend). USAID helped finance the microbicide study in South Africa that generated these results, and yesterday’s workshop was to come up with an action plan to get it approved by regulatory agencies and into the hands of women that need it.

It was smart to get this planning underway, as there are too many examples of good health technologies that go unused. It was also exciting for those attending, most of whom had been working in various ways for years to get to this point. Indeed, the first generation of microbicides didn’t work, and this second generation, now using AIDS drugs, was probably the last chance to keep the research going.

Raj started off the conference by sharing his trademark optimism: “I’m incredibly enthusiastic about today!” he exclaimed, noting that this research finding “changes the fundamental equation of how we address HIV around the world.” At the same time, he made clear what we all know, that “AIDS prevention requires a broad range of tools…all of which have some roll to play.”

Put simply, this is a great additional tool, especially for women, but it’s no silver bullet. Microbicides don’t protect from all infections, and will only work for women who can access it, afford it and use it every time they have intercourse -– all of which are significant challenges. There’s also a lot of work needed to get products necessary to regulatory approval in the donor world and in the affected countries, and to come up with strategies for integrating microbicides into broader HIV prevention strategies.

Raj urged the group to take a market-based approach, using lessons from the business world to look carefully at what’s needed to get the product out quickly and widely. Sometimes the public health world can learn a lesson from the business world, and this is one of those moments.

Also providing introductory remarks was Ambassador Melanne Verveer, a senior adviser to Secretary Clinton on gender issues (she worked with former First Lady Clinton in promoting US efforts on global HIV back in the late 1990s). She provided a sober reminder that HIV risk for women was about more than just the virus. Lack of economic opportunity and inadequate education, combined with longstanding cultural degradation, put women and girls at heightened risk for HIV –- and may very well inhibit their access to microbicides. So, she urged that planning for accelerating uptake of microbicides take these broader systemic challenges into account, and committed to full support from Secretary Clinton in that effort.

There’s lots of work ahead, and additional microbicides being studied, so expect to hear more from us on this. I’m particularly excited about microbicides that use impregnated rings that can stay inserted for long periods of time and therefore don’t require use of gels each time there’s a potential exposure. I also hope that work can begin to look at potential applications for rectal microbicides, which can protect women and men. Hats off to the researchers, the donors, and especially the women that volunteered to be part of the study!

Source.

[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.]

Build on Prevention Science Advances this World AIDS Day

New Prevention Advances: Can We Now Imagine a World Without AIDS?
via Huffington Post, by Jeffrey L. Sturchio, Ward Cates and Salim Abdul Karim

Last week, UNAIDS announced that at least 56 countries have stable or declining incidence of HIV/AIDS. Yet on World AIDS Day this week, there are still two new infections for every person put on antiretroviral therapy. However, a series of promising new scientific results in prevention, including three breakthrough trials in just 16 months, offer the first glimmer of hope that we may finally be able to achieve the "three zeros" -- zero new infections, zero stigma/discrimination and zero AIDS deaths. 

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.]

China experts design gel to protect women from HIV

from Reuters, by Tan Ee Lyn

Scientists in China and Hong Kong are designing a gel containing an experimental drug which they hope can reduce HIV infections in women. The search for such a prophylaxis is gaining urgency in China, with sex becoming the number one mode of HIV transmission and new HIV infections rising sharply among Chinese women.

The gel acts as an "entry inhibitor"-- blocking the human immunodeficiency virus (HIV) from gaining entry into host cells, Chen Zhiwei, director of the AIDS Institute at the University of Hong Kong, said in an interview. The experimental treatment drug used in this gel has passed animal tests and a small safety test in people, Chen said. Chen and his colleagues are now preparing to convert it into a microbicide - a gel that is inserted into the vagina or rectum before sex to prevent transmission of HIV, which causes AIDS.

Read more

Pitt working on microbicides formulated as films/strips

via Pittsburgh Tribune-Review, by Luis Fabregas

Borrowing a concept used to make breath strips, researchers at the University of Pittsburgh are developing a quick-dissolving vaginal film containing an HIV-blocking drug, officials said Wednesday.

"The idea is that it would dissolve quickly in the vagina to prevent HIV infection," said Sharon Hillier, a senior investigator at Magee-Womens Research Institute and co-principal investigator of the project. "It's a bit of an old technique, like the Listerine breath mint strip, but it's a whole new way of delivering the drug potentially in a less expensive way."

Read the rest.

Why Won’t AIDS Donors Confirm Their Best New Hope for Avoiding Future Treatment Costs

via Center for Global Development, by Mead Over

Celia Dugger must have known she would get a reaction.  She called from South Africa last week with the surprising news that a donor meeting in South Africa had failed to come up with the $100 million necessary to complete the preparatory research on microbicides as an HIV prevention tool for women.  Luckily for me, she considered my spontaneous reaction to be unprintable and persisted until she got a more coherent quote from me, a quote that appears in her succinct and informative New York Times article here.

Why so emotional?  I’ve spent the last few months estimating the billions of annual dollars required to keep alive the four-million-and-counting patients whom the US and others are supporting now on AIDS treatment.  And I’ve been projecting the hundreds of billions the US and other donors will have to spend over coming decades to sustain these patients and to expand AIDS treatment access to even a small share of the unmet need for it.  The idea that these SAME donors would balk at a mere $100 million to confirm that microbicides really work is astonishing.

Read the rest.