VOICE Lesson: It's Unfair to be Non-Adherent

This post by IRMA's Jim Pickett first appeared on the blog of the HIV Prevention Justice Alliance.


The VOICE results are extremely important to the field of new prevention technology research. I hope current/future/much-needed discussions about VOICE don’t get drowned out by the HYPE (yes, all caps HYPE) surrounding the “baby cure” story which has dominated coverage out of CROI so far.

If there is one VOICE lesson to focus on, it is adherence. Or in this case, the upsetting lack thereof. It is absolutely important to fully understand why so many of the women in the trial didn’t apply the gel, or take the pill. And it is critically important for scientists to develop things people actually WANT to use, and DESIRE. Perhaps a daily gel, or a daily pill, is simply not desirable for a lot of folks. Makes sense to me.

But here’s the rub. The field can’t move forward with product development when people don’t actually test-drive the product being investigated. Products can’t be improved without data from people who actually used the product. Sure, a daily gel or a daily pill may not be everyone’s idea of a good time… but the only way those ideas get translated from the clunky Model T Ford to a slick 2013 BMW is through a long, iterative process. Which requires trial participants to APPLY THE GEL and/or TAKE THE PILL.

I get that people join trials for all kinds of reasons, and that for many; it is their only access to healthcare. So, they may have no interest in actually participating in test driving anything, but are very excited about regular HIV and STD screening, counseling, access to condoms and lube, referrals to other services, etc. Can’t be mad at them for wanting those things. Right?

It’s a crime, really, or at the very least an outrage, that clinical trials end up being the only healthcare access point for too many folks. That needs to be addressed, on its own.

But…we simply can’t afford enrolling thousands of people into complicated and costly clinical trials to have them just forgo what they SIGNED UP to do. Let’s be brutally honest here, joining a trial to get health screenings and condoms is great for the individual – but it does NADA, NOTHING, NOOTCH for the community/communities fighting HIV who are desperate for new tools to prevent HIV.

Being in a clinical trial is a commitment to following the protocol as best as possible, and being honest when unable. Clinical trial participation necessitates a strong sense of altruism, a desire to help answer big questions for whole populations. I think it is unfair to everyone, especially highly impacted communities where HIV rates are soaring, and where the crisis is anything but over, for trial participants to sign informed consents and derive individual benefits from trials without fully engaging in the study protocols that would allow for potential population benefits.

There are not unlimited resources. In fact, they are shrinking (Hello Sequester!) We can’t continue to fund expensive, resource-intensive, multi-year trials in which most people only SAY they test drove the product.

Jim Pickett is the Chair of the International Rectal Microbicide Advocates (IRMA). This blogpost is part of our ongoing coverage of the 2013 Conference on Retroviruses & Opportunistic Infections (CROI). To read more perspective and analysis on the VOICE results at CROI, click here.

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  *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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IRMA Statement on VOICE Results

[Click here for the VOICE press release - "Daily HIV Prevention Approaches Didn’t Work for African Women in the VOICE Study" - from the Microbcide Trials Network]


IRMA, like the rest of new prevention technology researchers and advocates, is disappointed to learn that daily oral Truvada was not found to be an effective HIV intervention among the African women at risk for HIV who participated in the VOICE trial.

We applaud the efforts of the 5,029 women from South Africa, Zimbabwe, and Uganda who volunteered to participate in the VOICE trial. We also commend the Microbicide Trials Network and the National Institutes of Health for successfully executing this extraordinarily ambitious, important trial, and for contributing critical new information to the field.

Today at CROI 2013 we learned that the majority of women in the daily oral Truvada arm of VOICE were not taking their drugs regularly if at all. Rather than a biological explanation, it appears daily oral Truvada was not effective at preventing HIV among the women in the VOICE trial because the drug was not used regularly.

The results of VOICE indicate low adherence to all the drugs/regimens tested in the trial. There was also low adherence in the daily oral tenofovir and daily tenofovir gel arms. Both these arms were closed due to futility in late 2011 after separate reviews by the independent Data Safety and Monitoring Board. VOICE’s daily oral Truvada arm remained open until August 2012.

One of the biggest challenges the field faces is that of adherence. Clinical trials cannot show that a drug works to prevent HIV if trial participants do not take the drug. More must be done to accurately assess adherence during clinical trials in “real time”, and more must be done to develop HIV prevention interventions that people actually want to use, and like to use. But, we won’t be able to refine the drugs, the drug dosing strategies, and/or the drug delivery vehicles to make them more acceptable if trial participants are not adherent along the way.

Science is an iterative process. We are in the “car phone” phase of new prevention technologies - some of the drugs and dosing strategies are perhaps a little clunky. We all want to get to the “i-Phone” phase where we have interventions that are highly acceptable, and desired, but we won’t get there without going through the clunky phase first.

As the field moves forward, issues of recruitment are as important as adherence. Identifying potential trial participants who are most likely to be adherent during the trial is absolutely critical – and very challenging, as the way to achieve this is admittedly not clear.

The MTN-017 trial, a Phase II safety and acceptability study testing a reduced glycerin formulation of tenofovir gel, is getting ready to launch in the coming months. The study will enroll 186 gay men and transgender women at sites in Thailand, South Africa, Peru, and the United States, including Puerto Rico. It will be absolutely essential that MTN-017 volunteers take the study drugs as directed. If adherence is low during this trial, adequate amounts of safety data will not be collected, making it likely that efforts to develop tenofovir gel as a rectal microbicide will be halted permanently. Have no doubt, this would be a huge setback for rectal microbicide research, development, and advocacy efforts in general.

IRMA is very supportive of MTN-017’s inclusion of “real time” monitoring to assess adherence throughout the trial. This will allow investigators to understand and address challenges regarding adherence while the trial is underway, and will help participants make appropriate adjustments in “real time” to improve adherence outcomes. MTN-017 sites should also pay extra special attention to recruitment activities and work to engage and enroll individuals who are most likely to fully participate in the trial, and follow the various regimens being tested as directed.

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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The HIV Prevention Pipeline: A Future of Possibilities

via IRMA/AVAC, presented by Jim A. Turpin

Please register for this teleconference.
 
Meeting Description:

In the last two years there has been great progress in ARV-based prevention strategies - both in terms of PrEP and microbicides. Specifically, there has been enormous excitement and promise around two drugs - tenofovir and Truvada. And more recently, studies testing Dapivirine and Maraviroc have gotten underway.

But...  is that all there is?  What is happening in terms of pre-clinical work?

In this teleconference brought to you by IRMA and AVAC, the NIH's Jim Turpin will examine current and emerging prevention candidates and delivery systems beyond pills, gels and rings, giving us a fascinating peek into the HIV prevention pipeline that we don't often hear about, well before large efficacy trials are imagined, even before small Phase I safety studies are in the picture.

Jim will ask the questions on all of our minds: Is a sustainable pipeline of HIV prevention products beyond the current array of candidates possible? What does that look like? And what can advocates do to better engage in early, pre-clinical efforts years before human trials are in the picture?

Join our call to hear his answers - and provide your own.

Click here to convert the time of this call to your time zone.

When you register for the call, you will be provided a list of global toll-free dial in numbers., If you need us to dial you into the call, please let us know your number when you register. We will only dial in individuals who don't have access to toll-free numbers.

Presentation slides will be made available on the IRMA website here at least a day in advance of the call. You may download the slides and follow along that way, or simply log in to the ReadyTalk web interface on the day of the call and watch the slides there.

This call will be recorded. The recording will be made available on the IRMA website within a day or two after the call.

Questions? Email IRMA at rectalmicro@gmail.com - thanks!

Register for this meeting here.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

At the recently concluded XIX International AIDS Conference (AIDS 2012), not only the decibels went up on ending AIDS but also sane voices were heard demanding a well-costed and thought-through strategy on how to end AIDS. One of the strategies that will complement a comprehensive HIV prevention, treatment, care and support plan to end AIDS is preventing HIV transmission. In this context, we need to look beyond the Phase III trials in HIV prevention research so that if the product being tested is proved to be effective, we have the means and well-thought plan to make it available for those people in need, without delay.

The HIV prevention research is certainly going ahead with rectal microbicides phase II efficacy clinical trials (MTN017) about to begin in four countries (US, Thailand, South Africa and Peru), US FDA's approval to use 'Truvada' as pre-exposure prophylaxis (PrEP) for HIV prevention, vaginal microbicides research and HIV vaccine science progressing ahead, treatment as prevention (TasP) getting a buy-in as never before, among other positive developments that give us hope.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults

via Morbidity and Mortality Weekly Report

In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population.

Those recommendations remain valid for MSM, including MSM who also have sex with women (2). Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM.* This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Meet Toon - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Wipas Wimonsate (Toon), the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Toon is one of the six new bios just posted the other day, including individuals from Thailand, Kenya and the US.  Each will be featured on the blog, and you can read all of them here right now.


Wipas Wimonsate (Toon)
Bangkok, Thailand

"As nature is so diversified, why aren't HIV prevention technologies as well? People have different preferences, needs, and capabilities. If we are to be successful in HIV prevention, we have to understand and accept the nature of people, and that is diversity."

Toon is a medical and social researcher and community associate working with the Silom Community Clinic in Bangkok. The Silom Clinic will be a site for the Phase II rectal microbicide expanded safety and acceptability trial called MTN-017, which will be investigating a reduced-glycerin formulation of tenofovir gel applied rectally compared with oral Truvada among HIV-negative gay men, other men who have sex with men (MSM), and transgender women. His site is expected to begin enrolling volunteers in early 2013.

Outside of work, he enjoys playing badminton, reading, and watching television.

He first got involved with IRMA when he was asked to translate some materials on lubricant safety. "Safety of lubricants for rectal use: A fact sheet for HIV educators and advocates" is available in Thai thanks to Toon, as is the document Safety of lubricants for rectal use: "Questions and Answers for HIV educators and advocates."

Toon believes that rectal microbicides provide a protective option for those who choose not to utilize a condom. He also recognizes that rectal microbicides offer a different manner in which to encourage sexual health, and that the endeavor to develop safe, effective, acceptable and accessibile rectal microbicides will be a major contribution to humankind.

Toon has worked closely on the soon-to-be-released IRMA video ("The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials") being developed in partnership with the Microbicide Trials Network and Population Council. He is part of the team's Video Advisory Committee and has provided invaluable feedback on content, messaging and language. Translating from English into Thai is rather complicated, and Toon's guidance has been critical to ensure the team "gets it right." He also facilitated the video segments that were recorded in Thailand, and worked closely on the Thai focus groups which were designed and implemented to test the "rough cut" of the video.

Toon was greatly influenced by Dr. Frits van Griensven, the pioneer of HIV studies among Thai gay men, other MSM and transgender individuals. He is very excited for the upcoming studies in Thailand, and is eager to work towards zero new HIV infections rate gay men, other MSM and transgender individuals, locally and internationally.

Thank you, Toon, for all that you do!



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Meet Amber - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Amber Rucker, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Amber is one of six new bios just posted the other day, including individuals from Thailand, Kenya and the US.  Each will be featured on the blog, and you can read all of them here right now.


Amber Rucker
Boston, Massachusetts

"I truly respect an organization like IRMA that does not shy away from talking about sex and pushing for more research in the rectal microbicide field. This is really important work."

Amber is the Senior Research Associate at Fenway Health. Outside of work, she loves cooking and baking new and exciting recipes.

Amber became involved in IRMA through her current position and was intrigued by IRMA's ability to talk about sex and push for more research into the rectal microbicide field. She also believes that rectal microbicides are important because "receptive anal intercourse carries the highest risk of sexual HIV transmission. Providing individuals with other methods of protection against HIV and other STIs is vital for community safety."

She hopes that in time, the stigma associated with receptive anal intercourse will diminish, and men and women will feel more comfortable this very common behavior with health care providers.

Currently, Amber is working on a vaginal ring study called MTN-013/IPM 026. She is very excited about her studies, and is eager to see her research and work evolve.

With the upcoming MTN-017 trial, Amber will be involved in site activation activities, and will be conducting study visits. MTN-017 is the very first Phase II rectal microbicide expanded safety and acceptability study in the field and will recruit gay men, other men who have sex with men, and transgender women who are HIV negative. U.S. sites will launch later in 2012, and international sites are expected to begin enrolling in early 2013. The study will be investigating a reduced-glycerin formulation of tenofovir gel applied rectally compared with oral Truvada.

Amber's mother has been her greatest influence. Her mother has demonstrated leadership, strength, and compassion, and encourages Amber to pursue all her passions and goals fearlessly.

Thank you, Amber, for all that you do!


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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AIDS Foundation of Chicago Hails FDA Approval of the Antiretroviral Drug Truvada for HIV Prevention

[Press release from AIDS Foundation of Chicago - home to IRMA]

Historic decision makes Truvada the first drug approved to reduce the risk of HIV infection from sexual contact among HIV-negative individuals at elevated risk of infection

Today, the U.S. Food and Drug Administration approved the use of Gilead’s  antiretroviral drug Truvada for HIV prevention — known as  pre-exposure prophylaxis (PrEP).

The AIDS Foundation of Chicago lauds this historic decision.

Truvada has long been an important component of treatment regimens for people living with HIV. Multiple studies found that Truvada, when taken daily as PrEP, in combination with safer sex practices, significantly reduced the risk of sexually-acquired HIV infection among high-risk adults. For more than a year, the AIDS Foundation of Chicago (AFC) has urged the FDA’s study and approval of Truvada for PrEP.
PrEP is one piece of the puzzle to preventing the spread of HIV/AIDS, said David Ernesto Munar, AFC’s President/CEO, and it is an important tool to have in a growing array of HIV prevention strategies.

“AFC has long supported the development of new prevention technologies, including PrEP and vaginal and rectal microbicides,” Munar said. “The FDA’s decision today on Truvada is exciting. Our challenge now is to implement PrEP as strategically as possible, and to ensure the people who need it most, those who are most at risk for HIV, have access.”

AFC’s support of PrEP has been multifaceted.  Last year, AFC launched a website of video and written PrEP testimonials called My PrEP Experience. Another AFC initiative, Mapping Pathways , has investigated various HIV prevention strategies — including PrEP — in different cultural contexts around the world.

And earlier this year, AFC joined a national coalition of AIDS organizations in support of the FDA’s approval of Truvada for PrEP.
“This is an enormous turning point, a real game changer, in the fight against HIV,” said Jim Pickett, AFC’s Director of Prevention Advocacy and Gay Men’s Health. “The toolbox we have been working for decades to expand now has Truvada as PrEP.”

“We can make a huge dent in new infections if we incorporate this tool into our prevention programming, and provide people more methods to avoid HIV,” Pickett said. “We can look forward to more sex acts being protected, especially among individuals who have already chosen, for whatever reason, to not use condoms consistently.”

To read the FDA news release, click here.

To read Munar’s October 2011 Huffington Post op-ed piece on PrEP, “Don’t Delay HIV Prevention for Gay and Bi Men,” click here.

Founded in 1985 by community activists and physicians, the AIDS Foundation of Chicago is a catalyst for local, national, and international action against HIV/AIDS.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro. *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Meet Pedro - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Pedro Goicochea, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Pedro is one of six new bios just posted today, including individuals from Kenya,Thailand and the US.  Each will be featured on the blog, and you can read all of them here right now.




Pedro Goicochea
San Francisco, California

"It took us more than 30 years to realize that there is not one unique strategy to prevent HIV acquisition, and that combination prevention is key, and rectal microbicides must be part of the prevention toolbox."

Originally from Lima, Peru, Pedro is in charge of communications and community relations for the iPrEx OLE study, the open-label continuation of the iPrEx trial. iPrEx is the study that showed daily oral use of the ARV drug Truvada among gay men, other men who have sex with men (MSM), and transgender women worked to prevent HIV.

He enjoys his work because of the invaluable opportunities it provides for him to meet interesting people who are working really hard on finding ways to stop this epidemic. He takes pride in the sensitivity his team shows to community members and for highlighting their needs with scientists and stakeholders. Besides iPrEx OLE, Pedro also just finished a couple of other projects related to the feasibility of voluntary circumcision for HIV prevention in gay men and other MSM, and neonatal male circumcision for HIV prevention, in the jungles of Peru.

In his spare time Pedro loves to ride his bike. He enjoys "having destinations that I reach through the effort of pedaling." Pedro's biggest life influence was his mother, but he is also blessed to be surrounded by excellent people that have been an inspiration. In addition, he has lost several friends to HIV and this motivated him to do something about it.

He was introduced to rectal microbicides and IRMA when he met IRMA chair Jim Pickett through IRMA steering committee member and IRMA-ALC co-founder Jerome Galea. He believes that any strategy to help end the epidemic is useful and thinks that rectal microbicides are an important prevention technology because anal sex is the primary mode of HIV transmission among gay men and other MSM, and that women practice anal sex more than is reported or fully understood.

Pedro has played an important role on the soon-to-be-released IRMA video ("The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials") being developed in partnership with the Microbicide Trials Network and Population Council. He is part of the team's Video Advisory Committee and has provided invaluable feedback on content and messaging. He also worked closely on the focus groups (especially those conducted in Lima, Peru) which were designed and implemented to test the "rough cut" of the video with different populations to help ensure the proper messages are coming through. He says it has been a very inspirational expereince and he is really looking forward to see the final release. IRMA plans to release the final version of the video in early September, 2012.

Thanks Pedro, for all that you do!


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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The road to PrEP: trials, regulation and roll-out

via aidsmap.com, by Gus Cairns

Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence summit, Controlling the HIV epidemic with antiretrovirals, was told on 12 June.Some of these studies are underway but others are still in the design stage or in need of funding.

Dr Jim Rooney of Gilead Sciences, the manufacturer of tenofovir (Viread) and Truvada (tenofovir and FTC), the products being tested in the vast majority of these studies, told the meeting that up to 13,000 men who have sex with men (MSM) could end up being involved in 14 different studies and up to 19,500 heterosexual men and women in eight studies. These studies were particularly crucial in establishing whether PrEP might be less, or more, effective in open-label settings than in randomised placebo-controlled trials.

Some of these are ongoing or open-label extensions of studies such as Partners PrEP in 4758 sero-different couples in Kenya and Uganda, or iPrEx OLE (Open Label Extension) in 1500 MSM in six countries. 

Others are just beginning, such as the IPERGAY study of intermittent PrEP in gay men in France. While it is planned that this could eventually include 1900 men, researcher Bruno Spire told the IAPAC meeting that 300 participants had to be enrolled by February 2013 if the next phase of the study was to be funded, and that recruitment had been rather slow so far, partly because of "ideological obstacles" to there being a placebo arm.

Similarly, Dr Sheena McCormack of the UK's Medical Research Council told the meeting that, while the planned UK PROUD study of immediate versus delayed PrEP could eventually include 5000 MSM, only a pilot project in 300 MSM has so far been proposed, with a tentative start date (if the protocol is agreed) in October 2012. 

Read the rest.

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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FDA Delays Approval of HIV Prevention Drug by Three Months

via bloomberg.com, by Anna Edney

Gilead Sciences Inc. (GILD), the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.

The Food and Drug Administration moved the target date to Sept. 14 so it can review a plan by Gilead to ensure people wouldn’t misuse the drug, the Foster City, California-based company said yesterday in an e-mail. Gilead provided the agency a modified risk strategy on June 4, Cara Miller, a spokeswoman for the company, said in the e-mail.

The $14,000-a-year treatment would be the first approved to prevent healthy people from getting the virus that causes AIDS. It’s aimed at an estimated 415,000 Americans who are among those at highest risk for contracting HIV from sex, according to the Atlanta-based Centers for Disease Control and Prevention. While some advocates have said Truvada is an important tool to reduce infection, others have argued that users may gain a false sense of security from the pill and engage in riskier behavior.

Truvada, which makes it harder for HIV to multiply, was approved in 2004 to treat people infected with the virus. The drug will eventually get the FDA’s blessing for use as a preventative, said Ira Loss, a health policy analyst at Washington Analysis LLC. The announcement yesterday “just delays the inevitable,” he said in a telephone interview.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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PrEP Provides New Hope for HIV Prevention in Nigeria

via Leadership, by Winifred Ogbebo
*Mentions IRMA advocate Morenike Ukpong!*

Like a breath of fresh air, the news that a combination prevention drug would soon hit the Nigerian market is definitely something to cheer about, given Nigeria’s high prevalence of HIV rate, which is said to be second only to South Africa in the African continent. WINIFRED OGBEBO reports.

It is like Sunday-Sunday malaria drugs. But in this case, you take HIV drug to prevent HIV and HIV negative people, says the Director-General, National Agency for the Control of AIDS (NACA), Prof John Idoko, explaining the new prevention treatment drug, pre- exposure Prophylaxis.

“From what we learnt from malaria for example, he explains further, “if we give the drugs to somebody who doesn’t have HIV, and the person has sexual relationship with an HIV positive partner, it can prevent transmission from the positive person to the person. That is why it’s called a pre- exposure prophylaxis because before exposure, the person has taken the drugs and because he has the drugs in him, the virus cannot infect him or her.”

Also, Idoko says, “ If you take this sero-discordant couples; one is positive and the other is negative, instead of giving the drug to the negative person before the sexual relationship, just put the positive one on drug as soon as you know. It doesn’t matter what his CD-4 count is even if it’s 500, just give him the drugs. It has shown clearly one of the best study results that we have seen, as 96 per cent chance of the person transmitting HIV is blocked. So we call that treatment as prevention. So you can now imagine that if you go to a community, and they are using this method, your chances of blocking transmission are very high. We believe that these are the two things we need to put together as part of our combination prevention method.”

The pre-exposure prophylaxis is the newest HIV prevention tool that has been developed. It involves the use of Truvada, an antiretroviral to prevent HIV infection. A few studies have shown the ability of this drug to prevent HIV infection in sero-discordant couples, MSMs, transgenders and in men and women.

Read the Rest.



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FDA Hearing on Truvada as PrEP - Watch the Webcast!

On May 10, 2012 the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid June.

Watch the recorded webcast here.

Check out the slide presentations here.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world. *Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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POZ: David Evans Gets Practical About PrEP

[IRMA highly recommends this one. Brilliant, strategic, thoughtful, sober, forward-thinking - a must read]

via POZ, by David Evans

Excerpt:

Give people the facts--the whole picture--and let them decide whether PrEP is right for them

Let's tell people how effective the drug is when they actually take it as prescribed--over 90 percent effective--and stop quoting statistics from the clinical trials where they averaged all of the people together whether or not they were actually taking the drugs. People are going to need motivation to adhere well to PrEP and telling them that it will only cut their chance of becoming infected by 42 percent (the iPrEx study) or 75 percent (Partners PrEP) is not only dishonest, it could significantly undercut their willingness to take a pill every day. How would people feel if we said that condoms were only 30 or 40 percent effective and never revealed that this figure is true only because we counted all of the people who never used condoms in the first place?

Let's also stress that in the clinical studies, PrEP was used with condoms, at least some of the time by some of the participants, and that it shouldn't be seen as a complete substitute. That said, the fear that people will forgo condoms for PrEP is a reasonable one. Therefore, I believe strongly that we should be targeting PrEP to those who are struggling most with condom use, for whatever reason.

Let's also emphasize that while side effects were rare, and not immediately serious in the vast majority of PrEP-takers in trials, we honestly don't know what long-term side effects will look like. People who ultimately end up taking PrEP for more than two years are entering new territory, as are people who might have greater underlying risks for kidney or bone disease.

PrEP is not benign, but neither is HIV; let's strive for balance and accuracy in describing both. We all have a responsibility to correct inaccurate information where we find it, whether in our community publications or blogs, local planning meetings or in our groups of friends. We can never know who's in most desperate need of PrEP and who might be swayed inappropriately one way or the other by misleading or cherry-picked information.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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AIDSmeds: Rectal Microbicide Shows Better Safety in Laboratory Study

via AIDSmeds

Laboratory testing of a modified version of the Viread (tenofovir) microbicide gel provides further evidence that it may be safe for rectal use, according to a paper published online ahead of print by the Journal of Antimicrobial Chemotherapy.

The encouraging results contribute to a better understanding of the gel’s tolerability, already evident in preliminary findings from a 65-person Phase I clinical trial reported at the 19th Conference on Retroviruses and Opportunistic Infections earlier this year in Seattle.

“The lining of the rectum is much more fragile than the vaginal epithelium, so we can’t be certain a product like tenofovir gel that is safe for vaginal use will be completely safe to use in the rectum,” said lead study author Charlene Dezzutti, PhD, of the University of Pittsburgh School of Medicine and the Microbicide Trials Network (MTN) in an accompanying news announcement. “We are very encouraged by our laboratory data that suggest the reformulated gel could be safer for rectal use, and serve as a dual compartment gel for use in both the vagina and rectum.”

Read the rest.

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Medscape: FDA Panel Recommends First Drug for HIV Prevention

Read this excellent explanation/sumary via Medscape, by Janis C. Kelly

The US Food and Drug Administration's (FDA's) Antiviral Drugs Advisory Committee has strongly backed approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection.
In a marathon 12-hour session, the panel recommended approval of a supplemental indication for Truvada (emtricitabine/tenofovir disoproxil fumarate) for preexposure prophylaxis (PrEP) in:

• HIV-uninfected men who have sex with men,
• HIV-uninfected partners in serodiscordant couples, and
• other individuals (such as sex workers) who are at risk of acquiring HIV through sexual activity.

The panel also urged the agency to "put some teeth into" Gilead's proposed risk evaluation and mitigation strategy (REMS) because of concerns that healthy people taking Truvada for HIV prevention will be harmed if they become infected with HIV and do not change from single-drug PrEP prophylaxis to a 3-drug combination antiretroviral treatment regimen, that continuing single-drug Truvada after HIV infection will lead to development of Truvada-resistant viral strains, and that taking the PrEP regimen increases the risk for adverse effects, particularly kidney damage.

Read the rest.

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*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Many HIV/AIDS Advocates Support the FDA to Approve PrEP for HIV Prevention

via PRNewswire

In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada®) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women. Their comments, submitted in advance of a May 10 FDA Advisory Committee meeting, pointed to compelling evidence on the efficacy of TDF/FTC as PrEP and highlighted the unique potential of this intervention to help slow the HIV epidemic in the U.S.

With PrEP, HIV-negative individuals who are at risk for HIV take anti-HIV medications in order to reduce their chances of becoming infected if exposed to the virus. At the May 10 hearing, the FDA will consider data from clinical trials showing that TDF/FTC reduced the risk of sexual transmission of HIV in populations including men who have sex with men (MSM) and heterosexual women and men.

"The U.S. and international AIDS community overwhelmingly supports FDA's priority review of this potentially game-changing new tool to prevent HIV," said Mitchell Warren, executive director of AVAC. "The evidence is increasingly clear that daily PrEP can help reduce HIV risk in women and men who take it consistently as prescribed. While no single tool will be enough to stop the spread of HIV, PrEP could be a vital part of a comprehensive, global strategy to end the AIDS epidemic."

Despite some progress in reducing HIV incidence using other available methods, approximately 50,000 people become newly infected with HIV every year in the United States, and 2.6 million people were newly infected with HIV worldwide in 2010. Globally, half of all people infected with HIV are women and girls. In the United States, HIV infection continues to take a disproportionate toll on African Americans and Latinos; MSM, including transgender individuals; and the poor. Driving down HIV infection rates is a primary objective of the U.S. National HIV/AIDS Strategy, and is at the core of global efforts to end the AIDS epidemic.

Read the Rest.



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*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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The FDA Evalutes the Decision on PrEP for HIV Prevention

via The New York Times, Denis Grady

An advisory panel to the Food and Drug Administration is expected to vote Thursday on whether a drug already used to treat H.I.V. infection should also be approved to prevent it. Such a recommendation, if made, would mark the first time that government advisers have advocated giving antiviral medicine to healthy people who might be exposed through sexual activity to the virus that causes AIDS.

Studies have shown that people who take the medicine, Truvada, every day have a greatly reduced risk of infection.

The F.D.A. usually accepts the advice of its advisory panels, which are made up of outside experts, mostly from medical schools.

On Thursday morning, the panel evaluated studies of the once-a-day pill and heard scientific presentations about whether Truvada should be prescribed for people at high risk of infection, like gay men who have multiple sex partners, especially those who do not always use condoms, and people in relationships with someone who is H.I.V.-positive. Young black men who have sex with other men are at highest risk.

The drug is meant not to replace condoms and other safe-sex measures, but to be used with them for added protection.

Experts say better methods of prevention are needed because there are 50,000 new H.I.V. infections a year in the United States. Several speakers emphasized on Thursday that that number had not budged in 15 to 20 years. Counseling and condoms are not doing the job, they said, and many of the newly infected are men whose sexual partners do not realize they are H.I.V.-positive.

Read the Rest.


------------------- *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world. *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content. -------------------

We can't afford to dismiss any new options in the quest to end AIDS

Here is the letter from leading AIDS advocacy organizations sent to the FDA supporting a prevention indication for Truvada. IRMA is a co-signer,and supporter of these efforts.

The FDA will be reviewing Gilead's application for Truvada as PrEP on Thursday, May 10. Stay abreast of the developments on the PrEP Watch website.

Click here for the FDA's Antiviral Drugs Advisory Committee agenda, committee roster, etc for the review of Truvada as PrEP on May 10.

Click to enlarge.

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Cost Issues of PrEP Evaluated as HIV Prevention

via Pharmalot, by Ed Silverman

Late last year, Gilead Sciences took a widely anticipated and controversial step by seeking FDA approval to market its Truvada HIV pill to prevent infection, which is also known as pre-exposure prophylaxis or PrEP. The move was both welcomed and criticized by AIDS activists, reflecting a spectrum of views on making a preventive pill available on a large-scale basis.

To some, FDA approval would offer needed assistance in containing HIV and possibly clarify the extent to which such preventive measures are useful. To others, FDA approval raises the specter of creating a form of resistance to HIV due to widespread use, which would undermine effectiveness for existing Truvada patients and, therefore, diminish prevention efforts. In particular, critics worry people without HIV who take a preventive pill may engage in risky behavior.

A related issue, of course, is cost. Truvada carries a price of $26 a day, or roughly $10,000 a year, which may inhibit widespread usage. However, a new study suggests there is, indeed, value. Prescribing Truvada to men who have sex with men in the US would cost $495 billion over 20 years, but targeting only those at highest risk would lower costs to $85 billion, according to the study published in The Annals of Internal Medicine (here is the abstract).

Over the next two decades, the researchers calculated a total of 490,000 new infections if prevention is not undertaken, but if 20 percent of gay men take the pill daily, there would be nearly 63,000 fewer infections. And if just 20 percent of high-risk men took the drug, 41,000 new infections would be prevented over 20 years at a cost of about $16.6 billion.

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.]