Advocates Applaud Launch of MTN-017, World’s First Phase II Rectal Microbicide Study

[IRMA press release]

 

Trial Design Significantly Enhanced By Strong Community Input

October 2, 2013 – IRMA applauds the launch of the world’s first-ever Phase II rectal microbicide trial. The Microbicide Trial Network’s study, called MTN-017, will test a reduced glycerin formulation of tenofovir gel applied rectally. Volunteers consisting of gay men, other men who have sex with men, and transgender women will participate in the study at sites in the United States and in Thailand, South Africa, and Peru.

“Today feels like every holiday imaginable rolled into one,” said Jim Pickett, chair of International Rectal Microbicide Advocates (IRMA.) “The launch of the MTN-017 study is a milestone long in the making and marks a giant leap forward in the development of safe, effective, acceptable, and accessible products that could be used to prevent HIV during anal intercourse.”

IRMA is pleased to have participated in an intensive community input process with the Microbicide Trials Network that included in-person consultations with advocates and key stakeholders in Thailand, South Africa, Peru and the United States. “The dreams and desires of many men, women, and transgender individuals the world over can be heard loud and clear in the design of the MTN-017 trial. This deep collaboration between scientists and community members is key to the success of this trial and to the rectal microbicide field in general,” said Pickett.

When microbicides were first imagined, they were “vagina-centric.” While many embraced the notion of creating vaginal products women could control, the majority of the HIV/AIDS community— scientists and advocates alike— dismissed the possibility of developing rectal microbicides for use during anal intercourse as an HIV prevention method. It was not considered feasible and the pursuit was seen as hopeless, even laughable. At best, the rectal microbicide field would consist of testing vaginal microbicides for rectal safety, because these products would undoubtedly end up in the rectum despite their intended destination.

IRMA thanks the visionary scientists, advocates and funders like the U.S. National Institutes of Health who bucked prevailing “wisdom” and have remained steadfast in their commitment to developing new HIV prevention methods for use during anal intercourse.

“I feel like we are taking two giant leaps forward today. One in the fight against HIV, and the other in the fight against ignorance and small thinking,” said Pickett.

# # # #

International Rectal Microbicide Advocates (IRMA) is a global network, housed at AIDS Foundation of Chicago, comprised of more than 1,200 advocates, scientists, policy makers and funders focused on rectal microbicide research and advocacy and related issues such as access to safe, condom-compatible lubricants.

Learn more about the MTN-017 study here.

Watch this video “The Rectal Revolution is Here: An introduction to rectal microbicide clinical trials” in English, Spanish, or Thai.

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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.

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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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Meet Annette Larkin, A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of  Annette Larkin, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Annette is one of five new bios posted last week.



Annette Larkin
Alexandria, Virginia, USA

"It's possible that microcides will really find a home in the rectum, so to speak."

Annette is an IRMA advocate, a communications consultant and a guest lecturer at Georgetown University's grad school for communications. She is also the assistant editor of North Wind Magazine. Annette has additionally been working with CAMI - Coalition Advancing Multipurpose Innovations.

Besides being a fabulous IRMA advocate, Annette enjoys travelling, watching HBO's 'Girls', and hanging out with her gorgeous daughter Bella and boyfriend.

Annette first started engaging with IRMA because she found the group very dynamic and engaging and wanted to join in. Additionaly, she has workd with CONRAD, the developer of tenofovir gel for vaginal as well as rectal use.

Annette believes that rectal microbicides are important as a new HIV prevention technology because there seems to be an increase in the amount of people having anal sex, and lube is needed to maximize pleasure anyway. Her advice to IRMA is to keep believing in rectal microbicides!

Thank you, Annette, 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 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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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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AIDS 2012: Meet Rig

via BETA, by San Fransisco AIDS Foundation

Rig Rush of the Black AIDS Institute is the “mobilization coordinator of everything gay black male,” an advocate of better and earlier sex education for youth—and a volunteer in a rectal microbicide trial.

Throughout the MTN-007 study, which looked at the safety and acceptability of a gel containing the HIV drug tenofovir (Viread), Rig had regular HIV tests, answered questions about his sex life, underwent rectal exams and uncomfortable biopsies—and helped bring another HIV prevention tool one step closer.

The charming Mr. Rush spoke with BETA about his experience in the trial, his advice for others considering joining a microbicide study, and what words of wisdom he would give to his younger self if he could.

Rig was also featured as one of IRMA's Friendly Rectal Microbicide Advocates.  Check it out here.

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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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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South African Clinicians Outline Best Treatment for Prevention Practices

via mg.co.za, by Mia Malan

South African guidelines for the preventative use of HIV medication by men who have sex with men who are not infected with the virus are to be published in the peer-reviewed academic publication, Southern African Journal of HIV Medicine, this month.

The treatment, pre-exposure prophylaxis (Prep), consists of an antiretroviral (ARV) pill that is taken daily by HIV-negative people to lower their chances of becoming infected with the virus.

The guidelines were developed by a panel of microbiologists, clinicians, virologists, pharmacists and community representatives affiliated to the South African HIV Clinicians’ Society. 

Several recent studies have revealed that, if Truvada pills, which contain the ARVs tenofovir and emtricitabine, are taken regularly, they can reduce the risk of men who have sex with men of acquiring HIV by up to 72.8%.

Prep is part of a movement based on the use of ARVs to protect vulnerable groups who are consistently exposed to HIV. In “discordant” couples, where one partner is HIV positive and the other negative, the uninfected person is at a high risk of contracting HIV if condoms are not always used, particularly if the ­positive partner has a large amount of the virus in his or her blood or sexual fluids because he or she is not yet on ARVs.

HIV-infected people’s chances of infecting their sexual partners with HIV are significantly lower if they are using ARVs, as the medication reduces the amount of virus in their bodies. Men who have sex with men are particularly vulnerable, and HIV infections are on the increase in this group, despite awareness of the effectiveness of condoms

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 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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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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*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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Reformulation of Tenofovir Vaginal Gel Safe for Rectal Use

via Eurekalert.org

A change in the formulation of tenofovir gel, an anti-HIV gel developed for vaginal use, may make it safer to use in the rectum, suggests a study published online this week in the Journal of Antimicrobial Chemotherapy. In laboratory tests of rectal tissue, researchers from the Microbicide Trials Network (MTN) found that the reformulated gel was less harmful to the lining of the rectum than the original vaginal formulation, and just as effective in protecting cells against HIV.

"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, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and principal investigator of the MTN Network Laboratory. "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."

Tenofovir gel has shown some promise in reducing HIV risk in women through vaginal sex. But because the rectal epithelium – the lining of the rectum that serves as the first line of defense against HIV – is much thinner than the vaginal lining, the gel may not be safe or effective to use rectally. Indeed, unprotected anal sex is 10 to 20 times more likely to result in HIV infection than unprotected vaginal intercourse. By its nature, tenofovir gel is hyperosmolar – contains a higher concentration of sugars and salts relative to cells. This quality could have a harmful effect on the rectal lining by causing epithelial cells to shrink as they purge water to achieve balance. Weakened in this manner, the rectal epithelium may be less able to protect against HIV.

To make tenofovir gel safe and more amenable to rectal use, researchers from CONRAD, a research organization which holds the rights to develop the gel, reformulated it with a reduced amount of glycerin, a common additive found in many gel-like products. In laboratory tests conducted by MTN researchers, the reformulated gel was three times less likely to cause cells in rectal tissue to release water, and equally effective against HIV as the vaginal formulation.

Data from an early phase clinical trial of the reduced glycerin gel presented in March 2012 at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), suggested it was safe and acceptable in 65 HIV-negative men and women who used it rectally once a day for one week. Results from this study, called MTN-007, and future studies will have important implications for the development of a rectal microbicide that could help protect against HIV or other sexually transmitted infections during anal sex.


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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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PrEP Project Initiative Starting Throughout California

via California HIV/AIDS Research Program

In April 2012, the California HIV/AIDS Research Program (CHRP) of the University of California awarded grants totaling $11.8 million to three collaborative teams of investigators to test a potential HIV prevention medication among high-risk HIV-uninfected persons in several communities throughout California. The studies also will examine new strategies to engage and retain HIV-infected persons in care and treatment. Both of these strategies are expected to help curb the HIV epidemic in California.

Two of the collaborative teams of investigators will offer PrEP (pre-exposure prophylaxis with antiretroviral drugs) to high-risk uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) located in Los Angeles, San Diego, and Long Beach over the next four years. These investigators also will assess the implementation of TLC+ (testing and linkage to care plus treatment), a strategy to locate, engage, and retain HIV-infected persons in care and start them on life-saving treatment for their HIV infection

A third grantee consortium will not fully implement PrEP or TLC+ at the present time, but will instead plan and pilot PrEP/TLC+ implementation strategies for young MSM of color located in Oakland, Richmond, Berkeley, and other East Bay Area locations.

PrEP involves the provision of antiretroviral drugs and risk reduction counseling to high risk uninfected persons to prevent future HIV infection among those who potentially may be exposed to the virus. Previous international research trials have shown that PrEP has been very effective in preventing new HIV infections among MSM and selected other risk populations, but only when taken as prescribed in addition to ongoing risk reduction counseling. Recent studies have suggested that the mixed results found for some populations may be due to a lack of consistent adherence to the medication, leading to suboptimal or ineffective levels of drug in the body. In addition, other studies have suggested that identification and rapid institution of antiretroviral therapy for people infected with HIV not only improves survival of those treated, but also lowers the level of HIV virus in the community and might ultimately reduce HIV transmission rates.

This will be the largest PrEP/TLC+ demonstration project initiative in the U.S., and will be the first to test PrEP in several communities throughout California. In these demonstration projects in California, PrEP will be delivered as part of a comprehensive prevention package including risk reduction counseling, sexually transmitted infection screening, and other components. Daily Tenofovir/FTC (Truvada®, a tenofovir/emtricitabine two-drug combination pill manufactured and distributed by Gilead Sciences, Inc. of Foster City, CA) based PrEP will be offered to eligible uninfected high-risk men who have sex with men, as well as to transgender women. Gilead Sciences will provide the drug product (brand name Truvada®) to support these studies. The studies will adhere to safety and implementation guidelines issued by the Centers for Disease Control and Prevention.

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[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.]

Gene Expression: How Proteins Are Made and Our Cells Functions

By Natasha Thakkar, IRMA Intern

In the IRMA teleconference held on March 15th, 2012, Dr. Ian McGowan explained, the effects of 1% tenofovir gel on gene expression and regulation (click here for his slides). There were many questions on the call about gene expression and gene regulation, and because I studied Molecular and Cellular Biology at the University of Illinois Urbana –Champaign, I thought I would try to explain what it means as simply as possible. After all, many advocates are hearing about gene expression for the first time! So, gene expression occurs when the genetic information, which is provided by our DNA, is converted to RNA. The RNA is then converted to many different proteins by a process called translation. The proteins that are produced are needed for the functionality of the cell.

Our DNA is filled with genetic code that gives cells instructions on what protein to produce and when to produce it. Certain proteins need to be regulated or used at precise times. Cells can signal the regulators to control production of a protein. When the cell is lacking the need of a specific protein it will signal the gene to make more of the protein, this is called up-regulation. However, if there is too much of a protein, or a protein is not needed anymore the cell is signaled to slow down or stop the production of a certain protein. This is called down-regulation.

In the case of tenofovir gel, the gene sequencing tables show that the gel is causing the cells to down regulate, or turn off the genes from producing proteins after seven days of use. The reaction that is observed when the drug is applied better maps out protein and cellular behavior pathways. The findings observed in the MTN 007 trials show that the behavior of the cell when used with tenofovir causes the amount of proteins in the cell to decrease. For a further tutorial on the details of the science of gene expression or regulation, click here. Or email me at nthakkar@aidschicago.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.]

NYT: Setback on PrEP Results May Have Been Misunderstood

via The New York Times, by Donald G. McNeil Jr.

The failure of a daily pill to protect healthy African women against AIDS may not have been the pill’s fault but the women’s reluctance to take it, scientists at an important AIDS conference in Seattle were told this week.

Last April, a promising trial of “pre-exposure prophylaxis” — giving small protective doses of antiretroviral drugs to uninfected people — was stopped early because women were getting infected anyway. It was a discouraging setback.

But scientists at this week’s Conference on Retroviruses and Opportunistic Infections who analyzed blood samples taken from the women reported that only a quarter of those who got infected had any of the drug, Truvada, in their blood. That suggested they had not taken their pills.
Papers presented at the four-day conference offered findings both optimistic and scary. There were hints at a possible way to flush the virus out of its hiding places in cells, and at ways to let some patients safely take “vacations” from triple therapy.

It is not known why so few African women took their Truvada, but there is still an enormous stigma about AIDS in Africa, and a bottle of AIDS drugs in the home implies that someone there is sick, said Mitchell Warren, executive director of AVAC, a prevention advocacy group. Mr. Warren pointed out that Truvada had protected women in a different study that enrolled established couples in which only one partner was infected.

In a different study, researchers from the University of North Carolina at Chapel Hill showed that they had used a cancer drug, vorinostat, to purge the virus hiding in the CD4 cells of six men who were already doing well on triple-therapy cocktails.

Although the cocktails can make the virus vanish from the blood, it hides in different types of cells, ready to roar back if the patient stops taking the cocktails.

Another small trial, at the Wistar Institute in Philadelphia, gave patients synthetic interferon — a virus-blocker normally made by the human body — while they took “holidays” of up to six months from triple therapy. Nine of the 20 patients did not see their viruses rebound to dangerous levels. That result will not change clinical practice right away, said Dr. Luis J. Montaner, who led the study, but suggested an alternative to lifelong triple therapy, which can be debilitating.

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[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.]

Two Studies Show the Importance of Adherence in PrEP at CROI 2012

via AidsMap.com, by Gus Cairnes

Adherence makes all the difference to the efficacy of pre-exposure prophylaxis (PrEP), the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard today.

Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year.

In April 2011, the FEM-PrEP study found that giving HIV-negative women tenofovir/FTC (Truvada) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo.

In July 2011, however, the Partners PrEP study found that Truvada was 73% effective in preventing HIV transmission between heterosexual partners of different HIV status.

How do we explain why giving HIV-negative women antiretroviral pills made no difference to the HIV infection rate in one trial, but prevented at least two in every three infections in the other? The difference, it appears, is that in the Partners PrEP trial, adherence to the study medication was very high, whereas in FEM-PrEP, despite counselling and support, less than half the women took their PrEP pills regularly.

The Partners PrEP study

The Partners PrEP study enrolled 4758 serodiscordant couples in Kenya and Uganda; the HIV-negative partner was female in 38% of couples. This study had three arms: a daily tenofovir pill, a daily Truvada pill, or placebo.

There were 17 infections in participants on tenofovir, 13 on Truvada and 52 on placebo. Efficacy overall was 75% in those assigned Truvada and 67% in those assigned tenofovir, though confidence intervals (44% to 81% in tenofovir and 55% to 87% for Truvada) overlapped, so the efficacy of the two regimens was the same statistically. The same was true of efficacy observed in women (65%) and men (70.5%).

Adherence according to pill counts of unused medication was 97%. A substudy (Donnell) compared tenofovir levels in the blood of 29 out of the 30 people who became infected in the two PrEP arms with levels in a random selection of 198 people who did not become infected.

Tenofovir was undetectable in the blood of 70% of the people who became infected but only 18% of the people who did not, indicating a ‘true’ adherence level of about 80% – and having a detectable level of tenofovir in the blood was associated with an 86% reduction in HIV risk in those taking tenofovir and a 90% reduction in those on Truvada.

The FEM-PrEP study

In the FEM-PrEP study, 2056 HIV-negative women in South Africa, Kenya and Tanzania were randomised to take a daily Truvada pill or a placebo. The trial was stopped when an interim analysis found near-identical HIV infection rates in both trial arms. There were 33 HIV infections in women taking Truvada and 35 in women taking placebo; this translates into annual incidence rates of 4.7% and 5.0% respectively. This 0.3% difference is no difference at all, statistically speaking (hazard ratio 0.94, 95% confidence interval 0.59 to 1.52, p = 0.81).

Participants in the study said they took their pills 95% of the time and adherence as measured by pill count was 85%. However when drug levels of tenofovir and FTC were measured in the blood of women assigned to Truvada, the investigators found that less than 50% of the women who should have been taking the drug had actually done so in the last 12 days, and less than 40% within the last 48 hours.

In infected participants, 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive, 21% at the visit they tested positive, and 15% at both visits; in non-infected participants whose samples were taken at the same visits they were 35%, 38% and 26% respectively.

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[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.]

CROI 2012: iPrEx Researchers Test Dosage of PrEP

via AidsMap.com, by Gus Cairns

Further testing of drug levels in the blood and immune cells of gay men participating in the iPrEx trial of tenofovir/FTC (Truvada) pre-exposure prophylaxis (PrEP) has found that HIV infection in men assigned to Truvada was associated with a lapse in taking the drug after initially adhering reasonably well, rather than never having taken it at all, which was what the researchers originally thought. The research was presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle.

The testing also found that only a minority of participants appeared to be taking their drugs as prescribed, seven days a week, but that protection levels were very high – in the order of 96% of infections prevented – as long as participants took four or more doses a week.

Drug levels plummet three months before infection

The results of iPrEx, a large multi-country study of PrEP in gay men, were announced in 2010 and showed an overall efficacy of 42% – in the trial subjects as a whole, four out of ten HIV infections that would otherwise have happened were prevented if subjects were given Truvada pills to take daily rather than placebo pills. When drug levels were tested in the 48 participants who became HIV-infected on Truvada, and a random sample of uninfected participants, it was found, perhaps not surprisingly, that drug was detectable in only 10% of the infected participants but also, perhaps more surprisingly, in only 50% of the uninfected ones.

New measurements have now looked back at drug levels in stored samples in the months prior to infection and compared with drug levels in the same time period in uninfected participants. In the uninfected participants, consistently 45% or so had detectable drug in their samples across the whole length of the study – confirming that at least half of the participants simply never took their pills. In the infected participants average adherence rates started off the same as in the uninfected. They showed a slight decline in the first year of the trial but then declined to 10% in the three months preceding infection. This suggests a role for quarterly adherence reinforcement.

What levels of tenofovir are protective?

The researchers also wished to find out what levels of tenofovir in the blood were associated with protection against HIV. They did this by comparing drug levels in iPrEx participants with drug levels in a small study called STRAND, presented at last year’s conference (Liu),which gave participants directly-observed doses of tenofovir twice, four time or seven times a week and then measured drug levels in their hair. By then comparing the levels of protection seen in participants with specific drug levels in iPrEx, the researchers were able to compute what drug level was protective.

In iPrEx the average drug levels seen in infected people were consistent with less than one dose of tenofovir a week, but drug levels in those who were not infected were consistent with only about three doses a week. Only 18% of iPrEx participants had drug levels consistent with taking seven doses a week. The investigators used very sensitive tests to look at levels of metabolised tenofovir inside cells and found that a reduction of 90% in the risk of HIV infection correlated with a drug level of 16 femtomols per mol (fm/M – 16 in every million billion molecules by weight). The average level associated with seven doses a week in STRAND was about 38 fm/M and with four doses a week about 32 fm/M.

This enabled them to calculate that the protection offered by taking four doses of tenofovir a week was high, and more or less the same as taking seven doses – that is, in the order of 96%, with a minimum likely protectiveness of 90%. They also calculated that absolutely perfect adherence would offer 99% protection. Taking two doses a week (consistently) would still offer 72% protection, though within wide confidence intervals (56% to 96%) while the 42% level of protection actually seen in iPrEx was consistent with participants taking, on average, one dose a week.

This study has important limitations. STRAND did not measure FTC levels so the iPrEx researchers could not calculate what extra protection was offered by that drug. They also could not measure drug levels at the actual moment of exposure – they were measured at anything between 15 and 90 days after infection. And of course the ‘number of doses a week’ measure is purely an average – most participants probably had much more irregular patterns of taking their pills, with (amongst the 50% who took it at all) periods of good adherence interspersed by periods off drug, maybe correlated with times on and off sex. But it does give a guide to the likely minimum levels of tenofovir that people need to maintain in order to be protected from HIV.



[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.]

CROI Reports Rectal Tenofovir Trial Results

via AidsMap.com, by Gus Cairns

A gel containing 1% tenofovir formulated specifically for rectal use was much better tolerated than gels used in previous rectal microbicide trials when used in a safety study in 65 HIV-negative men and women, the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard yesterday.

The gel was also compared with other gels for any irritant or inflammatory effect on tissues. These tests included an in-depth ‘microarray’ analysis of a large panel of different human genes and uncovered a previously unsuspected effect: the tenofovir in the gel appeared to modulate the activity of a large number of genes in rectal tissue cells, primarily in the direction of reducing their activity.

Whether these genetic changes will have a synergistic or antagonistic effect on the efficacy of a tenofovir-based rectal microbicide is completely unknown as yet but illustrates that nucleoside antiretroviral drugs in topical formulations may have unexpected side-effects, as they do when used as treatment.

Background

Last year a study presented at CROI (Anton) found that a 1% tenofovir microbicide gel formulated for vaginal use (similar to the one used in the CAPRISA 004 trial) inhibited HIV infection of rectal cells taken from people using the microbicide by 80%. However the microbicide was unpopular in users, with only 25% reporting liking it, the majority of people reporting side-effects like diarrhoea, cramps and discomfort, and two out of eighteen subjects reporting severe side-effects that necessitated stopping use of the gel.

These side-effects, it is thought, are due to the gel having a high osmolality. This means it contains more salts than body fluid and this causes it to draw water out of cells, resulting in diarrhoea and abdominal discomfort. The Microbicide Trials Network therefore devised a low-glycerine formulation gel with an osmolality of 800 compared with 3000 for the CAPRISA 004 gel; the osmolality of body fluids is 300. Hyper-osmolar gels also strip cells away from the rectal lining and may actually increase vulnerability to HIV and STIs when used during unprotected sex.

Acceptability

The new formulation of the gel was far more popular and easier to tolerate than the vaginal one. Acceptability was nearly 87% as opposed to 25% last year for the tenofovir-containing formulation, 93% for the HEC placebo and even 67% for the gel containing N-9. Amongst specific side-effects, 16% versus 50% last year said they had regular diarrhoea while none, as opposed to 42% last year, experienced the need to rush to the toilet as soon as they applied the gel.

Inflammation markers and genes

Samples were taken from rectal tissues 9 centimetres and 16 centimetres inside from the anal opening and various tests made on inflammatory indicators and gene expression. Not surprisingly, the N-9 gel had the most effect on inflammatory markers, raising some and suppressing others.

Samples were tested using a ‘microarray’, a testing plate that detects the effect of the gels on hundreds of individual human genes and whether they are ‘switched on’ or supressed.

The effect of the HEC gel was completely neutral on genes, with fewer activated or suppressed than in the 16 people not using gel (16 genes versus 23). The N-9 gel affected 116 genes, mostly in the direction of increasing their activity. But the tenofovir gel affected 533 different genes, mostly in the direction of decreasing their activity.

Implications


The clinical significance of this is unknown, and processing the consequence of such a large number of changes in gene activity will take a long time. But Ian McGowan told aidsmap that the results, though unexpected, were not inexplicable.

“Tenofovir is a DNA chain terminator,” he said. “This is how it stops HIV.” He pointed out that the NRTI (nucleoside) drugs were well known for side-effects which had genetic causes ranging from fat loss (caused by damage to mitochondrial genes) through bone synthesis to nerve damage.

Essentially what this study shows is that, once the ‘noise’ from direct inflammation is taken away, it can be seen that NRTI drugs have direct effects on DNA activity in cells when applied topically, just as they do when taken orally. Whether these effects have any clinical consequences remains to be seen.

The next step will be a study called MTN017 in which tenofovir gel will be administered for eight weeks.




[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.]