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.

-------------------

  *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.

  -------------------

Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States

via PLoS Medicine, by Gordon Mansergh, Beryl A. Koblin, Patrick S. Sullivan

Summary Points:

Pre-exposure prophylaxis (PrEP) with anti-retroviral (ARV) medications is partially efficacious for preventing HIV infection among men who have sex with men (MSM) and heterosexuals.

As PrEP becomes available and prescribed for use among MSM a better understanding of willingness to use PrEP and avoidance of condom use are needed so that behavioral programs and counseling may be enhanced for maximum benefit.

Targeted messaging will be needed about ARV prophylaxis for various at risk populations, but the general message should be that condoms continue to be the most effective way to prevent HIV transmission through sex and that PrEP is an additional biomedical intervention.

As new effective biomedical intervention methods, such as PrEP, become available language about “protected” and “unprotected” sex, which used to exclusively mean condom use, will need to adapt.

Read the full article here.


-------------------
*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.
-------------------

What kind of prevention do gay men need?

 via aidsmap, by Gus Cairns

How do we stop the hyperepidemic in gay men?

A number of presentations at the 19th International AIDS Conference explored the 'hyperepidemic' of HIV amongst men who have sex with men, and especially black MSM.

A paper presented by Gregorio Millet (pictured above at a White House reception honoring people working in AIDS) showed that, at least in the USA, the extremely high incidence and prevalence of HIV in this group is not driven by higher levels of unsafe sex. Instead, very high prevalence, the ease with which HIV is transmitted during anal sex, and the fact that black men (and some other subpopulations of gay men) have sex within small and multiply-connected networks have created a situation in which HIV is hard to avoid.

Given this, what prevention methods would work in gay men? The one that has been talked about most keenly and which continued to generate a great deal of data and debate at Washington was pre-exposure prophylaxis (PrEP) - taking antiretrovirals (ARVs) to prevent, rather than treat, HIV.

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.

*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.
 -------------------

PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, by Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc. Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place. One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP. The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP. In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

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.

*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.

-------------------

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.



------------------- *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. -------------------

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.



-------------------

*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.

-------------------

Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via Lancet.com, by Salim S Abdool Karim  and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

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.
 
-------------------

aidsmap: NICE says sperm washing is no safer than effective treatment and timed intercourse

via aidsmap.com, by Roger Pebody

Draft UK guidance on fertility treatment says that sperm washing may no longer be necessary for couples where the man has HIV and the woman does not. As long as the man is on effective antiretroviral treatment and unprotected sex is limited to days when his partner is ovulating, “sperm washing may not further reduce the risk of infection.”

On the other hand, the guidance does not support the use of pre-exposure prophylaxis (PrEP) by the HIV-negative partner.

The National Institute for Health and Clinical Excellence (NICE) is an influential body which issues recommendations to the NHS about the most effective and cost-effective treatments to provide. Their draft guidance on fertility treatments – an update to a document previously issued in 2004 - was issued today and is open for consultation.

As in the previous version, people with HIV are not excluded from access to fertility treatments, such as intrauterine insemination (IUI) or in vitro fertilisation (IVF). Moreover the authors have removed a previous recommendation that the implications of the parent’s HIV infection for the child’s welfare “should be taken into account”.

The writing group reviewed in detail the scientific evidence for different methods that a couple could use to become pregnant, where the man has HIV and the woman does not. Previous guidance recommended sperm washing, but the experts also looked at the evidence for effective antiretroviral treatment and for pre-exposure prophylaxis.

“The evidence showed that whilst sperm washing did not appear to completely eliminate the virus in the semen on the basis of post-wash testing of prepared semen, the procedure appears to be very effective in reducing viral transmission in that no cases of seroconversion of the woman or the baby has been documented,” they found.

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.

-------------------

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.

-------------------

*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.

-------------------

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.



-------------------

*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.

 -------------------

PRESS RELEASE: AVAC Urges FDA Approval of PrEP Following Positive Advisory Committee Recommendation; Lays out Priorities to Ensure Access

Thursday, May 10, 2012

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536

Kay Marshall, kay@avac.org, +1-347-249-6375

AVAC Urges FDA Approval of PrEP Following Positive Advisory Committee Recommendation; Lays out Priorities to Ensure Access

New York, NY — AVAC hails the recommendation by an FDA Advisory Committee 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. Citing the urgent need for new HIV prevention options to stem HIV infections, AVAC urges the FDA to issue an approval for all men and women at risk, and is calling on public health agencies, governments, advocates and funders to take action to ensure access to TDF/FTC as PrEP.

                                                               

“This brings us closer to a watershed for global HIV prevention efforts,” said Mitchell Warren, executive director of AVAC. “PrEP, while not a panacea, will be an essential additional part to the world’s success in ending AIDS. For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope that we will achieve the end of the epidemic.”

“The evidence from the clinical trials presented today is clear:  If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP can dramatically reduce your chances of becoming infected,” Warren said.

Noting that the FDA typically, but not always, follows its committees’ recommendations, Warren said, “With their support for approval, the FDA’s expert panel and its own scientists have followed the evidence.  We hope and expect that the agency will follow their sound advice.”

"As a young black gay HIV-negative man, I see that the current prevention options are not stemming HIV incidence in my community,” said Matthew Rose, policy chair of the Young Black Gay men's Leadership Initiative and an AVAC PxROAR partner. “I know that a single drug or prevention strategy will not end this epidemic. But PrEP will give young gay black men tools that will allow them to manage their situation and make their own HIV prevention choices based on knowing all the options that exist.”

An action agenda for PrEP implementation

In anticipation of an FDA approval for TDF/FTC as PrEP, AVAC is calling for immediate actions to ensure that PrEP can be madeavailable to people at risk of HIV quickly, safely and through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections. These actions should take place in the US and in other countries that may take the FDA ruling as a positive signal for national introduction of TDF/FTC as PrEP.

“After decades of research, it’s thrilling that we can begin talking about access to a powerful new HIV prevention option,” Warren said. “Some funders and policymakers have been awaiting a signal from the FDA before launching demonstration projects or developing implementation plans.  The time for waiting is over. We need to get on with the work of setting priorities and rolling out PrEP to people who can benefit the most.”

AVAC’s recommendations include:

         Public health guidance:  The US Centers for Disease Control and Prevention, the World Health Organization and other public health agencies should issue guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible. Guidance is needed by providers and people at risk, and to help governments and funders set priorities for PrEP implementation.

         Demonstration projects:  Real-world studies are urgently needed to answer important questions about how best toimplement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, which research has shown to be essential for PrEP to work. Currently, only a limited number ofdemonstration projects are planned or underway.

         Funding:  In addition to funding robust demonstration projects, donors and governments should be planning for significant investments in well-designed PrEP initiatives. Funding for PrEP should not detract fromother essential HIV prevention and treatment efforts. However, funders should explore ways to repurpose funds that currently support lower-impact activities.

         Additional research:  Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and the FDA should stand ready to act on new data and further expand options for preventing HIV infection.

“PrEP, together with other prevention strategies that we have now and those still to be developed, could help to significantly reduce the global burden of HIV infections and could be a life-saving intervention for some men and women, Warren added. “Multiple clinical trials have clearly shown that PrEP is safe and effective when used as prescribed. We all must now act on the scientific evidence and translate itinto practice and impact. We simply cannot afford to dismiss any new options in the quest to end AIDS.”

#  #  #

For more information about PrEP and the steps needed to make it available to people in need, visit www.prepwatch.org and www.avac.org/prep. 

About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery ofAIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIVprevention options as part of a comprehensive response to the pandemic.

-------------------

*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.

 -------------------

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.

-------------------

*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.

-------------------

MSM Population in Bejing Express Interest in PrEP

via AIDSmap.com, by Micheal Carter

Few gay and other men who have sex with men (MSM) in Beijing have heard of pre-exposure prophylaxis (PrEP), investigators report in PLoS One. Despite this, over two-thirds of men said that they would be willing to take or consider PrEP.

“To our knowledge this is the first study to assess awareness and acceptability of PrEP among MSM in China,” write the authors. “Awareness of PrEP was rather low…however, 68% reported that they were definitely or probably willing to accept PrEP if available.”

The study was carried out in 2009 and 2010 prior to release of results from the IPrEX study, an international trial which showed that pre-exposure prophylaxis with oral Truvada (tenofovir/FTC) reduced the risk of HIV infection in men who have sex with men.

PrEP is considered a promising area of HIV prevention, but the factors associated with willingness to accept PrEP, adherence and the treatment’s impact on sexual risk behaviour are poorly understood.

Most of the research evaluating PrEP acceptability has been conducted in the US and other western countries. There are an estimated 740,000 HIV-positive people in China and, in recent years, prevalence of the infection has increased substantially among gay and other MSM. PrEP could therefore provide a useful prevention intervention for this population.

Investigators from Beijing wanted to establish awareness and acceptability of PrEP among gay and other MSM in the Chinese capital.

They designed a study involving 152 men who were tested for HIV and syphilis in 2009 and 2010. All the men reported sexual activity with another man. An explanation of PrEP was read to the men and they were asked if they had ever heard of this prevention technology. Further details of the therapy – including the need for high levels of adherence and potential side-effects – were then read to the study participants, who were asked if they would be willing to accept the treatment.

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.]

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.]

Researchers Report that PrEP May Be Accepted as HIV Prevention in UK's Gay Men

via AIDSmap.com, by Roger Pebody

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

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.]

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.

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.]

Researchers Investigate Acceptability for PrEP in Chinese MSM

via PLoS ONE, by Feng Zhou

Introduction

In pre-exposure prophylaxis (PrEP), antiretroviral (ARV) drugs are given to HIV-negative people to decrease their chance of becoming infected. Several studies conducted among men who have sex with men (MSM) have shown that PrEP awareness was very low, and few participants reported having the experience of PrEP use, even in some countries where it is available. Although strategies including abstinence, being faithful, and condom use (ABC) have been proved to be effective for prevention of HIV transmission, the virus still prevails among MSM. It was estimated that 2.6 million individuals were newly infected in 2009 worldwide, which 19% fewer than the 3.1 million in 1999. China had about 740,000 people living with HIV and 105,000 with AIDS by the end of 2009. Homosexual intercourse has become a major mode of HIV transmission since 2009, and the prevalence of HIV in MSM has increased significantly from 2.5% in 2006 to 8.6% in 2009. A sociological study has estimated that there are 1.8–2.4 million homosexual or bisexual men in mainland China. In China, high-risk behavior, such as multiple partners and unprotected sex, have been reported to be common in this group. Also, recent studies have reported rapid transmission of HIV in this specific population from various geographic areas in China, despite the efforts made by the national and local governments and non-governmental organizations in the past few years. New effective approaches are urgently needed for this population.

In recent decades, researchers have made great efforts to explore alternative biomedical interventions, such as male circumcision (MC), HIV PrEP and post-exposure prophylaxis (PEP), HIV vaccines, and microbicides. Among these potential strategies, PrEP is considered to be one of the most promising strategies in MSM. Several animal and human studies have suggested that ARV drugs might reduce the risk of HIV infection either by PrEP or by non-occupational PEP. A 12-month PrEP clinical trial of daily oral tenofovir disoproxil fumarate (TDF) for HIV prevention was performed among 400 HIV-negative Ghanaian women, and achieved good acceptability and >82% adherence. In November 2010, the US National Institutes of Health (NIH) announced the results of the iPrEx trial of PrEP conducted among 2499 HIV-seronegative MSM in six countries, which showed that daily oral Truvada, a combination of emtricitabine (FTC) and TDF, reduced risk of HIV incidence by 44%, with a median 1.2 years follow-up, compared with the placebo group, and >75% adherence was reached. These findings represent a major advance in HIV prevention research, providing the first evidence that PrEP, when combined with other prevention strategies, can reduce HIV risk among MSM. A further study is ongoing in HIV Prevention Trials Network (HPTN) 067 to evaluate the feasibility of intermittent dosing of PrEP. Recent results from Partners PrEP and CDC TDF2 have shown that PrEP with daily oral TDF/FTC or TDF was effective at reducing HIV risk in heterosexual men and women. However, the Fem-Prep program on Truvada, a closed clinical trial implemented by Family Health International (FHI) in partnership with research centers in Africa, does not support the theory of PrEP having an effect on HIV prevention. Therefore, some factors that might influence the efficacy of PrEP, including adherence, sexual behavior, or other factors still need to be determined.

The awareness and acceptability of new strategies are very important when they are recommended for use. Therefore, the objective of our study was to investigate the awareness and acceptability of PrEP among MSM and potential impact factors, which will provide suggestions and guidelines for future clinical trials in China.

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.]

PrEP May Shape HIV Prevention Strategies

via The Boston Globe, by Sean Cahill

Initial results from clinical prevention trials of pre-exposure chemoprophylaxis (PrEP), in oral pill form indicate that PrEP could be the “game changer” needed to more effectively fight HIV. PrEP involves taking antiretroviral medications to prevent HIV.

PrEP has shown partial efficacy with men who have sex with men (MSM) and heterosexuals. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.

Guidance from the US Public Health Service and the World Health Organization is expected later this year. The Food and Drug Administration announced February 13th that it would review Gilead Science’s application to use FTC-TDF (brand name Truvada) for PrEP by June 15th. Demonstration projects to develop real world best practices for implementing PrEP are underway or set to launch soon in the United States and in sub-Saharan Africa. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled up treatment—focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa—predicts that PrEP could significantly reduce HIV incidence and prevalence.

In February 2012, The Fenway Institute released an analysis of PrEP implementation issues, titled Pre-exposure prophyalxis for HIV prevention: Moving toward implementation. This report summarizes the state of PrEP and microbicide research as of early 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV. Based on a review of published research and interviews with policy makers, funders and other stakeholders, it examines regulatory developments and planning underway both within the U.S. and globally.

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.]

An Analysis of PrEP Data and Decisions Taken in 2011

via Treatment Issues, by Deirdre Grant

More than a decade ago, “AIDS Drugs for Africa” was one of the rallying cries for a global activist movement.The meaning was simple: treat HIV-positive people with potent, life-saving medications regardless of where they live, how much money they have or who they love. These days, the phrase has more meanings than we could have ever imagined. The past two years have brought a range of data on the use of antiretrovirals for HIV prevention in HIV-negative people, as well as a preventive strategy in HIV-positive people. These developments are exciting, but the situation is far from simple. There are questions about feasibility and about levels of effectiveness observed in different trials. Today, many people want to know: Can antiretrovirals (ARVs) be used for HIV prevention in HIV-negative people? If so, which types of products, programs and for which populations is this prevention most effective?

The answers to these questions depend on several factors, including science, policy, funding, community demand, andthe future of treatment access for people with HIV. Not surprisingly, the possibility of using an ARV based prevention method in HIV-negative people generates strong opinions, both in favor of such a prevention tool and those opposed. In light of the potential, many questions have arisen including: Is it feasible? Will people actually use a pill or a gel once a day? Is it ethical, given the enduring need for ARVs for HIV-positive people worldwide? And, do we know enough from the trials to-date to describe levels of safety and effectiveness anticipated in a real world health care setting?

None of these questions have been completely answered. But over the past year, there has been a steady stream of developments that have both complicated and clarified the discussions. Mixed data on topical PrEP, such as the vaginal microbicide 1% tenofovir gel, and oral PrEP in women have left scientists and advocates perplexed. Many fear that the obstacles inherent in providing ARVs to HIVnegative people—repeated HIV testing, the need to ensure access for HIV-positive people, additional staffing requirements, and more—will overshadow the potential of these new tools. For advocates who want to see a full exploration of what ARV-based prevention can do in their communities, it’s as important as it has ever been to stay informed of developments as they emerge and maintain a firm pursuit of the ultimate goal: to curb the epidemic by preserving health in HIV-positive people and preventing as many new infections as possible.

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.]