Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

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

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

Read the rest.


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

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

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

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

The AIDS Foundation of Chicago lauds this historic decision.

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

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

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

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

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

To read the FDA news release, click here.

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

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



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

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FDA Delays Approval of HIV Prevention Drug by Three Months

via bloomberg.com, by Anna Edney

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

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

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

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

Read the rest.


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*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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POZ: David Evans Gets Practical About PrEP

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

via POZ, by David Evans

Excerpt:

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

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

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

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

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

Read the rest.


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

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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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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.


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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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Medscape: FDA Panel Recommends First Drug for HIV Prevention

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

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

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

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

Read the rest.

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

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

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

via PRNewswire

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

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

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

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

Read the Rest.



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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.

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

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The FDA Evalutes the Decision on PrEP for HIV Prevention

via The New York Times, Denis Grady

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

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

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

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

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

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

Read the Rest.


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

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

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

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

Click to enlarge.

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Concerns about Gilead's Truvada used as HIV Prevention

via Financial Times, by Christine Livoti

Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.

Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.

Truvada has not been approved yet as a preventative therapy in HIV.

Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.

Slow uptake thus far

This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.

The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.

He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.

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.]

Open Letter to FDA Urging Immediate PrEP Review

via AIDS Foundation of Chicago

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part of a comprehensive prevention package including risk reduction counseling and condoms.

The rigorous priority review process applicable to efficacy supplements is the best means to promote public health by recognizing the potential of PrEP to offer a major advance in HIV prevention and deserving this priority “where no adequate alternate therapy exists or as a significant improvement compared to marketed products … including nondrug products or
therapies.”

Our organizations understand that granting priority review is not tantamount to a final approval. Nevertheless, we are hopeful that the full dossier of data on emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple clinical trials in different populations can lead to a responsible regulatory and marketing plan that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite many years of efforts to reduce HIV incidence using available counseling methods, some 50,000 new infections occur annually. Disparities persist so that incidence continues to concentrate among African Americans and Latinos, men who have sex with men (including transgender individuals), and the poor. These grim and stubborn facts led to the creation of the White House-directed National HIV/AIDS Strategy for the United States (NHAS), which lists enhanced prevention efforts as a primary objective. If emtricitabine/tenofovir disoproxil fumarate for PrEP satisfies FDA approval criteria, health programs and individuals will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the benefit of all patient disease groups when those tools were not yet available. We are not aware of any legitimate reason to thwart the faster introduction of medicines FDA determines to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act against the interests of patients to do so now. Unfortunately, recent actions by the AIDS Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA process of making responsible decisions about potentially useful medicines and public health. Those actions also foster misunderstandings of the careful balancing of risk and benefits that informs a mature marketing permission based on all available data. Those actions would also set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to review non-tenofovir-based regimens (e.g. maraviroc), microbicide gels, and intermittent PrEP. We urge that FDA continue its public health promotion goals now in the service of the critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the contact person for the organizations signing this letter and can be contacted at 1-212-796-6423 and mitchell@avac.org.

Yours sincerely,

AIDS Foundation of Chicago
AIDS Legal Referral Panel
AIDS Resource Center Ohio
AIDS Research Consortium of Atlanta
AIDS United
amfAR, The Foundation for AIDS
Research
Asian & Pacific Islander Wellness Center
AVAC: Global Advocacy for HIV Prevention
Black AIDS Institute
Caracole, Inc.
Chicago Black Gay Men’s Caucus
Fenway Health
HIV Prevention Justice Alliance
International Rectal Microbicide Advocates
Justice Resource Institute
LA Gay and Lesbian Center
National Alliance of State and Territorial
AIDS Directors
National Black Gay Men's Advocacy
Coalition
National Latino AIDS Action Network
National Minority AIDS Council
Ohio AIDS Coalition
Project Inform
San Francisco AIDS Foundation
SisterLove, Inc.
Ursuline Sisters of Youngstown HIV/AIDS Ministry
Us Helping Us







Read the PDF of the letter (with footnotes) here.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Don't Delay HIV Prevention for Gay and Bi Men

via The Huffington Post, by David Ernesto Munar

Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections.

With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the disease, to help prevent infection -- as part of a broad HIV prevention approach that includes condoms and safer-sex counseling.

But the longer the FDA waits before beginning its review of the HIV medication Truvada for prevention, the more lives will be unnecessarily lost. This is particularly true for those at greatest risk: gay and bisexual men.

We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men.

Last year the iPrEX trial, touted as the scientific breakthrough of the year by TIME magazine, found that gay, bi and other men who have sex with men who took Truvada, along with counseling and condoms, had 42 percent fewer HIV infections than with counseling and condoms alone. Among those who used the prevention pill most consistently, the drop in infections was far greater.

And remember the sobering context: between 2006 and 2009, the number of young gay African-American men infected with HIV in the United States increased by 48 percent, according to the U.S. Centers for Disease Control.

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.]

HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

[Press Release - October 18, 2011]

Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges FDA and Gilead to start the review process that could allow safe and appropriate approved PrEP use as a public health intervention, and not to delay review because of distinct questions about the safety and efficacy of PrEP in heterosexual populations.

[The letter is available online here. IRMA is a signatory.]

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone.

Advocates assert that the need for new HIV prevention strategies for MSM is urgent. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the United States. CDC logged an estimated 34% increase in HIV infections in young gay men between 2006 and 2009, and a 48% HIV increase among young black/African American gay men over the same period.

“We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men,” said Phill Wilson, executive director of the Black AIDS Institute. “We’ve had evidence of PrEP’s effectiveness in MSM for almost a year now. It’s time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. Prompt FDA review will help ensure that appropriate guidelines for PrEP use are established that can reduce HIV infections and safeguard public health.”

Data on PrEP in heterosexuals raise important but unique questions that may require further study. Two major trials in Africa found that PrEP reduces HIV infection risk in heterosexual men and women substantially. But two other studies present conflicting information about how PrEP works in heterosexuals. Critical and necessary efforts to understand how PrEP interacts with hormonal contraception, or how PrEP may impact pregnancy, however, should not delay access to a potentially lifesaving form of HIV prevention for MSM.

Before the results of the heterosexual PrEP studies were announced, the FDA and Gilead Sciences, the maker of the drugs, were reported to be ready to move quickly to consider approval of PrEP for those MSM who could benefit from the approach. Recent signs indicate, however, that FDA review of PrEP for this population may not start until the agency acquires more data on PrEP among heterosexuals—despite the urgent need for new HIV prevention strategies for MSM, and the fact that PrEP data in MSM were announced nearly one year ago.

“The FDA and Gilead Sciences should move quickly to ensure a thorough review of PrEP for MSM now, while they both work simultaneously and swiftly to thoroughly address questions and concerns about PrEP among heterosexual populations,” said Mitchell Warren, executive director of AVAC “Prompt FDA review of PrEP in MSM is the right thing to do for public health. In the midst of a growing HIV epidemic, HIV prevention delayed is HIV prevention denied.”


[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.]

A Donor Deferred: The Lifetime Ban on Blood Donations from Gay Men

via The Huffington Post, by Robert Valadez

"Save a life, give blood," read the sticker on a colleague's lapel. It sounds wonderful -- where do I sign up? Unfortunately, I can't donate blood because I'm gay. Many people are surprised to hear that gay men are prohibited from donating blood in most countries around the world, including the U.S. I've sat at several dinner parties, perched atop my advocacy soapbox, informing straights and gays alike of the U.S. Food and Drug Administration's (FDA) policy that permanently defers any man who has had sex with another man, even once, since 1977, from donating blood.

It wasn't long ago that I was unaware of the policy. Like many college students across the nation, I happily signed up to donate blood at the campus blood drive. In fact, I rallied a group of friends to join me in participating in one of our country's most noble civic duties. One by one, we were called to donate. However, when my name was called, I was escorted to speak with a phlebotomist rather than fitted with an arm tie and stress ball. I was informed that my blood would not be accepted. Not today, not ever again. It had nothing to do with having consumed questionable British meat products or having a deficiency in iron. Rather, I had answered yes to the question -- the one that asked if I had had sex with a man since the 1970s. Given that I was born in the 1980s, the question seemed oddly phrased to me, not to mention unclear as to the definition of sex. Regardless, I checked the box, unaware of its repercussions. Suddenly, I was blacklisted.

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.]

Pro/Con: Two views of U.S. prohibiting gay men's blood donation

via The Los Angeles Times, by Jessica Pauline Ogilvie

Last month, the United Kingdom lifted its long-standing ban on accepting blood donations from gay men. Instead, health officials there implemented a new policy that allows men to become blood donors as long as they haven't had sex with another man in the previous year.

With this decision, the U.K. joined France, Italy, Japan and eight other developed countries in allowing gay and bisexual men to contribute to the nation's blood supply. Many of those countries require sexually active gay men to wait a year before giving blood, while others have deferral periods of six months or five years. Some countries have regulations that focus on potential donors' risky sexual behavior rather than their sexual orientation.

In the United States, however, men who have sex with men are still subject to a lifetime ban on donating blood. The U.S. Food and Drug Administration implemented the ban in 1983 after an estimated 10,000 people with the bleeding disorder hemophilia became infected with HIV through transfusions of HIV-tainted blood.

That policy has become increasingly controversial in recent years. Some experts in the field of blood safety — as well as gay rights activists — say that it's discriminatory and that scientific advances in testing for HIV render it obsolete. Many would like to see the policy changed to resemble the U.K.'s one-year deferral policy or have the ban lifted altogether.
On the other side of the debate are those who say that men who have sex with men still face a heightened risk of contracting HIV and that even a small increased threat to the blood supply isn't justifiable.

The issue has divided major U.S. health organizations. Last year, the FDA denied a request to overturn the ban, but the American Red Cross and others support moving to a one-year deferral.

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.]

AIDS Health Foundation (AHF) Questions Truvada's Use as PrEP

via Business Wire News Releases, by AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF) unveiled a new print ad today that lays out data on the use of Gilead's blockbuster HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the U.S. Food & Drug Administration (FDA) for this new use of the drug. The information detailed in the "Gilead's Truvada as Prevention - Just the Facts" ad illuminates the reasons why it is premature for the U.S. Food & Drug Administration to consider approval of Truvada as PrEP. In the ad, AHF also calls on Gilead "to make certain that their drug when used for prevention does no harm to the individual or the overall public health."

The ad is scheduled to begin running this week in eight publications aimed at an LGBT (Lesbian, Gay, Bisexual and Transgender) audience: Bay Area Reporter in San Francisco, California; GA Voice in Atlanta, Georgia: Gay City News in New York, New York; South Florida Gay News in Miami/Ft. Lauderdale, Florida; Washington Blade in Washington, D.C.; and Windy City Times in Chicago, Illinois. It will begin running next week in the following publications: Frontiers Magazine in Los Angeles, California and Out Front in Denver, Colorado.

The push for FDA approval of PrEP has increased since November 2010 when the results of the iPrEx study were released. The study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 42%. Since then many have raised concerns about the consequences of widespread use of PrEP and its possible affect on behavior. Letters signed by 618 doctors and advocates have been sent to the FDA and to drug-maker Gilead Sciences urging a halt to pursuit of FDA approval for use of Gilead's blockbuster AIDS treatment drug Truvada as PrEP. In the letter sent by doctors--spearheaded by AHF--the doctors expressed concern that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections. Lack of real-world data has also been cited as a concern.

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.]

HIV Experts Create the Roadmap for Providing PrEP to Uninfected Individuals to Reduce the Risk of HIV Infection

Press release via Forum for Collaborative HIV Research

To stem the estimated 2.6 million new HIV infections that occur worldwide each year, more than 200 representatives from the scientific and HIV/AIDS communities took an important step in assessing the safety and public health implications of providing antiretroviral drugs to uninfected men and women exposed to HIV through sexual contact – a strategy called pre-exposure prophylaxis, or PrEP.

Assembling August 19 at an open public meeting and interactive webcast convened by the Forum for Collaborative HIV Research, these researchers, HIV/AIDS advocates, members of industry and representatives from National Institutes of Health, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and state public health departments applied the findings from a number of large trials to discuss a roadmap for FDA and CDC to develop guidance on the safe use of PrEP in otherwise healthy individuals at high risk of acquiring HIV. Held with the encouragement of FDA, this meeting has important implications for medical practice in the U.S. because recent data strongly support the efficacy of antiretroviral intervention for this purpose.

Although FDA has not yet approved PrEP to reduce HIV acquisition in uninfected individuals, one form of PrEP recently studied for use in healthy men or in couples where one partner is HIV positive –a daily pill containing tenofovir plus emtricitabine (TDF/FTC) – is FDA-approved for the treatment of HIV infection. In women, studies have also demonstrated the efficacy of prophylactic treatment with tenofovir applied as a vaginal gel.

“We now have findings from large studies that support a conclusion that PrEP is effective in gay and bisexual men, who represent more than half of new HIV infections in the U.S., and now, there is evidence that PrEP may reduce HIV infection in heterosexual men and women, the population hardest hit by HIV worldwide,” said Jur Strobos, MD, Deputy Director of the Forum. “We must however, apply these promising data to develop workable strategies that mitigate risk that may be associated with the prophylactic use of antiretrovirals. These include both medical and socio-behavioral risk. We must ensure that people at greatest risk for acquiring HIV receive a comprehensive package of prevention services, including regular HIV testing, condom provision, risk reduction counseling and management of other sexually transmitted infections. The purpose of our meeting was to help identify what the components of a complete package should be.”

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.]