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.]

Questions Surround PrEP Trials

via The New York Times, by David Tuller

In the past year, three landmark clinical trials have shown that a daily dose of the antiretroviral medication Truvada can protect individuals from infection with H.I.V. — a significant discovery, given the failure so far of all efforts to develop a vaccine against the virus.

Now researchers in San Francisco and Miami are planning to test this prevention strategy, called pre-exposure prophylaxis, or PrEP, in a pilot study supported by the National Institutes of Health. The researchers will soon recruit up to 500 uninfected men who have sex with men, especially those considered to be at greatest risk of infection, such as younger gay men and, in particular, African-Americans.

The men will be asked to take Truvada daily, and the researchers will monitor their compliance with the regimen, their sexual behavior and their health status. Already, though, the prospect of antiretroviral drugs’ being used for prevention as well as treatment is raising complex questions for researchers and advocates.

Will healthy uninfected people consistently take an expensive and powerful drug that can cause a range of side effects? Is it fair to provide medications to H.I.V.-negative individuals when so many of those already infected do not have access? Will those receiving the drug be more likely to engage in risky sex because they believe they are protected — even if they do not always take it as prescribed?

Read the rest.


[If an intem 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.]

Closure of oral Tenofovir arm in VOICE Pre-Exposure Prophylaxis trial: PrEP as a “niche intervention”?

via Incidence, by Roger J. Tatoud

The Microbicides Trial Network (MTN) September 28th that its VOICE (Vaginal and Oral Interventions to Control the Epidemic, MTN003) HIV Pre-Exposure Prophylaxis (PrEP) prevention study will discontinue the daily oral tenofovir arm of the trial. The decision follows an interim review of the trial’s data by its Data Safety and Monitoring Board (DSMB) which recommended that VOICE stops evaluating the oral tenofovir tablet (TDF, brand name Viread), because it will not be possible for the study to show a difference in effect between the drug and the placebo tablet (futility) for the prevention of HIV infection in the context of that study. Importantly, the DSMB did not found any safety issues associated with the use of TDF in any arm of the trial.

This is the third PrEP trial, after FEM-PrEP and TDF2, for which an interim review of the trial’s data led to a change of course of the study. Because the four other arms of the VOICE trial continue, there are no data available publicly yet to explain why tenofovir would not show effectiveness in this study when three other studies showed a dramatic reduction in the risk of HIV infection with tenofovir alone or in combination with another antiretroviral (see table below). However, Sharon Hillier and Ian McGowan of the Microbicide Trials Network noted that the study’s population – predominately women in their 20’s, could be an important factor.

“If there’s one thing we’ve learned over the years it’s that unmarried women in their 20s are in a very different place in their lives than married women in their 30s. People in different circumstances will make different choices about their use of condoms, their choice of partners and whether or not to use a biomedical prevention product. As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir, and even when we have more information available to us, understanding what exactly happened (or not) will not be simple.”

If confirmed (a full analysis of the data will not be available before several months) this would add to the challenge of defining a strategic use for PrEP in the general population or in populations at risk.

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.]

Microbicide Trials Network Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.
 
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.]

'Less education' associated with PrEP and PEP use: only one in five gay men yet aware of PrEP

via aidsmap, by Gus Cairns

A survey (Mansergh) of 454 HIV-negative gay men in four US cities (New York, Los Angeles, Chicago and San Francisco) has found that men with lower educational attainment (high school only) were more likely to use antiretrovirals informally for HIV prevention, either as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), than men who had had further education.

In a parallel survey of 557 HIV-positive gay men, men with lower educational attainment were, similarly, more likely to share their antiretroviral pills with HIV-negative partners to use as PrEP or PEP.

Taken together, 22% of the men in the two surveys were under 30, 35% in their 30s and 43% 40 or over. A third were black, 38% white and the rest Hispanic or of other ethnicity.

Roughly a third each of the sample had education only to high school level, to some college qualification, or to a university degree.

The survey asked both groups if they had used PrEP or PEP or, in the case of the HIV-positive men, provided it to others, in the last six months.

Informal use of PrEP or PEP was still comparatively uncommon; only a few per cent of those surveyed overall had used ARVs as prevention or provided them in the previous six mnoths.

However men with high-school-only education were two to six times more likely to report using one of these strategies.

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 from HIV-Positive Prevention Advocates Rejects Misinformation about PrEP

Close to 100 openly HIV-positive gay and bisexual men from across the United States and around the world have signed a new letter (http://tinyurl.com/pozPrEPletter) calling for an open discussion, “based on facts rather than on fear or misinformation,” of the challenges and opportunities presented by pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women. The new open letter is designed in part to urge FDA review of PrEP and to clarify facts about important PrEP research that advocates say have been misrepresented in a paid ad campaign sponsored by the AIDS Healthcare Foundation (AHF).

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. Much higher rates of protection were achieved among participants who took PrEP consistently.

Most of the HIV prevention community welcomed the news of a new tool that could significantly reduce infections in the populations at highest risk for HIV in many parts of the world. One HIV treatment provider, however, the AIDS Healthcare Foundation, has taken out an extensive series of full-page advertisements in gay papers around the country claiming that gay and bisexual men will act recklessly and will spread HIV if they are allowed to use PrEP. The AHF ad campaign claims that it is supporting gay and bisexual health by urging the U.S. FDA to ignore the PrEP study.

Today’s open letter challenges both the tone and content of the AHF communications and encourages “a full and factual discussion of the pros and cons of PrEP... based on facts, not misinformation.” Reminding the world that “gay and bisexual men invented safer sex…and have worked tirelessly to prevent new HIV infections,” the letter also points out that gay and bisexual men account for more than half of new HIV infections in the United States and are in particular need of new HIV prevention approaches.

"As an HIV positive gay man I signed this letter because I learned from experience we need all credible options to stop this epidemic. I owe my life to the fact that advocates and activists have pushed hard for decades to make effective AIDS drugs available to HIV-positive people,” said Kali Lindsey.  “Now we know that AIDS drugs can also play an important role in the health and well-being of HIV-negative gay men, how could we not move forward to reap the benefits of this research. It is not an option to ignore these findings.”

In July of this year the results of two addition studies, Partners PrEP (led by the University of Washington Department of Global Health) and TDF2 (led by the U.S. Centers for Disease Control and Prevention) demonstrated that PrEP is also safe and effective in heterosexual women and men. The Partners study found that participants who received PrEP experienced an average of 62-73% fewer HIV infections than those who received placebo. The TDF2 trial, conducted by the U.S. Centers for Disease Control found that the risk of HIV infection dropped by an average of 63% among those who received PrEP in addition to condoms and counseling. Data expected from the FEM-PrEP trial, which was stopped in April after it was determined that the trial would not be able to provide an efficacy result, will also provide additional information about PrEP use among women.

The new letter acknowledges that the PrEP, “is no magic solution to the HIV crisis,” and that research, “raises important questions…includ(ing) how to best support regular PrEP use; how to ensure the continued use of condoms and other precautions for those who decide to take PrEP; how to target PrEP to those who will benefit most; and how to pay for this new HIV prevention tool.”  Its signers express their commitment “to promoting safer sex and the open exchange of accurate information on HIV prevention,” and to “clarify the facts about PrEP, open up community discussion and make clear our belief that we are entitled to respect, accurate information and new HIV prevention tools.” The letter concludes by calling on all interested parties to “get the facts about PrEP, seek information, and express opinions…but to do so based on real information, not fear of the scientific process or prejudice against gay/bi men.”

The letter was coordinated by a group of U.S.-based AIDS advocacy organizations, including AIDS Foundation of Chicago, AVAC, International Rectal Microbicide Advocates (IRMA), and Project Inform.

Openly HIV-positive gay and bisexual men who wish to add their name to the letter can do so at: http://tinyurl.com/pozPrEPletter.


[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.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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.]

San Francisco First U.S. City to Offer PrEP

via Bay Area Reporter, by Matthew S. Bajko

San Francisco is expected to become the first city in the country to offer gay men an anti-HIV pill that has proven successful in stopping transmission of the virus that causes AIDS.

Officials with the National Institutes of Health and San Francisco public health officials are close to finalizing an agreement to launch in early 2012 a demonstration project for usage of pre-exposure prophylaxis or PrEP. The combination pill contains tenofovir and emtricitabine (Gilead Science's Truvada) and has proven to be highly effective during clinical trials studying its efficacy.

Under the contract, up to 300 men who have sex with men at high risk for contracting HIV would be enrolled in the pilot study. City Clinic would administer the program while Magnet, the gay men's health center in the Castro, would help identify suitable participants for the study.

"We are anticipating we will be the first municipality to implement a PrEP demonstration project and things are moving forward toward that goal," Dr. Grant Colfax, the city's director of HIV prevention, told the Bay Area Reporter this week. "We are hoping the demo project would be implemented in the first quarter of 2012."


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.]

Treatment and Prevention: Interview w/Uganda's Dr. Patrick Ndase

via The Observer, by Shifa Mwesigye

Excerpt:

"Uganda has participated just like several other African countries; [in research] you must go where infection is happening. The majority of HIV research in the early stages happened in Uganda because Uganda was heavily infested with the virus. As you remember we had prevalence rates of above 20% and then we had the so called Uganda success story after the zero grazing campaign.

"At the time, the countries in southern Africa which largely [depend on] tourism were silent on HIV infection. Now the countries that are laden with infection are Swaziland, Botswana, Zimbabwe, Zambia and South Africa. So majority of HIV prevention research is not happening in Uganda anymore. In fact it is difficult to get someone who wants to do HIV research to come to Uganda."

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.]

IRMA and AIDS Leaders Press Feds for Action on Promising New Prevention Tool

Just months after an AIDS drug demonstrated reasonable efficacy in preventing HIV infection in controlled clinical trials, seven leading AIDS organizations are urging the U.S. government to act quickly to determine if the results could translate to the real world.   Today, at an HIV prevention meeting hosted by the U.S. Centers for Disease Control and Prevention (CDC), the coalition of AIDS advocates called on officials from the U.S. Department of Health and Human Services (HHS) to address the shortage of funding and coordination around a new prevention approach known as pre-exposure prophylaxis (PrEP).

“HIV estimates released by the CDC two weeks ago—showing that new HIV infections have risen nearly 50 percent in young black gay men since 2006—make it clear that the status quo is failing to keep the epidemic in check,” said David Evans, director of research advocacy at Project Inform. “PrEP could be one of the more promising new options we have to offer young HIV-negative gay men at the highest risk of infection in the U.S., but until we expand PrEP programs in real-world settings we won’t be able to translate the trial results into public health impact.”

PrEP involves HIV-negative people taking antiretroviral medication before exposure to the virus to prevent infection.  Three clinical trials have demonstrated that when used consistently, PrEP is both safe and effective at preventing HIV infection, but it’s unknown if and how results apply outside of clinical trials.  Activists are urging the U.S. government to move quickly to fund and coordinate demonstration projects to evaluate PrEP in the real word and determine the best ways to use it.

“We are at a pivotal moment in HIV prevention, and what happens next hinges on a swift, coordinated effort to understand how PrEP can be used effectively by people at highest risk for infection,” said Dr. Judy Auerbach, vice president of research and evaluation at San Francisco AIDS Foundation.  “If we do too little, or the demonstration projects aren’t properly designed, there’s a real danger that we could lose the promise of one of the most important scientific breakthroughs in HIV prevention.”

Two PrEP demonstration projects are near launch, and others are under discussion, but funding remains uncertain and participating medical providers and institutions are not being coordinated. The groups issuing the call to action request that HHS respond rapidly to ensure that coordination takes place and that the projects with the highest likelihood of answering key research questions are fully funded.  These questions include the feasibility, desirability, uptake, and effectiveness of PrEP in different settings, among others.

“We cannot be content with budget constraints and calls to do more with less,” said Mitchell Warren, AVAC executive director. “Science has given us new ways to potentially significantly blunt the epidemic in the U.S. and around the world. We have an obligation to push to find the best ways to use antiretroviral drugs as prevention – both for HIV-positive people to reduce their risk of passing on HIV to others and for HIV-negative people to protect themselves. The U.S. government and other funders must move quickly to ensure the availability of resources for the essential next steps for PrEP, including demonstration projects and continued research.”

The call to action was issued by Project Inform, along with the AIDS Foundation of Chicago, AIDS United, amfAR: the Foundation for AIDS Research, AVAC: Global Advocacy for HIV Prevention, the Black AIDS Institute, the International Rectal Microbicide Advocates, National Alliance of State & Territorial AIDS Directors, the National Minority AIDS Council and the San Francisco AIDS Foundation.  It’s accompanied by a report called “PrEP: Roadmap to the Real World,” in which advocates detail key questions to be answered in demonstration projects.



[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 drug-prevention strategy carries risks

Via Nature News, by Erika Check Hayden.

When the US Food and Drug Administration approved Viagra in 1998, officials never considered one possible side effect of the drug: higher rates of sexually transmitted diseases among men who, thanks to Viagra, would become more sexually active. A powerful tool in the fight against HIV is raising similar questions about the possibility of unintended public-health consequences if drugs are approved for use in healthy people and cause them to alter their behaviour.

Several studies in the past year have reported that the very drugs used to treat people with HIV can also stop healthy people from becoming infected (see table). But people taking the drugs may adopt riskier behaviours because they feel protected — a phenomenon known as 'risk disinhibition' — undermining the benefit of the drugs and potentially infecting others. Moreover, those who become infected while taking the preventive regimen might develop drug-resistant viruses that they could then transmit to others. "You have this wonderful scientific breakthrough," says Kevin Frost, chief executive of the Foundation for AIDS Research in New York City. "But what are the practical implications?"

Researchers will mull over these issues on 19 August at a meeting convened by the Forum for Collaborative HIV Research in Washington DC. The questions have become more urgent since January, when the drug firm Gilead of Foster City, California, announced that it plans this year to ask the Food and Drug Administration (FDA) to approve its HIV drug Truvada for use in healthy people — in what is known as pre-exposure prophylaxis, or PrEP. Truvada, which contains the antiretroviral drugs tenofovir and emtricitabine, has been used in many of the PrEP trials. In the three clinical trials that have reported benefits for PrEP so far, once-a-day pills have cut a person's risk of acquiring HIV by between 44% and 73%, a variation that is due primarily to differences in how strictly patients stuck to the daily regimen. Although the need for PrEP is greatest in poor countries, approval in the United States could greatly expand the market for Truvada, which generated US$2.65 billion in sales last year.

Read the rest here.

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

Gay Men: PrEP Acceptable and Unlikely to Change Risk Behaviour

Via AIDSMap, by Michael Carter.

Approximately 50% of gay men said they were likely to use pre-exposure prophylaxis (PrEP), but few reported that it would lead to a change in their risk behaviour, according to data presented to the International AIDS Society conference in Rome.

Nevertheless, the investigators were concerned that even minor increases in rates of unprotected anal sex could offset the benefits of pre-exposure prophylaxis.

The IPrEX study showed that PrEP significantly reduced the risk of infection with HIV for gay and bisexual men. Overall, men who took PrEP had their risk of HIV reduced by 44%. If adherence was high, the risk was reduced by 73%.

“PrEP offers much promise as the first biomedical intervention to have success in at-risk men who have sex with men,” comment the researchers.

They therefore undertook further analysis to see how likely the men who participated in the study were to use PrEP and if its availability would change their HIV risk behaviour.

They undertook a survey in December 2010, immediately following the release of the IPrEX results, using Facebook and Black Gay Chat to recruit participants. A total of 1155 gay and other men who have sex with men were recruited to the study.

Participants completed a questionnaire about their knowledge and willingness to use PrEP; perceptions of the risk of HIV infection from unprotected anal sex with or without PrEP; perceptions of sexual pleasure; and perception of likelihood to experience sexual pleasure with or without a condom and with or without PrEP.

The men had an average age of 33 years, 75% were white, and 51% reported unprotected anal sex at least once in the last twelve months.

Only a third of men had heard of PrEP before the release of the study results. Just under half of individuals reported that they were “very” or “extremely” likely to use PrEP.

Unprotected anal sex without a condom was widely considered to involve a high risk of HIV.

The availability of PrEP did not alter the perception of the risk associated with HIV in the majority of men, regardless of whether they were the insertive (75%) or receptive (60%) partner in anal sex.

Three-quarters of men stated that the 44% efficacy of PrEP in the IPrEX study would not affect their use of condoms. However, 7% reported that they would use condoms less frequently.

Read the rest here.

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

Petition for informed debate about PrEP. HIV+ gay and bi men, please SIGN BELOW!

The release of data from the iPrEx study of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women has led to a good deal of debate about whether and how PrEP should be used.

Unfortunately, some of that debate has been fueled by misrepresentations of the study data and, perhaps more alarmingly, by groundless assertions that gay/bi men and other men who have sex with men (MSM) will misuse PrEP, spread drug resistance and act without regard to their health or the health of others if PrEP is made available. A paid ad campaign by the AIDS Healthcare Foundation running in gay papers across the country has contributed to spreading false ideas both about PrEP and about the commitment of gay/bi men to care for themselves and others. We reject those false assertions and want a full and factual discussion of the pros and cons of PrEP in our community.

Recently, two additional studies, Partners PrEP and the CDC's TDF2 study have confirmed the safety and efficacy of PrEP, this time in heterosexual women and men.

A small group of HIV positive gay/bi men who are committed to promoting safer sex and the open exchange of accurate information are circulating the following letter to help clarify the facts about PrEP, open up community discussion and make clear our belief that we are entitled to respect, accurate information and new HIV prevention tools.

This sign on letter is part of a broad array of advocacy activities being undertaken by the national PrEP Committee. Members of the PrEP Committee include individuals from a host of organizations working on PrEP and other new prevention technologies who meet regularly by phone and email to share information and strategize.

For allies who are not HIV+ gay/bi men, you can learn more about this work and how to participateby sending an email to Jim Pickett at jpickett@aidschicago.org.

We encourage HIV+ gay/bi men who are allied in the fight against AIDS to help us clear the record about PrEP by signing on to this letter.

Read the letter and add your support 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.]

Washington D.C.: Public Meeting on Safety Issues in PrEP

An invitation from the Forum for Collaborative HIV Research:

Safety Issues in Pre-exposure Prophylaxis for HIV negative individuals, proposals for management of safety concerns, and pending plans for scale-up

Forum for Collaborative HIV Research

1608 Rhode Island Avenue, NW

Washington, DC 20036

August 19, 2011

8:30am - 4:00pm

The Forum for Collaborative HIV Research has been tasked by our collaborators in the public health community, including the US Food and Drug Administration, to convene an open public meeting to address safety issues that may surround the introduction of biomedical approaches to prevent HIV infection. Recent data from the iPrEx, Partners PrEP and CDC’s TDF2 studies support a conclusion that pre-exposure prophylaxis (PrEP) with antiretrovirals may be effective at preventing transmission of infection in otherwise healthy, vulnerable individuals upon exposure to HIV. This important finding may lead to scale-up, broad use of PrEP and, potentially, approval of a PrEP indication.

Recently, the drug development paradigm has also shifted with more focus on safeguarding individuals on medications. Premarket studies can miss important safety signals, either because the patient population is different and limited by enrollment criteria, too small to see low incidence events, or exposure is not long enough to identify latent effects. Compensatory behavioral issues may also be a concern upon scale-up. Appropriate communication strategies to reach the intended healthcare provider and the intended vulnerable populations must be identified and formulated. Mechanisms to anticipate and/or control the development of resistant HIV are also important. Finally, public focus as a result of our meeting may identify additional public health issues that should be addressed as well.

The Forum meeting will follow our usual format of panel discussions featuring stakeholders, including academics, trialists, clinicians, community advocates, public health professionals, and others. Each will be asked by a moderator to address a set of pre-prepared questions. Four panels are planned: (1) What are the safety issues of concern with pre-exposure prophylaxis?; (2) what are potential remedies to control safety risks and their pros and cons?; (3) what are the public health implications?; and (4) finally, a panel will summarize and identify next step.

Because of limited space, public participation in the meeting room will be limited to one participant per organization. An overflow room will be available for attendees on an as-needed basis. The meeting will be webcast to enhance national dissemination. Written supplementary questions can be directed to the panels. Webcast attendees can also submit written questions via instant messaging.

Registration: Register online at http://prep-reg.com/ to attend the public meeting or to view the live webcast.

Location: 1608 Rhode Island Avenue NW, Washington, DC 20036
Date and Time: August 19, 2011 8:30 AM-4:00 PM

________________________________________
Forum Announcements

Studies show new progress in HIV testing in emergency departments

July 29

A CDC sponsored supplement released in the Annals of Emergency Medicine details new HIV testing efforts in Emergency Departments. "Emergency departments play a critical role in helping people learn their HIV status, connecting them to life-prolonging care, and helping them avoid transmitting the virus to others"said Jonathan Mermin, MD, Director of CDC's Division of HIV/AIDS Prevention. Click here to read more

Controlling the HIV Epidemic - The Promise of ARV-Based Prevention: Presentations now available

July 28

Presentations made at the Forum co-sponsored IAS Satellite Symposium "Controlling the HIV Epidemic - The Promise of ARV-Based Prevention" are now available. Click here to read more

Statistical Methods for Causal Inference in Observational and Randomized Studies: Course fees increase on August 1

7/26/11 This course concerns statistical methods for causal inference using observational and experimental longitudinal data. The course will focus on the application of methodological advances in statistical and causal research to improve the design and interpretation of safety analyses. These analyses will become increasingly important in the post-marketing safety environment for new drugs.

Dates: September 26-28, 2011.
Location: UC Washington Center, Washington, DC.

To register, please use the following link: www.hivforum.org/stats2011

[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.]

"Magic" Pills and Potions - Hocus Pocus or Plus Plus?

IRMA chair Jim Pickett was part of a forum on PrEP in Seattle a few months ago called "The Magic Pill?" hosted by the wonderful Gay City Health Project. Here is his talk - live action AND slides - in two glorious parts!

[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+ gay and bi men! Sign-on letter supporting an informed debate about PrEP based on facts, not misinformation - Please SIGN ON

The release of data from the iPrEx study of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women has led to a good deal of debate about whether and how PrEP should be used.

Unfortunately, some of that debate has been fueled by misrepresentations of the study data and, perhaps more alarmingly, by groundless assertions that gay/bi men and other men who have sex with men (MSM) will misuse PrEP, spread drug resistance and act without regard to their health or the health of others if PrEP is made available. A paid ad campaign by the AIDS Healthcare Foundation running in gay papers across the country has contributed to spreading false ideas both about PrEP and about the commitment of gay/bi men to care for themselves and others. We reject those false assertions and want a full and factual discussion of the pros and cons of PrEP in our community.

Recently, two additional studies, Partners PrEP and the CDC's TDF2 study have confirmed the safety and efficacy of PrEP, this time in heterosexual women and men.

A small group of HIV positive gay/bi men who are committed to promoting safer sex and the open exchange of accurate information are circulating the following letter to help clarify the facts about PrEP, open up community discussion and make clear our belief that we are entitled to respect, accurate information and new HIV prevention tools.

This sign on letter is part of a broad array of advocacy activities being undertaken by the national PrEP Committee. Members of the PrEP Committee include individuals from a host of organizations working on PrEP and other new prevention technologies who meet regularly by phone and email to share information and strategize.  

For allies who are not HIV+ gay/bi men, you can learn more about this work and how to participateby sending an email to Jim Pickett at jpickett@aidschicago.org.

We encourage HIV+ gay/bi men who are allied in the fight against AIDS to help us clear the record about PrEP by signing on to this letter.

Read the letter, and sign on here.

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

New, Long-Term PrEP Study Announced

Via Now Chelsea, by Sam Spokony.

Few methods of HIV prevention have been as promising, or as controversial, as pre-exposure prophylaxis (PrEP). After a history of underground practice and off-label prescriptions, the approach has recently begun to receive serious attention from researchers, policy makers and health care advocates.

An outgrowth of post-exposure prophylaxis (or PEP, a short-term antiretroviral treatment that has been used since the early 90s to decrease the likelihood of HIV infection after exposure to the virus, either occupationally or through sex), PrEP is a similar antiretroviral that can be taken by HIV-negative individuals in order to help prevent them from seroconverting (being infected).

The results of a Phase III clinical study known as iPrEx were published in the New England Journal of Medicine on November 23, 2010. The study showed that, in a group of 2,499 gay men, PrEP — in the form of a combination of drugs under the brand name Truvada — was 44 percent effective in preventing HIV seroconversion.

Under the guidance of Dr. Roy Gulick (director of the Weill Cornell Medical College HIV Clinical Trials Unit), a new experiment called the NEXT (Novel Explorations of Therapeutics) PrEP Study will begin this fall. It will include 400 at-risk, HIV-negative gay men, and will take place over 48 weeks at 12 sites across the U.S. and Puerto Rico.

The NEXT PrEP Study will differ from iPrEx in that its primary experimental group will receive a daily regimen of the drug maraviroc (brand name Selzentry). The control group will receive Truvada, and two other experimental groups will receive combinations of maraviroc and either tenofovir or FTC (the two individual drugs that make up Truvada). A major goal of the study, along with testing the HIV-prevention efficacy of maraviroc, will be to gauge the side effects of the drug on participants.

“The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks,” Gulick told Chelsea Now in a July 23 phone interview [This is actually a major factual error. For example, the average follow-up in iPrEx was 14 months - IRMA]. “Now, since this is a drug we’re giving to healthy people, the next step is exploring further to prove that it is both safe and tolerable for them.”

Read the rest here.

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