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."


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

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.”

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

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.

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

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.

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

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.]

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.]