Gay men weigh their risk behavior choices with PrEP

via AIDS Map, By Michael Carter

“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.

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.

Unprotected anal sex without a condom was perceived as very pleasurable by approximately 50% of respondents.

Read more. 

HIV researcher plans new PrEP study

via Chelsea Now, By Sam Spokony

[One major factual error in that article: “The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks.” For example in iPrEx, average follow up was 14 months. Otherwise, a very informative article.]

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.

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 inaccurate. The guys in iPrEx, for instance, were followed about 14 months - LifeLube]. “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 more.

Drug study sees up to 92-percent cut in HIV risk among gays

via Google, By AFP

[ This article offers a good overview of the data behind studies around pre-exposure prophylaxis]

Volunteers who responded most to a cocktail of antiretroviral drugs in an HIV prevention trial among gay men had a reduced risk of 92 percent of being infected by the AIDS virus, researchers said on Wednesday.

They presented the work as a last-minute, or "late-breaker", contribution to the world forum on AIDS science in Rome.

The research looked at a group of men who took part in a major trial called iPrEx HIV Prevention Study.
iPrEx explored the idea that an uninfected person taking daily AIDS drugs could be shielded from the human immunodeficiency virus (HIV), a novel approach called pre-exposure prophylaxis, or PrEP.

The overall findings, published last November, found that use of a drug called Truvada reduced HIV infections by 44 percent compared with a dummy pill, also called a placebo.

The new study looked at a sub-set of men who had the highest concentrations of the drug in their blood -- a telltale that they had been highly disciplined about taking the pill and that their system had also absorbed it better.

Read more.

iPrEx OLE to Build on News that PrEP Slows HIV Infections Significantly in Both Men Who Have Sex with Men and Heterosexual Women and Men

 via iPrEx News

The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, has begun at clinical trial sites around the world. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study. Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.

In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill).

HIV infection rates in the iPrEx study dropped by 90% among those who used PrEP consistently enough to have detectable drug in the body. The HIV risk reduction benefits of PrEP were in addition to those provided by safer sex counseling, condoms, HIV testing and the detection and treatment of sexually transmitted infections. iPrEx study results were published in the New England Journal of Medicine in November, 2010.

The news of the start of iPrEx OLE follows the announcements by two other major PrEP studies, Partners PrEP and the CDC study in Botswana, known as TDF2, which demonstrated the safety and efficacy of PrEP in heterosexual women and men.

AdvertisementiPrEx OLE is a continuation of the iPrEx study that will collect additional data on PrEP efficacy, safety and adherence. All HIV-negative participants who took part in the original iPrEx study and who wish to participate will receive FTC/TDF for HIV prevention for 72 weeks through iPrEx OLE. No placebo will be used in the Open Label Extension.

"We are in a critical moment in HIV prevention research," said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. "iPrEx provided the first proof of an important new method of HIV prevention that can help slow the global toll of 2.6 million new HIV infections each year. Partners PrEP and the TDF2 study have now expanded that finding by demonstrating the effectiveness of PrEP in heterosexual women and men.

Developing and deploying proven HIV prevention methods -- including PrEP, microbicides, vaginal gels, clean needles, medical male circumcision, early treatment, counseling, testing, condoms and suppressive therapy for pregnant women will all be key to slowing the global epidemic."

Read more.

Is PrEP the future of HIV prevention?

via Chelsea Now, By Sam Spokony

A recent sense of optimism surrounding PrEP was a result of the Chemoprophylaxis for HIV Prevention in Men study (also known as iPrEx), a Phase III clinical study — sponsored by the National Institutes of Health (NIH) through a grant to the J. David Grant Institutes at the University of California at San Francisco — that began in July 2007 and was published in the New England Journal of Medicine of November 23, 2010.

The iPrEx study focused on 2,499 sexually active men who have sex with men and transgendered women who have sex with men — all of whom were HIV-negative at the time of enrollment. The study’s experimental group received a PrEP treatment — a daily tablet that combined 200 milligrams of the drug emtricitabine, or FTC, and 300 milligrams of the drug tenofovir (a combination known by the brand name Truvada) — while the control group received a placebo.

In all, 100 cases of HIV infection occurred among participants in the iPrEx study. Thirty-six infections occurred among the 1,251 participants who were chosen to receive Truvada, while 64 occurred among the 1,248 participants who had received the placebo. Based on those numbers alone, PrEP was approximately 44 percent effective in preventing seroconversion.

While 44 percent efficacy might not be seen as wholly significant, what created perhaps a greater stir among researchers was analysis of the infected members of the experimental group. Blood tests revealed that, of the 36 men receiving PrEP who had seroconverted, 33 had no traces of the drug in their body prior to their positive HIV tests.

This data presented a startling result: if the subjects who were supposed to have been taking Truvada daily — but were apparently not — were not counted, the efficacy of PrEP treatment rose from 44 percent to more than 90 percent.

Read more.

Prevention Revolution or Magical Thinking?Feast of Fun podcasts LifeLube's forum on Pre-exposure Prophylaxis- Listen

via feast of Fun

June 15, 2011, from the Center on Halsted in Chicago, LifeLube hosted a live community forum on Pre-exposure Prophylaxis (PrEP). World renowned LGBT podcasters, Feast of Fun, moderated the discussion as panelists and guests were engaged on one of the most exciting developments in the fight against HIV.

 The conversation was joined by:

 Dr. Bob Grant, the protocol chair for the groundbreaking study, iPrEx.

 Keith Green of the AIDS Foundation of Chicago, who is a consultant for Project PrEPare, which explores the acceptability and feasibility of the trial among men who have sex with other men.

Rico Herrera, a Chicago gay youth currently participating in the trial via Project PrEPare.

Plus- live questions from the audience.

The forum went off without a hitch thanks to the help of our community partners:
Association of Latin Men for Action
Chicago Black Gay Men’s Caucus
Communities of Color Collaborative
Project CRYSP
Feast of Fun

Click for the podcast

Forum explores Truvada's use in fighting HIV

via Windy City Times

Thanks to Windy City Times for doing an excellent article on the PrEP forum last week.

Experts on the study sat down with Feast of Fun podcasters Fausto Fern�"s and Marc Felion at Center on Halsted June 15 to talk about what the study means and if Truvada could signal the end of the pandemic. Present were Dr. Robert Grant of Gladstone Institute, Keith Green, director of federal affairs at AIDS Foundation of Chicago, and a youth who participated in a similar study Green conducted in Chicago.

Read more.

LifeLube's NEXT Forum: Prevention Revolution or Magical Thinking - IS A DAILY PILL THE ANSWER?

SAVE THE DATE: June 15, 2011

Center on Halsted

6pm - 9pm

RSVP and more info to come. Stay tuned.

Taking a Pill for HIV Prevention: a great explanation of the science and its impacts

via AIDS Treatment News, by John S. James

This is an excellent description of the iPrEx study that showed daily Truvada could protect against HIV, and the implications for gay men.


Excerpt:

No one we know thinks that all gay men should take Truvada.

But using this new prevention option in a targeted way should help a lot to control the HIV/AIDS epidemic. Remember that in any epidemic, if each person infected infects fewer than one other person on the average, and this can be maintained, then the epidemic will end.

And it turns out that a disproportionate amount of transmission takes place very early in someone's HIV infection -- when viral load is extremely high, but people do not know and seldom even suspect that they are infected, so they are much less careful about risk to others, than if they did know their status.

Read the rest.

Community Forum: iPrEx - What Next? A Chicago discussion on HIV meds as prevention

Next Wednesday, December 15
Center on Halsted, Chicago

Click for a closer look

Bay Area Reporter - Turnaround seen in AIDS fight

via Bay Area Reporter, by Liz Highleyman

Despite the lack of major treatment breakthroughs, 2010 is shaping up to be a pivotal year in the history of the AIDS epidemic.

Two key trials have recently provided the first evidence that biomedical prevention methods can help reduce new infections, the latest UNAIDS figures suggest that HIV incidence and death have finally started to decline, and a growing number of experts are even starting to talk about the prospect of a cure.

To mark the 23rd commemoration of World AIDS Day on December 1, UNAIDS released its latest global epidemiology report, revealing that new HIV infections have fallen by nearly 20 percent over the past decade, while the number of AIDS-related deaths have dropped by a similar percentage during the past five years.

Read the rest.

After news that HIV pill prevents infection... now comes the tricky part

via CNN
by Kevin Fenton, director of the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention at the Centers for Disease Control and Prevention (he's gay, btw)

Excerpt:

First, we need to learn how best to implement the pre-exposure prophylaxis approach in the real world. The study results were achieved in a controlled trial, in which men received regular prevention and adherence counseling -- including messages about condom use, HIV testing, testing and treatment for other sexually transmitted diseases and close safety monitoring.

The challenge before us is how do we make this work in diverse health care settings?

Read the rest.

BIG: Trial Shows AIDS Pill Can Prevent HIV Among Gay Men

AIDS Drug Shown to Prevent HIV 
in Multinational Trial of HIV-Negative Gay Men

Data Suggests Need for Rectal Gel Option

[via our sister IRMA - International Rectal Microbicide Advocates]

Results of the world’s first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today. Data from this trial, called iPrEx, indicated an estimated 43.8% reduction of new HIV infections among men who took an antiretroviral tablet daily to prevent HIV, compared to those who took a placebo pill.[Read the article.]

“This discovery alters the HIV prevention landscape forever. While this level of efficacy is relatively strong, PrEP is not quite ready for prime time and work remains before this strategy is rolled out. However, we are thrilled to have a new prevention option beyond male and female condoms visible on the horizon,” said Jim Pickett, Director of Advocacy at AIDS Foundation of Chicago and Chair of IRMA – International Rectal Microbicide Advocates.

The iPrEx trial evaluated the safety and efficacy of the antiretroviral (ARV) drug TDF/FTC (brand name Truvada) taken once daily for HIV prevention among HIV-negative gay men, transgender women, and other men who have sex with men (MSM).

The participants, 2,499 in all, included individuals from Peru, Ecuador, Brazil, South Africa, Thailand and the United States. Half the men were randomized into the active arm that received Truvada, and the other half were randomized into the placebo arm and received a look-alike pill with no active ingredient. The participants and the researchers did not know who was in either arm.

Enrollment for the trial began in June 2007 and was completed in December 2009. The primary analysis of the results released today includes participants who were followed until May 1, 2010, or for an average of 14 months.

Each participant was tested for HIV at monthly trial visits and given intensive pre-and-post test counseling. Additionally, they were regularly screened for sexually transmitted infections and received condoms, making up a very robust prevention package.

At the end of the trial, there were 36 infections in participants who received Truvada and 64 in recipients who took the placebo. Researchers calculated that the use of Truvada reduced new HIV infections by an estimated 43.8% overall when compared to placebo. While there appeared to be few side effects reported by the men who were taking the Truvada tablet, it is clear that much more information is needed regarding long term safety of this drug.

Other PrEP trials are ongoing. Results from studies among heterosexuals in Africa and injection drug users in Thailand are expected next year.

It is important to emphasize the factors that led to successful use of Truvada to prevent HIV in iPrEx. Taking the pill regularly was one of the most important. Efficacy appeared to be higher among those participants who took the study drugs consistently. Men who did not take the pill regularly did not see a protective benefit. Regular HIV testing and ongoing monitoring by a physician was also critical. For this strategy to work, each of these pieces, including a doctor’s prescription, need to be in place.

“The study team found that about half of the men in the active arm of the trial were in fact not taking their pills regularly, if at all,” said Pickett. “It is not clear why this happened, but it certainly suggests that alternate means of using ARVs to prevent HIV infection may be more acceptable for these men. The primary means of transmission among gay men and other MSM is through unprotected anal intercourse. If we develop an ARV as a gel or lubricant applied rectally – a rectal microbicide – it could be more acceptable for some individuals who don’t like taking pills.”

Many gay men and other MSM already use lubricants for anal intercourse, so they wouldn’t have to modify their behavior to achieve higher levels of protection with a rectal microbicide formulated as a lubricant. Adopting a new behavior—such as taking a pill every day—can be a considerable challenge for some.

Dr. Ian McGowan, one of the principal investigators of the Microbicide Trials Network and Scientific Vice Chair of IRMA agreed. "The data from the iPrEx study are encouraging but the less than ideal adherence rate to oral PrEP clearly show that we need additional prevention approaches such as rectal microbicides that could be used by men and women at risk of HIV infection through unprotected receptive anal intercourse," he said.

The world's third rectal microbicide trial is currently underway with sites in Pittsburgh, Pennsylvania; Boston, Massachusetts; and Birmingham, Alabama. Scientists are testing the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. The trial is planning to recruit a total of 60 men and women.

While the rectal microbicide field has gained significant momentum, more focus and resources are needed. In 2010, U.S. $7.2 million is being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011 – 2014, to U.S. $10 million/year and must increase further to U.S. $44 million (a six-fold increase) in the years 2015 – 2020. These targets need to be met to ensure a minimum of candidate products are moving through the research pipeline into late stage testing for effectiveness.

Just as we use a combination of drugs to treat individuals living with HIV, we need a combination approach to prevention. That approach should include male and female condoms, sterile syringes, and access to treatment as well as new interventions like PrEP, topical microbicides, and vaccines. Adequate funding must continue for all of the methods we currently have, and it must continue for the new strategies that are still being developed as well.

In a global context where millions of individuals do not have access to life saving medications, it is imperative that funding provided for PrEP accessibility not compete with funding for treatment. Treatment funding has not kept pace with the need.

IRMA congratulates the trial sponsors, scientific collaborators and partners who conducted this landmark trial, with special thanks to the 2,499 participants in the study who volunteered so much of their time and energy. Their extraordinary contribution to HIV prevention science brings us another step closer to a day without AIDS, and for that we are supremely grateful.