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.]

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.]

IAS 2011: Day 4 Press Release

OFFICIAL PRESS RELEASE – DAY 4

16.30 (CET), WEDNESDAY JULY 20

Late Breaker extracts - newsmakers

First global study of real-world circumcision rollout conducted over three-year period in South Africa amongst 110,000 adults shows a marked reduction (>60%) of HIV acquisition among circumcised adult men .

Elvitegravir once-daily is non inferior to raltegravir twice-daily in treatment experienced patients

iPrEx study: new, long-term data from the first large-scale clinical trial to demonstrate the efficacy of oral pre-exposure prophylaxis shows the durability of PrEP for HIV prevention

Wednesday, 20 July, 2011 (Rome, Italy) -- Researchers presenting late breaking research  on the final day of  the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) have today focussed on new studies in the field of circumcision, pre-exposure prophylaxis (PrEP) and antiretroviral treatment. The IAS 2011 conference has been attended by over 5000 researchers, clinicians and community leaders since Sunday in Rome.

• The roll-out of male circumcision in the South African township of Orange Farm (ANRS 12126) is curbing the spread of HIV ( 16.30-17.30, SR2)

B. Auvert1, D. Taljaard2, D. Rech2, P. Lissouba3, B. Singh4, D. Shabangu2, C. Nhlapo5, J. Otchere-Darko2,T. Mashigo2, G. Phatedi2, R. Taljaard2, M. Tsepe2, M. Chakela2, A. Mkhwanazi2, P. Ntshangase2, S. Billy5,D. Lewis4

1Univeristy of Versailles, Versailles, France, 2Progressus, Johannesburg, South Africa, 3Inserm 1018, Villejuif, France, 4NICD-NHLS, Johannesburg, South Africa, 5SFH, Johannesburg, South Africa

Three years after the start of the male circumcision roll-out (ANRS 12126) in the South African township of Orange Farm (110 000 adults), a reduction in HIV prevalence and incidence among men has been observed. These findings demonstrate for the first time that male circumcision roll-out is effective at community level in curbing the spread of HIV. This research is coordinated by Inserm U1018/UVSQ and conducted by Progressus (South Africa), the National Institute of Communicable diseases of the NHLS (South Africa) and is financed by the French National Agency for Research on AIDS and Viral Hepatitis ANRS.

"The real-world effect of the roll-out of medical male circumcision (MMC) on the HIV epidemic has been until today, unknown,” said Professor Bertran Auvert, Professor of Public Health at the University of Versailles and  principal investigator of  the  study.

“This study demonstrates that adult male circumcision works to reduce the spread of HIV in an African community highly affected by the epidemic. Reducing the number of new infections with adult male circumcision will save lives and reduce the need for antiretroviral therapy. This study shows also that the roll out of adult safe male circumcision should become a top health priority in Southern and Eastern Africa and that a strong political commitment is needed now,” concluded Auvert.

• Completed observation of the randomized placebo-controlled phase of iPrEx: daily oral FTC/TDF pre-exposure HIV prophylaxis among men and trans women who have sex with men (16.30-17.30, SR2)

 R. Grant1,2, V. McMahan1, A. Liu3, J. Guanira4, M. Casapia5, J. Lama4, T. Fernandez6, V. Veloso7, S. Buchbinder3, S. Chariyalertsak8, M. Schechter9, L.-G. Bekker10, K. Mayer11, E. Kallas12, P. Anderson13, K.R. Amico14, D. Glidden2, for the iPrEx Study Team

1Gladstone Institutes, San Francisco, United States, 2University of California - San Francisco, San Francisco, United States, 3San Francisco Department of Public Health, San Francisco, United States, 4INMENSA, Lima, Peru, 5ACSA, Iquitos, Peru, 6Equidad, Guayaquil, Ecuador, 7FIOCRUZ, Rio de Janeiro, Brazil, 8RIHES, University of Chiang Mai, Chiang Mai, Thailand, 9Project Praca Onze, Hospital Escola Sao Francisco de Assis, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil, 10Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa, 11Fenway Health, Boston, United States, 12University of Sao Paulo, Sao Paulo, Brazil, 13University of Colorado Denver, Aurora, United States, 14University of Connecticut, Storrs, United States

New research will be presented from investigators of the iPrEx study, the first large-scale clinical trial to demonstrate the efficacy of oral pre-exposure prophylaxis (PrEP) as HIV prevention. Data presented here demonstrate that the HIV prevention impact of PrEP was durable throughout the iPrEx study and across participant subgroups, with no evidence of HIV drug resistance among individuals infected with HIV after starting PrEP and a very low rate of side effects.

"PrEP is an important HIV prevention tool with the potential to prevent significant numbers of new HIV infections," said iPrEx Protocol Chair Robert Grant, investigator at the Gladstone Institute of Virology and Immunology in San Francisco and Associate Professor of Medicine at the University of California.

"These data confirm that PrEP is safe and effective in MSM, one of the populations most affected by HIV worldwide. A four-continent open-label extension of the iPrEx study is underway. Global and national public health experts and advocates should work expeditiously to determine how to best make this lifesaving HIV prevention tool available for MSM, who bear the brunt of the epidemic in many parts of the world, “concluded Grant

• Results of the Gilead 145 trial: Elvitegravir once-daily is non inferior to raltegravir twice-daily in treatment experienced patients: 48 week results from a phase 3 multicenter, randomized, double blind study (16.30-17.30, SR1)

 J.-M. Molina1, A. LaMarca2, J. Andrade Villanueva3, B. Clotet4, N. Clumeck5, Y.-P. Liu6, L. Zhong6, A. Cheng6, J. Szwarcberg6, S.L. Chuck6, for the Study 145 Group

1Hopital Saint Louis, Paris, France, 2Therafirst Medical Center, Fort Lauderdale, United States, 3HospitalCivil de Guadalajara, CUCS, U de G, Guadalajara, Mexico, 4Hospital Universitario Germans Trias i Pujol, Barcelona, Spain, 5C.H.U. St Pierre, Brussels, Belgium, 6Gilead Sciences, Foster City, United States

This is the first head to head comparison of elvitegravir an investigational once-daily HIV integrase inhibitor to raltegravir, the only approved integrase inhibitor today.

In this international phase III study involving 234 sites in United States, Europe, Canada, Mexico, Australia and Puerto Rico, 702 HIV-infected patients failing their current antiretroviral regimen with drug-resistant viruses, were randomized to receive in a double-blind fashion either once-daily elvitegravir or twice daily raltegravir in combination with a boosted protease inhibitor and a third agent. The primary efficacy endpoint at week 48 demonstrated similar efficacy of the two regimens with a virologic response rate (plasma HIV viral load below 50 copies/ml) of 59 and 58% in the elvitegravir and raltegravir arms, respectively using an intent to treat analysis, with a treatment difference of 1.1% (95% CI : -6.2;8.2).

The safety of the two regimens was also similar with only 2-3% of patients in both arms discontinuing treatment because of adverse events. Finally, the emergence of integrase resistance among patients with virologic failure was only 27% and 21% in the elvitegravir and raltegravir arms, respectively.

Overall, these results demonstrate the efficacy and safety of elvitegravir in combination with a ritonavir-boosted protease inhibitor for treatment-experienced patients, and position elvitegravir as an alternative once-daily integrase inhibitor. 

“For many people, HIV treatment might just have got simpler,"   said Jean-Michel Molina, the study’s principal investigator and Head  of   the  Department of Infectious Diseases at the  Hopital Saint Louis in Paris. “This  study is good news  for people living with HIV -  pending FDA approval they  will  now have available a new antiretroviral drug that only needs to be taken once a day which in itself will also promote better adherence,” concluded Molina.
[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.]

Building the momentum to prevent HIV in MSM

Via The Lancet, by Thomas J Coates.

Larry Kramer, on accepting the Tony Award last month from the Theatre Guild-American Theatrical Society for The Normal Heart as Best Revival of a Play said: “To gay people everywhere, whom I love so dearly…we are a very special people, an exceptional people, and…our day will come.” My day came in 1982 when I secured an Assistant Professorship in the Department of Medicine at the University of California, San Francisco. I set about establishing a behavioural medicine clinic fully integrated into general medicine practices, researching chronic disease prevention, and teaching interns and residents about psychological issues. One guest speaker, a social worker, led a discussion with the residents about the special medical needs of gay men. He was dead a month later from what later became known as AIDS.

The “special and exceptional people” cited by Kramer had lived through the 1970s and fought for human rights in the USA. That was followed in 1981 with the scourge of AIDS that could have knocked the wind out of the gay community. Instead, the community rallied and used its skills and talents to advocate for resources to develop community-based systems of care and prevention, and to ensure that human rights were not trampled.

Unleashing that energy and skill to build a global movement to improve HIV prevention and care services for men who have sex with men (MSM) is long overdue. Momentum is building and Chris Beyrer and co-authors make an important contribution. The Global HIV Epidemics among Men Who Have Sex with Men documents the extent of the HIV epidemic and outlines what needs to happen to ensure that everything possible is being done to prevent and treat HIV infection in MSM worldwide.

This volume documents the need in terms of the numbers, but also addresses the scenarios in which HIV epidemics among MSM exist in low-income and middle-income countries. The first scenario they describe, characterising the HIV epidemic in most of Latin America, is one in which MSM are the predominant exposure mode for HIV infection in the population. In these countries MSM are ten to over 100 times more likely to have HIV than the general population. By contrast, eastern Europe and central Asia have the highest rates of HIV among injection drug users (IDUs), but MSM are still several times more likely to have HIV than the general population. A different scenario is found in sub-Saharan Africa where HIV is widespread among heterosexuals, but even in these contexts MSM can have two to 20 times higher prevalence of HIV than the general population estimates. South, southeast, and northeast Asia are characterised by epidemics that have equal contributions from MSM, IDUs, and heterosexuals, although MSM are still at least ten times more likely to have HIV than the general population.

The needs come not only from the numbers. Beyrer and his co-authors document well the lack of prevention technologies focused on male-to-male transmission. They note that much effort has been expended on encouraging voluntary HIV counselling, testing, and behavioural interventions to decrease rates of unprotected anal intercourse by encouraging less risky sexual behaviours. Although important, such strategies are probably insufficient to produce immediate or lasting change in HIV transmission. Male circumcision may be effective for reducing acquisition of HIV through anal intercourse but we will never know for sure because of the challenges of conducting a trial to prove efficacy. Antiretroviral-based prophylactic approaches provide the best opportunity for managing HIV among MSM. In the wake of the IPREX, CAPRISA 004, and HPTN 052 trials, it is now time to accelerate efforts to determine if similar benefits can be obtained with rectal use of these or similar compounds. In some countries, like Peru where the epidemic is concentrated in MSM, providing universal access to care with MSM-sensitive services could actually change the overall trajectory of disease spread.

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.]

Open-Label Extension of iPrEX HIV PrEP Study Begins at 11 Sites in 6 Countries

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 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.]

PrEP Media Round-Up - It Works for Heterosexuals Too!

[UPDATED JULY 18]

The exciting news was announced last week that pre-exposure prophylaxis has been shown to work for heterosexual men and women as well as MSM. This is HUGE for HIV prevention.

Below is a selection of news items and press releases we have collected on the two studies that reported out last week. In the comments feel free to share your reactions to this news.

Washington Post: Two studies show that drugs used to treat AIDS can be used to prevent HIV infection, too

EurekAlert (Microbicide Trials Network): VOICE study will continue as it considers what action to take after results of 2 trials

CDC: CDC Trial and Another Major Study Find PrEP Can Reduce Risk of HIV Infection among Heterosexuals

iPrEX News: Two Major Studies Prove HIV Pre-Exposure Prophylaxis (PrEP) Works in Heterosexual Women and Men; Build on iPrEx Data Showing PrEP Reduces HIV Infections in Men Who Have Sex with Men

Wall Street Journal: AIDS Drugs Can Prevent Infection, Studies Show

AIDSMAP: Two major studies show that HIV drugs prevent infection

New Vision: Drugs prevent HIV infection up to 73%

Science Now: Anti-HIV Pills Show Powerful Effect Against AIDS

Reuters: 2-Once-daily AIDS pill can slash HIV infection risk

POZ: PrEP Reduces HIV Risk in Two Major Studies

PlusNews: HIV/AIDS: More proof that PrEP works

New Scientist: One cheap pill protects healthy people from HIV

The Daily Nation: Daily dose of drug ‘lowers risk of HIV infection’

Fit Perez: New Pill Could Prevent HIV

Project Inform: Project Inform urges government action following the positive results of two PrEP studies in heterosexual men and women

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

PrEP: Prevention Revolution or Magical Thinking

One of the most exciting developments in the fight against HIV is a recent study that concluded that gay men could significantly reduce their risk of infection by taking an existing anti-HIV medication on a daily basis.


Earlier this month our friends at Feast of Fun and Lifelube hosted a forum in Chicago to discuss the iPrEx study published this winter. It was an energetic and exciting discussion with scientists, advocates, and real people taking the pill on the possibilities and concerns surrounding PrEP. For those too far or too busy to make it, Feast of Fun recorded the forum as a podcast, available for free on their website. Please check out the podcast and share your thoughts on the study.



Keith Green, Marc Felion, Dr. Bob Grant and Fausto Fernós - Forum Hosts and Participants


[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 ALC Presents on PrEP and Rectal Microbicides for Lima's Gay Community

by Steve Miralles

On May 11th, IRMA ALC (América Latina y el Caribe), based at Epicentro Gay Men’s Community Center in Lima, Peru, hosted a presentation on PrEP and rectal microbicides.

More than 15 men attended the presentation that was facilitated by IRMA-ALC leaders Steve Miralles and Jerome Galea.

The 15 community members included doctors, lawyers, psychologists and others participated in an open discussion/dialogue about these HIV prevention interventions under investigation and information was shared on the current state of the field of rectal microbicides and the inclusion of Lima in a RM study hopefully in 2012. 

Also, the results of the PrEP study (iPrEx) which took place in Lima was discussed along with the study’s results and how PrEP could change the HIV panorama.

Participants received IRMA's Spanish edition of the report “From Promise to Product” (De la Promesa al Producto: Avanzando en la Investigación y Promoción de los Microbicidas Rectales) AVAC fact sheets on iPrEx and other information and resources available in Spanish thanks to the IRMA-ALC team.

Now underway is the preparation of a radio program about rectal microbicides and iPrex to be aired in July on Epicentro's weekly program Espacio Común and an article for the next edition of Epicentro's magazine La Antena.

Visit IRMA ALC on Facebook. And check out the IRMA ALC page on the IRMA website to see some of those Spanish resources.

Also available in Spanish are IRMA's documents on lube safety:

Safety of lubricants for rectal use: A fact sheet for HIV educators and advocates

Safety of lubricants for rectal use: Questions & Answers for HIV educators and advocates

[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.]

Acceptability of pre-exposure prophylaxis as an HIV prevention strategy: barriers and facilitators to pre-exposure prophylaxis uptake among at-risk Peruvian populations

IRMA Steering Committee member Jerome T. Galea is lead author of this fascinating paper. Here he provides an overview of the study.

Click here to access the full paper.

"The study examined pre-exposure prophylaxis acceptability (PrEP) among female sex workers, male-to-female transgendered persons and men who have sex with men in Lima, Peru.  Focus groups explored social issues associated with PrEP acceptability and Conjoint Analysis – a consumer research market technique – assessed the preferences participants had with regards to eight hypothetical PrEP “scenarios”.  This was the first study of it's kind to apply this technique.

"Each scenario was made up of the same characteristics but differed slightly (for example, higher cost versus lower cost; daily dosing versus non-daily dosing; some side effects versus no side effects, and so on).  Participants had to rank the scenarios in order of preference taking into account all of the product’s chacteristics, and in doing so expressed the value they placed on the various characteristics.  Focus groups helped to explain the reasons behind the preferences made.

"There were some unexpected findings. For example, cost trumped effectiveness; a low-out-of pocket cost had the single greatest impact on PrEP acceptability. While we expected cost to be an important factor we were surprised that it was more important than the ability of the product to actually prevent HIV infection. 

"Another surprise was that in the focus groups we learned that participants preferred that PrEP be dispensed in health centers as opposed to pharmacies. This surprised us as we hypothesized that pharmacies would provide faster, easier and more widespread access, but participants cited privacy concerns with PrEP being dispensed by pharmacies.

"The next step is to replicate this sort of research to more populations at risk in different settings. We have learned that the existence of an effective product does not guarantee its use (recent studies on the female condom, for example, highlight the challenges of understanding the needs and perceptions of the target user and also the necessity of dispelling myths that often arise when new products are introduced). 

"We cannot generalize our findings to all persons at risk for HIV, in Peru or elsewhere, but do propose it as a model for future exploration of the topic now that oral PrEP has been shown to work but has not yet been scaled up for widespread use."

*Read AIDSmeds coverage of this study 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.]

HIV PrEP Explained: Critical Prevention Opportunity

via AIDS Treatment News, by John S. James

This is a superb description of the iPrEx trial, with a smart analysis of it's implications. A must-read.

Excerpt:

Why did so many of the study participants not take the Truvada?

No one knows for sure at this time. But something unusual and unexpected happened in this study. This clinical trial took place at 11 sites in 6 countries -- with two of the 11 sites in the United States (Boston and San Francisco -- with 113 U.S. participants on Truvada, 114 on placebo). And adherence at the U.S. sites was much better than at the non-U.S. sites -- 97% among all the U.S. participants, considered extremely good, compared to far less overall. The "44% effective" headline just averages these very different situations.

We know of three theories about this difference: (1) The U.S. participants were about 10 years older on the average (though this would hardly explain the huge adherence differences observed); (2) Many of the non-U.S. participants were living at home and probably not “out” to their families, so they would have needed to conceal their participation in the study, making adherence difficult; or (3) Boston and San Francisco have excellent HIV treatment access, perhaps the best in the U.S., while in many countries most people with HIV are dying with no treatment at all. So trial participants may have given or sold their pills to someone with immediate need.

We think that the latter is most likely.

Whatever the reason, the excellent U.S. adherence shows that people can use the drug properly for prevention. And in the future, patients will know that they are getting the active drug (not a placebo), and that it has been proven to work -- both of which should boost adherence. Researchers need to find out what went wrong at some of the sites, and learn how fix it.

But the bottom line is that we do have proof of principle that Truvada prophylaxis can work in high-risk gay men, and prevent close to 100% of the HIV infections that would otherwise occur.

Read the rest.

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

PrEP: A Possible Approval Like No Other

Via Poz, by Tim Horn

The AIDS Healthcare Foundation began a paid advertisement campaign urging Gilead Sciences to refrain from seeking approval from the U.S. Food and Drug Administration for Truvada for use of the combination tablet as HIV prevention, in an approach known as pre-exposure prophylaxis, or PrEP.

The ads were met by an outcry from the community. One prominent organization, the HIV Prevention Justice Alliance, issued a sign-on letter , dated March 16, urging the FDA "to examine the study results of PrEP rather than playing to speculation and fear."

While I agree that PrEP should be considered as an option in the HIV prevention toolkit and would ultimately support an effort by Gilead to expand Truvada's labeling to include PrEP--should the company petition the FDA for approval--I am also of the mind that a green light from the FDA should not be met with the rush-to-treatment that typically follows approval of a drug.

Given how little we know about the safe application of PrEP in a real-world setting--read: outside of a clinical trial--not to mention the expense of a comprehensive prevention program that includes PrEP, I think more feasibility studies need to take place before we consider a widespread HIV prevention program involving PrEP.

Here's what we do know: PrEP is effective in one population of at-risk individuals: men who have sex with men (MSM). The iPrEx clinical trial, sponsored by the National Institute of Allergy and Infection Diseases (NIAID) of the U.S. National Institutes of Health (NIH) and co-funded by the Bill & Melinda Gates Foundation, involved a large sample size (approximately 2,500) of MSMs. The study, which had sound design and statistical analysis, proved Truvada use resulted in significantly fewer infections compared with those using a placebo.

Read the rest

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Is Africa ready for PrEP?

Via Incidence0.org, by Adebisi Ademola Alimi

One of the biggest breakthrough in HIV clinical research, since the outbreak of the epidemic 30 years ago, is the recent success in a clinical trial of a new HIV prevention approach based on the daily use of the antiretroviral drug Truvada by HIV negative person to prevent HIV transmission (Called PrEP, for Pre-Exposure Prophylaxis).

The results of the iPrEX trial raised hope but also many questions and concerns as showed by the ensuing debate about what the next step should be. Divergences culminated with the Aids Health Foundation (AHF) petitioning the FDA not to consider Gilead’s request for a licence to use Truvada for the prevention of HIV infection and a joint counter response by a number of HIV advocacy organisations.

But for me as an advocate and an African living in Europe, the most important thing on my mind is “Will Africa be able to access PrEP?” Providing ARV to HIV negative people in Africa needs to be considered in light of the challenge of accessing treatment in Africa, where more than 50% of HIV positive people in the world live (UNAIDS report).

Even if PrEP drugs become available, what are the mechanisms in place to ensure that it will not be tribalized in a continent where there are some indications that access to ARVs is based on political and ethnical loyalty and where there are evidences of bribery at the delivery point, misused of funds and a non-negligible ARVs black market leading to ARVs being dispensed to increasing numbers of patients at the periphery of the health system. One has to be skeptical about the PrEP implementation process in this context.

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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.]

Debate PrEP based on facts

Via Ebar, by Dr. Robert Grant

A robust public debate is under way about the potential use of anti-HIV drugs to prevent HIV infection (also known as pre-exposure prophylaxis or PrEP). Our study, called iPrEx, provided the first conclusive evidence that the daily use of PrEP with the FDA-approved HIV treatment Truvada can significantly reduce HIV infection risk in gay, bisexual, and other men who have sex with men and transgender women, when delivered as part of a comprehensive package of prevention services, including condoms.

Recently, a private health care provider has begun a paid advertising campaign urging the FDA not to even consider approving the use of PrEP – charging, among other things, that MSM will stop using condoms if PrEP is permitted. The pros and cons of PrEP use should be vigorously debated – but that debate should be based on facts, rather than the assumption that MSM will not act to protect themselves and others from infection. Here are the facts about the iPrEX study:

The protection provided by PrEP and condoms together could have a substantial impact in reducing new HIV infections among MSM worldwide.

A diverse group of 2,499 HIV-negative MSM and transgender women on four continents with a range of sexual practices participated in iPrEx. All participants received a comprehensive package of HIV prevention services. Half also received Truvada, while the other half received a placebo (blank pill). Neither the study participants nor the investigators knew which pill they received during the study.

Men in both study groups reduced their risk behaviors and increased their condom use – demonstrating that MSM can use PrEP and condoms together. PrEP does not protect against other sexually transmitted infections and should never be considered as a substitute for condom use or other safer sex precautions.

Much more work lies ahead to determine whether PrEP can help stop HIV infections in other populations, such as heterosexuals and injection drug users, to better understand possible side effects of PrEP, to support consistent pill use among people who want to use it, and to ensure that PrEP is seen as one element of an HIV prevention strategy that includes regular condom use.

Additional studies are also under way to test whether other anti-HIV medicines (including pills, gels, and other formulations) are safe and effective for HIV prevention.

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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.]

Chicago Dept Public Health: HIV Pre-Exposure Prophylaxis Medication: New Hope for Prevention Poses Important Questions

Analysis and guidance from the Chicago Department of Public Health

New research shows that anti-retroviral drugs, long used to treat people infected with HIV/AIDS, can also prevent at-risk individuals from being infected with the virus in the first place. The most recent trial results in the Pre-exposure Prophy-laxis Initiative (iPrEx) represent a major breakthrough for HIV prevention, which has relied heavily on strategies to change behavior. HIV infects as many as 2.7 million people each year throughout the world.

According to the study published in the New England Journal of Medicine on No-vember 23, 2010, high-risk populations who received a daily dose of Pre-exposure Prophylaxis (PrEP) on average reduced their incidence of HIV infection by 43%.

The issues discussed here will be the source of much debate as the federal government determines how to best craft HIV prevention policy in light of the new developments.


[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.]

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

[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.]

Critical reflections around PrEP: Questions, concerns, and suggestions for next steps

by Keith R. Green, MSW (Co-Chair Elect, Chicago Black Gay Men’s Caucus)

As Project Director of the only U.S.-specific acceptability and feasibility pre-exposure prophylaxis (PrEP) trial in adolescents ages 18-24 - Project PrEPare - I must qualify the following statements by saying that my views are my own. They do not in any way reflect the thoughts or beliefs of the Adolescent Trials Network for HIV/AIDS Interventions (ATN), my current employer. My views on this topic are mine alone and, as a Black man who is sexually intimate with other men (diagnosed with HIV as an adolescent), they come from a very personal place.

Formalities aside, I should start by saying that I am very excited about the data that has come forth from the National Institutes of Health’s Pre-Exposure Prophylaxis Initiative (iPrEx). This international research study showed that the antiretroviral drug Truvada, when offered as a component of a comprehensive prevention package that includes condoms, counseling, and regular HIV/STI screening, was associated with a 44% reduction in HIV infections in participants who took it compared to those who took placebo. Additionally, a nearly 73 percent reduction in infections was seen in participants who took the study drug more than 90 percent of the time. I perceive PrEP to be a much needed weapon in our arsenal against the havoc that HIV is wreaking on gay, bisexual, and same gender loving communities, and this data demonstrating such a significant degree of efficacy fills me with hope.

I also very much appreciated the opinion piece that Dr. Kevin Fenton (Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the Centers for Disease Control and Prevention) wrote for CNNOpinion, outlining some of the cautions around this potential prevention option. I completely agree with him. This is just one study testing this intervention, and many unanswered questions remain, particularly with respect to what this data means for the populations most impacted by the epidemic in the United States.

Though the NIH iPrEX dataset is relatively large in numbers (2499 participants in total), U.S. men who have sex with men (MSM) are terribly underrepresented. In fact, less that 10 percent (less than 250 people) of the sample was from two U.S. cities combined (San Francisco and Boston). I have not seen the racial/ethnic background of the U.S. cohort—however, I think that it’s safe to say that the numbers get even smaller as it relates to people of color and young people of color in particular.

That said, the way that this data has been represented in the U.S. media is deeply disturbing. And the fact that the U.S. Centers for Disease Control and Prevention (CDC) immediately issued a fact sheet regarding the implications of this data, complete with incomplete guidelines for use and considerations for roll out, without a clear research agenda around these objectives, is downright scary. (I want to reiterate that I appreciate Dr. Fenton’s opinion piece, but it came nearly a week after the fact sheet. I understand the intent behind both, but from what I’ve read, a caution statement released on the same day as the data would have been much more in order than a fact sheet.)

One of the key messages from the NIH study is that adherence to the PrEP regimen is paramount to its success at combating the virus. I admit that I do not know a whole lot about the cultural variances around adherence (in Lima, Peru compared to Brooklyn, New York, per se), but I do know that African Americans, particularly those here in Chicago where I live, have a very rocky relationship with antiretrovirals. Recent surveillance data issued from the Chicago Department of Public Health found that only about 43 percent of African American MSM who knew their HIV status at the time of that survey were engaged in care that involves antiretrovirals. The reasons behind this are not clear, but anecdotally, we can speculate about them. Primarily, I believe, it has to do with our fragile history with the healthcare system, and the lack of trust that we have developed as a result. A lack of trust that all Americans can probably relate to, considering the abundance of malpractice suits and recalled prescription drugs that abound in our country.

That said, many critical concerns come to mind when I think about how the use of Truvada as PrEP could play out in the real world, particularly for the populations most impacted by the epidemic in this country at this time. Rocky relationships with antiretrovirals have equated to decreased engagement with them among African American gay, bisexual men, and same gender loving men. 

Truvada is one of the most widely prescribed antiretrovials (mostly due to its convenient dosing schedule and its presence in Atripla – the once-daily ‘miracle pill’). Therefore, considering the troubled relationship that African American MSM in Chicago have with antiretrovirals in general, is it possible that there are increased levels of resistance to Truvada among HIV positive men in the community? And, if so, could it be possible that an African American gay, bisexual, or same gender loving man who decided to take Truvada as PrEP (as a primary prevention with or without other proven prevention options), is at greater risk of being exposed to virus that is resistant to Truvada, leaving him not as protected as he believes he is? And, if he becomes infected and is infectious until he is diagnosed, is there not potential for him to pass on more resistant virus to others in the process?

I need to be clear that I understand that these concerns could be generalized to other populations. Much of this could be true for gay, white men or men from Lima, Peru, and that’s my whole point. We don’t have enough information to make any assumptions, really!

There are so many critical questions that must be answered before we allow those seeking to avoid contracting HIV to become convinced of the safety and efficacy of Truvada as PrEP:
•    Will African American MSM take PrEP as it must be taken in order for it to work? (Which includes taking it as a component of a comprehensive prevention package that includes condoms, counseling, and regular HIV/STI screening?
•    Does the general public understand that PrEP must be combined with other safe sex practices to derive the greatest protection from HIV?
•    Are we communicating, completely and honestly, the full range of risks involved with PrEP? Or do we really understand the full range of risks, particularly as it relates to resistance and how the potential for it varies from population to population?
•    What are the long-term effects associated with taking antiretrovirals preventatively?
•    Are we communicating effectively the fact that PrEP is not the ticket to a free ride on the “Sex Express”? (Condoms and other proven prevention strategies MUST be used)
•    Are we still advocating for regular HIV/STI screening and the power of knowing one’s status?

It is my sincere hope that the HIV/AIDS advocacy community will raise its voice LOUDLY to these concerns, and that the powers that be at the CDC, NIH, and other research institutions will explore the warnings and thoughtfully design research studies with strong behavioral and clinical outcomes that have these questions in mind. The future of HIV prevention in our country is dependent upon it. 

*** A community forum to discuss the iPrEX data and its potential impact on the future directon of Project PrEPare will take place in the Michael Leppen Theater at the Center on Halsted, 3656 N. Halsted, on Wednesday, December 15th 2010 from 6:30-8:30pm. The discussion will be co-facilitated by Jim Pickett, Director of Advocacy for the AIDS Foundation of Chicago and Chair of the International Rectal Microbicide Advocates.


[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.]