PrEP acceptable to gay men and few report that it would change their 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.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Notes from India: Concerns and Challenges Around PrEP

At present, India has approximately 2.4 million people living with HIV out of its total population of approximately 1,210 million people (a prevalence of 0.03%). In 2009, close to 1.2 million people were newly infected. According to a recent United Nations report, there has been a 50 percent decline in the number of new HIV infections in the country over the last decade.

India has made significant strides in tackling HIV/AIDS in recent years, with the government’s efforts actively being supported by the Bill & Melinda Gates Foundation, the World Bank, and the United States Agency for International Development. Many Indian NGOs work to provide care facilities, ARV medicines and education for people living with HIV. There has also been consistent work towards spreading awareness, from communicating key messages though concerts, radio shows, and TV spots with famous Bollywood stars to innovative initiatives such as promoting condom use through kite flying during popular festivals.

However, much remains to be done. “Most importantly, the government needs to step in because we need better laws – laws that will enable behavior change and help us fight HIV effectively. There are some draconian laws that stigmatize sex workers and intravenous drug users, making life very unsafe for them. MSM community building is nearly impossible due to the hostile environment. Sex education also needs to be made legally mandatory in the school system. These steps would help bring about real change,” says Anjali Gopalan, Executive Director of NAZ India, a Mapping Pathways partner organization.

How is India responding to pre-exposure prophylaxis (PrEP)? Says Anjali, “My sense is that many people are still very uncomfortable and not quite able to figure out why we’re talking about PrEP in the Indian context. Many senior people in the field feel the focus needs to be on TLC+.” There could be a few reasons for this view. First, India is a low-prevalence country, and people in the HIV prevention field believe this makes it very different from places like South Africa where the prevalence among the general population is very high. Second, there have been great difficulties in procuring ARV drugs for people living with HIV recently. “There are massive stockouts – the government is saying they don’t have the money to buy more drugs – we’re trying to move drugs from centers where they are less utilized to others where they are needed more. There is a lot of concern in the country, especially with global funding not available right now,” explains Anjali.

When it comes to PrEP, the common view in India (and elsewhere) appears to be that to take away dwindling funding and hard-to-get ARV drugs from HIV-positive people and directing them toward HIV-negative people is not a realistic or justifiable step. Of course, others are quick to point out that it is not a case of either/or – PrEP is simply one more new tool with which to prevent HIV infections. The public health community is still in the phase of gathering data on PrEP and figuring out the best possible way to utilize this new option in a variety of regions with different target populations.

Cultural differences may also play a part. For instance, homosexuality is still largely taboo in India and drug users are commonly seen as people who “knowingly put themselves at risk”. Discordant couples face a similar issue: No-one sees a problem with giving ARV drugs to people who are infected. But some doctors and social workers have indicated an aversion to giving drugs to those who are not infected on the assumption that they may indulge in high-risk behavior.

There are other significant questions for India, and for other countries contemplating whether they will implement PrEP or not: How does one ensure compliance among people who are healthy?  How does one ensure that side-effects, if any, are taken care of? How would one follow up? Will private practitioners be involved? India is still grappling with basic infrastructural and supply-chain issues, which makes these extremely important concerns.

“The Mapping Pathways team is trying to help answer these very questions,” says Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. “It’s time to gather all of this new data that’s pouring in and make sense of it, see how it can be applied in real scenarios. PrEP might make sense for some communities and situations, and it might not for others. Our end goal is to give decision-makers all the information they need to make informed decisions.”


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Special Prevention Conference Session: Where Should ARV-based Strategies be on the HIV Prevention Map?

Special Mapping Pathways Input Session at the 2011 National HIV Prevention Conference in Atlanta: Where Should ARV-based Strategies be on the HIV Prevention Map?

The results of recent clinical trials demonstrate that anti-retroviral based prevention strategies hold great promise for ending the HIV epidemic, while simultaneously raising important and challenging questions for the HIV community.

A research-driven, community-led global understanding of the emerging evidence based around the adoption of ARV-based prevention strategies is essential to answering these questions and in deciding where, how, and if these strategies are on the prevention maps of cities, states, and/or countries.

Join AIDS United and the AIDS Foundation of Chicago- two members of the international Mapping Pathways team - at the 2011 National HIV Prevention Conference, Monday, August 15 5:30-7:00 p.m. in the Hyatt Regency Hotel Roswell Room, to share your perspectives and concerns in this facilitated open discussion and help map pathways to sound decision making.

SPACE IS LIMITED. Email zfellows1@aidsunited.org to RSVP and secure your spot.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Antiretroviral prevention methods 'not in competition' with each other

Via AIDSMap, by Keith Alcorn.

Antiretroviral prevention methods are not in competition, and policy makers and providers need to start to thinking about how antiretrovirals, pre-exposure prophylaxis and microbicides will be provided as part of a combination prevention package – and who will benefit most from each method, delegates heard at a satellite meeting on the opening day of the Sixth International AIDS Society Conference (IAS 2011) in Rome.

“You don’t want to have the family planning clinic here, the pills clinic here, the injections clinic here, and the microbicides clinic over here,“ said Dr Stephen Becker of the Bill and Melinda Gates Foundation.

Delegates were discussing the rapidly changing landscape of HIV prevention methods that use antiretroviral drugs. One year ago, at the International AIDS Conference in Vienna, the world heard the results of the CAPRISA study, which showed that a microbicide gel containing tenofovir halved the risk of HIV infection in women who used the vaginal gel consistently.

Since then results from four studies have added to the array of prevention methods that exploit antiretroviral drugs to prevent transmission or acquisition of HIV infection:

• The iPrEx study showed that taking the antiretroviral combination Truvada (tenofovir and emtricitabine (also known as FTC) reduced the risk of HIV infection in men who have sex with men by 44%.
• The HPTN 052 study showed that early treatment reduced the risk of HIV transmission to an uninfected regular partner by at least 96%.
• The Partners study showed pre-exposure prophylaxis with Truvada or with tenofovir alone reduced the risk of HIV infection by between 62% and 73%.
• The TDF2 study showed that  pre-exposure prophylaxis with Truvada reduced the risk of infection by between 62% and 78%.

The first tenofovir-containing microbicide could receive regulatory approval by the end of 2013, subject to positive results from a confirmatory trial now taking place in South Africa. That study is testing exactly the same dosing regimen as that used in the CAPRISA study, the so-called BAT 24 dosing schedule: one dose Before, one After, and no more than Two doses in 24 hours.

A second CAPRISA study (008) is testing the roll-out of tenofovir gel through family planning clinics in KwaZulu-Natal, comparing the monthly testing and follow-up schedule used in the original CAPRISA study with a three-monthly schedule, in order to examine the feasibility and acceptability of providing a microbicide through existing health services that target sexually active women.

Although the South African government has already begun investing in the scale-up of production facilities to manufacture the gel, the extent of demand for the microbicide is still unclear. Studies of women’s’ attitudes towards the microbicide will be needed to gauge demand, but a lot of work will also be needed to develop demand – and to make sure that women understand how they could benefit from using the microbicide.

“We need to reach out to women who don’t perceive themselves to be at risk, and we should be getting communities to rally round to be early adopters of tenofovir gel,” said Samu Dube of the Global Campaign for MIcrobicides.

“We need to get the product to the places where women are: the family planning clinics, the immunisation centres, antenatal clinics. We also need to target the school health system.”

However, work will also be needed to convince the providers of those services that they have a role to play in expanding women’s opportunities to protect themselves from HIV infection.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Safety Issues in PrEP: A Public Meeting

 You are invited to a public meeting with the Forum for Collaborative HIV Research in Washington D.C.:

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

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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

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]