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.]

Rectal Microbicides at the IAS

There wasn't a ton of rectal microbicide coverage at the recent IAS in Rome, but here is some content from the conference on this topic.

Acceptability of potential rectal microbicide delivery mechanisms for HIV prevention
Abstract
Slides/Audio

Acceptability of microbicides and other new prevention technologies among MSM in Greater Buenos Aires, Argentina
Poster

Mobilizing MSM community in Nigeria to support rectal microbicides development (the author is Kadir Audu, head of IRMA Nigeria and Community Vice Chair on the IRMA Steering Committee.)
Abstract



[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.]

Experts hash out guidelines for HIV trials involving men who have sex with men

Via Spoonful of Medicine.

 Last week’s encouraging results from two trials showing that prophylactic use of AIDS drugs in HIV-negative people can help prevent infection has underscored the value of studying new preventative treatments, particularly in high-risk groups. And one of the highest risk groups remains men who have sex with men — a term used to include men who might not self-identify as gay.

In the US, for example, men who have sex with men (MSM) represent about 2% of the population, but they accounted for 59% of new HIV diagnoses in 2009. Strikingly, a global review estimated that only 3.3% of HIV prevention spending goes to address the needs of the MSM community in parts of the world where the epidemic is concentrated.

In hopes of facilitating more work in this area, experts from groups such as the Foundation for AIDS Research (amfAR) and the International AIDS Vaccine Initiative held a session at the International AIDS Society meeting here this week to discuss a draft set of guidelines. Although the World Medical Association and UNAIDS have published research principles for biomedical trials in the past, the authors of the newly drafted guidance say it’s the first of its kind to specifically advise on HIV research among individuals who fall into the MSM and LGBT (gay, lesbian, bisexual, transgender) categories.

The draft guidance stresses that consensual same sex practices are illegal in some countries and stigmatized, sometimes by the findings of HIV research itself. “That is a real obstacle to the response,” says Chris Beyrer, director of the Johns Hopkins Center for Public Health & Human Rights in Baltimore, Maryland, an institute involved in drafting the document. He adds that the problem is “really troubling” in former Soviet states such as Uzbekistan and Ukraine where the epidemic is intensifying.

Clinical staff themselves sometimes face coercion. For instance, as many as nine AIDS workers were imprisoned briefly in Senegal in 2009. To help trial investigators and volunteers avoid dangerous or difficult situations, the document sets out a checklist for researchers, encouraging them to reach out to MSM and LGBT community leaders at the early planning stages of each clinical trial and to involve them in communicating the findings once the experiment is complete. It also encourages scientists to institute emergency plans in case participants or staff face threats.

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.]

'Funding gap' imperils science exploits, AIDS forum hears

Via AFP, by Richard Ingham.

"Science is running much faster now than what we can implement and what we can pay for."

The four-day Rome conference, ending Wednesday, heard the outcome of several landmark trials.

The biggest found that giving early drug therapy to people with HIV reduced the risk of infecting others by a massive 96 percent.

Other trials found that giving antiretrovirals to a non-infected partner reduced the risk by around two-thirds.

These amount to two powerful new choices -- "treatment as prevention" and "pre-exposure prophylaxis" (PrEP) -- to brake transmission of the AIDS virus.

They join male circumcision, a proven measure to protect men, to which a vaginal microbicide, still under test, may one day be added for women.

In 2009, more than 33 million people were living with HIV and 2.6 million people became newly infected.

Making inroads into this tally means stumping up more money swiftly, said Julio Montaner, director of the BC Centre for Excellence in HIV/AIDS in British Columbia, Canada.

The higher early cost would lead to dividends, though. Eventually fewer people would ultimately become infected -- and people on treatment contribute to the economy because they are healthy rather than a burden to it through sickness.

"It could pay for itself in about a decade," calculated Jean-Paul Moatti, an economics professor at France's University of the Mediterranean in Marseille, southern France.

The financial outlook, though, is worrying.

Between 2001 and 2009, help for fighting AIDS in low- and middle-income countries rose nearly 10-fold, from $1.6 billion to $15.9 billion each year.

But in 2010, resources declined as Western countries, the mainstay of external funding, tightened the belt in response to their fiscal restraints.

Today, some 6.6 million people in poor countries have grasped the drug lifeline, but another nine million are still in need of treatment.

Reaching them by 2015, in line with the newly stated goal by UN members, will require between $22 billion and $24 billion annually.

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.]

From 'What if' to 'What Now': Implementing the New Prevention Technologies

Via AIDSMap, by Gus Cairns.

Two consecutive sessions at the sixth International AIDS Society conference in Rome yesterday were devoted, now we have convincing scientific data on the benefits of treatment as prevention and PrEP, to putting these new prevention methods into practice.

“We have moved from ‘What if?’ to ‘What now?’” was the comment of Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), on what else we need to know, what barriers need to be addressed , and what resources might be required, to maximise the promise of antiretroviral-based prevention.

Anthony Fauci, Director of the US National Institute of Allergies and Infectious Diseases (NIAID), said: “We now have a solid scientific foundation to say that even in the absence of a vaccine we have the capacity to end the epidemic. I can’t go to the US President and say: 'We can cure HIV.’ But I can say ‘Ending the epidemic is scientifically doable’.”

Earlier, however, Nancy Padian from the Office of the US Global AIDS Coordinator had outlined formidable challenges still to be answered if antiretroviral treatment could bring about this goal.

She said that questions still needing answers include whether antiretroviral drugs (ARVs) really are a durable and reliable means of viral load suppression over a period of years and whether increasing the proportion of people on treatment would lead to increased levels of resistance. The biggest practical question, however, was whether treatment as prevention would work in situations where a high proportion of transmissions came from people with acute, recent HIV infections.

The biggest barriers to treatment as prevention, however, are stigma and lack of resources. Implementing ARV-based prevention would not only be expensive in terms of drugs; it would require added human resources and increased training and task-shifting for prevention counsellors so they can deal with biomedical data. There would also be added costs in terms of tests and monitoring.

The other big barrier will be the stigma of being tested, she said, particularly for at-risk populations in societies where injecting drug use, male-male sex, or sex work were criminalised and stigmatised. Treatment as prevention would require people not simply to test and then go to more supportive community organisations for prevention advice; it required a much closer relationship with medical personnel who might be prejudiced or feared to be so.

Mitchell Warren issued a call to action to implement the new strategies, but his presentation was tempered by realism. “We have evidence, we have data, and we now need to make decisions,” he said.

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.]

Investment in HIV Prevention Research

A report released yesterday by HIV Vaccines and Microbicides Resource Tracking Working Group at the IAS conference in Rome "found that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision.":

"2010 has been a year of retrospection, a time for looking back over the 30 years since the first published report of the mysterious illness that would come to be known as AIDS. As sobering as this anniversary has been, it has also been a time for some optimism and calls to end the epidemic. These calls may not be simply wishful thinking, fueled as they have been by promising research results over the past two years in vaccines, microbicides, pre-exposure prophylaxis using antiretrovirals (PrEP), and antiretroviral treatment as prevention—results that have energized the entire HIV prevention field.

The first good news came at the end of 2009, when researchers in the RV 144 Thai vaccine trial reported that a vaccine combination had reduced risk of infection by 31 percent—the first clinical evidence that a preventive AIDS vaccine would be possible. Then, in July 2010, the CAPRISA 004 trial team announced its findings–that use of 1% tenofovir (TDF, also known as Viread®) vaginal gel reduced women’s risk of HIV infection by 39 percent—providing the first proof that a microbicide would be possible. This news was followed in November 2010 by the announcement from the iPrEx trial team that daily oral tenofovir/emtricitabine (TDF/FTC, also known as Truvada®) had reduced risk of HIV infection by an estimated 44 percent overall in men who have sex with men (MSM) and transgender women, and proved for the first time that HIV prevention using PrEP would be possible. And finally, in early 2011, the HIV Prevention Trials Network (HPTN) 052 trial established that use of antiretroviral therapy (ART) by HIV-positive individuals reduced transmission to their partners"

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

[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.]

Growing sense of hope at international Aids conference

From the Guardian, by Sarah Boseley.

There appears to be real excitement at the International Aids Society conference in Rome (sadly I'm not there in person, but that is the feedback). There is still no vaccine on the horizon - once the biggest hope - but the news from recent studies that taking antiretroviral drugs protects people without HIV from infection (see the story here) and reduces the risk of people with HIV passing it to their partners (here) has changed the landscape. Suddenly we are in a world where Aids is more preventable than ever before - and both prevention and treatment come pill-shaped.

So there is no shortage of important people calling for more funds and more action to roll out drugs to the nine million people in developing countries estimated to need them right now. Michel Sidibé, executive director of UNAIDS, said it was an affront to humanity that there were gaps in coverage.

"We have to remember that history will judge us not by our scientific breakthroughs, but how we apply them," he said.

There are practical difficulties in the way of getting the drugs to all who need them, but beyond the rhetoric and the big picture, there are organisations which are trying to find better ways forward. The Drugs for Neglected Diseases Initiative, for instance, which has been doing excellent work on a select group of conditions - human African trypanosomiasis, leishmaniasis, Chagas disease and malaria - has decided to take on the needs of children with HIV. Paediatric formulations of antiretrovirals are inadequate. Children are not small adults. They don't just need a few less tablets - they need drugs that can be given in doses suitable for their weight and may need syrups rather than pills. This is Dr Bernard Pécoul, executive director of DNDi:

"There are millions of children with HIV/AIDS in low- and middle-income countries, but their needs are absent from the HIV research and development agenda, and this is largely because they are poor and voiceless and do not represent a lucrative market. Working with partners, we hope to help fill this terrible gap and offer improved treatment options for children with HIV/AIDS."

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 3

Today is Day 3 of the exciting conference happening in Rome, and IRMA has a lot of interesting information to report. Here is the press release for Day 3, and below it are links to important and fascinating presentations from and articles about the conference.

Via IAS.

OFFICIAL PRESS RELEASE – DAY 3

                                                         EMBARGOED UNTIL 11.00 (CET), TUESDAY JULY 19

Plenary speakers address challenges in the delivery of sustained antiretroviral therapy in developing countries, call for social scientists to take their place at the HIV/AIDS policy- making table, and stress the need for a long-term response to AIDS

Tuesday, 19 July, 2011 (Rome, Italy) -- Researchers speaking in the second plenary session of the 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) have today provided insights into the future direction of HIV/AIDS policy making and alerted delegates to the challenges that developing countries continue to face in the delivery of large- scale antiretroviral therapy (ART) coverage.

The presentations reflect the breadth of expertise among the more than 5,000 researchers, clinicians and community leaders attending the conference, which runs from 17-20 July in Rome.

“The AIDS response up until now has led to unprecedented mobilization of populations and significant progress in terms of prevention and treatment,” said IAS 2011 International Chair and IAS President Elly Katabira. “However, given the projections we have made of infections over the next decade, together with the growing number of people living longer with HIV, it makes perfect sense to discuss whether a remodeling or fine-tuning of that response might more effectively meet the new challenges that lie ahead.”

“Discussion around the future direction of HIV/AIDS policy must begin to give a far greater voice to the social sciences,” said Stefano Vella, IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS).  “The social and political sciences are a vital element in helping us to improve prevention efforts, especially in developing countries where major challenges remain in the effective roll-out of ART.”

The Social Barriers to Effective HIV Prevention

In her plenary remarks, Susan Kippax (Australia), Emeritus Professor at the Social Policy Research Centre, University of New South Wales, Sydney, suggested that in understanding HIV prevention efforts, people’s behaviours cannot be separated from their social, cultural and political structures, and the biomedical cannot be distinguished from the non-biomedical. Kippax argued that there is a need for social scientists to be at the table when it comes to discussing what many experts currently consider to be the greatest challenge to HIV/AIDS policy making - prevention.

Irrespective of whether prevention programmes or interventions advocate the use of condoms, clean needles and syringes, microbicides, pre- or post-exposure prophylaxis, or treatment as prevention - all prevention requires that people change their social practices: changes which cannot be effectively sustained unless they are supported by broader social transformation.

Challenges of Antiretroviral Therapy (ART) in Developing Countries

Serge Eholié (Ivory Coast) Professor of Tropical and Infectious Diseases at the Medical School of the University of Abidjan, focused on the challenges of sustaining antiretroviral therapy initiatives in developing countries.

A decade after the first antiretroviral therapy initiatives were initiated in developing countries, the number of HIV-infected individuals receiving ART has significantly increased. Recent data estimate that six million HIV-infected patients started ART and four and a half million of them (75 per cent) live in sub-Saharan Africa, and significant results have been obtained in decreasing mortality and morbidity.

Seven areas were identified as challenging in the ongoing delivery of ART in developing countries:

• financing the sustainability of ART-programmes, particularly in the context of the current adverse economic climate and with insufficient contributions from national governments;
• the high incidence of mortality and severe mortality during the first year following ART-initiation;
• the adaptation of programmes, physicians, countries and partners to the WHO 2010 revised guidelines for adults and adolescents;
• an increasing number of HIV-infected patients failing first-line treatment: the cost of second line treatment is four to five times higher than first line regimes. It is challenging for countries and partners to afford second line treatment, and difficult for physicians to detect first-line failure early enough;
• detectingfirst-line treatment failure earlier and prescribing an effective and safe second line regimen in light of the expense of the latter;
• management, diagnosis and treatment of side effects; 
• retention of patients: data for cohorts studies show that 25%-30% of HIV patients starting treatment are lost to follow up after 12-24 months;
• socio-political instability and humanitarian crisis and natural disasters

 AIDS: The Need for a Long-term Response

Peter Piot (Belgium), Director of the London School of Hygiene & Tropical Medicine, London, concluded the plenary session by reflecting that given the enormous mortality and human suffering caused by the AIDS epidemic, the nature of the global response to the AIDS epidemic has been framed as an emergency. Yet the ultimate duration of the emergency has rarely been discussed.

In spite of a recent decline in interest and funding for AIDS, UN member states recently adopted a "Political Declaration on HIV/AIDS: intensifying our efforts to eliminate HIV/AIDS" with ambitious goals for the next five years. Projections from aids2031 and UNAIDS estimate that over the coming two decades,  there may still be one to one and a half million new infections and one million deaths annually, with resources required to curb infections well in excess of currently available funds.

The combination of these developments, as well as the longer life expectancy of many people infected with HIV, provides a compelling argument for the need for a long term view on the AIDS response. In addition, resource constraints dictate that effective investments leading to the best possible outcomes in both the short and long term are necessary, and right now.

 ---

 Session abstracts and presentations for "Novel Approaches to Prevention Interventions and Measurement" can be found here. Especially of note for rectal microbicide advocates is this presentation.

Also of interest is this abstract of work done by IRMA - Nigeria: "Mobilizing MSM community in Nigeria to support rectal microbicides development", and the abstracts/powerpoints in this session: "Treatment Is Prevention: The Proof Is 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 2 Press Release

OFFICIAL PRESS RELEASE – DAY 2

16.30 (CET), MONDAY JULY 18

Antiretroviral Treatment is HIV Prevention: The proof is here

Leading researchers and international experts to discuss the policy and prevention implications of three groundbreaking trial results: the HPTN O52 study, the Centers for Disease Control and Prevention TDF2 study and the University of Washington Partners PrEP Study

Monday, 18 July, 2011 (Rome, Italy) -- A special press conference at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) will today feature a panel consisting of researchers from the CDC TDF2 study, the Partners PrEP Study and the HPTN 052 study. They will be joined by Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), Gottfried Hirnschall, Director of the HIV Department of the World Health Organization (WHO) and Elly Katabira, IAS 2011 International Chair and President of the International AIDS Society (IAS). The IAS 2011 conference opened yesterday, Sunday 17 July and runs until Wednesday 20 July and is being attended by over 5000 researchers, clinicians and community leaders.

In light of announcements this past week about new data on PrEP effectiveness, both the HPTN 052 abstract session (16.30, SR1) and press conference have been expanded to include presentations on the Partners PrEP Study and the CDC’s TDF2 study, both of which were released on 13 July in the US. The presentation on the CDC study was originally scheduled for a late breaker session at IAS 2011 on Wednesday 20 July.

“Treatment is prevention and these three studies provide the proof,” said Katabira.

“The XI International AIDS Conference in Vancouver in 1996 is remembered as the conference that heralded the arrival of combination antiretroviral treatment. The IAS 2011 Conference will be remembered as the beginning of the treatment as prevention revolution.”

“These studies mark a turning point in HIV science and in HIV prevention,” said Stefano Vella, IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS). “The urgent challenge now is to implement treatment as prevention in the developing world.”


Press conference line up:

Chair: Stefano Vella: IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS)


Myron Cohen: HPTN 052 Protocol Chair and Associate Vice Chancellor for Global Health and Director of the Institute of Global Health and Infectious Diseases at the University of North Carolina

About the HPTN 052 study:

The HIV Prevention Trials Network (HPTN) 052 study found that men and women, who were already infected with HIV, had a reduced risk of transmitting the virus to their uninfected sexual partners by 96% through early initiation of combination antiretroviral therapy (cART). HPTN 052 also found that early initiation of cART benefits the HIV-infected individual.

HPTN 052 was designed to evaluate whether early versus delayed use of cART by HIV-infected individuals would reduce transmission of HIV to their uninfected partners and benefit the HIV-infected individuals as well. During the course of the study, 39 participants who had been HIV-uninfected at the start of the study became infected with HIV. Of those, 29 were linked transmissions, where the virus from the originally-infected partner was confirmed by genetic analysis to be the source of infection in the newly infected sexual partner. Only one of the 29 infections occurred in the early cART arm. Based on the latest analyses, this one transmission most likely occurred close to the time the couple enrolled in the study and before HIV viral replication could have been suppressed by cART in the infected participant.

The new analyses also provide more insight as to how early initiation of cART benefits the HIV-infected person. Individuals who were put on early cART maintained higher absolute CD4 counts than those in the delayed arm, who received treatment when their CD4 counts fell below 250 cells/mm³ or an AIDS-related event occurred. Early cART was also associated with a 41% reduction in HIV-related illnesses or death, a direct benefit for the HIV-infected partner. The reliable suppression of HIV among HIV-infected people in the early treatment arm suggests potential impact on adherence when the infected individual is informed that their cART may also benefit their partner.


Michael C.Thigpen: Principal study investigator and epidemiologist at the Centers for Disease Control and Prevention (CDC), USA

About the TDF2 study:

The CDC TDF2 study was a randomized, placebo-controlled trial examining the safety and efficacy of a once-daily tablet containing tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known by the brand name Truvada) for reducing the risk of HIV acquisition among heterosexual men and women at two sites in Botswana. In addition to study medication, all participants received a comprehensive package of HIV prevention services. The study provides strong evidence that a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex. The study, conducted in partnership with the Botswana Ministry of Health, found TDF/FTC reduced the risk of acquiring HIV infection by roughly 63 percent overall in the study population (95% CI, 21.5 to 83.4; p= 0.0133) ,and by 78 percent among trial participants believed to be taking study medications (95% CI 41.2 to 93.6, p=0.0053). Adherence (as measured by pill count) was high, both among those receiving TDF/FTC and those receiving placebo (84.1 percent and 83.7 percent, respectively). Reported sexual risk behavior was similar between the two study arms. Consistent with other PrEP studies, preliminary analyses did not identify any significant safety concerns associated with daily use of TDF/FTC.


Jared Baeten: Co-leader of the Partners PrEP Study and epidemiologist at the University of Washington, USA

About the Partners PrEP Study:

This is a phase III, randomized, double-blind, placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir for the prevention of HIV-1 acquisition among HIV-1 seronegative partners in heterosexual HIV-1 serodiscordant partnerships. The study is funded by the Bill & Melinda Gates Foundation. The University of Washington coordinated the trial, in collaboration with investigators at nine sites in Kenya and Uganda. The study enrolled 4758 HIV-1 serodiscordant couples; HIV-1 uninfected partners were randomly assigned in equal numbers to one of three study groups: one group received tenofovir, one emtricitabine/tenofovir, and one matching placebo. All study participants received a comprehensive package of HIV-1 prevention services. On 10 July 2011, the Partners PrEP Study independent Data and Safety Monitoring Board (DSMB) recommended, after review of the study data, that the study results be publically reported and the placebo arm be discontinued, because of definitive demonstration of HIV-1 protection from pre-exposure prophylaxis (PrEP) in the study population. Tenofovir reduced HIV-1 risk by 62% (95% CI 34 to 78, p=0.0003), emtricitabine/tenofovir by 73% (95% CI 49 to 85, p<0.0001). Efficacy for tenofovir and emtricitabine/tenofovir were not statistically different. 62% of HIV negative participants were male, 38% were female: both PrEP medications reduced HIV-1 risk in men and women. Adherence to the daily PrEP medication was very high – more than 97% of dispensed doses of the study medications were taken. More than 95% of participants were retained in study follow-up. Safety parameters were comparable across the three study groups.


Anthony Fauci: Director, NIAID, USA

Fauci will remark on the implications for prevention research. He will talk about the collective importance of these studies in finding new HIV prevention methods and the optimism that these combinations when viewed in total will help to end the HIV/AIDS epidemic.


Gottfried Hirnschall: Head of the HIV Department at the WHO, Switzerland

Over the past year, WHO has been developing recommendations for couples HIV testing and counseling. More than half of all people living with HIV do not know their infection status, and therefore, may transmit HIV unknowingly. By partners testing together and mutually disclosing their test results, couples can learn about their options for HIV prevention and treatment.

The findings of the three cited studies above will be reflected in WHO guidelines for couples HIV testing and counseling and also to develop broader guidance on the strategic use of antiretrovirals for treatment and prevention of HIV.


Elly Katabira: International Chair IAS 2011 and IAS President

Katabira will talk about the implications of the three cited studies for HIV professionals


[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 1 Press Release

The 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention began yesterday in Rome, Italy. Here is the press release from yesterday's events:

OFFICIAL PRESS RELEASE – DAY 1

17.00 (CET), SUNDAY JULY 17

AIDS is at a scientific watershed, says IAS 2011 International Chair Elly Katabira at the opening of the world’s largest open scientific conference on HIV and AIDS

Michel Sidibé, UNAIDS Head, adds that history will judge us not by our scientific breakthroughs on AIDS, but how we apply them

Sunday, 17 July, 2011 (Rome, Italy) - More than 5,000 AIDS researchers, scientists, clinicians, community leaders and policy experts gathered in Rome for the opening of the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) have welcomed the growing momentum in biomedical research, but have warned that the benefits of these advances need to be evenly shared between the global North and South. Opening Session speakers also used this occasion to call on the Italian government to re-commit to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

“We are at a scientific watershed in the global AIDS response,” said IAS 2011 International Chair and International AIDS Society President Elly Katabira. “We have witnessed two years of significant biomedical advances, the likes of which we have not seen since the antiretroviral breakthroughs of the mid 1990s. The excitement around these advances in research - whether they be the CAPRISA 004 vaginal gel, the HPTN 052 study on treatment as prevention, talk around the path towards a cure, or the encouraging signs on PrEP and vaccines – is very much driving the debates and discussions that we are going to see in Rome over the next few days.”

“IAS 2011 delegates, like many professionals working in the international response to HIV, are understandably excited about recent scientific breakthroughs. However, we need to ensure that the advances we are making in research such as the now proven concept of antiretroviral treatment as a means of HIV prevention – is translated into action for people in developing countries,” said IAS 2011 Local Co-Chair Stefano Vella, Research Director at the Istituto Superiore di Sanità (ISS). “Advances in science need to be matched by advances in resourcing. I call on the Italian government to recommit itself as a donor nation to the Global Fund to Fight AIDS, Tuberculosis and Malaria.”

In an Opening Session keynote speech, UNAIDS Executive Director Michel Sidibé said that gaps in access to HIV treatment within and between countries and key populations were an affront to humanity that can and must be closed by innovations in developing, pricing and delivering treatments and commodities for HIV, TB, malaria, reproductive health and other health issues.

“We have to remember that history will judge us not by our scientific breakthroughs, but how we apply them,” said Sidibé.

The IAS Conference series focuses on the translation of research into practice, particularly in low- and middle-income countries.


Opening Session

The emphasis on the real-world application of science was also reflected in today’s Opening Session, which began with welcoming remarks by IAS 2011 Co-Chairs, a message from Giorgio Napolitano, President of the Republic of Italy, an address from Giovanni Alemanno, Mayor of Rome, followed by a community welcome by Filippo von Schloesser, President of Fondazione Nadir Onlus. Mr von Schloesser said the Italian government‘s waning commitment to HIV/AIDS was a major concern to people living with HIV.

IAS 2011 will reveal promising new data across all four scientific tracks – particularly in the areas of HIV treatment as prevention, HIV cure efforts, new drugs and new antiretroviral combinations, and the scale up of effective prevention and treatment interventions in resource-limited settings. From a scientific perspective, this is a time of optimism which was last seen in the mid 1990s, when the promise of combination antiretroviral therapy (ART) first became real. IAS 2011, while urging governments and donors to commit to continued and increased commitment to HIV and AIDS across all programme areas, will stress the necessity to respect the Sydney declaration – the declaration released during the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention, which stated that 10 per cent of all HIV funding should go on research.


[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.]