Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States

via PLoS Medicine, by Gordon Mansergh, Beryl A. Koblin, Patrick S. Sullivan

Summary Points:

Pre-exposure prophylaxis (PrEP) with anti-retroviral (ARV) medications is partially efficacious for preventing HIV infection among men who have sex with men (MSM) and heterosexuals.

As PrEP becomes available and prescribed for use among MSM a better understanding of willingness to use PrEP and avoidance of condom use are needed so that behavioral programs and counseling may be enhanced for maximum benefit.

Targeted messaging will be needed about ARV prophylaxis for various at risk populations, but the general message should be that condoms continue to be the most effective way to prevent HIV transmission through sex and that PrEP is an additional biomedical intervention.

As new effective biomedical intervention methods, such as PrEP, become available language about “protected” and “unprotected” sex, which used to exclusively mean condom use, will need to adapt.

Read the full article here.


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Sustainable HIV prevention possibilities present choices, challenges

via Science Speaks, by Antigone Barton

When he looks at what biomedical science can do in the next decade to prevent HIV transmission, Jim Turpin of the National Institutes of Health said, he thinks of the lyrics of a Timbuk3 song: “The future’s so bright I gotta wear shades.”

By, which, actually, he means — don’t get blinded by the light; the search for answers will require focus.
“The challenge is not the lack of options,” he said, “but prioritizing the best options.”

Turpin, program officer and branch chief in the Prevention Sciences Program in the Division of AIDS at NIH”s  National Institute of Allergy and Infection Disease spoke this morning in webinar titled “The HIV Prevention Pipeline: A Future of Possibilities.” The webinar was sponsored by the International Rectal Microbicide Advocates (IRMA) and AVAC Global Advocacy for HIV Prevention.

After a series of disappointments in the quest for a vaccine or microbicide to prevent HIV transmission, the last two years offered hope, in strategies using antiretroviral medicine to prevent acquiring HIV, organizers point out. But, with a diversity of prevention needs and challenges among women and men worldwide still demanding answers, is that all there is?

Or, as Turpin put it, “Do we currently have what it takes to create a sustainable prevention pipeline?”

Read the rest.


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What kind of prevention do gay men need?

 via aidsmap, by Gus Cairns

How do we stop the hyperepidemic in gay men?

A number of presentations at the 19th International AIDS Conference explored the 'hyperepidemic' of HIV amongst men who have sex with men, and especially black MSM.

A paper presented by Gregorio Millet (pictured above at a White House reception honoring people working in AIDS) showed that, at least in the USA, the extremely high incidence and prevalence of HIV in this group is not driven by higher levels of unsafe sex. Instead, very high prevalence, the ease with which HIV is transmitted during anal sex, and the fact that black men (and some other subpopulations of gay men) have sex within small and multiply-connected networks have created a situation in which HIV is hard to avoid.

Given this, what prevention methods would work in gay men? The one that has been talked about most keenly and which continued to generate a great deal of data and debate at Washington was pre-exposure prophylaxis (PrEP) - taking antiretrovirals (ARVs) to prevent, rather than treat, HIV.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

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Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults

via Morbidity and Mortality Weekly Report

In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population.

Those recommendations remain valid for MSM, including MSM who also have sex with women (2). Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM.* This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.

Read the rest.


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Rectal microbicide research gives hope for HIV protection

via Citizens News Service, by Somya Arora

According to the Microbicides Trials Network (MTN), HIV continues to disproportionately affect racial minorities and men who have sex with men (MSM). MTN estimates that 5 to 10 percent of the world’s population engages in anal sex and globally, MSM are 19 times more likely to be infected with HIV than the general population. Unprotected anal sex is the primary driver of the HIV epidemic among this population. The risk of becoming infected with HIV during unprotected anal sex is 10 to 20 times greater than unprotected vaginal sex, because the rectal lining being only one-cell thick, it allows the virus to easily reach immune cells to infect. 

“Rectal microbicides are critical to turn the tide of the AIDS pandemic as we know that unprotected anal intercourse is the riskiest of HIV related behaviours. Human beings, all over the world, regardless of gender and sexuality, have anal intercourse and a lot of this is unprotected because they do not have access to condoms and/or because of the mistaken notion that anal intercourse is safer than vaginal intercourse with regards to contracting HIV. Having more tools for protection, in addition to what we already have, I think would be absolutely critical,” says Jim Pickett, Director (Advocacy), Chicago AIDS Foundation and founder-chair of International Rectal Microbicide Advocates (IRMA).

In an update on the CHARM (Combination HIV Antiretroviral Rectal Microbicide) Program, Dr Ian McGowan, Professor of Medicine, University of Pittsburgh, and Co-principal Investigator MTN, informs that, “Microbicides are products that can be applied to the vaginal or rectal mucosa with the intent of preventing or significantly reducing the risk of acquiring Sexually Transmitted Infections including HIV. Combination antiretrovirals are more potent and more useful as rectal microbicides. The rationale behind the CHARM programme is that we need a rectal specific combination antiretroviral microbicide.”

Read the rest.


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Characteristics Qualifying Gay Men for Intermittent PrEP

via AllAfrica.com, by Michael Carter

Older, better-educated gay men who use sexual networking sites and have sex outside the context of committed relationships may be appropriate targets for intermittent pre-exposure prophylaxis (PrEP), US research published in the online edition of the Journal of Acquired Immune Deficiency Syndromes suggests.

The investigators found that individuals with this profile were more likely to plan their sexual encounters and to have anal sex fewer than three times per week.

“Our study serves to better characterize MSM [men who have sex with men] who may most benefit from event-based intermittent PrEP,” comment the authors.

The iPrEX study involving gay and other MSM showed that PrEP significantly reduced the risk of acquiring infection with HIV.

However, adherence is a major barrier to the success of PrEP. There are also concerns about its cost and potential side-effects. Intermittent dosing has been proposed as a way of overcoming these limitations. A recently published study showed that adherence was also challenging when an intermittent dosing strategy was used.

This treatment strategy involves taking a dose of antiretroviral therapy before a risky sexual encounter, with a second dose taken shortly after.

This strategy will only be suitable for people who engage in risky sex fewer than three times per week, and who plan their sexual encounters.

Investigators in the US wished to establish a better understanding of the characteristics of gay men and other MSM who fulfilled these criteria.

HIV-negative gay men were recruited to the study using social networking sites in late 2010. All were sexually active (defined as anal sex within the previous month). The men supplied demographic data, as well as information about their sexual risk behaviour, how they planned their sexual encounters, their use of sexual networking media and their relationship status.

A total of 1013 men participated in the research. Their median age was 28 years. Most (56%) participants reported that their last anal sex was unprotected.

Read the rest.


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 *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via Lancet.com, by Salim S Abdool Karim  and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

Read the Rest.


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*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
 
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Fenway Releases PrEP Policy Paper

viaFenway Health

Pre-exposure chemoprophylaxis (PrEP)—taking antiretroviral medications to prevent HIV transmission—could be a “game changer” for HIV prevention. PrEP has demonstrated partial efficacy with men who have sex with men (MSM), transgender women, and heterosexuals in several recent studies. Recent modeling of PrEP implementation coupled with scaled up treatment predicts that PrEP could significantly reduce HIV incidence and prevalence. And if PrEP is accompanied by sustained care, behavioral interventions, and safety monitoring, PrEP need not lead to increased sexual risk behavior or drug resistance.

The latest Policy Focus from The Fenway Insitute summarizes the state of PrEP and microbicides research as of January 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV.

The Fenway Institute’s analysis found that the most effective prevention interventions will be those that combine behavioral interventions, structural interventions, and emerging biomedical technologies, such as PrEP and microbicides. The analysis concludes with recommendations for implementation of PrEP, including:
■If the U.S. Food and Drug Administration (FDA), which is considering approving FTC-TDF for use as PrEP, feels that research on PrEP’s efficacy among heterosexuals is inconclusive, it should consider approving PrEP for MSM now separately and consider heterosexuals, IDUs and other populations in the near future as the science advances;

■The World Health Organization (WHO) should issue guidance on PrEP that takes into account the promising results of the iPrEx study, Partners PrEP, and the Botswana CDC study;

■Following the release of the Bangkok injection drug user (IDU) trial results, if appropriate the U.S. Centers for Disease Control and Prevention, the U.S. Public Health Service, and the WHO should issue guidance for PrEP with IDUs.;

■States should provide access to PrEP as a critical prevention service and prescription medication under the Essential Health Benefits provision of the Affordable Care Act;

■State Medicaid programs should also cover PrEP as a cost-saving measure that will improve public health and ultimately save money in health care costs;

■Provision of PrEP to MSM and transgender women should occur in a broader context of ensuring clinically competent health care to gay, lesbian, bisexual and transgender people.

Read the Full Report.


[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.]

Plasma and rectal viral load correlated in HIV-positive gay men: supports use of treatment as prevention

via European AIDS Treatment Group, by Michael Carter

Viral load in the blood and rectal secretions of HIV-positive gay men are highly correlated, according to US research published in the September 1st edition of the Journal of Infectious Diseases. The study also showed that the presence of sexually transmitted infections did not increase rectal viral load.

Individuals with a plasma viral load above 1000 copies/ml were significantly more likely to have detectable virus in the rectum.

“Our data add substantially to the few published studies of HIV shedding in rectal secretions of MSM [men who have sex with men],” comment the investigators, “we were able to quantify HIV RNA in rectal secretions, demonstrate the linear correlation between increasing plasma load and rectal viral load and determine a threshold plasma viral load that distinguished detectable from undetectable rectal viral load.”

They also believe that their findings have important implications for current debates about the use of HIV treatment as prevention, commenting: “Combination antiretroviral therapy will have a similar effect on reducing HIV transmission in MSM, as seen in studies of heterosexual discordant couples.”

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.]

Early ARV Treatment Will Save Lives in South Africa

Via All Africa.

Government's decision to offer free ARV treatment to people with CD4 counts of 350 or less has been welcomed as a life-saver.

The South African government's announcement that it will give antiretroviral medication to people with HIV who have CD4 counts of below 350 will save lives and prevent infection.

This is according to Medecins Sans Frontieres (MSF), which welcomed the announcement made by Deputy President Kgalema Motlanthe on Friday (12 August).

Until Friday, people were only able to get ARVs if their CD4 count was below 200 unless they were pregnant or had tuberculosis.

"The decision to start people on HIV treatment earlier, before they become sick with diseases like tuberculosis, marks a critical moment for this country that is so hard hit by the epidemic," said Dr Gilles van Cutsem, Medical Coordinator for MSF in South Africa.

"When people are started earlier on ARV treatment, they are less likely to die, less likely to become ill, less likely to need hospitalisation and more likely to stick to their treatment in the long run."

A study conducted by MSF last year in Lesotho found that patients who started treatment above CD4 200 were 68% more likely to survive than patients those who started ARVs when their CD4 count was below 200.

Van Cutsem added that starting people on ARVs earlier was likely to prevent new infections as "ARV treatment dramatically reduces the spread of the virus to others, by making people living with HIV less infectious by up to 96 percent".

Meanwhile, a study published in PloS journal in July predicts that making ARVs available to people from CD4 of 350 would have a dramatic effect on the community of Hlabisa in northern KwaZulu-Natal.

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.]

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.]

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.]

CHINA: CAIDS deaths hit 'peak' as 7,700 die

Via China.org.cn

AIDS deaths are believed to be peaking on the Chinese mainland as many from the large number of people infected with HIV in the 1990s because of unsanitary blood-selling schemes develop full-blown AIDS, a senior health official said on Tuesday.

By the end of last year, the total reported number of AIDS deaths had reached 68,000, according to statistics from the ministry. Since 2008, AIDS has become the country's top infectious killer and it claimed the lives of 7,700 people in 2010 alone.

"As those infected in the 1990s have developed full-blown AIDS, the number of deaths has surged," Hao noted, adding that poor drug compliance largely because of side effects added to the number of deaths. To address the problems, the government cracked down on the illegal plasma-selling schemes, enhanced safety supervision and management of blood collection, and offered free medication to all patients. Currently, China has about 740,000 people living with AIDS/HIV, including 140,000 full-blown AIDS patients, official statistics show.

Hao urged people with the virus to accept the free medication they are entitled to and the first-line antiretroviral regimen, and said the government is making efforts to also provide free second-line drugs to those in need. The first-line antiretroviral regimen has helped reduce the fatality rate of full-blown AIDS patients on medication from 10.8 percent in 2005 to 4.6 percent last year.

In the past few years, men who have sex with men (MSM) have become one of the most vulnerable groups for contracting AIDS/HIV, experts said. Among the 44,000 new HIV infections detected in 2010, nearly 13 percent were infected through gay sex, according to the Ministry of Health. "AIDS/HIV became rampant among the MSM population which has an average HIV prevalence of 5 percent nationwide," Hao said. He noted that the infection rate is 0.05 percent among the general population.

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Starting HIV treatment when CD4 cell count dips below 500 improves AIDS-free survival

Via aidsmap, by Michael Carter

Patients who start antiretroviral therapy when their CD4 cell count dipped below 500 cells/mm3 are less likely to develop an AIDS-defining illness than individuals who start treatment with a CD4 cell count of 350 cells/mm3, an international team of investigators report in the Annals of Internal Medicine. However, initiating HIV treatment with a CD4 cell count of approximately 500 cells/mm3 did not reduce the risk of all-cause mortality.

“If the goal is to prevent AIDS-defining illness or death, our findings support cART [combination antiretroviral therapy] initiation once the CD4 cell count decreases below 500 cells/mm3,” comment the investigators.

Nevertheless, results of the study will undoubtedly inform the debate about the best time to start antiretroviral therapy.Treatment guidelines in Europe currently recommend that AIDS-free patients should start therapy when their CD4 cell count is in the region of 350 cells/mm3. However, US guidelines advocate treatment when an individual’s CD4 cell count falls under 500 cells/mm3.

Large randomised trials are currently underway to try and determine the optimum time to start HIV therapy. However, their results are not expected for several years. Because of this continuing uncertainty investigators from the HIV-CAUSAL Collaboration undertook a prospective observational study involving approximately 21,000 adult patients enrolled in cohorts in Europe and the US.

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UGANDA: As food prices bite, HIV-positive people turn to kitchen gardens

Via IRIN, PlusNews

The small 10m by 15m garden behind Agnes Oroma's house in northern Uganda's Gulu district is much more than a hobby garden; according to HIV-positive Oroma, it is one of the main reasons she is in good health. She grows indigenous vegetables and tomatoes to supplement her daily diet of beans, maize meal and silver fish; Oroma also proudly shows off a sisal sack in which she grows onions.

"Do not ignore that little space behind your house, it can do a lot to feed you cheaply and lessen your financial burden that would enable you spend on other essentials to keep you healthy on your daily ARV treatment," 31-year-old Oroma told IRIN/PlusNews.

In the face of rising global fuel prices and a prolonged dry spell, Ugandans are dealing with steep increases in the price of food that have sparked protests in many parts of the country. Oroma and other HIV-positive patients in Gulu town are becoming more self-reliant in an effort to maintain a healthy diet and stay on their antiretroviral medication. Oroma's group of backyard farmers has grown to 30 in the past few months.

"Food was my biggest worry for my treatment; I had become weaker because my body didn't have the strength to withstand the potency of the ARV drugs. Since I started growing these vegetables, producing more food, I feel a lot of improvement and I have the strength to do other things. I now take my medication without worries because I know the food I grow can keep me going for another day,"said Maurine Kilama.

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HIV Envelope Discovery Could Reveal New Vaccine Targets

Via hivandhepatitis.com

An international study headed by a UC Davis scientist describes how a component of a potential HIV vaccine opens like a flower, undergoing one of the most dramatic protein rearrangements yet observed in nature.

The finding could reveal new targets for vaccines to prevent HIV infection and AIDS. A paper describing the work was published online this week in the journal Proceedings of the National Academy of Sciences.

In the new study, researchers from the U.S., Sweden and France explored the structure and behavior of the HIV envelope protein complex, which could potentially serve as a component of a vaccine aimed at eliciting the human immune system to generate antibodies against HIV.

"By opening up these less exposed regions, we might be able to raise more broadly cross-reactive antibodies to HIV," said R. Holland Cheng, professor of molecular and cellular biology at UC Davis and senior author of the study.

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Kenya: Counselling, not alarm device, had best effect on ART adherence

Via aidsmap, by Carole Leach-Lemens

Patients in Nairobi, Kenya getting intensive early adherence counselling when starting antiretroviral therapy were 29% less likely to have poor adherence and 59% less likely to have virological failure compared to those getting no counselling Michael H Chung and colleagues reported in a randomised, controlled trial published in the March issue of PLoS Medicine.

The positive effects of counselling on adherence were seen immediately after starting antiretroviral therapy and maintained throughout the18 month follow-up period. Use of an alarm device had no effect on adherence or virological outcomes. Public health concerns that scale-up of antiretroviral treatment in sub-Saharan Africa would lead to poor adherence and widespread drug resistance have been proven wrong, note the authors.

The authors conclude “as antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counselling should be implemented to decrease the development of treatment failure and spread of resistant HIV.”

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New recommendations to reach 2015 goals for AIDS response

Via unaids.org

Thirty years into the AIDS epidemic, investments in the AIDS response are yielding results, according to a new report released today by United Nations Secretary-General Ban Ki-moon.

Titled Uniting for universal access: towards zero new HIV infections, zero discrimination and zero AIDS-related deaths, the report highlights that the global rate of new HIV infections is declining, treatment access is expanding and the world has made significant strides in reducing HIV transmission from mother to child.

Between 2001 and 2009, the rate of new HIV infections in 33 countries—including 22 in sub-Saharan Africa—fell by at least 25%. By the end of 2010, more than 6 million people were on antiretroviral treatment in low- and middle-income countries. And for the first time, in 2009, global coverage of services to prevent mother-to-child transmission of HIV exceeded 50%.
 
“World leaders have a unique opportunity at this critical moment to evaluate achievements and gaps in the global AIDS response,” said Secretary-General Ban Ki-moon at the press briefing in the Kenyan capital. “We must take bold decisions that will dramatically transform the AIDS response and help us move towards an HIV-free generation.”  
 
“Thirty years into the epidemic, it is imperative for us to re-energise the response today for success in the years ahead,” said UNAIDS Executive Director Michel Sidibé, who joined Mr Ban for the launch of the report. “Gains in HIV prevention and antiretroviral treatment are significant, but we need to do more to stop people from becoming infected—an HIV prevention revolution is needed now more than ever.”

Mobilizing for impact  In the report there are five recommendations made by the UN Secretary-General to strengthen the AIDS response:

• Harness the energy of young people for an HIV prevention revolution;
• Revitalize the push towards achieving universal access to HIV prevention, treatment, care and support by 2015; 
• Work with countries to make HIV programmes more cost effective, efficient and sustainable;
• Promote the health, human rights and dignity of women and girls; and Ensure mutual accountability in the AIDS response to translate commitments into action.

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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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