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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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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The road to PrEP: trials, regulation and roll-out

via aidsmap.com, by Gus Cairns

Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence summit, Controlling the HIV epidemic with antiretrovirals, was told on 12 June.Some of these studies are underway but others are still in the design stage or in need of funding.

Dr Jim Rooney of Gilead Sciences, the manufacturer of tenofovir (Viread) and Truvada (tenofovir and FTC), the products being tested in the vast majority of these studies, told the meeting that up to 13,000 men who have sex with men (MSM) could end up being involved in 14 different studies and up to 19,500 heterosexual men and women in eight studies. These studies were particularly crucial in establishing whether PrEP might be less, or more, effective in open-label settings than in randomised placebo-controlled trials.

Some of these are ongoing or open-label extensions of studies such as Partners PrEP in 4758 sero-different couples in Kenya and Uganda, or iPrEx OLE (Open Label Extension) in 1500 MSM in six countries. 

Others are just beginning, such as the IPERGAY study of intermittent PrEP in gay men in France. While it is planned that this could eventually include 1900 men, researcher Bruno Spire told the IAPAC meeting that 300 participants had to be enrolled by February 2013 if the next phase of the study was to be funded, and that recruitment had been rather slow so far, partly because of "ideological obstacles" to there being a placebo arm.

Similarly, Dr Sheena McCormack of the UK's Medical Research Council told the meeting that, while the planned UK PROUD study of immediate versus delayed PrEP could eventually include 5000 MSM, only a pilot project in 300 MSM has so far been proposed, with a tentative start date (if the protocol is agreed) in October 2012. 

Read the rest.

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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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CROI 2012: Recent Results Presented by Partners PrEP Study

via MedPage Today, by Michael Smith

Giving anti-retroviral drugs to HIV-negative people can reduce their risk of acquiring the virus from an HIV-positive partner, a researcher said here.

In a large randomized controlled trial in Africa, this type of pre-exposure prophylaxis, or PrEP, cut the risk of infection by up to 75% compared with placebo, according to Jared Baeten, MD, of the University of Washington Seattle.

The so-called Partners PrEP study is "clearly proof of concept" that treating the uninfected partner in a heterosexual couple can be a good approach to prevention, Baeten told reporters at the annual Conference on Retroviruses and Opportunistic Infections.

The trial is a mirror image of the major study reported last year – the HPTN 052 trial – that found that treating the infected member of such couples reduces the risk of transmission by more than 90%.

Given those findings – and the increasing desire of physicians to treat HIV-positive people as early as possible – the results of Baeten's study may fall on stony ground.

But Baeten told MedPage Today he thinks there will be a place for treatment of the negative partner.

Taken together, the two studies show "a high degree of protection with the use of anti-retrovirals," he said.

But in the heterosexual epidemics in much of the developing world, he said, people face "difficult choices about individual treatment, individual risk, and risk decision making, often related to the desire for pregnancy."
When, for one reason or another, the HIV-positive partner can't start treatment or doesn't want to start, offering therapy to the other partner makes sense, he said.

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.]

FEM PrEP Study Releases Trial Results

via MedPage Today, by Ed Susman

Pre-exposure prophylaxis with antiretroviral drugs failed to prevent women in Africa from becoming infected with human immunodeficiency virus (HIV) – apparently because more than half the women failed to take their medication.

The incidence of HIV infection among previously uninfected women treated with a co-formulation of emtricitabine and tenofovir (Truvada) was 4.7 per 1,000 person-years compared with a rate of 5 per 1,000 patient-years among women in the placebo group (P=0.81), said Lut Van Damme, MD, PhD, senior scientist at FHI 360, in Durham, N.C.

In a press briefing here at the Conference on Retroviruses and Opportunistic infections, Van Damme said it was likely that lack of adherence resulted in the failure to show a difference between those women on the active antiretrovirals and those who received placebo.

"The women in the study seriously overestimated adherence," she said. The participants told researchers that they took their assigned medicine 95% of the time. Pill counts indicated that 85% of the pills were not returned at regular points in the trial. But tests for emtricitabine/tenofovir in the blood of patients showed that only about 40% of the women had levels of the drug that would indicate the pills had been ingested within 48 hours of the tests.

The study was stopped early when an interim analysis showed that it was unlikely to prove positive.

The so-called FEM-PrEP was a randomized, double-blinded, placebo-controlled trial of once-daily oral emtricitabine/tenofovir. The primary effectiveness endpoint was incident HIV infection during 52 weeks of follow-up.

Participants attended screening, enrollment, and follow-up visits monthly. HIV seroconverters were taken off the product and followed for an additional 52 weeks

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.]

Pros and Cons of Treatment as Prevention

via a&u, by Jeannie Gibbs

Post-exposure prophylaxis (PrEP) is the provision of antiretrovirals (ARVs) to HIV-negative people in order to prevent HIV infection. In light of recently released data, a heated debate is raging in the HIV community on how and if PrEP should be implemented. A vast array of ethical, financial, and medical concerns have been expressed, in fact too many to address in one article. However, most agree that PrEP (with more research), although not a single solution to preventing the continued spread of HIV, should be added to the arsenal of HIV prevention strategies where it is needed most.

Many contend that PrEP cannot be justified at the present time in all populations while millions already living with HIV are in desperate need of treatment. At the same time, the need for additional effective prevention methods, particularly among serodiscordant couples, men who have sex with men who practice unsafe sex, and disenfranchised women is immense, leading most to agree that PrEP should be explored for these groups.

Despite the concerns regarding PrEP, many in the HIV community view the recent PrEP data as a dramatic step and a valuable tool in reducing HIV transmission. “We’re excited about PrEP,” states Frank Oldham, president and CEO, National Association of People with AIDS. “Not because it will end HIV in America. It won’t and can’t. The epidemic is caused as much by poverty, homophobia, and an unfair healthcare system as it is by a virus, and no prevention tool, however promising, is going to end it until we do something about those problems. But PrEP has real promise for people for whom other prevention tools aren’t working—like sex workers, homeless youths, and women who aren’t in a position to negotiate safer sex with their partners. PrEP isn’t for everyone. We need to know more about its safety for women and adolescents. We need safeguards to make sure it isn’t given to people who already have HIV. But used wisely PrEP will save lives.”

Michael Ruppal, executive director of The AIDS Institute, echoes NAPWA’s concerns for caution and more data as well as their enthusiasm for PrEP’s potential. “The study data about PrEP offers some of the most exciting hope for stopping the transmission of HIV. With that comes a responsibility to be diligent to do more to answer long-term questions such as drug safety, efficacy, cost, access and ensuring additional studies. We all have a responsibility to educate ourselves and others about the truths surrounding PrEP and not let myths and fear drive our actions.”

Perhaps the greatest concern voiced by those both supportive and critical of PrEP is the high cost of this prevention modality. Close monitoring is essential for those on PrEP, adding to the cost of its use. Frequent HIV testing is necessary to prevent drug resistance from occurring from the use of suboptimal therapy if a person unknowingly seroconverts. Routine monitoring for ARV-related toxicities and adverse events, particularly kidney damage, loss of bone density, and changes in fat metabolism, which have been observed in clinical trials, must be conducted, as well as additional research to measure the long-term effects of ARVs on HIV-negative individuals.

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.]

First combination ARV vaginal ring for HIV prevention being tested in Phase I safety trial

via EurekAlert

In the first clinical trial of a vaginal ring combining two antiretroviral (ARV) drugs, researchers from the Microbicide Trials Network (MTN) are collaborating with the International Partnership for Microbicides (IPM) to evaluate whether the ring is safe for use in women. If the ring does prove to be safe, it could be considered for further testing, and eventually be evaluated for its effectiveness as a microbicide for protecting women against HIV infection through vaginal sex.

The trial, which is funded by U.S. National Institutes of Health and goes by the name MTN-013/IPM 026, is evaluating a ring that contains the ARVs dapivirine and maraviroc. Each of these drugs works against HIV in a different way. Dapivirine belongs to a class of ARVs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that prevent HIV from making copies of itself. Maraviroc, on the other hand, is an entry inhibitor that blocks HIV from getting inside target cells.

The dapivirine-maraviroc ring is the first combination microbicide to enter clinical trials. It is also the first vaginal microbicide containing an entry inhibitor.

The ring was developed by IPM, a non-profit product development partnership headquartered in Silver Spring, Maryland, in collaboration with Queens University Belfast (Belfast, Northern Ireland). The belief is that combining the two drugs, which act at different points in the HIV "life cycle," may provide greater protection against HIV than a single drug alone.

Globally, women comprise half of the 34 million people living with HIV. In sub-Saharan Africa, women represent nearly 60 percent of adults with the virus. In most cases women – especially young women – acquire HIV through unprotected heterosexual sex with an infected partner. Because the use of condoms is often not an option, there is an urgent need for effective prevention strategies that women can control themselves. Toward this end, vaginal microbicides in the form of a gel or a ring, for example, are being developed to provide women with new tools to protect themselves against HIV.

Vaginal rings provide slow, continuous delivery of a drug or multiple drugs to cells inside the vagina over a period of weeks or months. Marketed vaginal ring products include those used for contraceptive delivery and hormone replacement. However, vaginal rings can also be used as a vehicle for delivering potent ARV drugs into the vagina to prevent HIV infection. Because they could be used for one month at a time, vaginal rings may offer a long-acting and convenient prevention option for women.

MTN-013/IPM 026, which is now screening potential participants, will enroll 48 healthy, HIV-negative women ages 18-40 at the University of Pittsburgh, Fenway Institute in Boston and the University of Alabama at Birmingham. Researchers will evaluate the ring's safety and how well women like or are willing to use the ring. In addition, different tests will be performed to help determine how much of each drug is taken up by the cells usually targeted by HIV and whether drug levels are sustained throughout the four weeks the ring is worn.

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.]

Legal Case in India Threatens HIV Drug Access for Poorest

via The Bureau of Investigative Journalism, by Melanie Newman

"India is literally the lifeline of patients in the developing world, especially in the poorest parts of Africa…If Sec. 3(d) is overturned, it means any meaningful effort to make these vital medicines available will be put in jeopardy."

A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world.

More than 90% of drugs used to treat children with AIDS in Africa come from Indian generic manufacturers, according to the medical NGO Medicins Sans Frontieres. And if the Swiss pharmaceutical giant Novartis wins a case it has brought against the Indian government, MSF fears that supply could dry up.

Novartis is seeking patent protection for its leukaemia drug Glivec, whose patent has expired in India. It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’.

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.]

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.]

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.]

Microbicide Trials Network Statement On The Partners PrEP Study And The CDC's TDF2 Study: VOICE Study Will Continue

Via Medical News Today.

Researchers from two major HIV prevention trials announced favorable results of an approach called oral pre-exposure prophylaxis, or PrEP. One of these trials, the Partners PrEP Study, has provided the strongest evidence yet of PrEP's effectiveness.

Information from both studies will need to be fully evaluated before it can be determined what impact they will have on another major trial that is ongoing. Investigators for VOICE - Vaginal and Oral Interventions to Control the Epidemic, and the study's sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), hope to complete their evaluation as soon as possible. In the meantime, the five-arm study involving more than 5,000 women in sub-Saharan Africa will continue as currently designed.

PrEP involves the use of antiretroviral (ARV) drugs commonly used in the treatment of HIV by individuals who are not infected. In the Partners PrEP Study, researchers from the University of Washington and their collaborators in Uganda and Kenya, evaluated the safety and effectiveness of daily use of two ARVs - tenofovir and Truvada®, the brand name for a tablet combining tenofovir and emtricitabine - among men and women in a discordant relationship with a partner who is HIV-positive. The study enrolled 4,758 serodiscordant couples.

There were 62 percent fewer HIV infections among participants assigned to take the ARV tenofovir daily compared to participants who took a placebo tablet, and 73 percent fewer infections among those who took Truvada. In statistical terms, the results leave little doubt they are not due to chance. However, the study was not able to say whether Truvada or tenofovir works better than the other in preventing HIV.

The results came to light during a review conducted by Partner PrEP's independent Data Safety and Monitoring Board (DSMB) just a few days ago, on July 10. The DSMB found the results so compelling that it recommended that it stop testing in the placebo group. The research team will be making arrangements so that participants who had been randomly assigned to take a placebo tablet can instead receive one of the study's active study products. Participants in the other two groups will continue to be followed.

In the second study, a smaller trial that involved 1,200 heterosexual men and women in Botswana, researchers from the U.S. Centers for Disease Control and Prevention (CDC) found that 62.6 percent fewer HIV infections had occurred in the group of participants assigned to take Truvada than in the placebo group. The CDC team will be reporting more details about the findings of the study, known as TDF2, at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome next week.
 
Both sets of results bolster the findings of iPrEx, which late last year provided the first evidence that oral PrEP can help prevent HIV. iPrEx found Truvada - together with a comprehensive HIV prevention package - was safe and 44 (43.8) percent more effective than a placebo tablet for protecting against HIV in men who have sex with men. The two studies' favorable results also raise more questions about what happened with FEM-PrEP. Two months ago, researchers announced the trial would be stopping earlier than planned because an interim review of the study's progress by its data monitoring committee determined that even if the study were to continue, it would not be able to conclude whether or not Truvada is effective in its population of women. The study team is still collecting data. A final report is not expected until late this year or early 2012.

Few conclusions can be drawn from the CDC study concerning the effectiveness of Truvada specifically in women. And although Partners PrEP found tenofovir and Truvada worked well for both men and women, the study provides more information about how these drugs can protect heterosexual men from getting infected than it does about how these drugs can protect women from getting infected from a partner with HIV. That's because in most of the 4,758 couples enrolled (62 percent) it was the male who was the uninfected partner.

VOICE involves 5,029 women from Uganda, South Africa and Zimbabwe. VOICE is testing not only daily use of an ARV tablet - Truvada or tenofovir, but also a vaginal microbicide containing tenofovir in gel form. VOICE is the only trial evaluating both a tablet and a gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women may prefer.
 
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 HIV Prevention Research Roadmap

Via our friends at AVAC.

Where: Rome, Italy

When: July 17 - July 20, 2011

The IAS Conference on HIV Pathogenesis, Treatment and Prevention is held every two years, and this year it will take place in Rome, July 17-20. The 2011 conference has a program that includes many sessions on a range of HIV-related topics. AVAC has compiled a roadmap that includes the range of HIV prevention research-related sessions planned for the conference. You can download a PDF of the current roadmap here (both detailed and abridged versions).

Or view the conference's Programme-at-a-Glance system, go to pag.ias2011.org and select the HIV Prevention from the roadmap drop-down menu.


AVAC is working with various partners on the following sessions that may be of interest:

Sunday, July 17


•10:15–13:15: Satellite, MR 1: Controlling the HIV Epidemic, the Promise of ARV-based Prevention (A flyer for this session is available.)

•12:30–14:30, Satellite, MR 2: GPP in Action: Introducing the 2nd Edition of Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials and Examples of its Implementation in Current Research

•14:45–16:45: Satellite, MR 2: HIV Vaccines and the Prevention Revolution: Shortening the Path to the End of the Epidemic


Monday, July 18

•18:30–20:30: Satellite, MR 3: Pre-Exposure Prophylaxis (PrEP): How Will the Future Pipeline Look Like?


Tuesday, July 19

•7:00–8:30, Satellite, MR 4: Zeroing out New Infections Through Prevention Tools and Technologies

•16:30–18:00, Bridging Session, SR 1: Use of Antivirals in Prevention—Current Challenges and Controversies
•18:30–20:30, Satellite, MR 3: Can We End the Epidemic?

And, for those of you who won't be attending in person, you can follow the conference proceedings from afar via regular reports from NAM, the official online partner for scientific reporting at IAS 2011, and post-conference coverage from Clinical Care Options (CCO), the official online partner for scientific analysis at IAS 2011. In addition, the Global Health Council will be blogging from the conference. Finally, you may follow IAS 2011 on Facebook and Twitter as well as AVAC on our own AVAC on our own Facebook and Twitter pages for updates.

[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.]

Project Inform Reports: Financing Recommendations for PrEP

Project Inform recently released a report titled Financing and Delivery Mechanisms to Increase Pre-Exposure Prophylaxis (PrEP) Access in Populations at High-Risk of HIV Infection. Available here, the report discusses issues related to financing for PrEP to ensure that it becomes a viable, accessible prevention method for MSM. Here as an excerpt from the executive summary of the report:

One promising new HIV prevention strategy is the use of ARVs as pre-exposure prophylaxis (PrEP) among high-risk men who have sex with men (MSM). Several clinical and cost-effectiveness studies demonstrate that PrEP has the potential to reduce HIV infection rates for high-risk MSM in a cost-effective way. However, policymakers continue to face questions regarding how to improve drug adherence, offer services to the most high-risk individuals including African-American and Latino MSM and transgender women, and ensure that adequate financing mechanisms are in place to pay for the many biomedical and behavioral components of PrEP.

Policymakers seeking to increase PrEP access must further contend with the current political reality of constrained financial resources for public health assistance, including for state Medicaid programs and for HIV prevention programs that serve individuals at high-risk of HIV infection. Strategic opportunities for financing and delivery still exist, but numerous public and private sources will need to be mobilized for PrEP to reduce HIV infections in significant numbers.

Key financing and delivery opportunities include Gilead’s application for FDA approval of a prevention label for Truvada; National Institutes of Health (NIH) and Centers for Disease Control (CDC) funding for demonstration projects in San Francisco, Boston, and other U.S. cities; private and public health insurance coverage for PrEP; a Gilead-funded Patient Financing and Delivery Mechanisms to Increase PrEP Access 5 Assistance Program to help low-income patients pay for PrEP; and opening the PrEP drug market to non-Truvada PrEP formulations. Given that new clinical and cost evidence for PrEP is expected to arrive from a variety of studies and projects in the coming years, policymakers will need to adapt their implementation of PrEP accordingly.

Policy Recommendations:
The recommendations in this report are designed to help HIV policymakers and advocates like Project Inform improve PrEP access in a manner that is clinically effective, cost-appropriate, and politically feasible in line with existing research and evidence.

Consequently, this report recommends the following:
          1.) Support Gilead’s request for FDA approval of a prevention label for Truvada
          2.) Encourage the NIH and CDC to finance demonstration projects
          3.) Ensure public insurance coverage for PrEP through state Medicaid programs
          4.) Ensure private insurance coverage for PrEP
          5.) Advocate that Gilead develop a Patient Assistance Program (PAP) for PrEP
          6.) Encourage non-Truvada PrEP formulations and promote price breaks for Truvada
          7.) Promote PrEP in tandem with other combination approaches to HIV prevention

[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.]

AIDS Summit at the UN: Not Enough Talk About Sex

Via the Huffington Post, by Evelyn Leopold.

World leaders gathered at the United Nations to mark the 30th anniversary of the HIV/AIDS epidemic and put out a 102-paragraph declaration. Adrienne Germain, the president of the International Women's Health Coalition (IWHC), has been working on women's issues all her adult life and was active in the 1994 Cairo conference on women, also known as the CPD (International Conference on Population and Development). In an interview with the Huffington Post, Germain and Alexandra Garita, an international policy program officer at IWHC, discuss the declaration and the controversies that arise whenever sex is on the agenda. The declaration, produced every five years, gives U.N. agencies a mandate for their programs and advises governments where best to spend monies.

Q: What about access to family planning, to birth control?

AG: We lost reproductive rights and reproductive health language from the 1994 Cairo document and from early drafts here. Reproductive rights, for example, also includes the right to freely and responsibly decide on the number and spacing of one's children. If you lose that and you have no reference to family planning services in the document, then you basically have no reference to contraception for women. You also don't have protection for women living with HIV who are sterilized without their consent and who are forced to have abortion. It is not a rare occurrence in southern Africa (including South Africa).

Q: And how about the new studies on early intervention of Antiretroviral drugs (ARV) to reduce transmission, which are welcomed as a major breakthrough?

An important development is using ARV treatment much earlier in a person's life in order to reduce the amount of virus in the body. Therefore the person will be less able to transmit the virus to someone else and you can use treatment as prevention. In this document, it is treated as a miracle breakthrough. We don't look at it that way. Probably about half the people in the world who are living with HIV don't know it. You are most infectious right after you have been infected. But at that time you have no symptoms at all so why would you go forward with testing? So to think that a medicine, a drug, is going to end this epidemic when we don't even know how to get more people to come forward for testing -- is really foolish. But debates on how best to end the epidemic go on all the time -- how we should all be giving much more time to prevention. Yet this document ends up with four paragraphs -FOUR!-on prevention. Does that make much sense? No. Not in our book.

Q: Homosexuals and prostitutes were a big issue five years ago, even among some delegates from the Bush administration. Has this changed?

They are in the document for the first time. There was one paragraph that names the community of drug users, men who have sex with men and sex workers. That is very good. But this listing is used once only and then there is UN mumbo-jumbo in other paragraphs where you should have specific references about the kinds of interventions needed to reach this population and what they face in their lives. And there is nothing on human rights for these people (despite the UN secretary-general's speech).

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.]

Bloomberg Editorial: Treatment has Grown, Prevention Has Languished

via Bloomberg

AIDS has been with us, officially, for 30 years, since the U.S. Centers for Disease Control and Prevention reported the first cases. This unhappy anniversary is perhaps as good a time as any to spell out why the global response to AIDS is in need of serious adjustment.

Annual spending on AIDS worldwide has risen to $15.9 billion. The bulk of this money goes to the treatment and care of indigent people who are HIV-positive. Without question, the investment in anti-retroviral therapy, or ART, has saved lives. Today, the treatment is provided to about 36 percent of those in the developing world who qualify for it under World Health Organization guidelines.

United Nations member states have pledged to raise that to almost 100 percent. Universal treatment has become the principal mission of many AIDS organizations around the world; governments and philanthropies have followed their lead.

The idea of treating everyone who has the human immunodeficiency virus, regardless of ability to pay, is laudable. The problem is, the laudable runs the risk of crowding out both the practical and the doable. As programs for treatment have grown, those focused on prevention have languished or gotten short-shrift.

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.]

NEWS ROUNDUP: Early HIV Treatment Can Reduce Transmission Risk By 96%, Study Results Show

via Kaiser Family Foundation


Results from a multicountry clinical trial, sponsored by the National Institute for Allergy and Infectious Diseases (NIAID), show that HIV-positive people who take combination antiretroviral therapy (ART) can reduce the risk of transmitting the virus to their HIV-negative partners by 96 percent, U.S. researchers announced on Thursday "[i]n what is being hailed as a breakthrough in HIV prevention," the Los Angeles Times reports (Maugh, 5/13).

The randomized controlled trial, run by the HIV Prevention Trials Network and named HPTN 052, was meant to run another four years, but an interim analysis by an independent monitoring group prompted NIAID to halt the trial and release the results, ScienceInsider writes. The study, conducted since 2005 at 13 sites in nine countries, recruited 1,763 couples, 97 percent of whom were heterosexual, in which one partner was HIV-positive at enrollment. None of the HIV-positive partners had taken ART, and their CD4 cell counts, a measure of the immune system's health, were between 350 to 550. "Half the participants received immediate treatment, and the other half did not start [therapy] until their CD4 count dropped to 250 or they developed an AIDS-related symptom, according to ScienceInsider (Cohen, 5/12).

Analysis "identified 39 new cases of HIV among the previously uninfected partners. In 28 of these cases, genetic analysis confirmed that one partner had infected the other. Of these 28 infections, 27 – or 96 percent – occurred among couples in which the HIV-infected partner did not start antiretroviral therapy immediately," HealthDay/U.S. News reports (Reinberg, 5/12). The couples were all counseled on safe sex practices, given free condoms and provided treatment for sexually transmitted infections, BBC News adds (Gallagher, 5/12).

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID Director Anthony Fauci said in a statement (5/12).

The New York Times notes that though the trial was "relatively large," there are limitations to interpreting the results for other populations, like men who have sex with men, because nearly all "of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual" (McNeil, 5/12).

Treating HIV-positive participants early also improved other health outcomes, the Los Angeles Times reports, noting that the results showed 17 cases of disseminated tuberculosis (TB) among those whose treatment was deferred compared with three cases among the treatment group (5/13). According to Bloomberg News, researchers will continue to monitor study participants to determine whether treatment benefits persist (Cortez/Bennett, 5/13).

Treatment As Prevention

"Until now, antiretroviral therapy was known to improve the health of people infected with human immunodeficiency virus, but this is the first study to show a solid impact on preventing transmission to an HIV-negative partner," Agence France-Presse reports (Sheridan, 5/12).

Though the preliminary results "are likely to end, or at least diminish, a bitter feud within the AIDS world over how much funding should go to treatment versus prevention," funding "will be a major obstacle," the Wall Street Journal writes. With more than five million HIV-positive people on treatment at the end of 2009, and another 10 million in need of the drugs based on international treatment guidelines, UNAIDS has estimated a treatment funding shortfall of more than $7.5 billion, the Wall Street Journal notes (Schoofs/McKay, 5/12).

Observational studies have shown a benefit to early HIV treatment, leading UNAIDS last year to adopt "as its goal" a "test and treat" policy that "encourages doctors to start people on treatment as soon as they test positive for HIV," the New York Times states. Still, "[f]or lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists," the newspaper adds (5/12).

UNAIDS Executive Director Michel Sidibe said, "This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option," adding, "Now we need to make sure that couples have the option to choose treatment for prevention and have access to it," according to Reuters (Steenhuysen, 5/12). Sidibe said "he hopes the new results will compel pharmaceutical companies to lower the price of ARVs as the demand for the drugs expands," that "new partnerships will form to advocate for increased funding and that the findings will be prominently discussed next month at the United Nations High Level Meeting on AIDS in New York City," ScienceInsider reports (5/12).


[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.]

ARVs Dramatically Reduce Risk of Passing HIV to Healthy Partners

via Health Behavior News Service, by Glenda Fauntleroy

When one partner in a couple is infected with HIV and the other is not, treatment with antiretroviral drugs can dramatically lower the chances of the infected partner passing along the disease to his or her mate, a new evidence review finds.

Patients with HIV receive a combination of drugs is given as part of antiretroviral therapy (ART) to stop progression of the disease. The new review discovered that when patients with HIV are on ART, their partners had more than a five-fold lower risk of getting the virus than in couples without treatment.

“We weren’t particularly surprised having followed this literature for awhile,” said reviewer George Rutherford of Global Health Sciences at the University of California, San Francisco. “The magnitude of the effect was somewhat surprising, though.”

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.]