Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

At the recently concluded XIX International AIDS Conference (AIDS 2012), not only the decibels went up on ending AIDS but also sane voices were heard demanding a well-costed and thought-through strategy on how to end AIDS. One of the strategies that will complement a comprehensive HIV prevention, treatment, care and support plan to end AIDS is preventing HIV transmission. In this context, we need to look beyond the Phase III trials in HIV prevention research so that if the product being tested is proved to be effective, we have the means and well-thought plan to make it available for those people in need, without delay.

The HIV prevention research is certainly going ahead with rectal microbicides phase II efficacy clinical trials (MTN017) about to begin in four countries (US, Thailand, South Africa and Peru), US FDA's approval to use 'Truvada' as pre-exposure prophylaxis (PrEP) for HIV prevention, vaginal microbicides research and HIV vaccine science progressing ahead, treatment as prevention (TasP) getting a buy-in as never before, among other positive developments that give us hope.

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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.

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PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, by Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc. Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place. One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP. The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP. In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

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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*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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aidsmap: NICE says sperm washing is no safer than effective treatment and timed intercourse

via aidsmap.com, by Roger Pebody

Draft UK guidance on fertility treatment says that sperm washing may no longer be necessary for couples where the man has HIV and the woman does not. As long as the man is on effective antiretroviral treatment and unprotected sex is limited to days when his partner is ovulating, “sperm washing may not further reduce the risk of infection.”

On the other hand, the guidance does not support the use of pre-exposure prophylaxis (PrEP) by the HIV-negative partner.

The National Institute for Health and Clinical Excellence (NICE) is an influential body which issues recommendations to the NHS about the most effective and cost-effective treatments to provide. Their draft guidance on fertility treatments – an update to a document previously issued in 2004 - was issued today and is open for consultation.

As in the previous version, people with HIV are not excluded from access to fertility treatments, such as intrauterine insemination (IUI) or in vitro fertilisation (IVF). Moreover the authors have removed a previous recommendation that the implications of the parent’s HIV infection for the child’s welfare “should be taken into account”.

The writing group reviewed in detail the scientific evidence for different methods that a couple could use to become pregnant, where the man has HIV and the woman does not. Previous guidance recommended sperm washing, but the experts also looked at the evidence for effective antiretroviral treatment and for pre-exposure prophylaxis.

“The evidence showed that whilst sperm washing did not appear to completely eliminate the virus in the semen on the basis of post-wash testing of prepared semen, the procedure appears to be very effective in reducing viral transmission in that no cases of seroconversion of the woman or the baby has been documented,” they found.

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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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Digital Technologies Changing the face of HIV Prevention

via Advocate.com, by By Gurmit Singh & Christopher S. Walsh

Why are we so fixated on finding a medical solution when, as social networks revolutionize sex in our community, gay men are successfully using new technology to combat HIV?

More and more gay men are hooking up online. The explosion of “Gaydar culture” through Xtube, Manhunt, Adam4Adam, and Grindr can increase risky sexual behavior, spawning fears of a new wave of HIV infections, particularly among young gay men. Yet, as new digital technologies change the way we enjoy sex and experience relationships, they are also changing the face of the AIDS response in remarkable ways.

In recent years, the global AIDS establishment has become fixated on medical approaches to HIV prevention. The success of antiretroviral therapies and new clinical trials on pre-exposure prophylaxis (PrEP) have transformed the field, and “Treatment as prevention” is now promoted by the US PEPFAR, UNAIDS and the WHO.

The prospect of ending the HIV epidemic with a simple pill is seductive – but falsely so.

Fuelled by disparity and discrimination, HIV slams communities on the margins of society. Gay men have experienced this since the beginning of the epidemic, yet the medical establishment continues to advocate for chemical “quick fixes” to an exceedingly complex social problem. We cannot let these medical – albeit important – scientific advances distract us from what social science researchers have been telling us for years: the roots of this epidemic lie in the lack of health and human rights for gay men, other men who have sex with men (MSM) and transgender people in the developed and developing world.

Fortunately, just as we did at the beginning of the AIDS epidemic, our communities are taking the lead in tackling these fundamental challenges. As digital technologies become integral to our lives, they have become equally central to innovative HIV education, prevention and care efforts. These technologies enable us to work together in ways never before possible, offering unprecedented opportunities to tackle the many barriers that make our communities vulnerable to HIV.

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

Researchers Report that PrEP May Be Accepted as HIV Prevention in UK's Gay Men

via AIDSmap.com, by Roger Pebody

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

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

The Challenges that Arise When Using ARV's as HIV Prevention

via AIDSmeds, by Tim Horn


Excerpt:

A key question from HPTN 052 is whether the results can be generalized to other contexts, Cohen and his colleagues explain. Examples include heterosexual couples with CD4 counts lower and higher than those studied in HPTN 052; high-risk heterosexual individuals, notably sex workers and their clients; men who have sex with men (MSM); and injection drug users (IDUs).

With regards to MSM and IDUs, the authors note, a World Health Organization expert committee concluded that there is no reason to presume that treated, HIV-positive MSM will not be rendered less contagious as a result of ARV therapy. “However,” Cohen and his colleagues write, “the biology of HIV transmission is sufficiently different in IDU and MSM as compared to heterosexual transmission, warranting further consideration and study.

“For example, the number of HIV variants acquired and the efficiency of transmission are higher in MSM and IDU than in heterosexual transmission,” they note in recalling one study. “Additionally, whether [ARV therapy] reduces infectivity through anal sex by the same order of magnitude as for vaginal sex remains uncertain. Although such an effect is widely assumed, this is a key missing piece of evidence.”

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

Microbicides Conference Changing to a More Integrated HIV Prevention Conference

via AIDSmap.com, by Gus Cairns

The International Microbicides Conference held in Sydney this week will be the last of its kind, delegates were told in a closing plenary today.

From 2014 onwards, it is planned, a single biennial conference on all aspects of HIV prevention will be held.
Globally, the two largest funders of HIV prevention research are the US National Institutes of Health's Office of AIDS Research and the Bill and Melinda Gates Foundation. Gina Brown of the Office of AIDS Research and Stephen Becker of the Gates Foundation shared the podium to make a joint speech outlining the reasons for no longer funding separate conferences, and instead convening a programme committee to plan a biennial global HIV prevention conference.

They said they were proposing an "integrative prevention meeting" in recognition of the fact that no one HIV prevention method is likely to end the epidemic and that different methods can be synergistic. Stephen Becker said that the demand for a more integrated approach to HIV prevention “was being voiced from the ground up", by community advocates and NGOs, as well as by donors who wished to see more efficiency and less duplication of effort within the field.

Cross-cutting dialogue between specialists pursuing different areas is more likely to generate combinations of prevention approaches than individual approaches being pursued in neighbouring research 'silos', Becker added.

There was duplication of effort in some areas. Much of the animal-model and mucosal-immunity work being done in the HIV prevention technologies underlay HIV vaccine development as much as it did microbicide development. he said. And, he added, the social and behavioural research that underpinned prevention technology research by helping to understand which populations need what HIV prevention methods formed the same backdrop, whether what was being developed was a vaccine, a microbicide or the roll-out of a circumcision programme.

Gina Brown said that a world HIV prevention conference planning committee would be convened immediately, comprising experts from all fields including social sciences and community advocacy. In common with the international microbicides conferences, which have been held biennially since 2002, the last of the the annual AIDS Vaccine conferences, which started in 2000, will be held in 2013 in Barcelona. Other prevention conferences, such as next week's second international Treatment as Prevention Workshop in Vancouver, will also no longer receive funding as separate events.

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

HIV/AIDS Treatments Compromised by Budget Cuts

via Nature News, by Erika Check Hayden

Preventing the spread of HIV used to mean testing people for infection and encouraging them to practise safe sex. Increasingly, it also means prescribing drugs, as studies show that giving infected people or their uninfected partners antiretroviral drugs as soon as an infection is diagnosed can help to check the spread of AIDS.

Yet at this week’s annual Conference on Retro­viruses and Opportunistic Infections in Seattle, Washington, there was growing concern that financial austerity in the United States and elsewhere is eating away at the funding needed for a worldwide prevention effort.

Many scientists and advocates agree that there is now an “awesome possibility to prevent the spread of HIV”, says Sharonann Lynch, HIV policy adviser for Médecins Sans Frontières (MSF, also known as Doctors Without Borders) in New York. “If we decrease the money invested in treatment now, we are squandering the best opportunity we’re going to have to get ahead of the wave of new infections.”

Last month, US President Barack Obama’s 2013 budget request proposed a 10.8% cut to direct international aid for HIV programmes under the President’s Emergency Plan for AIDS Relief (PEPFAR) which, together with previous cuts, would slice more than US$1 billion from the fund’s 2010 level (see ‘Sliding support’). And last November, the Global Fund to Fight AIDS, Tuberculosis and Malaria said that it would not hand out any more funds for scaling up AIDS treatments until 2014 because of tightening budgets in donor countries (see Nature 480,159–160; 2011).

The shortfalls come as a slew of results presented this week reinforce a growing consensus about the power of early treatment for HIV infections. The latest data are part of a trend that accelerated last May, when HPTN 052, a clinical trial run by the multinational HIV Prevention Trials Network, showed that giving antiretroviral drugs to people who are HIV-positive can stop them from passing the virus to their uninfected partners (M. S. Cohen et al. N. Engl. J. Med. 365, 493-505; 2011). In light of such results, the World Health Organization is expected to issue new guidelines for managing HIV in couples soon.

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

Concerns about Gilead's Truvada used as HIV Prevention

via Financial Times, by Christine Livoti

Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.

Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.

Truvada has not been approved yet as a preventative therapy in HIV.

Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.

Slow uptake thus far

This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.

The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.

He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.

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

PrEP: Attitudes and Acceptance Among Potential User Groups

via PLoS One, by Andreas B. Eisingerich, Ana Wheelock, Gabriela B. Gomez, Geoffrey P. Garnett, Mark R. Dybul, Peter K. Piot

Background

The use of antiviral medications by HIV negative people to prevent acquisition of HIV or pre-exposure prophylaxis (PrEP) has shown promising results in recent trials. To understand the potential impact of PrEP for HIV prevention, in addition to efficacy data, we need to understand both the acceptability of PrEP among members of potential user groups and the factors likely to determine uptake.

Methods and findings

 Surveys of willingness to use PrEP products were conducted with 1,790 members of potential user groups (FSWs, MSM, IDUs, SDCs and young women) in seven countries: Peru, Ukraine, India, Kenya, Botswana, Uganda and South Africa. Analyses of variance were used to assess levels of acceptance across different user groups and countries. Conjoint analysis was used to examine the attitudes and preferences towards hypothetical and known attributes of PrEP programs and medications. Overall, members of potential user groups were willing to consider taking PrEP (61% reported that they would definitely use PrEP). Current results demonstrate that key user groups in different countries perceived PrEP as giving them new possibilities in their lives and would consider using it as soon as it becomes available. These results were maintained when subjects were reminded of potential side effects, the need to combine condom use with PrEP, and for regular HIV testing. Across populations, route of administration was considered the most important attribute of the presented alternatives.

Conclusions

Despite multiple conceivable barriers, there was a general willingness to adopt PrEP in key populations, which suggests that if efficacious and affordable, it could be a useful tool in HIV prevention. There would be a willingness to experience inconvenience and expense at the levels included in the survey. The results suggest that delivery in a long lasting injection would be a good target in drug development

Read the full study here.



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

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.

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

Behavioral or Biomedical... Or both?!

via gaycitynews.com, by Perry N. Halkitis, Ph.D., M.S

"But is this radical shift from the behavioral to the biomedical the right course of action for all of us?

 

For me there are two bigger issues — one which I will fully address here, and the other to which I will allude."

Despite our best attempts over the last 30 years, the HIV epidemic continues unabated. There are 1.2 million identified infections in the United States, with another several hundred thousand likely undiagnosed. The impact of this ongoing health challenge is noted most dramatically and definitively evidenced among gay men, who represent somewhere in the vicinity of two to five percent of the population — but constitute 50 percent of all AIDS-related deaths, over 50 percent of all infections and over 50 percent of newly diagnosed infections.

With millions and millions of dollars spent on HIV prevention and research — and despite the best attempts of behavioral researchers and leading AIDS service organizations to modify our risk behaviors — the epidemic continues. Initial campaigns focusing on using a condom have, over time, morphed into programs underscoring the importance of efficacy, temptation and motivation to help shape behavior. But the infections continue to spread. So what has gone wrong?

Some, including myself at times, have pointed the finger at behavioral change programs that are overly simplistic, focusing on sex as an act free of emotion or passion (and in many cases, drugs). But sex is more than simple logic, or rational decision-making. Many behavioral programs have oversimplified a very complex behavior — and the programs we have developed or the research we have enacted has ultimately failed to translate to real lives. I often wonder if the folks developing these programs actually have sex themselves.
Some may argue that we have contained the disease. But how true is that when young gay men, especially Blacks and Latinos, are seroconverting at such high rates? Even among White men, there is an uptick in the incidence of new infections as this group navigates its 30s. We simply haven’t gotten it right.

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

Don't Delay HIV Prevention for Gay and Bi Men

via The Huffington Post, by David Ernesto Munar

Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections.

With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the disease, to help prevent infection -- as part of a broad HIV prevention approach that includes condoms and safer-sex counseling.

But the longer the FDA waits before beginning its review of the HIV medication Truvada for prevention, the more lives will be unnecessarily lost. This is particularly true for those at greatest risk: gay and bisexual men.

We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men.

Last year the iPrEX trial, touted as the scientific breakthrough of the year by TIME magazine, found that gay, bi and other men who have sex with men who took Truvada, along with counseling and condoms, had 42 percent fewer HIV infections than with counseling and condoms alone. Among those who used the prevention pill most consistently, the drop in infections was far greater.

And remember the sobering context: between 2006 and 2009, the number of young gay African-American men infected with HIV in the United States increased by 48 percent, according to the U.S. Centers for Disease Control.

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

Treatment alone will not win war against HIV

via Cape Argus, by Sipokazi Fokazi

If South Africa is to win the battle against HIV/Aids it cannot rely solely on treatment, and must explore prevention strategies that would target those most at risk, including women and children, a Cape Town scientist and HIV researcher has cautioned.

Professor Linda-Gail Bekker, head of the Desmond Tutu HIV Centre, at UCT, said although the effect of HIV treatment was starting to show with the number of deaths beginning to even out, the country would not win the battle with treatment alone.

Bekker was speaking during a meeting hosted by the Microbicide Media and Communication Initiative, an advocacy group that gathers research in microbicides by a range of organisations.

She warned that reliance on treatment would at some stage become unaffordable and unsustainable.

Finance continued to be a problem for many countries, and paying for antiretroviral drugs was becoming expensive.

“Given the financial difficulties, countries will somehow have to come up with plans on how to bring infection levels down.”

The focus needed to be on strategies that achieved behavioural change.

One of the most important things for South Africa was knowing its epidemic – who was most at risk, who was passing HIV to whom, and where the epidemic was concentrated.

UNAids information was that four population groups remained at risk: men who had sex with men, commercial sex workers, prisoners, and intravenous drug users.

In South Africa, young women and pregnant women could be added to that list.

Bekker suggested targeting, directing and tailoring prevention interventions to reduce infection rates.

“You need to know where most of your infections are occurring, and then to work out how best to intervene. I believe it has been a mistake to think one size fits all,” she said.

One area in which South Africa could start shutting the door was in the mother-to-child transmission of HIV.

“We need to wipe out paediatric infection.”

South Africa could not afford to allow transmission of the virus from mother to child.

“If we don’t prevent this, those children will need treatment for the rest of their lives and it will be expensive for the country. We can bring our mother-to-child HIVinfection rate to below 1 percent.”

Researchers had made great strides in HIV prevention studies, particularly in the field of microbicides.

Bekker said it was important that prevention packages be tailored to population groups that were most at risk.

Such strategies would have to take into account biomedical, behavioural and structural components.

“We are in a very exciting period where a whole range of biomedical technologies are showing partial but significant efficacy. Combinations of these prevention technologies in the future will give people options.”

Among the most promising interventions being researched by the Desmond Tutu HIV Centre and its partners was a rectal microbicide, for those practising anal sex. The proposed study would be carried out here and in other places around the world.



[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.]

Questions Surround PrEP Trials

via The New York Times, by David Tuller

In the past year, three landmark clinical trials have shown that a daily dose of the antiretroviral medication Truvada can protect individuals from infection with H.I.V. — a significant discovery, given the failure so far of all efforts to develop a vaccine against the virus.

Now researchers in San Francisco and Miami are planning to test this prevention strategy, called pre-exposure prophylaxis, or PrEP, in a pilot study supported by the National Institutes of Health. The researchers will soon recruit up to 500 uninfected men who have sex with men, especially those considered to be at greatest risk of infection, such as younger gay men and, in particular, African-Americans.

The men will be asked to take Truvada daily, and the researchers will monitor their compliance with the regimen, their sexual behavior and their health status. Already, though, the prospect of antiretroviral drugs’ being used for prevention as well as treatment is raising complex questions for researchers and advocates.

Will healthy uninfected people consistently take an expensive and powerful drug that can cause a range of side effects? Is it fair to provide medications to H.I.V.-negative individuals when so many of those already infected do not have access? Will those receiving the drug be more likely to engage in risky sex because they believe they are protected — even if they do not always take it as prescribed?

Read the rest.


[If an intem 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.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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.]

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.]