PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, 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.

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Mapping Pathways @ TasP and PrEP summit in London

Original content from the Mapping Pathways blog team

While last year was all about data collection for the Mapping Pathways project, this year our core mission is to disseminate findings and liaise with the global HIV-treatment and prevention community at large around the use of ARVs for prevention.

Mapping Pathways members will have the chance to do just that in London this week.  The International Association of Physicians in AIDS Care (IAPAC), in partnership with the British HIV Association (BHIVA), is currently hosting an evidence summit (June 11 and 12) titled “Controlling the HIV Pandemic with Antiretrovirals: Treatment as Prevention and Pre-exposure Prophylaxis."

Jim Pickett from the AIDS Foundation of Chicago, will be representing Mapping Pathways and presenting some PrEP-specific findings at the summit. Ben Brown, another member of the Mapping Pathways team from the Desmond Tutu HIV Foundation, is also on a panel, and RAND team members Molly Morgan Jones and Joanna Chataway will be attending.

“The summit brings together a whole mix of people – from community advocacy organizations, drug companies, insurance companies, researchers, policymakers and advocates from 50 countries – both global north and global south. All actors that have a stake in HIV-prevention and treatment will be there. There will be a goldmine of information and a good opportunity to talk about the Mapping Pathways project and what we’re trying to accomplish,” says Pickett.

The summit will serve as a forum for the presentation of data and discussion about the implementation of Treatment as Prevention (TasP – which Mapping Pathways refers to as TLC+) and PrEP in different settings.

An important deliverable of the summit is a consensus statement outlining some key TasP and PrEP implementation recommendations which would then be disseminated at the International AIDS Conference in Washington, DC this summer and to IAPAC’s clinician network in over 100 countries as well as with their other medical and nursing tie-ups worldwide.

We will share Jim’s slides on the blog, and provide a link to all the presentations made at the summit as well in the coming days.

Stay tuned to the Mapping Pathways blog for news and updates from the IAPAC summit and the upcoming AIDS 2012 conference in July in Washington D.C.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

PrEP Provides Hope to HIV Prevention in Nigeria

via Leadership Newspapers, by Winifred Ogbebo

Like a breath of fresh air, the news that a combination prevention drug would soon hit the Nigerian market is definitely something to cheer about, given Nigeria’s high prevalence of HIV rate, which is said to be second only to South Africa in the African continent. WINIFRED OGBEBO reports.

It is like Sunday-Sunday malaria drugs. But in this case, you take HIV drug to prevent HIV and HIV negative people, says the Director-General, National Agency for the Control of AIDS (NACA), Prof John Idoko, explaining the new prevention treatment drug, pre- exposure Prophylaxis.

“From what we learnt from malaria for example,  he explains further, “if we give the drugs  to somebody who doesn’t have HIV, and the person has  sexual relationship with an HIV positive partner, it can prevent transmission from the positive person to the person. That is why it’s called a pre- exposure prophylaxis because before exposure, the person has taken the drugs and because he has the drugs in him, the virus cannot infect him or her.”

Also, Idoko says, “  If you take this sero-discordant couples; one is positive and the other is negative, instead of giving the drug to the negative person before the sexual relationship, just put the positive one on drug as soon as you know. It doesn’t matter what his CD-4 count is even if it’s 500, just give him the drugs. It has shown clearly one of the best study results that we have seen, as 96 per cent chance of the person transmitting HIV is blocked. So we call that treatment as prevention. So you can now imagine that if you go to a community, and they are using this method, your chances of blocking transmission are very high. We believe that these are the two things we need to put together as part of our combination prevention method.”

The pre-exposure prophylaxis is the newest HIV prevention tool that has been developed.    It involves the use of Truvada, an antiretroviral to prevent HIV infection. A few studies have shown the ability of this drug to prevent HIV infection in sero-discordant couples, MSMs, transgenders and in men and women.


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FDA Hearing on Truvada as PrEP - Watch the Webcast!

On May 10, 2012 the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid June.

Watch the recorded webcast here.

Check out the slide presentations here.


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New Project Initiative Involving PrEP Research Throughout California

via California HIV/AIDS Research Program

In April 2012, the California HIV/AIDS Research Program (CHRP) of the University of California awarded grants totaling $11.8 million to three collaborative teams of investigators to test a potential HIV prevention medication among high-risk HIV-uninfected persons in several communities throughout California. The studies also will examine new strategies to engage and retain HIV-infected persons in care and treatment. Both of these strategies are expected to help curb the HIV epidemic in California.

Two of the collaborative teams of investigators will offer PrEP (pre-exposure prophylaxis with antiretroviral drugs) to high-risk uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) located in Los Angeles, San Diego, and Long Beach over the next four years. These investigators also will assess the implementation of TLC+ (testing and linkage to care plus treatment), a strategy to locate, engage, and retain HIV-infected persons in care and start them on life-saving treatment for their HIV infection

A third grantee consortium will not fully implement PrEP or TLC+ at the present time, but will instead plan and pilot PrEP/TLC+ implementation strategies for young MSM of color located in Oakland, Richmond, Berkeley, and other East Bay Area locations.

PrEP involves the provision of antiretroviral drugs and risk reduction counseling to high risk uninfected persons to prevent future HIV infection among those who potentially may be exposed to the virus. Previous international research trials have shown that PrEP has been very effective in preventing new HIV infections among MSM and selected other risk populations, but only when taken as prescribed in addition to ongoing risk reduction counseling. Recent studies have suggested that the mixed results found for some populations may be due to a lack of consistent adherence to the medication, leading to suboptimal or ineffective levels of drug in the body. In addition, other studies have suggested that identification and rapid institution of antiretroviral therapy for people infected with HIV not only improves survival of those treated, but also lowers the level of HIV virus in the community and might ultimately reduce HIV transmission rates.

This will be the largest PrEP/TLC+ demonstration project initiative in the U.S., and will be the first to test PrEP in several communities throughout California. In these demonstration projects in California, PrEP will be delivered as part of a comprehensive prevention package including risk reduction counseling, sexually transmitted infection screening, and other components. Daily Tenofovir/FTC (Truvada®, a tenofovir/emtricitabine two-drug combination pill manufactured and distributed by Gilead Sciences, Inc. of Foster City, CA) based PrEP will be offered to eligible uninfected high-risk men who have sex with men, as well as to transgender women. Gilead Sciences will provide the drug product (brand name Truvada®) to support these studies. The studies will adhere to safety and implementation guidelines issued by the Centers for Disease Control and Prevention.

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Evaluation of PrEP Data and Decisions Taken in 2011

via Treatment Issues, by Deirdre Grant

More than a decade ago, “AIDS Drugs for Africa” was one of the rallying cries for a global activist movement.The meaning was simple: treat HIV-positive people with potent, life-saving medications regardless of where they live, how much money they have or who they love. These days, the phrase has more meanings than we could have ever imagined. The past two years have brought a range of data on the use of antiretrovirals for HIV prevention in HIV-negative people, as well as a preventive strategy in HIV-positive people. These developments are exciting, but the situation is far from simple. There are questions about feasibility and about levels of effectiveness observed in different trials. Today, many people want to know: Can antiretrovirals (ARVs) be used for HIV prevention in HIV-negative people? If so, which types of products, programs and for which populations is this prevention most effective?

The answers to these questions depend on several factors, including science, policy, funding, community demand, andthe future of treatment access for people with HIV. Not surprisingly, the possibility of using an ARV based prevention method in HIV-negative people generates strong opinions, both in favor of such a prevention tool and those opposed. In light of the potential, many questions have arisen including: Is it feasible? Will people actually use a pill or a gel once a day? Is it ethical, given the enduring need for ARVs for HIV-positive people worldwide? And, do we know enough from the trials to-date to describe levels of safety and effectiveness anticipated in a real world health care setting?

None of these questions have been completely answered. But over the past year, there has been a steady stream of developments that have both complicated and clarified the discussions. Mixed data on topical PrEP, such as the vaginal microbicide 1% tenofovir gel, and oral PrEP in women have left scientists and advocates perplexed. Many fear that the obstacles inherent in providing ARVs to HIVnegative people—repeated HIV testing, the need to ensure access for HIV-positive people, additional staffing requirements, and more—will overshadow the potential of these new tools. For advocates who want to see a full exploration of what ARV-based prevention can do in their communities, it’s as important as it has ever been to stay informed of developments as they emerge and maintain a firm pursuit of the ultimate goal: to curb the epidemic by preserving health in HIV-positive people and preventing as many new infections as possible.

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

NYT: PrEP Trial Results are Re-examined

via The New York Times, by Donald G. McNeil Jr.

The failure of a daily pill to protect healthy African women against AIDS may not have been the pill’s fault but the women’s reluctance to take it, scientists at an important AIDS conference in Seattle were told this week.

Last April, a promising trial of “pre-exposure prophylaxis” — giving small protective doses of antiretroviral drugs to uninfected people — was stopped early because women were getting infected anyway. It was a discouraging setback.

But scientists at this week’s Conference on Retroviruses and Opportunistic Infections who analyzed blood samples taken from the women reported that only a quarter of those who got infected had any of the drug, Truvada, in their blood. That suggested they had not taken their pills.

Papers presented at the four-day conference offered findings both optimistic and scary. There were hints at a possible way to flush the virus out of its hiding places in cells, and at ways to let some patients safely take “vacations” from triple therapy.

It is not known why so few African women took their Truvada, but there is still an enormous stigma about AIDS in Africa, and a bottle of AIDS drugs in the home implies that someone there is sick, said Mitchell Warren, executive director of AVAC, a prevention advocacy group. Mr. Warren pointed out that Truvada had protected women in a different study that enrolled established couples in which only one partner was infected.

In a different study, researchers from the University of North Carolina at Chapel Hill showed that they had used a cancer drug, vorinostat, to purge the virus hiding in the CD4 cells of six men who were already doing well on triple-therapy cocktails.

Although the cocktails can make the virus vanish from the blood, it hides in different types of cells, ready to roar back if the patient stops taking the cocktails.

Rooting some out with vorinostat “may not be the magic bullet,” said Dr. David Margolis, the study’s lead researcher, “but it suggests we can build a path that may lead to a cure.”

Another small trial, at the Wistar Institute in Philadelphia, gave patients synthetic interferon — a virus-blocker normally made by the human body — while they took “holidays” of up to six months from triple therapy. Nine of the 20 patients did not see their viruses rebound to dangerous levels. That result will not change clinical practice right away, said Dr. Luis J. Montaner, who led the study, but suggested an alternative to lifelong triple therapy, which can be debilitating.

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

BHIVA Reports on the Need for Additional PrEP Studies

via AidsMap.com, by Gus Cairns

A position statement by the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) has concluded that as yet the data on the efficacy of pre-exposure prophylaxis (PrEP) is not compelling enough for it to be offered to patients on demand, and that it should only be prescribed in the context of a clinical research study until more data on its efficacy is gathered.

The BHIVA/BASHH position contrasts with that of the US Centers for Disease Control, which issued guidance for doctors prescribing PrEP to patients last year.

The two UK organisations, which represent HIV and STI healthcare workers respectively, conducted a consultation on PrEP last year which included in-person and telephone conferences with a variety of UK treatment and prevention stakeholders in the UK (including NAM), and the creation of an ongoing PrEP Working eGroup.

The finalised position statement notes that in 2010 there was the highest-ever number of new HIV infections in gay men in the UK (over 3000, 81% acquired here) and adds that this “continued increase in infections...underscores the urgent need to...rethink our overall strategy for HIV prevention at a time when the NHS is undergoing change.”

It also however notes that the data on the efficacy of PrEP has so far been widely disparate (see Aidsmap reports on the iPrEx, PartnersPrEP, TDF2, FemPrEP and VOICE trials), in contrast to convincing evidence both for the efficacy of condoms when used consistently and correctly and of treatment as prevention.

It also notes that these are many unanswered questions in the case of PrEP: will it be affordable and cost-effective? Will it increase the likelihood of drug resistance? Are there long-term toxicity concerns for HIV-negative people taking it? And will it induce people to abandon condom use? It also notes there has never been a systematic evaluation of behaviour-change programmes in the UK, also in contrast to the US.

It concludes that “it is imperative to gather [more] evidence for the value of PrEP in the UK” and that therefore “We recommend that ad hoc prescribing is avoided, and that PrEP is only prescribed in the context of a clinical research study”. Until then, “regular HIV testing, the diagnosis and treatment of other STIs, and intensive health promotion activities...should be implemented in preference to PrEP.”

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

Researchers Explain the Role of Adherence in PrEP Trials at CROI 2012

via AidsMap.com, by Gus Cairns

Adherence makes all the difference to the efficacy of pre-exposure prophylaxis (PrEP), the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard today.

Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year.

In April 2011, the FEM-PrEP study found that giving HIV-negative women tenofovir/FTC (Truvada) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo.

In July 2011, however, the Partners PrEP study found that Truvada was 73% effective in preventing HIV transmission between heterosexual partners of different HIV status.

How do we explain why giving HIV-negative women antiretroviral pills made no difference to the HIV infection rate in one trial, but prevented at least two in every three infections in the other? The difference, it appears, is that in the Partners PrEP trial, adherence to the study medication was very high, whereas in FEM-PrEP, despite counselling and support, less than half the women took their PrEP pills regularly.    

The Partners PrEP study

The Partners PrEP study enrolled 4758 serodiscordant couples in Kenya and Uganda; the HIV-negative partner was female in 38% of couples. This study had three arms: a daily tenofovir pill, a daily Truvada pill, or placebo.

There were 17 infections in participants on tenofovir, 13 on Truvada and 52 on placebo. Efficacy overall was 75% in those assigned Truvada and 67% in those assigned tenofovir, though confidence intervals (44% to 81% in tenofovir and 55% to 87% for Truvada) overlapped, so the efficacy of the two regimens was the same statistically. The same was true of efficacy observed in women (65%) and men (70.5%).     

Adherence according to pill counts of unused medication was 97%. A substudy (Donnell) compared tenofovir levels in the blood of 29 out of the 30 people who became infected in the two PrEP arms with levels in a random selection of 198 people who did not become infected.

Tenofovir was undetectable in the blood of 70% of the people who became infected but only 18% of the people who did not, indicating a ‘true’ adherence level of about 80% – and having a detectable level of tenofovir in the blood was associated with an 86% reduction in HIV risk in those taking tenofovir and a 90% reduction in those on Truvada.  

The FEM-PrEP study

In the FEM-PrEP study, 2056 HIV-negative women in South Africa, Kenya and Tanzania were randomised to take a daily Truvada pill or a placebo. The trial was stopped when an interim analysis found near-identical HIV infection rates in both trial arms. There were 33 HIV infections in women taking Truvada and 35 in women taking placebo; this translates into annual incidence rates of 4.7% and 5.0% respectively. This 0.3% difference is no difference at all, statistically speaking (hazard ratio 0.94, 95% confidence interval 0.59 to 1.52, p = 0.81). 

Participants in the study said they took their pills 95% of the time and adherence as measured by pill count was 85%. However when drug levels of tenofovir and FTC were measured in the blood of women assigned to Truvada, the investigators found that less than 50% of the women who should have been taking the drug had actually done so in the last 12 days, and less than 40% within the last 48 hours.

In infected participants, 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive, 21% at the visit they tested positive, and 15% at both visits; in non-infected participants whose samples were taken at the same visits they were 35%, 38% and 26% respectively.

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

CROI 2012: Results of iPrEx Trial Show Effective Dosage of PrEP

via AidsMap.com, by Gus Cairnes

Further testing of drug levels in the blood and immune cells of gay men participating in the iPrEx trial of tenofovir/FTC (Truvada) pre-exposure prophylaxis (PrEP) has found that HIV infection in men assigned to Truvada was associated with a lapse in taking the drug after initially adhering reasonably well, rather than never having taken it at all, which was what the researchers originally thought. The research was presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle.

The testing also found that only a minority of participants appeared to be taking their drugs as prescribed, seven days a week, but that protection levels were very high – in the order of 96% of infections prevented – as long as participants took four or more doses a week.

Drug levels plummet three months before infection

 The results of iPrEx, a large multi-country study of PrEP in gay men, were announced in 2010 and showed an overall efficacy of 42% – in the trial subjects as a whole, four out of ten HIV infections that would otherwise have happened were prevented if subjects were given Truvada pills to take daily rather than placebo pills. When drug levels were tested in the 48 participants who became HIV-infected on Truvada, and a random sample of uninfected participants, it was found, perhaps not surprisingly, that drug was detectable in only 10% of the infected participants but also, perhaps more surprisingly, in only 50% of the uninfected ones.

New measurements have now looked back at drug levels in stored samples in the months prior to infection and compared with drug levels in the same time period in uninfected participants. In the uninfected participants, consistently 45% or so had detectable drug in their samples across the whole length of the study – confirming that at least half of the participants simply never took their pills. In the infected participants average adherence rates started off the same as in the uninfected. They showed a slight decline in the first year of the trial but then declined to 10% in the three months preceding infection. This suggests a role for quarterly adherence reinforcement.

What levels of tenofovir are protective?

 The researchers also wished to find out what levels of tenofovir in the blood were associated with protection against HIV. They did this by comparing drug levels in iPrEx participants with drug levels in a small study called STRAND, presented at last year’s conference (Liu),which gave participants directly-observed doses of tenofovir twice, four time or seven times a week and then measured drug levels in their hair. By then comparing the levels of protection seen in participants with specific drug levels in iPrEx, the researchers were able to compute what drug level was protective.

In iPrEx the average drug levels seen in infected people were consistent with less than one dose of tenofovir a week, but drug levels in those who were not infected were consistent with only about three doses a week. Only 18% of iPrEx participants had drug levels consistent with taking seven doses a week. The investigators used very sensitive tests to look at levels of metabolised tenofovir inside cells and found that a reduction of 90% in the risk of HIV infection correlated with a drug level of 16 femtomols per mol (fm/M – 16 in every million billion molecules by weight). The average level associated with seven doses a week in STRAND was about 38 fm/M and with four doses a week about 32 fm/M.

This enabled them to calculate that the protection offered by taking four doses of tenofovir a week was high, and more or less the same as taking seven doses – that is, in the order of 96%, with a minimum likely protectiveness of 90%. They also calculated that absolutely perfect adherence would offer 99% protection. Taking two doses a week (consistently) would still offer 72% protection, though within wide confidence intervals (56% to 96%) while the 42% level of protection actually seen in iPrEx was consistent with participants taking, on average, one dose a week.

This study has important limitations. STRAND did not measure FTC levels so the iPrEx researchers could not calculate what extra protection was offered by that drug. They also could not measure drug levels at the actual moment of exposure – they were measured at anything between 15 and 90 days after infection. And of course the ‘number of doses a week’ measure is purely an average – most participants probably had much more irregular patterns of taking their pills, with (amongst the 50% who took it at all) periods of good adherence interspersed by periods off drug, maybe correlated with times on and off sex. But it does give a guide to the likely minimum levels of tenofovir that people need to maintain in order to be protected from HIV.



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

CROI Researchers Share Partner PrEP Results

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 in 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.

In a discordant partnership, it's already part of recommendations that the HIV-positive partner be treated, commented Wafaa El-Sadr, MD, of Columbia University in New York City, who was not part of the study but who chaired a press conference at which details were presented.

But she concurred with Baeten that there are likely to be cases where treating the negative partner is the right choice. For instance, she told MedPage Today, "they may not be confident the positive person is taking their medicine."

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

CROI 2012: Researchers Present FEM PrEP 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

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

The year ahead: Q&A with Jim Pickett

Original content from the Mapping Pathways team

MP: In terms of studies and projects, what are you most looking forward to this year?

JP: It’s going to be an eventful year in the HIV prevention world – I’m excited, energized, and daunted, all at the same time! I’m looking forward to just following the science and seeing where that takes us. For instance, rectal microbicide trials are taking an international leap and moving up into phase 2, which is HUGE.

The other big aspect we all need to focus on this year is getting into the implementation particulars around PrEP. There is a PrEP implementation project starting in the US – about 500 gay men split between San Francisco and Miami who will be given PrEP. This is an actual implementation project, NOT a research study, and we hope to learn a great deal from it. There are critical questions around delivering the intervention: How do you get the pill to people? How do you help make sure they’re adherent? How do you keep them in the loop for ongoing testing, so you know soon if they seroconvert? We don’t know the answers because we’ve never done it! It will be very interesting and informative to see how that plays out…what comes up, what works, what’s a problem, and what needs to be changed.

There are also studies (some are happening and some are scheduled to begin in 2012) looking at different ways of dosing PrEP. Right now, we have proof that PrEP used every day works. But what about intermittent dosing – a few times a week or just around the time of sex? What about those strategies? We won’t have hard data in this year but we’ll start learning more. If we can, in fact, do intermittent dosing, or dosing just around the time of sex, that could be great – it would reduce costs, and importantly, make it easier for people to adhere. We may also find out that intermittent dosing, or dosing around the time of sex, doesn’t work. Whatever we find out will be critical to assess as we move forward with PrEP as an HIV prevention strategy.

MP: What are your thoughts on the upcoming US presidential election?

JP: I’m daunted by the 2012 American elections. Whatever happens will be critical for the entire world in terms of how we move forward with the provision of services, science, and research. American elections are always important for everybody, with far-reaching implications – and this time, the stakes are really high. It’s a critical year. But I guess you could say that about every election. When wouldn’t we say it’s critical?

MP: What about the global political landscape?

JP: If you look at politics globally, with economic crises rolling across much of the world, how governments support this work or not will be really important. We don’t want to lose ground. UNAIDS put out a report in November – an annual global snapshot – that shows that 50% of people who need treatment are now on treatment. That’s a big jump up, a good number. We’re going in the right direction and we’ve been able to achieve that even in tough times. But you’re only as good as you are today and we don’t want to lose that ground – we want to move to a place where everyone who needs treatment has it, not just half. Half is better than where we were, but we need to move forward.

We all need to keep a close eye on global politics and how that affects priorities in terms of both provision of treatment for people with HIV and ongoing work in prevention. We can’t treat ourselves out of this. We have to have a solid mix of prevention and treatment and care. Our approach needs to be holistic; if we start throwing things to the side and looking at one or two “magical” solutions, we’re going to be in trouble. When you have new things, there’s a desire to say that the old things don’t work, let’s just look at the new things and throw everything else out. Also, in times of economic scarcity, there is a tendency to pare down. We have to be smarter, use our money more strategically. Does everything work equally well? No. Can we get rid of some things? Probably, yes. But that requires a lot of thought and analysis, and every decision needs to be localized.

I think that’s what this year is going to be characterized around...how we start to make sense – and use – of all this science we’re amassing. We’re getting more and more into the rubber-hits-the-road phase.

MP: In terms of conferences in 2012, what are the highlights for you?

JP: The 2012 International Microbicides Conference will take place in Sydney in April. And the granddaddy of all conferences, the International AIDS Conference, is being held in Washington, DC in July. It’s the first time it’s been in the US for a couple of decades because we had a ban on people with HIV traveling here, which precluded us from being able to host that conference. The ban was recently lifted by the Obama administration. This conference is going to be a big deal. It’ll put the spotlight on DC, in terms of DC’s support for HIV/AIDS both domestically and internationally. It’ll also be another great opportunity for Mapping Pathways to disseminate information and we’re hoping we’ll be able to utilize that huge stage – the biggest AIDS stage there is.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team.

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