Antiretroviral prevention methods 'not in competition' with each other

Via AIDSMap, by Keith Alcorn.

Antiretroviral prevention methods are not in competition, and policy makers and providers need to start to thinking about how antiretrovirals, pre-exposure prophylaxis and microbicides will be provided as part of a combination prevention package – and who will benefit most from each method, delegates heard at a satellite meeting on the opening day of the Sixth International AIDS Society Conference (IAS 2011) in Rome.

“You don’t want to have the family planning clinic here, the pills clinic here, the injections clinic here, and the microbicides clinic over here,“ said Dr Stephen Becker of the Bill and Melinda Gates Foundation.

Delegates were discussing the rapidly changing landscape of HIV prevention methods that use antiretroviral drugs. One year ago, at the International AIDS Conference in Vienna, the world heard the results of the CAPRISA study, which showed that a microbicide gel containing tenofovir halved the risk of HIV infection in women who used the vaginal gel consistently.

Since then results from four studies have added to the array of prevention methods that exploit antiretroviral drugs to prevent transmission or acquisition of HIV infection:

• The iPrEx study showed that taking the antiretroviral combination Truvada (tenofovir and emtricitabine (also known as FTC) reduced the risk of HIV infection in men who have sex with men by 44%.
• The HPTN 052 study showed that early treatment reduced the risk of HIV transmission to an uninfected regular partner by at least 96%.
• The Partners study showed pre-exposure prophylaxis with Truvada or with tenofovir alone reduced the risk of HIV infection by between 62% and 73%.
• The TDF2 study showed that  pre-exposure prophylaxis with Truvada reduced the risk of infection by between 62% and 78%.

The first tenofovir-containing microbicide could receive regulatory approval by the end of 2013, subject to positive results from a confirmatory trial now taking place in South Africa. That study is testing exactly the same dosing regimen as that used in the CAPRISA study, the so-called BAT 24 dosing schedule: one dose Before, one After, and no more than Two doses in 24 hours.

A second CAPRISA study (008) is testing the roll-out of tenofovir gel through family planning clinics in KwaZulu-Natal, comparing the monthly testing and follow-up schedule used in the original CAPRISA study with a three-monthly schedule, in order to examine the feasibility and acceptability of providing a microbicide through existing health services that target sexually active women.

Although the South African government has already begun investing in the scale-up of production facilities to manufacture the gel, the extent of demand for the microbicide is still unclear. Studies of women’s’ attitudes towards the microbicide will be needed to gauge demand, but a lot of work will also be needed to develop demand – and to make sure that women understand how they could benefit from using the microbicide.

“We need to reach out to women who don’t perceive themselves to be at risk, and we should be getting communities to rally round to be early adopters of tenofovir gel,” said Samu Dube of the Global Campaign for MIcrobicides.

“We need to get the product to the places where women are: the family planning clinics, the immunisation centres, antenatal clinics. We also need to target the school health system.”

However, work will also be needed to convince the providers of those services that they have a role to play in expanding women’s opportunities to protect themselves from HIV infection.

Read the rest here.

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

Models: Tools to Improve Decision Making about HIV

Via AIDS.gov, by Ronald Valdiserri, M.D., M.P.H.

For those of us who work in the HIV/AIDS field, the month of July was dominated by exciting HIV prevention news coming out of the International AIDS Society meeting in Rome. Results from the HPTN 052 study showed that early, compared to delayed, antiretroviral treatment resulted in a 96% reduction in HIV transmission to uninfected partners. The TDF2 study conducted by CDC in partnership with the Botswana Ministry of Health, found that a once-daily pill containing two anti-HIV drugs reduced the risk of acquiring HIV infection by about 63% in a study population of healthy, heterosexual men and women. These and other study findings continue to add weight to the notion that HIV treatment is prevention. All of us are encouraged when we think about how these findings could be translated into real world settings in a way that would bring us closer to achieving the goals of the National HIV/AIDS Strategy.

Without minimizing the tremendous enthusiasm that rightly attends the prevention breakthroughs that were presented in Rome, I would like to talk about another scientific discussion that took place in July. As it turns out, this meeting was also held in a world capital, although to a much smaller audience. And while the results of this two-day meeting didn’t garner media attention the same way as the Rome meeting did, the topics under discussion were no less consequential.  In mid-July, I was very fortunate to attend a two-day workshop on “Modeling and Evidence-Based Decision Making” sponsored by amfAR, the Foundation for AIDS Research and cosponsored by the Kaiser Family Foundation, the National Alliance of State and Territorial AIDS Directors, and the Urban Coalition for HIV/AIDS Prevention Services. Meeting participants included colleagues from state and local departments of health, academia, federal government, and professional and community-based organizations.

Colleagues from Los Angeles, San Francisco, Maryland, and New York City shared with us their experiences with using various models to assist in making decisions about “optimizing” HIV prevention investments. Using different approaches, each of these health departments was trying to answer the same question, “What combination of prevention services and activities will result in the greatest reduction of the number of new HIV infections?”

At the onset of the meeting, we were reminded that modeling is used in other areas of health and public policy decision-making, especially when leaders are trying to combine diverse information from a variety of sources in order to make sound decisions at a population level.  However, even the biggest fans of modeling reminded us that a model is not a “crystal ball” nor is it infallible.  Instead, what models do is provide a tool to help us make better decisions about complex realities. Good models should always be clear about the inputs and assumptions that were used to generate the results. And perhaps most importantly, they should be used to guide rather than to conclude any discussions about how best to allocate resources.

Read the rest here.

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

Treatment As Prevention: We Urgently Need Policy Guidance

Via PLoS, by Nathan Ford.

The International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome has been hailed as a landmark conference for HIV prevention. Just as the AIDS conference in Vancouver in 1996 marked the beginning of the international effort to roll out antiretroviral therapy globally, so Rome will likely be remembered as the beginning of a new era in biomedical prevention.

The results of the HTPN 052 discordant couples trial, which found the greatest incidence reduction of any prevention intervention evaluated to date, were met with a standing ovation. This trial found a 96% reduction in HIV transmission and a 40% reduction in serious complications, in particular tuberculosis (TB), among patients starting ART early, at CD4 350-550 cells/mm³.

Implementation of this strategy is, however, hampered by lack of guidance from the World Health Organization. Draft guidelines for the provision of ART in discordant couples have been in process for many months, and their release was first announced in May, and then again July. However, by the end of the conference it remained unclear when the guidelines would be released, or what they would say.
Rumours spread in the conference corridors that WHO had been pressured to delay the release. Some suggested the issue at stake was to find the right balance in investment between the results of HTPN 052 and those of the recently completed pre-exposure prophylaxis trials that also reported a substantial prevention benefit.

There are at least three reasons why such a trade off is wrong.

First, providing ART earlier is desirable for more reasons than reduced HIV transmission: the HIV-positive individual receives treatment at a stage in their disease that developed country guidelines already consider therapeutically beneficial; their risk of developing incident diseases, in particular TB, is substantially reduced; reducing TB incidences confers the additional public health benefit of reducing the risk of TB transmission.

Second, discussions about whether to give ART to HIV-positive or HIV-negative individuals are ethically problematic. Economics has long been described as the ‘dismal science’, but it is hard to think of a more dismal economic proposition than to delay giving ART to people already infected with the pathogenic HIV virus in order to give the drugs to HIV-negative individuals instead.

Third, there are fundamental practical differences to the two approaches. Implementing the results of HTPN 052 means further extending what is already happening (giving ART to HIV-infected individuals); in contrast, giving ART to HIV-negative, at-risk individuals requires extensive operational research to help define what is essentially an entirely new programmatic approach.

Read the rest here.

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

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

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

At Home or in Rome, Online Resources to Keep You Connected to IAS 2011

via IAS

The 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) kicks off on Sunday, 17 July and promises to offer a wealth of important scientific news, including the first full presentation on HPTN 052 and new data on a wide-range of topics including elite controllers, gene therapy, effectiveness of existing treatment regimens, co-infections, microbicides, PrEP, task-shifting, and decentralization of care.

There are a number of online resources for those following at home and those attending the conference. All can be accessed through the conference website.

Programme-at-Glance

The Programme-at-a-Glance (PAG) will include slides with audio from more than half of the sessions, including all plenary sessions and most oral abstract sessions. Audio/slides for most sessions will be posted within six hours, though in some cases it will take 12-24 hours.

Abstracts

Abstracts will be available through the PAG and posted at the time of presentation.

Rapporteur Reports

Rapporteurs will prepare summaries of all sessions along with daily summaries in each track, available here.

Blog

The Conference Blog is live and already has posts from a variety of guest authors. We’ll be posting more this week and tracking key developments during the conference and encourage your feedback, thoughts and ideas.

Twitter

We are tweeting – @ias2011 – and encourage you to tweet and re-tweet along with us, using #IAS2011.

Facebook

Follow IAS 2011 on Facebook for updates on and links to key sessions and developments, as well as photos, video highlights and interviews.

YouTube

The IAS 2011 YouTube channel has past interviews and talks from conference speakers and leadership and we’ll be adding more from the conference.

Photo Library

Free, high-resolution photos for use by the media and others (with appropriate credit) will be available through the IAS 2011 online media centre.

Online Partners Coverage

News Reports by NAM
NAM will offer news stories on major scientific presentations on aidsmap.com and publish a free daily news bulletin in English and translated into French, Portuguese, Spanish and Russian. Sign up here to receive the bulletin via email.

Scientific Analysis by CCO Clinical Care Options’ (CCO) online coverage at clinicaloptions.com will begin the week of 17 July and include expert audio highlights, capsule summaries of important clinical data, downloadable slidesets and more.

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