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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*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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New Microbicide May Block Virus From Infecting Cells

via The University of Utah U News Center

University of Utah researchers have discovered a new class of compounds that stick to the sugary coating of the AIDS virus and inhibit it from infecting cells – an early step toward a new treatment to prevent sexual transmission of the virus.

Development and laboratory testing of the potential new microbicide to prevent human immunodeficiency virus infection is outlined in a study set for online publication by Friday in the journal Molecular Pharmaceutics.

Despite years of research, there is only one effective microbicide to prevent sexual transmission of HIV, which causes AIDS, or acquired immune deficiency syndrome. Microbicide development has focused on gels and other treatments that would be applied vaginally by women, particularly in Africa and other developing regions.

To establish infection, HIV must first enter the cells of a host organism and then take control of the cells’ replication machinery to make copies of itself. Those HIV copies in turn infect other cells. These two steps of the HIV life cycle, known as viral entry and viral replication, each provide a potential target for anti-AIDS medicines.

“Most of the anti-HIV drugs in clinical trials target the machinery involved in viral replication,” says the study’s senior author, Patrick F. Kiser, associate professor of bioengineering and adjunct associate professor of pharmaceutics and pharmaceutical chemistry at the University of Utah.

“There is a gap in the HIV treatment pipeline for cost-effective and mass-producible viral entry inhibitors that can inactivate the virus before it has a chance to interact with target cells,” he says.

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.]

New AIDS microbicide has huge potential, but needs funding

via ONE, by Todd Summers

At the big International AIDS Conference in Vienna a few weeks back, there was wide coverage of positive trial results for a new microbicide –- a gel that women can use to reduce their risk of getting infected with HIV.

Giving women a prevention tool that they can use to protect themselves from the virus is critical. Right now, they have to depend on men to use condoms or other methods — and you can see how well that’s going.

The next step in moving the microbicide forward is to conduct confirmatory studies to validate this first one. This ensures that the study wasn’t somehow flawed, and that the product is safe and predictable. Unfortunately, the New York Times reported over the weekend that donors are dragging their feet in funding these studies.

This just cannot be accepted. We need the U.S. and other rich countries to put forward the relatively modest amounts needed to conduct the validation trials to put them on the fast track for completion.

These investments in prevention technology make huge public health and financial sense, helping ensure that we meet the treatment needs of those already living with HIV.

As Melinda Gates said in a great speech four years ago (at the International AIDS Conference in Toronto), “No matter where she lives, who she is, or what she does — a woman should never need her partner’s permission to save her own life.”

A microbicide is the best hope we have — until there’s a vaccine, of course -– of giving women some control over their own HIV risk. So, let’s get these studies going.

Source.

Gates Lays Out Approach to Reducing Financial Impact of AIDS Epidemic

Via Medscape, by Daniel M. Keller, PhD

In a plenary speech here at AIDS 2010: XVIII International AIDS Conference, Bill Gates, cochair of the Bill & Melinda Gates Foundation and nonexecutive chairman of Microsoft, opened by telling the audience that in these times of constrained national budgets and investments in global health, he is still an optimist about fighting AIDS. He cited recent progress, with 5 million people now receiving antiretroviral treatment worldwide, up from fewer than half a million only 6 years ago. The rate of new HIV infections has fallen by 17% since 2001, he said.


He attributed the progress to scientists, clinicians, community workers, advocates, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. During the past 20 years, more than 2 dozen antiretroviral drugs have been developed, many of which are now being made cheaply enough to serve developing nations, and regimens have been simplified, making it easier for people to adhere to them.

For more click here. 

 

Funding for rectal microbicides has DECREASED in two years

According to the latest report just released by the HIV Vaccines and Microbicides Resource Tracking Working Group, funding for rectal microbicides research has decreased significantly in the past 2 years.

When IRMA last tracked resources dedicated to RM research in 2006, we estimated that US$7.2 million was spent globally. According to the report Adapting to Realities: Trends in HIV Prevention Research Funding 2000-2008, released earlier this week, that amount decreased to US$5 million in 2008.

7X more funding needed
In 2006, IRMA called for a five-fold increase in annual funding for rectal microbicide research and development: from about US$7 million to US$35 million per year for the next 10 years. This is what we estimated would be needed – conservatively – to bring at least one effective rectal microbicide through all stages of research.

Now, we need a seven-fold increase from US$5 million to US$35 million.

More diverse funding needed
Nearly 100% of all global investment for rectal microbicides development comes from one source: US public and philanthropic institutions. Most of this US investment comes from the government. While this support is appreciated, a much more diverse funding base is needed.

Where are the governments and research institutions? Where are the foundations?

Australia?
Belgium?
Canada?
Denmark?
France?
Germany?
Ireland?
The Netherlands?
Norway?
Spain?
Sweden?
The UK?
The European Commission?
The Bill & Melinda Gates Foundation?
The Rockefeller Foundation?
UNFPA?
The World Bank?

All of them have contributed to microbicides research, for which we are eternally grateful. But they should also contribute specifically to rectal microbicide research. The entire rectal microbicides field should not be funded solely by the US NIH and amfAR.

Recognised need
It is ironic that in the same time period that saw rectal microbicides become increasingly recognised as an essential component of HIV prevention research, global investment faltered.

Investment in rectal microbicide development MUST INCREASE at this critical time when the HIV prevention field is more willing than ever to acknowledge the need to address the prevention needs of those who engage in anal sex: heterosexual women and men, gay men and other men who have sex with men from around the world – including in Africa, Latin America and the Caribbean, Asia-Pacific, Europe and North America.

Funds needed to move research agenda forward
Exciting research projects are ready to move forward: rectal safety trials, rectal-specific formulation work, lubricant safety, acceptability research, research into incidence, prevalence and context of anal intercourse in various populations around the world. More funding is desperately needed to maintain a robust research agenda.

Read IRMA’s 2006 report: Rectal Microbicides: Investments and Advocacy

Read the HIV Vaccines and Microbicides Resource Tracking Working Group report: Adapting to Realities: Trends in HIV Prevention Research Funding 2000-2008

Read IRMA’s 2008 report: Less Silence, More Science: Advocacy to Make Rectal Microbicides a Reality





Join efforts to advocate for more investment in rectal microbicide development!

Scientists Debate HIV Prevention Products - NPR today

[NOTE - not a word on rectal microbicides, and a rather pessimistic take on microbidide development from the Gates Foundations's Tachi Yamada]

via Morning Edition, March 10, 2009

For years now, scientists have tried to find a product that would give women in developing countries more control in protecting themselves against sexually transmitted HIV. They have yet to find a universally effective and safe method.

A recent study presented at the Conference on Retroviruses and Opportunistic Infections in Montreal highlighted the dilemmas in this field — a gel to prevent HIV worked in 30 percent of the women who tried it. Many scientists have dismissed those results because there was a 1-in-10 chance that the effect was due to chance. Others who had great expectations riding on the findings were encouraged.

Still, Tachi Yamada (pictured), director of global health policy for the Bill and Melinda Gates Foundation, was concerned that the results were presented as promising.

"To me, it was very unfortunate," says Yamada. "In fact, there should be a little bit of concern that this is now the fifth or sixth trial that came out statistically insignificant."

Read the rest.

Listen Now [4 min 50 sec]

2009 Annual Letter from Bill Gates: Progress on AIDS

[Note from the IRMA chair - while IRMA is very happy the Gates Foundation is deeply supportive of microbicide research, in addition to other new prevention technologies, it is very disappointing that Mr. Gates defines a microbicide as "a gel a woman can use to protect herself from getting infected." Of course, we all know that microbicides are being developed for use by gay men and men who have sex with men. Why is this fact ignored?]


[excerpted from his full letter]

On the AIDS front, you have probably read articles talking about failed trials of vaccines and microbicides. (A microbicide is a gel that a woman can use to protect herself from getting infected.) Although these results are setbacks, in each case we are learning and moving ahead with improved approaches. I am quite hopeful that in the next four to six years we will have either a pill or a microbicide that people can use to protect themselves temporarily from getting HIV. When used on a large scale they will dramatically reduce the annual rate of infection, which is currently 2.7 million. I feel a huge sense of urgency to make sure a pill or microbicide is developed as soon as possible. There are some great scientists working on this, and I am spending lots of time asking them what the bottlenecks are and understanding how we can make faster progress. The intensity reminds me of my time at Microsoft, when we were competing with other companies to make the best database or word processor. However, in this case the competitor is a virus and all of humanity is on the same team, wanting to work together to defeat the virus.

When we get a vaccine it will be even more impactful than a pill or a microbicide, because a vaccine will protect people for much longer. But given the complexities involved, even with the great work being done, it is very likely to be more than 10 years before we have one in widespread use.

To stay alive, people with HIV need to start using anti-retroviral drugs before their immune systems become weakened, usually within five years of becoming infected. In 2003, only 400,000 people were being treated, and now some 3 million are. That is a phenomenal increase. The biggest reason for it is that the United States funded the President’s Emergency Plan for AIDS Relief and managed the effort very well. In addition the United States, along with a number of other countries, has funded the Global Fund for AIDS, Tuberculosis, and Malaria. This is a good example of how scientific innovations, in this case the invention of anti-retroviral drugs, can reach the poorest with help from governments, foundations, and drug companies. Although less than 5 percent of people with HIV/AIDS live in rich countries, it was the market demand from these wealthier patients that drove the large R&D investment in these drugs.

Read his full letter.

Grant Opportunities at Gates

Grand Challenges Explorations, Round 2

The Bill & Melinda Gates Foundation is now accepting grant proposals for Round 2 of Grand Challenges Explorations, a US $100 million initiative to help scientists pursue innovative ideas for solving major global health problems.

Anyone can apply, regardless of education or experience level. Grant proposals are being accepted online until November 2, 2008, on the following topics:

-New! Create new vaccines for diarrhea, HIV, malaria, pneumonia, and tuberculosis

-New! Create new tools to accelerate the eradication of malaria

-Create new ways to protect against infectious diseases

-Create drugs or delivery systems that limit the emergence of resistance

-Create new ways to prevent or cure HIV infection Explore the basis for latency in tuberculosis

Initial grants will be $100,000 each, and projects showing promise may have the opportunity to receive additional funding of $1 million or more. Full descriptions of the topics and application instructions are available here. We hope you can help us spread the word in the coming weeks and months about this exciting initiative. Thank you for your support and continued commitment to solving the world's greatest health challenges.