In Conversation with Joe Romano

Joseph Romano, Ph.D., has been involved in HIV/AIDS research and development for 20 years. In the last decade, he has focused on the development of HIV microbicides. We checked in with Joseph to get his thoughts on a number of things: the microbicide pipeline, the recent HPTN 052 results, clinical trials and the hardest part about his job.

MP: How would you characterize the state of the microbicide pipeline? Right now, the main focus seems to be on ARV-based products. Is there a chance that we may see some non-ARV-based microbicide products in the near future?

JR: The current focus on ARV-based products is the result of some earlier failures with non-ARV microbicide products, and the lack of a robust set of other options to develop. ARVs are very potent and very specific inhibitors of HIV infection, and recent studies have shown that vaginal gels containing an ARV (tenofovir) as well as oral use of ARV pills (Truvada) can prevent transmission of HIV in specific populations. It is likely that these positive results will fuel the development of additional ARV-based microbicide products in the foreseeable future.

However, there remains a need for something other than ARVs. One of the concerns with ARV-based microbicides is over the issue of resistance. In situations where someone is HIV positive and unaware of their status, the use of a microbicide product could lead to the selection of resistance in this person, and that could compromise the ability to treat this person in the future with same class of ARV therapeutics.  This is why large efficacy studies involving ARV-based prevention products are typically conducted with a great deal of HIV testing, and are also accompanied by seroconverter trials to study HIV infections that do occur in participants during microbicide trials. Another issue with ARVs is that they are very specific and are typically only active against HIV. Compounds that afford a wider spectrum of protection against other STIs would be more desirable.

There are a number of groups working on things like plant lectins and natural defence molecules that are part of the innate immune system. There are also groups exploring herbal products or extracts from such products. These alternative products are typically not as potent as ARVs and are mostly in very early stages of investigation and development.

MP: What are your thoughts on the preliminary findings from the HPTN 052 study? 

JR: The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts. First, in terms of the potential of this strategy to reduce transmission, it is clearly an effective option. The study also established the benefits to infected individuals of employing treatment regimens to HIV-positive people with the inclusion parameters used for the trial.

Of course, there are some issues associated with this strategy as well. Proper product adherence over the long term will be necessary, and this is typically a challenge. Rollout of this strategy will also present challenges, in terms of cost and with regard to capacity to properly administer care.  It is possible that these results will also raise questions on the value of providing drugs to infected individuals as per HPTN 052, versus distribution of drugs to uninfected populations as per an oral PrEP strategy.

However, in terms of the results themselves, this is an extremely important outcome which will likely have significant ramifications going forward.  It will be important to remember that despite these findings, the development of other prevention strategies for HIV-negative people will remain an important priority.

MP: What issues are you most concerned about at the moment? 

JR: I have two concerns regarding microbicides and HIV prevention product strategies. First, a clear lesson from recent (as well as earlier) clinical trials is that product adherence remains a major challenge to the field. Trial participant compliance with product use directions is difficult to achieve, and perhaps even more difficult to measure. Thus, the dependence of these strategies on proper compliance with product use by trial participants (as well as populations receiving access to such products after approval) will always present a challenge to achieving adequate efficacy. There needs to be some innovative thinking and development with regard to achieving higher and consistent rates of proper product adherence. Novel drug delivery technologies and strategies that reduce the dependence on users to bear the burden of compliance are essential. Innovative ways to measure product adherence accurately must also be developed in order to achieve proper evaluation of products in clinical trials.

My second concern is with regard to efficacy trial strategies in the post-placebo control era.  It will not be feasible from a cost or capacity perspective to run multiple non-inferiority studies with HIV prevention products.  Innovative trial design as well as the development of robust surrogates for efficacy will be crucial for the field going forward.

MP: What is the hardest part about your job?

JR: There are two things: The slow pace and high failure rate that are inherent in the drug development process, and the effects of resource constraints on good science. Neither of these is specific to microbicides or HIV prevention – unfortunately they are a part of drug development in any setting.

Joseph Romano, Ph.D., is President at the NWJ Group, LLC. He provides strategic and operational consulting in the fields of pharmaceutical and biotechnology, with expertise in drug, vaccine, device and diagnostics development.


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

On the Ground with Brian Kanyemba: A snapshot of advocacy in Africa

It’s one thing to read about HIV advocacy and prevention and another to experience it first-hand, on the ground, day to day. That’s how Brian Kanyemba experiences it. He is the research assistant at the Desmond Tutu HIV Foundation, a Mapping Pathways partner organization. A core part of Brian’s job involves traveling through South Africa’s villages and cities, talking to people about issues surrounding men who have sex with men (MSM), and what the prevalence of HIV means within this group of people. Of late, his focus has been on putting forward the “meaningfulness of Pre-Exposure Prophylaxis (PrEP)” within the South African context, especially for the MSM community. This is no easy task.

Let’s talk about sex
“South Africa is a really interesting and dynamic place,” says Brian. “We might have gay rights and rights access of services across all sexual orientations, but when you start to talk about MSM, or about PrEP as an intervention among MSM, this is faced by a huge mental wall.” This wall extends to talking about rectal microbocides as well, mostly due to the taboo against anal sex. Currently in development, rectal microbocides, or “topical PrEP”, are ARV-based products that might reduce the risk of HIV infection when used topically in the rectum during anal intercourse. These are in phase II, with an expected phase III to be carried out in Africa and possibly Cape Town (to learn more about rectal microbocides and PrEP click here and here). “No one will come forward to talk about this openly,” says Brian, “because in Africa, anal sex is associated with homosexuality, and homosexuality in Africa is not okay.”

One way Brian goes around this taboo is by using a simple game about sexual pleasure called “Mapping the Body”. While talking to people, he introduces the discussion on rectal microbicides by drawing three images on the board: a simple figure of a man, a woman, and another man. “I say, ‘Guys let’s put stars on areas where one can be sexually stimulated’,” says Brian. “You get amazing ideas from the group. And some people will say to put a star on the anal area, and then from there it is easier to link to PrEP and to introduce rectal microbocides.” By conducting a matter-of-fact discussion focused on pleasure and the body, Brian finds the group is much better able to accept the idea of rectal microbocides as a form of protection.

“Heck no… I am not interested.”
Despite his innovative methods, Brian has run into some pretty big walls where the topic of MSM and PrEP is concerned, especially within the healthcare sector and even the government. At a meeting with a parliament member who represents HIV issues, Brian recalls that when he brought up the topic of MSM and PrEP, she said, “’Oh no, can you please stop there because that doesn’t exist in my frame of mind.’” Says Brian, “This was a woman in the parliament whose job was to discuss issues of HIV. So, I’m talking to her about MSM being a group of people who have a high prevalence of HIV infection and she just says, ‘Heck no, we’re not going to talk about that topic now. I am not interested.’”

Brian clearly remembers his most unexpected encounter with homonegativity – it was at a focus-group PrEP presentation that he conducted in Durban, the third-largest city in South Africa. Recalls Brian, “I put the word MSM on the board, and do you know what one woman participant said? She said, ‘By MSM do you mean men who have sex with men? Yes, they must die; and if not, they must be killed!’” The woman participant who said this was on the community advisory board for one of the major HIV trials in South Africa, which made the statement all the more startling for Brian. “I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’”

A personal quest and mission
For Brian, the advocacy began many years ago in Zimbabwe, when he was just 19 and right out of college. He says, “As I was growing up, it was just accepted that being gay is bad. That is one of the reasons I left Zimbabwe, because of the way gay people are treated, are not spoken about.” He vividly remembers the moment that he began on his path as an HIV advocate, “A very close friend of mine was diagnosed with HIV and he was gay and, at the end of the day, he committed suicide. He didn’t understand HIV, he didn’t understand that it’s not a death penalty, he didn’t know that you can access treatment, he didn’t know that ARV treatment and care is available… and so advocacy become a passion, it was so personal to me.”

Despite the intense societal taboo, Brian worked in Zimbabwe on HIV and gay rights issues for almost a decade. His first job was with the National Army, working at the provisional hospitals on HIV and AIDS issues, ARV rollout, and providing counseling services for homosexuals. Says Brian, “I was working in the psychiatric department of the hospital… they realized I was gay, so they sent me to the lunatic asylum!”

Brian’s journey hasn’t been easy, and yet he continues with dedication, enthusiasm and hope. Why? Why not choose an easier job, an easier path? Brian’s response is prompt, “They say in my culture that when a funeral happens next door, you say ‘Ah ok, there is a funeral.’ But when a funeral happens in your house, it becomes a personal issue. When my friend passed away, I thought, ‘Ok, I need to put on my armour and start fighting this war now. I am going to stop this. I am going to stop thinking like a young person, and I am going to fight and go forward fighting for all my friends and for my community.’ It was very early in my life that I decided this, and I am not going to stop.”

Brian is a research assistant with the Desmond Tutu HIV Foundation, a Mapping Pathways partner organization. He is also an advocate fellow with the AIDS Vaccine Advocacy Coalition (AVAC), and is an active member of the International Rectal Microbicide Advocates (IRMA). He has been very involved with IRMA's Project ARM - Africa for Rectal Microbicides, and is an integral member of the Project ARM video working group, which is producing an African-focused video on anal sex and rectal microbicides.

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

India says 'no' to policy that would block access to affordable medicines

Via Médecins Sans Frontières.

India formally announced at the UN High Level Meeting on HIV and AIDS that it will not accept data exclusivity, a provision harmful to access to affordable medicines, as part of a free trade agreement (FTA) currently being negotiated with the European Union (EU). 

Although this is an important victory for the global mobilisation against the potential negative impact of the FTA on access to medicines, further harmful measures remain on the negotiating table, the international medical humanitarian organisation Médecins Sans Frontières (MSF) said today.

“MSF and other treatment providers depend on a sustainable flow of affordable generics from India to treat people across the developing world. Saying ‘no’ to data exclusivity will reach far beyond India’s borders in terms of ensuring access to affordable medicines in developing countries”, said Dr Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines.  “This is a big victory, but we’re not letting up until we see all the potentially harmful policies off the table”.

By delaying the registration of generic versions of a medicine by up to ten years, data exclusivity would effectively have given a backdoor monopoly status to companies, even for drugs that do not deserve a patent under India’s law. The clause, which was criticised by global health actors including the Global Fund, WHO, UNAIDS, and UNITAID, threatened to further limit price-busting generic competition in India, thanks to which the price of HIV medicines has fallen by 99 per cent over the last 10 years.

The announcement by India at the AIDS Summit now means both the EU and India have officially confirmed data exclusivity will not be part of the FTA text. MSF is now calling on Europe to remove other harmful clauses from the EU-India FTA negotiations.

“Europe is still pushing provisions on the enforcement of intellectual property that are of great concern for procurers and suppliers of medicines, like MSF, as they put us at risk of litigation or court orders that prevent us from delivering medicines to patients,” said Michelle Childs, Director of Policy/Advocacy of MSF’s Access Campaign.

Read the rest here.

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

The Economic Effect: HIV/AIDS in the US

At the CROI conference earlier this year, Julie Davids asked a question that lies at the very heart of HIV prevention – “What needs to happen to ensure that PrEP doesn’t become a hard-to-get intervention?” Now, halfway through the year, we checked in with her. Below, Julie shares her thoughts on how dollars-and-cents issues have serious repercussions with regard to the HIV/AIDS situation in the US.

“While there has been much debate over the use of antiretrovirals (ARVS) for HIV prevention, the entire HIV prevention and treatment landscape overall is also in a state of flux in the US. In the era of the National HIV/AIDS Strategy, many questions have arisen. Perhaps the most important is this – what prevention/treatment methods can be brought to scale for population-level impact? There has been lots of effective work that has helped prevent HIV and save lives, but what can be scaled up to a point where it can start to reduce incidence? There are initiatives that work very well but are too expensive to bring to larger scale. People are also wondering if there are targeted ways of delivering PrEP to ensure maximum impact without incurring enormous amounts of expenditure.

The global economic crisis has only exacerbated the situation. The effects of the sustained downturn in the US are deep and hard to untangle. In some areas, the impact is specific and tangible: many organizations and initiatives that provide HIV prevention, treat and care are shutting down and others are under lot of duress. So, understandably, when it comes to using ARVs for prevention, people are saying, “We’ve been told not to expect any new money – in fact, we’ve braced ourselves for cuts in funding. If we’re talking about adding something new, where is the money going to come from? And is this the best use of the available resources?”

But the effects are also larger and more intangible, in terms of a generalized anxiety and fear. The recession is hitting the most marginalized the most severely. One of the main drivers of HIV incidence in the US is poverty – and we’re seeing a sharp increase in poverty and homelessness. People are scrambling to find housing and put food on table, to retain a sense dignity as they struggle to provide for their families. These factors create vulnerability to health challenges and in this regard HIV/AIDS is more the rule than the exception. We may sharpen and tailor HIV prevention to be more effective, but I fear this could be counterbalanced by the effects of the downturn, leading to persistently high HIV incidence.

I believe that it is a political, economic and human tragedy that the first time our country has had a national HIV/AIDS strategy is exactly at the same time that we’re being told there are no resources to put it fully into place. We’re being told that other things in the country, such as the income of bankers, remain more important than people’s health. We are, in significant ways, being restrained from putting our best minds and hearts at the forefront of this effort. When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded. In the history of the HIV/AIDS epidemic, there have been some excellent ideas but they have languished because they just aren’t resourced at the appropriate level – I think we may see a lot of this in the next few years. The impact of economic injustice, which was already driving the epidemic, will remain a deciding factor in the HIV/AIDS context for some time to come.”

Julie Davids is the Director of National Advocacy and Mobilization at AIDS Foundation of Chicago, a Mapping Pathways partner organization. She coordinates the HIV Prevention Justice Alliance (HIV PJA).

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

CAPRISA Team Acknowledged for Outstanding Achievement in Global Health

Via EurekaAlert.

[June 20, 2011] the CAPRISA 004 study leadership team [was] awarded the inaugural Drug Information Association (DIA) President's Award for Outstanding Achievement in World Health. The award recognizes the team's significant contribution to the field of HIV prevention and is being presented during the opening plenary of the annual DIA conference. The CAPRISA 004 study demonstrated the effectiveness of tenofovir 1% gel in reducing the risk of HIV and herpes infection in women.

"The CAPRISA 004 trial provides new hope for women who bear the brunt of the HIV epidemic in Africa. When implemented, it could have a profound impact on the course of this epidemic," said Study Co-principal Investigator Dr. Salim S. Abdool Karim, Director of CAPRISA and Pro Vice-Chancellor (Research) of the University of KwaZulu-Natal, South Africa. "This breakthrough would not have been possible without the close collaboration between the three South African and the three U.S. partners who led this study; I am proud and honored to receive this award on behalf of this remarkable team."

The Center for the AIDS Program of Research in South Africa (CAPRISA) of the University of KwaZulu-Natal and Columbia University spearheaded the trial in partnership with FHI and CONRAD, with the support of USAID, and the South African government through the Technology Innovation Agency (TIA). Gilead Sciences donated the active ingredient for the manufacture of the gel.

"We are pleased that the DIA has recognized the CAPRISA team's outstanding achievement and significant contribution to the fields of microbicide research and HIV prevention," said Howard Jaffe, M.D., President and Chairman of the Board of the Gilead Foundation. "Gilead congratulates the principal investigators, study staff and partners, and commends the courageous women who participated in this historic trial."

The CAPRISA 004 study of tenofovir gel involved 889 women at two sites in KwaZulu-Natal, South Africa. Women in the study were advised to use the gel up to 12 hours before sex and again soon after having sex, for a maximum of two doses within 24 hours. Women using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug can reduce the risk of HIV in women.

"USAID made the right decision in supporting the CAPRISA 004 trial. We were thrilled to collaborate with the South African government in funding the study and we continue to work closely with a wide range of partners in planning for all of the aspects of implementation as we await the results of confirmatory trials," said Dr. Jeff Spieler, Senior Technical Advisor in Science and Technology in Population and Reproductive Health (PRH) at USAID.

Read the rest here.

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

Understanding the barriers to PrEP uptake

While formulating PrEP strategies, it is imperative that we, the HIV/AIDS prevention community, take into account the target community's concerns. By understanding the possible barriers and coming up with solutions, we can help ensure maximum possible effectiveness.

As per the findings of a study conducted in Peru and published in the International Journal of STD and AIDS, significant barriers among at-risk groups include concerns about cost, efficacy, and side-effects. The study was conducted by a team of researchers from UCLA and Lima, Peru; it included female sex workers, male-to-female transgendered individuals, and MSM.

To know more, check out aidsmap's round-up of the study here and EurekAlert!'s detailed article here.

On a related note, the Mapping Pathways project is also in the process of trying to gather perspectives on these questions from folks in our current focus areas – the US, South Africa, and India. If you’re interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – we encourage you to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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

HPTN 052: Responses, benefits and challenges

The HPTN 052 study's compelling interim results on "treatment as prevention" are eliciting strong reactions from various players in the HIV/AIDS prevention community. According to UNAIDS, "the breakthrough is a serious game-changer", and AVAC has stated that "the upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account." Other have voiced concerns that the evidence may not be compelling enough for some segments; for instance, in Sub-Saharan Africa, where most people remain untested, the methodology used in the HPTN 052 study may not be as effective as hoped.

There are other critical questions as well: How will we improve rates of diagnosis without coercion? How will governments and communities build the capacity to treat people with HIV promptly and effectively? What are the cost implications?

A few days ago, aidsmap published an excellent article, tackling these issues and concerns. To read more about the reactions, the possible benefits, the challenges and proposed solutions, and the dollars-and-cents issues, click here.

Also, folks from the US, South Africa and India who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – are highly encouraged to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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

FACTS 001 trial announced in South Africa

Yesterday was a big day in the world of HIV prevention and treatment. The FACTS 001 study was announced - a follow-up study to confirm the effectiveness of tenofovir and to verify the CAPRISA 004 results in "larger, more diverse populations". The Phase III trial will be conducted by FACTS (Follow-on African Consortium for Tenofovir Studies) and led by Professor Helen Rees, the Executive Director of WHRI (Wits Reproductive Health and HIV Institute). Read on for excerpts from two articles on the study.

Times LIVE

The Big Read: South African scientists are launching an important HIV clinical trial to confirm the efficacy of a gel that reduces the risk of women getting HIV.

This is the first South African-led consortium to conduct HIV research at seven centres, said the executive director of the Wits Reproductive Health and HIV Institute, Professor Helen Rees.

Until now, multi-site trials were led by international scientists collaborating with local peers.

"The planning for the Facts study is well under way and we hope to be in the field by August," said Rees.

The past year has seen a revolution in HIV-prevention research sparked by three exciting results - one being the gel.

A Tenofovir vaginal gel proved 39% effective at protecting young women from HIV and halved the risk of Herpes HSV-2, according to the Caprisa 004 study in KwaZulu-Natal.

Facts aims to confirm these results.

To read on, click here.

allAfrica.com

Pretoria — After encouraging results on a vaginal gel containing the antiretroviral drug tenofovir, which reduces HIV infection and risk of contracting genital herpes, a follow-up study to test the safety of the gel has been launched.

The Phase III trial, to be known as FACTS 001, will be conducted by the Follow-on African Consortium for Tenofovir Studies (FACTS) led by Professor Helen Rees, who is the Director of the Wits Reproductive Health and HIV Institute (WRHI). It is expected to start by the end of July and run for 24 months.

The study prior to this, known as CAPRISA 004, was conducted last year by the Centre for the Aids Programme of Research in South Africa (CAPRISA) on nearly 900 women in KwaZulu-Natal.

It showed that the use of the gel reduced HIV infection by 39 percent and also reduces the risk of contracting genital herpes by 51 percent.

However, CAPRISA 004 was a relatively small trial (Phase IIb trial) and was not designed for licensure purposes.

On Tuesday, the Department of Science and Technology, in partnership with the United States, launched FACTS 001, which will test the safety and effectiveness of 1 percent tenofovir gel.

FACTS 001 will be a bigger study than CAPRISA 004, involving 2200 women aged 18 to 30 years at seven trial sites across South Africa.

Read the rest of the article here.

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

Please take the Mapping Pathways survey and help shape the future of HIV prevention

The Mapping Pathways project has launched on online survey to collect input from individuals in our three target countries - India, South Africa, and the United States.

Folks who are interested in new ways to prevent transmission of HIV - and want to help shape our project goals and deliverables - are highly encouraged to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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

The Importance of Affordable Antiretroviral Therapy

by Aldona Martinka

The UN high-level meeting on HIV/AIDS last week highlighted the importance of accessable and affordable ARVs in developing countries. These hold potential for both treatment and prevention, but their availability in impoverished areas may soon be threatened.

Before CIPLA in India began to produce ARV cocktails for around a dollar a day in 2001, the treatment could be thousands of dollars, completely out of reach for the vast majority of the world. Since then the competition has greatly increased the affordability of these treatments, making them viable options for countless people that would not have had access to them otherwise.

Free Trade Agreements may restrict production and distribution of the more affordable generic versions of antiretrovirals through the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. This agreement already restricts access to recently developed pharmaceuticals in the southern hemisphere, but negotiations could worsen the situation according to Modern Ghana, "Studies show that FTAs with US resulted in 79% of 103 off-patent medicines not having any generic equivalent in Jordan and in price differences of up to 845,000% in the same therapeutic segment in Guatemala."

The EU is also pushing to create clauses in a trade agreement with India that would limit pharmaceutical production. This has potentially devastating effects in developing countries which depend on affordable drugs from manufacturers like those in India that would be affected. The reason for this is member states pushing to prop up the interests of their own pharmaceutical enterprises, often at the expense of the countries that most need these treatments.

Hope comes in the form of the Bangkok Declaration on Free Trade Agreements and Access to Medicines, a declaration supported by people and groups from Asia, Africa, and Latin America, some of the most-affected areas. The Bangkok Declaration opposes the creation of any more Free Trade Agreements, saying that they put corporate welfare above the welfare of millions living with AIDS that would be denied treatment.

To find out more about Free Trade Agreements and generic pharmaceuticals, visit here, here and here.

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

South Africa: Use ARVs to Eliminate HIV in the Next 30yrs

Via allAfrica.com, by Mary Dutki.

A plan to eliminate HIV and AIDS using antiretroviral drugs (ARVs) within the next 30 years has been unveiled by scientists from the South African Centre for Epidemiological Modeling and Analysis (SACEMA).

The plan which was unveiled last month in San Diego, California at a meeting of the American Association for the Advancement of Science proposes the aggressive use of blanket HIV testing followed with ARVs for all individuals testing positive for HIV.

With 33.4 million people living with HIV/AIDS in 2008, 2.7 million new HIV infections and 2 million deaths due to AIDS within the same year, scientists are turning their focus on antiretroviral therapy which they consider to be the only real success so far in HIV prevention. Antiretroviral therapy lowers the amount of the HIV virus in the blood to levels that render HIV positive individuals virtually non-infectious.

The scientists argue that antiretroviral treatment has so far been given too late in the course of many individuals' lives and thus treatment has not helped in reducing transmission rates.

This time however they are suggesting early testing and treatment, targeting the most sexually active population.

Read the rest here.

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

Have a Coke and an Anti-Retroviral - Fighting AIDS in Tanzania

via Slate, by Sonia Smith

A Coca-Cola truck rumbled down the road, ferrying its bubbly, sugary cargo to shops and kiosks in the northern part of the country around the edge of Kilimanjaro National Park. The one thing you can be sure of finding in any far-flung corner of Tanzania is a bottle of Coke. A new pilot program—the first of its kind—aims to make anti-retroviral drugs as easily accessible as a bottle of soda by tapping into Coca-Cola's established delivery network throughout Tanzania.

Tanzania's government supply-chain agency, the Medical Stores Department, currently distributes anti-retrovirals, malaria medication, and other drugs to 500 points around Tanzania, but President Jakaya Kikwete wants medicine taken to the doorsteps of all of the country's 5,000 health facilities. Widening the distribution net so broadly could prove a daunting task, since Tanzania's current distribution system is already overtaxed, and even the best health facilities have trouble keeping all the necessary medicines in stock.

Enter Coca-Cola. The beverage giant, which opened its first bottling plant in Tanzania in 1952, has spent decades finding the most efficient way to reach distant villages and adapting to changing roadway conditions.

Read the rest.

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

Sean Strub: Treatment Refusal = Criminal?

 via POZ Magazine, by Sean Strub

I was pleased to have the chance to provide some comments this morning at the Global AIDS Treatment in Bryant Park in New York City. What I had to say did not please those who are determined to put every single person with HIV on treatment, whether they need it or not...

... It is vital for all of us to understand how anti-retroviral treatment can reduce one's infectiousness, or provide some protection against infection for those who are negative.

That fact, for many is reason enough to start treatment, including some who do not medically need treatment for themselves, like those with high CD4 counts.

But it is wrong for anyone to assume everyone who has HIV "should" be on treatment in order to reduce infectiousness...

Read the rest.

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

Treatment is Key to Prevention of HIV/AIDS, Doctors Say

Via UCSF, by Dan Fost.

Doctors fighting HIV/AIDS have a new strategy working for them: Use the treatment of the disease as a way to prevent it – a strategy borne of the growing effectiveness of that treatment in the three decades since the disease first emerged.

“Treatment revolutionized AIDS,” says Diane Havlir, MD, professor of Medicine at UCSF and chief of the AIDS program at San Francisco General Hospital and Trauma Center. “Treatment changed AIDS from a uniformly fatal disease to a chronic disease.”

And now, Havlir says, “today’s treatment is also prevention.” Timely treatment can stop the spread of HIV/AIDS in many ways. In patients, it stops the virus from progressing into AIDS, and it prevents damage to organs such as the heart, liver and kidneys, which occurs in untreated AIDS. Treatment also greatly reduces the risk of HIV transmission.

Havlir cites the most encouraging news to date, the National Institute of Allergy and Infectious Diseases’ HPTN 052 study, released in May 2011, which reported a 97 percent reduction in HIV transmission among discordant couples – couples in which one partner is HIV-infected and the other is HIV-negative – when the HIV-infected partner is treated with antiretroviral therapy relatively early in the course of HIV infection.

The so-called 052 study – conducted by the HIV Prevention Trials Network (HPTN) – released its results four years early because the prevention effectiveness of the antiretroviral drugs now commonly used to treat HIV infections was so clear-cut.

That news put one more arrow in the quiver of scientists and doctors looking not only to attack HIV, but to stop it.

“Certainly we’re hoping that the next 30 years of HIV can be the last 30 years, especially in San Francisco, where we have the community resources and knowledge to put an end to the epidemic,” says Grant Colfax, MD, director of the HIV Prevention and Research Section in the San Francisco Department of Public Health AIDS Office. Colfax, who trained at UCSF, is adjunct faculty at the university today.

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: Protecting patient autonomy

via POZ, by Joseph Sonnabend, M.D.

Patient autonomy is just a particular instance of individual autonomy, a term that may sound pretty dry and academic but if we used the term individual freedom we would essentially be talking about the same thing.

Respect for the autonomy of the individual may be the most important of the principles that form the foundation of medical ethics. (1)

One attribute of personal autonomy is: "the capacity to be one's own person, to live one's life according to reasons and motives that are taken as one's own and not the product of manipulative or distorting external forces." (2)

There is no disagreement about the importance of respect for individual autonomy but as I'll explain, it seems that its pre-eminence is being questioned in some proposals to use antiretroviral treatment to prevent transmission of HIV.

The recent demonstration that antiretroviral treatment can prevent transmission of HIV among serodiscordant heterosexual couples is great news. However, when the person offered treatment has not yet been shown to personally benefit from it, an ethical issue needs to be addressed. This is because it has yet to be reliably shown that for people with greater than 350 CD4 lymphocytes, starting treatment immediately rather than deferring it confers a net benefit; indeed, it may even prove to be harmful. START is a randomized controlled trial now enrolling that will provide needed information, but we will have to wait several years for its results. The issue isn't whether people with greater than 350 CD4 lymphocytes should or should not receive treatment. A respect for their autonomy means that the decision whether or not to do so is made by them and is made free from coercion.

Read the rest.


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

HIV/AIDS: Young people at highest risk of HIV infection

Via PlusNews.

That young people are particularly vulnerable to HIV and AIDS is well established, but a new report reveals for the first time new data on HIV prevalence in this group, which accounts for almost half of new adult infections globally.

The Opportunity in Crisis report, released on 1 June by the UN Children’s Fund (UNICEF), UNAIDS and other UN agencies, found that an estimated 2,500 young people aged 15-24 become infected with HIV every day, with young women and girls particularly vulnerable.

“The picture is grim,” said Elhadj As Sy, UNICEF director for eastern and southern Africa, at the launch of the report in Johannesburg. “The faces of young people living with HIV are predominantly African and female… of the five million HIV-positive young people, close to four million are in sub-Saharan Africa. More than 60 percent are young women and in sub-Saharan Africa, this share jumps to 72 percent.”

While the report suggest that prevention is working, and some progress has been made, Susan Kasedde, senior specialist in HIV Prevention with UNICEF, warned that countries were falling “far, far short” in their efforts to address HIV among young people and had not invested enough in these programmes.

“Strategies and plans are devised, but money is not allocated, or when it is, efforts are not effectively coordinated, and are not at sufficient scale or are not [of] sufficient quality to ensure the greatest impact from the investment,” the report found.

At the UN General Assembly Special Session (UNGASS) on HIV/AIDS in 2001, countries agreed to cut HIV infection among young people by 25 percent by 2010, but only a 12 percent reduction has been achieved.

As Sy said the greatest barrier was stigma and discrimination, particularly in relation to young people at high risk of infection, such as young men who have sex with men, sex workers and injecting drug users, who have been driven underground by discrimination that often prevents them from accessing HIV services.

Read the rest here.

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

South Africa Marks AIDS Treatment Milestone

Via Forbes, by Thandisizwe Mgudlwa.

AIDS patients and government officials on Friday celebrated the 10th anniversary of a pioneering program that brought AIDS drugs to impoverished South Africans, a program patients credited for saving their lives.

Patients and officials danced and sang in Cape Town's gritty Khayelitsha area to mark the establishment of a Medecins Sans Frontieres program that showed sophisticated treatment could work and people would stick to schedules for taking a cocktail of drugs in impoverished areas. International experts had questioned that at the time.

"Medecins Sans Frontieres, I would call them activist doctors," said Vuyiseka Dubula of the Treatment Action Campaign, South Africa's best known AIDS activist organization. "The West or the northern world said we were too poor to treat, they said, 'They can't even tell the time.' To their surprise, we beat them on adherence. We adhere better than they do."

Khayelitsha resident Thobani Ncapai was losing weight, vomiting and sick with diarrhea in 2001.

"I'm happy to have MSF coming to Khayelitsha," said 40-year-old Ncapai, one of the clinic' first AIDS patients. "Otherwise I would not have received this treatment and I would not have survived."

Read the rest here.

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

95,000 Adolescents Living With HIV in India: UN Report

Via DNA India.

India, where 95,000 adolescents are living with HIV, has been listed along with the sub-Saharan countries having the highest number of youngsters infected by the deadly virus, according to a UN report.

In the age group of 10-19 years, India with 46,000 infected girls and 49,000 boys, has been ranked tenth in the list of countries most affected with HIV in 2009, the report 'Opportunity in Crisis: Preventing HIV from early adolescence to young adulthood' said.

Read the rest here.

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

HIV infections fell by over 50% in India from 2001-09

Via DNA India.

The rate of new HIV infections fell by more than 50% in India between 2001 and 2009, double of the average decline in the world, according to a new report released today by UNAIDS.

"In India, the rate of new HIV infections fell by more than 50% and in South Africa by more than 35%; both countries have the largest number of people living with HIV on their continents," according to 'AIDS at 30: Nations at the Crossroads' study.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) report said the global rate of new HIV infections declined by nearly 25% between 2001 and 2009.

As the world marks 30 years of AIDS, UNAIDS estimates about 34 million people are living with HIV and nearly 30 million people have died of AIDS-related causes since the first case of AIDS was reported on June 5, 1981.

It said about 6.6 million people were receiving antiretroviral therapy in low and middle-income countries at the end of 2010, a nearly 22-fold increase since 2001.

Read the rest here.

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

South Africa and HIV: Insights

Mark Chataway is co-chairman of Baird’s CMC, a Mapping Pathways partner organisation. Here, he talks about his visit to South Africa and his thoughts on the region in the context of HIV treatment and prevention strategies.

I was in South Africa last week, working with our Mapping Pathways colleagues to finalise the ExpertLens survey questionnaire. It’s a very exciting time – we’re going use this survey for in-depth discussions with high-level policymakers, key opinion leaders and pivotal civil society figures. The information we get will help us crystallise the project’s outputs. The idea is to make sure we provide data and analyses that are relevant and helpful for all the key stakeholders.

My visit to the country once again brought into sharp focus for me just how significant South Africa and the rest of the southern African region are in the context of HIV treatment and prevention strategies.

Sub-Saharan Africa is the most heavily affected region in the world with regard to HIV. Swaziland has an adult HIV prevalence of 26% (the highest in the world) – the epidemic reduced the country’s life expectancy rate to 31 years as of 2007. South Africa has the highest number of people living with HIV in the world – 5.7 million as of 2007. The incidence rate in South Africa is declining, but not nearly as fast as it needs to.

The pressure on South African decision-makers is even greater because of the manner in which the HIV situation was handled by former president, Thabo Mbeki, and his government. The links were often parodied: Mbeki did question the very link between HIV and AIDS as well as the value of antiretroviral drugs for treatment, but he was never as hostile as many suggested he was.  The Health Minister, Dr Manto Tshabalala-Msimang, suggested the use of garlic, lemon juice and beetroot but, probably, not as substitutes for antiretrovirals (although she was widely reported as having done so), rather as a way of managing opportunistic infections. There is no evidence that beetroot ever helped anyone but some traditional African medicines do seem to hold promise in managing fatigue and diarrhoea (in well-controlled trials, no less). There have been non-political controversies too; for instance, the evaluation of a US-funded behaviour change programme called LoveLife.

Keeping in mind the scale of the HIV epidemic, South African policymakers’ decisions about prevention and treatment are going to be crucial not just for their own country but for the entire region. They’ll have to take a call on where to spend money in the future, and the range of options is growing: circumcision, behaviour change, treatment, microbicides and vaccine research, just to name a few. South Africa has, in the past, funded a big AIDS vaccine research programme – in fact, I was on the government panel that reviewed it. The government is now making great efforts to get the funding required for larger trials for microbicides – it has put in a lot of its own money in and is hoping international donors will also provide funds.

The HIV budget is a massive part of South African government spending, and it will have to be justified in years to come. With all the other demands on government funding (education, housing, other health demands), decision-makers need to see whether their efforts are paying off and will continue to do so. The all-important question will remain: will continued action help force this epidemic into faster reverse?

I have worked in Southern Africa since the late 1980s and I think that governments in much of the region – and in South Africa, in particular – have more capacity now to act on good research than they have ever had before. Many South African government officials are very impressive and are hungry for objective findings with which to provide advice for their ministers. That’s why I think that Mapping Pathways is so important.



On a related note, the Mapping Pathways project is also in the process of trying to gather perspectives on these questions from folks in our current focus areas – the US, South Africa, and India. If you’re interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – we encourage you to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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

Reuters: 30 years on, AIDS fight may tilt more to treatment

via Reuters, by Julie Steenhuysen and Barbara Lewis

After 30 years of AIDS prevention efforts, global leaders may now need to shift their focus to spending more on drugs used to treat the disease as new data show this is also the best way to prevent the virus from spreading.

The U.N. General Assembly will take up the issue [this] week as it assesses progress in fighting the disease -- first reported on June 5, 1981 -- that has infected more than 60 million people and claimed nearly 30 million lives.

Guiding the meeting is groundbreaking new data that shows early treatment of the human immunodeficiency virus, or HIV, can cut its transmission to a sexual partner by 96 percent.

"There had been for a long time this artificial dichotomy or artificial tension between treatment versus prevention. Now it is very clear that treatment is prevention and treatment is an important part of a multifaceted combination strategy," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases division of the National Institutes of Health (NIH), told Reuters.

Read the rest.

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

Bloomberg Editorial: After 30 Years of AIDS, Push Harder for HIV Prevention

via Bloomberg

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

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

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

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

Read the rest.

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

Lancet: Towards an improved investment approach for an effective response to HIV/AIDS

via The Lancet

Summary

Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends. Until now, advocacy for resources has been done on the basis of a commodity approach that encouraged scaling up of numerous strategies in parallel, irrespective of their relative effects. We propose a strategic investment framework that is intended to support better management of national and international HIV/AIDS responses than exists with the present system. Our framework incorporates major efficiency gains through community mobilisation, synergies between programme elements, and benefits of the extension of antiretroviral therapy for prevention of HIV transmission. It proposes three categories of investment, consisting of six basic programmatic activities, interventions that create an enabling environment to achieve maximum effectiveness, and programmatic efforts in other health and development sectors related to HIV/AIDS. The yearly cost of achievement of universal access to HIV prevention, treatment, care, and support by 2015 is estimated at no less than US$22 billion. Implementation of the new investment framework would avert 12·2 million new HIV infections and 7·4 million deaths from AIDS between 2011 and 2020 compared with continuation of present approaches, and result in 29·4 million life-years gained. The framework is cost effective at $1060 per life-year gained, and the additional investment proposed would be largely offset from savings in treatment costs alone.

Click here for full text, free (just need to register.)

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

The end of AIDS? Are We There After 30 Years?

Thirty years on, it looks as though the plague can now be beaten, if the world has the will to do so...

via The Economist

Excerpt:

If AIDS is defeated, it will be thanks to an alliance of science, activism and altruism. The science has come from the world’s pharmaceutical companies, which leapt on the problem. In 1996 a batch of similar drugs, all of them inhibiting the activity of one of the AIDS virus’s crucial enzymes, appeared almost simultaneously. The effect was miraculous, if you (or your government) could afford the $15,000 a year that those drugs cost when they first came on the market.

Much of the activism came from rich-world gays. Having badgered drug companies into creating the new medicines, the activists bullied them into dropping the price. That would have happened anyway, but activism made it happen faster.

The altruism was aroused as it became clear by the mid-1990s that AIDS was not just a rich-world disease. Three-quarters of those affected were—and still are—in Africa. Unlike most infections, which strike children and the elderly, AIDS hits the most productive members of society: businessmen, civil servants, engineers, teachers, doctors, nurses. Thanks to an enormous effort by Western philanthropists and some politicians (this is one area where even the left should give credit to George Bush junior), a series of programmes has brought drugs to those infected.

The result is patchy. Not enough people—some 6.6m of the 16m who would most quickly benefit—are getting the drugs. And the pills are not a cure. Stop taking them, and the virus bounces back. But it is a huge step forward from ten years ago.

What can science offer now? A few people’s immune systems control the disease naturally (which suggests a vaccine might be possible) and antibodies have been discovered that neutralise the virus (and might thus form the basis of AIDS-clearing drugs). But a cure still seems a long way off. Prevention is, for the moment, the better bet.

There are various ways to stop people getting the disease in the first place. Nagging them to use condoms and to sleep around less does have some effect. Circumcision helps to protect men. A vaginal microbicide (none exists, but at least one trial has gone well) could protect women. The new hope centres on the idea of combining treatment with prevention.

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

What's preventing prevention?

How national AIDS responses are failing in prevention efforts for key populations – an analysis of available data

via International HIV/AIDS Alliance

Several decades after the start of the global AIDS pandemic, data confirms that most low- and middle-income countries still do not adequately focus their HIV prevention efforts on the key populations of sex workers, men who have sex with me, transgender people, and people who use drugs.

Of all low- and middle-income countries that report standard information to the United Nations on their AIDS responses, more than half fail to include timely data concerning these key populations.

According to the International HIV/AIDS Alliance, which has conducted a review of 132 country reports, this is a strong indicator of the current level of national AIDS efforts devoted to reaching populations that are most affected by HIV.

Read more.

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

Lifelong Antiretroviral Therapy Unsustainable, Experts Say; One-Time HIV Treatments Must Replace ART

via Medscape Medical News, by Robert Lowes

Although more HIV-infected individuals are receiving life-saving antiretroviral therapy (ART) 30 years after AIDS was identified, researchers must also find cures and vaccines to eliminate the need for this lifelong and challenging treatment, according to an article published online May 31 in the Annals of Internal Medicine by 2 leaders of the National Institute of Allergy and Infectious Diseases (NIAID).

Carl Dieffenbach, PhD, director of the NIAID Division of AIDS, and NIAID director Anthony Fauci, MD, write that lifelong, daily-dosage ART is not a sustainable strategy in a world where 2.5 million people become infected with HIV each year.

To help them stick to their drug regimen, patients receiving ART require a healthcare system capable of delivering long-term care similar to the model used in the United States to manage patients with diabetes.

In an obvious nod to developing nations ravaged by HIV, the authors write that the need for long-term care creates a formidable challenge for "resource-limited settings and for patients who lack adequate health care coverage." They note that ART is given to only 1 in 3 HIV-infected individuals in the world who need it.

Cure Possibilities

One solution, write Drs. Dieffenbach and Fauci, is devising a 1-time cure for HIV, which could fall into 2 different categories. Researchers could find a true "sterilizing" cure that completely eradicates the virus from the body or a "functional" cure that permanently suppresses the virus to a harmless level.

In the case of a sterilizing cure, researchers must solve the problem of cells remaining latently infected even though ART has reduced blood levels of HIV to near zero. When ART ends, these latently infected cells cause the infection to recur.

Investigators are experimenting with ways to flush out the virus from "this persistent reservoir" so it can be treated with ART. Key to the success of this strategy is the development of a simpler, more accurate way of measuring the latent HIV reservoir.

Despite its treatment limitations, ART nevertheless promises to play an important role in preventing HIV infection through preexposure prophylaxis (PrEP) and treatment-as-prevention, according to Drs. Dieffenbach and Fauci. They point to the CAPRISA 004 trial, in which a vaginal gel containing tenofovir lowered the risk for HIV infection in sexually active women by 39%.

Likewise, the iPrEx study showed that a daily regimen of emtricitabine, 200 mg, and tenofovir disoproxil fumarate, 300 mg (Truvada, Gilead Sciences), was 44% effective in preventing infection in men who have sex with men and in transgendered women. The risk for infection decreased by 73% in those who took their pills on 90% or more of the days in the study.

Cautious Optimism

An example of treatment-as-prevention, not discussed in the article, is a recent trial showing that ART given to a group of HIV-infected individuals — most of whom were heterosexual — with relatively healthy immune systems was 96% effective in preventing infection in their partners.

The "ideal cornerstone" of a prevention strategy, the authors write, would be a safe and effective vaccine. The quest for such a vaccine has met with repeated failures, although several recent advances have led to "a degree of cautious optimism." For example, researchers have found that sexual transmission of HIV often appears to begin with a single "founder virus" that differs from the various strains that develop over time in an infected person.

This insight may create new targets for vaccines. In addition, a 2009 vaccine trial in Thailand reported 31% efficacy in preventing HIV infection — a modest success that future trials can build on.

A vaccine that guards against all forms of sexual transmission — including blood-borne transmission — would work in tandem with a growing number of other evidence-based prevention strategies ranging from PrEP to adult male circumcision, according to Drs. Dieffenbach and Fauci.

"Researchers are unlikely to achieve transformative successes in HIV with a unidimensional approach," they write. "Instead, this will require various versions of combination prevention strategies, depending on the target population."


Source.

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