The Business Leadership Council for a Generation Born HIV Free was launched together with a Social Media Syndicate that is designed to reach billions of people around the world, getting them to join in action to take the number of HIV-infected births from 390,000 a year to zero within 48 months, making it the world’s largest social media movement of its kind. The Syndicate will evolve to focus on other UN Health Millennium Development Goals over the coming months.

The Business Leadership Council has enlisted leading executives to bring the know-how, finances and commitment of the private sector together with government efforts, and is part of the Global Steering Group led by Michel Sidibe, the Executive Director of UNAIDS, and Ambassador Eric Goosby, United States Global AIDS Coordinator.

Health experts agree that eliminating HIV infections among newborn babies is fully achievable by the end of 2015, but doing so will require a joint effort of the private and public sectors. Financial experts increasingly recognize the high return and cost-effectiveness of investing in disease prevention.

“The private sector is playing a key role in improving health and well-being around the world through its strong engagement in the Every Woman Every Child movement,” said United Nations Secretary General Ban Ki-moon. “Innovative partnerships are critical to meeting our goal of eliminating new HIV infections among children by the end of 2015.”

“We have 48 months to get this done,” said John Megrue, Chief Executive Officer of Apax Partners US, and Chair of the Business Leaders Council. “This is one of the clearest humanitarian goals of our time, and we can do it.”

The Social Media Syndicate will coordinate the most influential individual publishers to generate a mass social mobilization and be led by Randi Zuckerberg, founder of R to Z Studios and former marketing director at Facebook. The syndicate expands on a model that was used successfully to help raise $200 million to fight malaria.

“We have all seen how organizing through the social web can change the world. Now with the Social Media Syndicate, we can unleash that power to achieve ambitious goals to improve people’s health around the globe,” said Ms. Zuckerberg. “As a mother myself, I know everyone with children can agree that no child should be born with HIV.”

To mark the launch at WEF, the Social Media Syndicate simultaneously broadcast its first social message through Twitter, Facebook and other social media about ending HIV transmission to children, and it is expected to generate more than 100 million impressions. At Davos, Ms. Zuckerberg has interviewed several principals involved with the initiative for video broadcast through social media. She described how people’s individual social media networks can be used to independently amplify pressing issues to reach the UN Health Millennium Development Goals.

Ambassador Goosby participated in today’s launch, and added: “The science is clear that achieving a generation born HIV-free is possible. It is also a smart investment that will save lives and pay dividends in many of the world’s emerging economies. The Business Leadership Council and the Social Media Syndicate will marshal the power of the private sector, converging business acumen, technology and other assets to support country-led efforts to prevent new infant infections and save mothers’ lives. I commend these business leaders for their commitment and partnership.”

Dominic Barton, Worldwide Managing Director of McKinsey and Company, said: “To achieve this crucial goal, we must focus on effective program execution – a task which business leaders everywhere are well placed to support. Every executive committed to making a positive impact on society should join us. It’s an honor for McKinsey to be part of this cause.”

Cynthia Carroll, Chief Executive of Anglo American, said: “It is truly unconscionable that out of the roughly 1.4 million global HIV-positive pregnancies each year, we still see some 390,000 new child infections. That’s 28% – not much better than if we did nothing at all. We would not tolerate such poor performance in business and there is no earthly reason why mothers should tolerate such a burden of disease in their newborn babies. I am excited to see everyone here joining in our determination to achieve the goal of an HIV free generation. This is achievable by the end of 2015 and makes unmistakable business sense from both a humanitarian point of view and as a simple return on investment.”

Michel Sidibe, Executive Director of UNAIDS, said: “The entire UN community stands fully behind the Business Leadership Council and their resolve to end new HIV infections among children by 2015. It is inspiring to see so many corporate leaders come together for a noble and yet entirely realistic goal.”

The joint initiatives will work closely with UNAIDS and other partners, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, the world’s leading financing institution dedicated to supporting large-scale prevention, treatment and care for these three diseases, and other partners. The Global Fund, which has already committed over US$22 billion worldwide, is a unique public-private partnership in global health that has proven highly effective.

Members of the Business Leadership Council already include its Chairman, John Megrue, Chief Executive Officer of Apax Partners US; Dominic Barton, Worldwide Managing Director of McKinsey & Company; Steven Burke, Chief Executive Officer of NBC-Universal; Nathan Kirsh, Chief Executive Officer of Jetro; Norman Payson M.D., Chief Executive Officer of Apria Healthcare Group; Sir Martin Sorrell, Chief Executive Officer of WPP; Cynthia Carroll, Chief Executive of Anglo American; and Jamie Cooper-Hohn, Co-founder, President and CEO of Children’s Investment Fund Foundation.

The news conference can be seen via: http://wef.ch/presser

A new website includes more information, including a striking video presentation: http://for-a-generation-born-hiv-free.org/

SOURCE Business Leadership Council

Copyright (C) 2012 PR Newswire. All rights reserved

On the plus side it pleases me tremendously that Sangamo is moving swiftly with their technology–where CD4s or stem cells can be modified to resist HIV infection though the use of zinc fingers. Their pace compared to other similar biotechs has been pretty fast. So far, there have been no hiccups or signs of a problem. There have, however, been some intriguing findings.

In one trial of heavily treatment-experienced individuals, some of the study participants had stunning and sustained increases in their CD4 counts. In a second study, one of the participants by chance carried a natural mutation in his CD4s that made the cells partially resistant to infection. This is because the participants’ CD4 cells have fewer functional CCR5 co-receptors on their surface, a coreceptor HIV needs to infect the cells. It looks like this study participant might have started controlling his virus almost completely during an interruption in his antiretroviral (ARV) therapy following the zinc finger treatment. If a person could go months or years without the need for ARVs this would, in essence, be a type of functional cure.

The two new trials announced by Sangamo represent a logical next step. The company is going to test their therapy in an entire group of people who have the same mutation as the patient mentioned above and then let them stay off of ARV therapy as long as their virus stays under control. A second similar study will be attempted in people without the mutation, but researchers will first give the participants a mildly immunosuppressive drug to make “space” for the new zinc-finger-modified CD4 cells.

While neither study would automatically (based on publicly available information) exclude people who’s CD4s never rose very high on ARV therapy–a group scientists refer to as immunologic non-responders–both studies are emphasizing that success will only be measured based on people’s viral load responses. In essence, if they can’t get at least some people to undetectable and keep them there, the trials could be seen as a failure and this very promising development plan could be brought to a standstill.

I understand the need to aim for quick and demonstrative success when you don’t have deep pockets and must constantly look for investments or partnership opportunities with bigger companies. That said, I would be happier if Sangamo would launch a third trial with the primary goal being to significantly elevate CD4 responses in immunologic non-responders and to look in more intensive ways at how functional those new CD4s are in protecting those individuals from health problems and opportunistic infections. Right now there are few promising treatments under study to boost CD4s in immunologic non-responders and I’d hate to see one of them demolished under the weight of lofty ambitions.

About four years ago at the International AIDS Conference in Mexico City, Tony Fauci gave a much-lauded talk about the possibility of a cure and his belief in it. In that talk, he highlighted that a functional cure or one that actually removed every last trace of HIV from the body (a sterilizing cure), would be most likely in people we caught within days or weeks after infection. I turned to a top AIDS researcher at the conference and asked whether this meant that people who’d lived with HIV for a really long time, particularly immunologic non-responders, would get left in the dust in the search for a cure. He winced, then said, “I hope not.”

SB-728-T is a zinc finger DNA-binding protein transcription factor (ZFP TF). It disrupts the gene responsible for making CCR5 co-receptors on the surface of CD4 cells, to which HIV bonds. When CD4 cells can’t produce functional co-receptors, it is much harder for HIV to infect them.

The aim of SB-728-T therapy is to grow a new population of CD4 cells that are resistant to HIV infection, and thus make antiretroviral (ARV) therapy unnecessary.

The rationale for using SB-728-T comes from the case of Timothy Brown, an HIV-positive man with leukemia who received two stem cell transplants from a donor who inherited two mutated CCR5 genes (CCR5 delta32), from his father and mother, and was genetically unable to produce CD4 cells that carry functional CCR5 co-receptors. Such individuals rarely become infected with HIV. And in cases where only one mutated CCR5 gene is inherited, HIV infection can occur, but the disease tends to progress slowly.

In Brown’s case, not only did the stem cell therapy cure his cancer, but it also appears to have cured his HIV infection. All efforts to locate HIV in the man’s body have been unsuccessful.

Sangamo is hoping that treating a person’s own stem cells with SB-728-T and then reinfusing them will, over time, replace HIV-susceptible cells with HIV-resistant CD4s and reduce the need for continuous antiretroviral therapy.

“We are delighted to be able to open these two important clinical studies ahead of schedule,” said Geoff Nichol, MB ChB, Sangamo’s executive vice president of research and development. “Data from earlier Phase 1 trials demonstrated a statistically significant relationship between the number of circulating [CD4s] in which both CCR5 genes are modified and the reduction in HIV viral load in infected subjects during an interruption of antiretroviral therapy. Both of these new [Phase II] clinical trials are specifically designed to confirm and further investigate these findings.”

The new studies employ two approaches to increase the number of infused CD4 cells in which both CCR5 gene copies are modified using SB-728-T. The first study, an extension of an ongoing trial (SB-728-902), will explore the effect of SB-728-T treatment on viral load in people living with HIV who inherited one CCR5 delta32 genetic mutation. The second study (SB-728-1101), involving people living with HIV without the CCR5 delta32 mutation, involves a pre-infusion course of chemotherapy to significantly enhance the proliferation of the gene-modified CD4 cells in the body.

In the extension of the SB-728-902 trial, up to 20 HIV-positive volunteers with one copy of the CCR5 delta32 deletion who are currently receiving ARV therapy will be enrolled and will receive a single intravenous infusion of 5 billion to 30 billion SB-728-T-modifed CD4 cells. Two months later, these volunteers will undergo a 16-week ARV treatment interruption. HIV treatment will be restarted if the patients’ CD4 cells drop below 350 or if their viral loads are above 100,000 for three weeks in a row. After 16 weeks, only those who maintain undetectable viral loads will be permitted to remain off therapy. 

The SB-728-1101 trial will mainly evaluate the safety and tolerability of Cytoxan (cyclophosphamide) chemotherapy, administered one day before being infused with SB-728-T-modified CD4 cells. Cytoxan is a chemotherapeutic drug used to temporarily reduce the numbers of CD4 cells in the body, which then rapidly repopulate once the drug is discontinued.

Chemotherapeutic “conditioning” therapy has been used to enhance engraftment of cells in the treatment of cancer and for numerous autoimmune diseases. The drug has been previously used in people living with HIV, with studies demonstrating that while the drug does reduce CD4s, it does not have a long-term effect on CD4 cell counts.

In addition to safety, the study will evaluate the effect of Cytoxan—administered intravenously at a dose of either 200 milligrams (mg), 500 mg or 1,000 mg—on SB-728-T engraftment, the effect of SB-728-T treatment on viral load following ARV therapy interruption, the change in CD4 cell counts and the long-term persistence of SB-728-T. At least nine people living with HIV receiving ARV therapy will be enrolled in the study.

Six weeks after receiving the infusion of SB-728-T-modifed CD4 cells, patients with CD4 cell counts of at least 500 will undergo a 16-week treatment interruption. Therapy will be reinstituted in the event the CD4 cell count falls below 500 or viral load exceeds 100,000 for three weeks.

In the early years of having HIV I didn’t see a future for myself past 30. I was 18 when I was infected and back then unlike today it seemed more likely you would die then live a longer life with a manageable routine of medication.

Of course when it seems like you have a ticking clock over your head you become reckless and have a feeling of ‘what’s the point’. I was in that place. I stopped dreaming and going after goals. Instead of making a To-do list my list consisted of destructive behaviors that went against who I truly was deep inside. Yet how could I show people who I was inside when I didn’t even give myself permission to look within.

It was years of spinning my wheels going nowhere just waiting for the Grim Reaper to finally get to my name on the list. In the meantime I let my anger of the situation guide me and I truly become that slogan, “hurt people, hurt people”. Not realizing the only person I was hurting was myself.

Before I knew it Dick Clark was dropping the ball again, then again, then again and the death that I thought was waiting for me seemed to have forgotten about me. I had my awakening moment when I realized that; hey I’m not going anywhere.

It was then I told myself I can stay in this moment of pain and keep holding my breath or look at the gift of life that I was given. Others around me had passed on to a higher plane but I was still here. I was still living with the gift that God had given me, which was the ability to wake up each day with everything functioning. The gift of life.

I’m here.

I couldn’t use the excuse of my status for why I was not going after my dreams, especially when all this time God was telling me, “I’m not done with you”

Since I had my waking moment and put my life in drive and dealt with all the internal and external forces that were holding back, I started to move. When I started to release the people who were draining my positivity and started to surround myself with positivity, things started to change. When I looked in the mirror and started to look at the greatness and not the flaws, I started to grow into myself. When I accepted myself and made no more excuse for my flaws, I started to see me.

Now it felt that each New Year was not one of holding on to grief and ‘shoulda, coulda’ woulda’s’. It was now a time for me to say, this is what I’m going to do and it’s going to get done. I see why the New Year is represented by a young baby and an old man. The young represents the rebirth of who we are and the old man represents the letting go of old issues that is old and gone and should no longer be part of us.

More than a resolution, it was a promise that I was going to live my life the best I could despite what was living in me as I was the one truly in control. Health, eating habits, friends they were in the front seat and negativity, drama and grudges they were dropped, just like the ball in Times Square.

So I celebrate not only the arrival of each year but also the ability to awake for each day. I truly am blessed and when the ball drops this year I recognize my gift and will join the chorus of others and shout out loud….

Happy New Year!!!

Ron Paul, Chris Wallace Need AIDS Education
By Oriol R. Gutierrez Jr. on January 3, 2012 4:21 PM | 2 Comments
In his 1987 book Freedom Under Siege, current Republican presidential candidate and U.S. Representative Ron Paul (D-Texas) wrote this about people with AIDS: “The individual suffering from AIDS is certainly a victim, frequently a victim of his own lifestyle, but this same individual victimizes individual citizens by forcing them to pay for his care.”

In a January 1 interview with Chris Wallace on Fox News, Paul was asked if he still supported that position and basically said yes. Wallace then asked him if people with AIDS should be denied health insurance. Paul said no, but he directly implied that people with AIDS should pay more for their health insurance.

Paul points out that smokers are often asked to pay more for their health insurance, which is true. What he fails to see is that the smoking comparison doesn’t really apply. Should the people who did not acquire HIV through unprotected sex pay more? Most people who acquired HIV through unprotected sex (like myself) did not intend to be harmed. Most people who smoke do so fully aware of the health risks. By Paul’s logic, it seems to me that he should be in favor of higher health care costs for all people who have had unprotected sex.

Paul’s beliefs notwithstanding, perhaps the most appalling thing in this interview was how Wallace asked Paul about health insurance for people with AIDS: “Congressman, do you think someone who suffers from AIDS should not be entitled to health insurance as opposed to, let’s say, somebody who has a homo, heterosexual transmitted disease?”

Wallace committed many no-nos with this question. On style, enough with the “suffers from AIDS” phrase, please. Saying “has AIDS” is sufficient, thank you very much.

Just to back up my annoyance, here’s the entry on AIDS from the National Lesbian & Gay Journalists Association (NLGJA) stylebook:
AIDS: Acquired Immune Deficiency Syndrome, a medical condition that compromises the human immune system, leaving the body defenseless against opportunistic infections. Some medical treatments can slow the rate at which the immune system is weakened. Do not use the term “full-blown AIDS.” Individuals may be HIV-positive but not have AIDS. Avoid terms such as “AIDS sufferer” and “AIDS victim” because they imply powerlessness. Use “people with AIDS” or, if the context is medical, “AIDS patients.”

On substance, Wallace made an even more egregious error. By saying a “heterosexual transmitted disease” (I’m sure he meant “heterosexually”), he directly implies that HIV is essentially a gay thing. His slip up of including “homo” before “heterosexual” seems to underscore this belief.

Obviously gay people are disproportionately impacted by HIV/AIDS, but the virus does not discriminate by sexual orientation. Wallace should know better. All journalists should know better.

Though much attention is being paid to efforts to achieve sterilizing HIV cures—those akin to what was achieved in Timothy Brown, the “Berlin Patient,” who underwent high-dose chemotherapy and two stem cell transplants to render his immune system impervious to HIV and essentially snuff the virus out completely—there are also proposed strategies to achieve functional HIV cures. With a functional cure, HIV remains detectable in the human body, but no viral replication is found in the absence of ARV therapy.

Typically, discontinuing ARV therapy leads to a rapid rebound in viral load, likely because HIV persists in a large number of long-lived cellular reservoirs in the body that are not affected by standard medications. Some researchers believe that the immune system does have the ability to keep viral replication in check, but that the high volume of HIV that returns following ARV treatment discontinuation quickly overwhelms the immune system. In turn, some scientific teams have been interested in pairing drugs that attack cellular reservoirs of HIV with standard ARV therapy, to see if they can blunt the proliferation of virus following treatment discontinuation and therefore provide the immune system with an opportunity to maintain control of the virus on its own.

Researchers such as David Margolis, MD, at the University of North Carolina in Chapel Hill are studying HIV reservoir-targeting therapies in human subjects. Meanwhile, there is much to be gained from exploring similar approaches in animal models, notably macaques infected with SIV, HIV’s simian counterpart.

The experiments conducted by Savarino and his colleagues involved 18 SIV-infected macaques receiving ARV therapy and, in some cases, drugs targeting long-lived SIV reservoirs. Five macaques in particular received ARV therapy in combination with auranofin—an approved medication, sold under the brand name Ridaura, used to treat rheumatoid arthritis and previously shown to be capable of killing memory CD4 cells (a major long-lived HIV reservoir)—and the glutathione synthesis inhibitor buthionine sulfoximine (BSO), which has been shown to help eliminate HIV-infected cells.

After a series of treatment cycles combining ARV therapy first with auranofin and then with BSO, extremely low viral “set points”—viral loads below 200 copies in the absence of treatment—were maintained for more than 100 days in three of the macaques.

“The change in viral load set point was positively correlated with the number of drugs potentially acting against the viral reservoir that the monkeys had received,” Savarino and his colleagues wrote in the study abstract, “thus suggesting that drugs acting against viral targets alone”—such as antiretrovirals—“are insufficient to induce viral load containment in the absence of therapy.

“The results of the present study,” the authors conclude, “show that anti-reservoir strategies may indeed result in spontaneous control of viral load in the chronic phase of the infection and pave the way to a functional cure for AIDS.”

Thirty years after the first reported cases of HIV/AIDS, today, World AIDS Day, we take time to pause and remember those that we have lost in the fight against HIV/AIDS, to celebrate their lives and to advocate for the nearly 1.2 million people living with HIV in the United States. In recognition of World AIDS Day, President Obama announced this morning the availability of $50 million in new resources for Ryan White Programs. $35 million will be allocated to support the AIDS Drug Assistance Program (ADAP- otherwiseknown in Ohio as OHDAP) and $15 million for Part C Programs across the United States. 

Today’s announcement follows the recent speech and eloquent vision of an “AIDS-free generation” by Secretary of State Hillary Clinton last month.”We applaud the Obama administration for today’s renewed commitment and action toward bringing an end to the HIV epidemic, commented Bill Hardy, CEO of AIDS Resource Center Ohio (ARC Ohio). 

The Obama administration launched our nation’s first ever National HIV/AIDS Strategy in July 2010, a push to improve domestic HIV prevention and access to care. Thirty years into the HIV epidemic, recent HIV Incidence estimates indicate nearly 50,000 new infections annually in U.S. While overall incidence has stabilized, populations of gay bisexual men of all races and ethnicities continue to see a steady and unacceptable increase in HIV infection, with alarming rates among young gay and bisexual men of color. 

“Looking toward the road ahead, we need a unified commitment, at the federal, local, and state level that addresses program and policy initiatives necessary for ending the HIV epidemic” commented Tyler Andrew TerMeer, Director of the Ohio AIDS Coalition – a Division of the AIDS Resource Center Ohio.TerMeer continued,“Advocates around the country today stand united calling for that renewed commitment. A commitment that means achieving the sum of zero. Zero new infections, zero discrimination, and zero AIDS-related deaths.”   

The $35 million in increased funding for ADAP will go to state ADAPs to support grants to states to help nearly 3,000 individuals with HIV/AIDS access life-saving HIV/AIDS drugs. A distribution process for this funding has not yet been announced, however it is expected that a portion of the ADAP funding will be provided to all states and the remainder to states with severe need. The funding directed to the Ryan White Part C program for HIV medical clinics across the country will target areas where HIV infections have increased and HIV care andtreatment services are not readily available. This additional funding is expected to provide services to 7,500 more patients across the country. A complete transcript of the President’s remarks can be found online. 

“Over the past 30 years we have made extraordinary progress in our battle against HIV/AIDS,” says Hardy. “Still we face significant challenges.  Most Americans living with HIV are still not receiving adequate treatment, and one-fifth of HIV-positive individuals are unaware they are infected.  Still, we are committed to making 2011known as the moment that began to turn the tide of the epidemic throughout Ohio communities, commented Hardy.” In strong stance against the epidemic, this year, ARC Ohio announced strategic mergers with the Columbus AIDS Task Force (CATF) and the OAC to ensure sustainable, quality services for Ohioans. 

With nine regional offices, this year ARC Ohio will provide supportive services and linkage to care for 3,500 HIV- positive individuals across Ohio.  Thousands more will be reached with advocacy, evidence-based prevention and testing services.   For more information go to www.arcohio.org

Contact: Tyler Andrew TerMeer – 614-340-6712 

termeer@ohioaidscoalition.org

Plans for the newest Tibotec-Gilead FDC development strategy follow a similar announcement in June indicating plans to produce a single tablet combining Prezista with cobicistat.

During the past decade, a number of different HIV drugs have been combined into single pills, both to reduce the total number of pills that people with HIV take and to extend the rights of companies to exclusively sell their drugs. The most successful of these combinations, Atripla—which contains Bristol-Myers Squibb’s Sustiva (efavirenz) and Gilead’s Truvada (tenofovir plus emtricitabine)—was the first to combine drugs from two different companies.

To date, no protease inhibitors (PIs) have been co-formulated with other necessary agents to allow for complete one-pill, once-daily regimens.

The complete FDC being developed by Tibotec and Gilead will contain two approved drugs—Prezista and Emtriva—with two still-experimental agents: cobicistat and GS 7340.

Cobicistat is currently in Phase III studies and is being explored as an alternative to Norvir (ritonavir) to boost blood levels of other PIs.

GS 7340 is a “prodrug” of tenofovir (sold as Viread)—its mechanism of action is the same, but it requires a dose that is 10 times lower than Viread and provides greater effectiveness. Though Gilead announced in 2004 that it had no interest in further developing the drug, arguing that it “does not believe that GS 7340 has a profile that differentiates it to an extent that supports its continued development,” the company now plans to conduct a Phase II study to explore its efficacy, in preparation for its combined formulation with Prezista, cobicistat and Emtriva.

“We are pleased to once again be partnering with Tibotec to advance and simplify HIV treatment for patients,” said Norbert Bischofberger, PhD, Gilead’s chief scientific officer, in the company’s announcement. “This is the first time we are developing a protease inhibitor–containing single-tablet regimen, and we’re able to do that based on the small milligram size of GS 7340, which is less than one tenth of the amount of the 300 mg of tenofovir disoproxil fumarate contained in Viread and Truvada.”

Gilead will be responsible for the formulation, manufacturing, registration and, subject to regulatory approval, distribution and commercialization of the single-tablet regimen worldwide. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets.

Volunteers from the Ursuline Piazza’s Club 95 will make a panel remembering twenty of our HIV-positive friends who have died since the start of our program in 2007.  This workshop is being made possible by a partnership of The MetroHealth System, Cleveland Institute of Art, Stitch Cleveland, Pins & Needles and The DBJ Foundation. 

The AIDS Memorial Quilt (64 panels) can be viewed on Tuesday, November 29th from 6 – 8 p.m. at Cleveland Institute of Art, Joseph McCullough Center, 11610 Euclid Avenue, Cleveland, Ohio 44016 and again at the Closing Reception on Wednesday, December 7th from 5:30 – 7:30 p.m.  Featuring 64 panels of the Quilt plus all of the newly created panels from the workshops at MetroHealth Medical Center, Main Campus, Rammelkamp Atrium, 2500 MetroHealth Drive, Cleveland, OH 44109.

For more information about this project, please visit www.metrohealth.org.

For more information about The AIDS Memorial Quilt, please visit www.aidsquilt.org.