INCREASED HEPATITIS C INFECTIONS RELATED TO INJECTION DRUG USE OF PERSONS OVER 30

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Increases in Hepatitis C Virus Infection Related to Injection Drug Use Among Persons Aged <30 Years — Kentucky, Tennessee, Virginia, and West Virginia, 2006–2012

Evidence suggests drug injection and prescription opioid abuse are fueling hepatitis C increases in four states east of the Mississippi River. Surveillance data show a national increase in acute hepatitis C virus (HCV) infections from 2006-12, with the largest increases occurring east of the Mississippi River. To better understand the increase in HCV and its correlation to injection drug use, researchers reviewed surveillance data from four states showing a 364 percent increase in cases — Kentucky, Tennessee, West Virginia, and Virginia — along with drug treatment admissions data. Nearly half (44.8 percent) of HCV cases occurred among people under 30, with a median age of 25. Significant increases in both urban and non-urban areas were found, with more than double the rate of cases occurring in non-urban areas. The majority of those diagnosed were white, and equally as likely to be male as female. Of the cases for which risk data were identified, 73.1 percent reported injecting drugs. Data showed increases in the proportion of persons under 30 admitted for abuse of any opioid (21.1 percent), abuse of prescription opioids (16.8 percent), and injection of any opioid (12.6 percent). While HIV prevalence in this population is currently low in these four states, the regional increase in HCV infections raises concerns about the potential for an increase in HIV infections, as injection drug use is a risk factor for both HIV and HCV. Combined, these findings highlight the need for increased HCV testing, care, and treatment services within substance abuse treatment programs.

FIRED DENTAL ASSISTANT TO RECEIVE $85,000 IN CASE INVOLVING DISPOSAL OF CONTAMINATED NEEDLES

FROM:  U.S. LABOR DEPARTMENT  

Court orders dentist to pay $85K to employee fired for safety complaint
Assistant raised dangers of used needles as Dr. N. Terry Fayad allegedly sought cost savings

BOSTON, Mass. — It began when Massachusetts dentist Dr. N. Terry Fayad changed his practice's procedure for disposing of contaminated needles. He told those in his Beverly-based office to first remove the protective caps before dropping them into sharps disposal containers, allegedly to fill the containers with more used needles and reduce the frequency and cost of their disposal.

Concerned that she and her co-workers could be exposed to needle stick injuries and the risk of infection from bloodborne pathogens such as hepatitis and HIV, a dental assistant raised the issue with Fayad. When he dismissed her concern, she filed a complaint with the U.S. Department of Labor's Occupational Safety and Health Administration. After an OSHA inspector visited on Nov. 23, 2010, Dr. Fayad fired her later that day.

A whistleblower investigation followed and, in September 2011, the Department of Labor sued Fayad in the U.S. District Court for the District of Massachusetts. In its complaint, the department charged that the dentist violated the anti-retaliation provisions of the Occupational Safety and Health Act. The suit eventually went to trial before U.S. District Judge George A. O'Toole.

Judge O'Toole has ruled in favor of the department and ordered Fayad's practice, N. Terry Fayad, D.M.D., P.C., to pay the worker $51,644.80 in back wages and ordered both Fayad and the practice to pay her $33,450.26 in compensatory damages. The judge found that the employee's firing by Fayad shortly after OSHA began its inspection was retaliatory and a violation of section 11(c) of the OSH Act.

"This worker suffered needless financial and emotional distress because Dr. Fayad chose to disregard a clear and important principle: Employees have the right to contact OSHA and raise workplace health and safety concerns with their employer without fear of termination or retaliation," said Greg Baxter, OSHA's acting regional administrator for New England. "Employers must pay attention to this verdict. It makes it clear that there will be legal and financial consequences if you retaliate against your employees in this manner."

"The OSH Act gives employees both a right to a safe and healthy workplace, and a right to voice concerns about workplace conditions, without fear of adverse consequences," said Michael Felsen, the department's New England regional solicitor of labor. "This case demonstrates the Labor Department will pursue legal remedies aggressively when employers fire workers or try to intimidate them into silence when they assert those rights."

The court also entered an injunction against Fayad, his P.C., and their agents and employees, preventing them from violating the anti-retaliation provisions of the OSH Act, and directing the defendants to post a notice to their employees stating that they will not in any way discriminate against employees for activities protected by the Act.

The case was tried on the Secretary's behalf by Senior Trial Attorney Kelly Lawson and Trial Attorney Nathan Goldstein of the department's regional Office of the Solicitor in Boston.

OSHA's health inspection resulted in the Fayad practice being cited for violations of OSHA's bloodborne pathogen and hazard communication standards. The violations were corrected and he paid a fine of $11,000 in 2012.

OSHA enforces the whistleblower provisions of the OSH Act and 21 other statutes protecting employees who report violations of various airline, commercial motor carrier, consumer product, environmental, financial reform, food safety, health care reform, nuclear, pipeline, worker safety, public transportation agency, maritime and securities laws.

Employers are prohibited from retaliating against employees who raise various protected concerns or provide protected information to the employer or to the government. Employees who believe that they suffered retaliation for engaging in protected conduct may file a complaint with the secretary of labor to request an investigation by OSHA's Whistleblower Protection Program.

REMARKS WITH SIR ELTON JOHN BEFORE THEIR MEETING

FROM:  U.S. STATE DEPARTMENT 

Remarks

John Kerry

Secretary of State

Outer Office

Washington, DC

October 24, 2014

SECRETARY KERRY: It’s my enormous pleasure to welcome Sir Elton John here to the State Department. We met a few years ago when we were talking and I was still in the Senate about the challenge of PEPFAR and creating the next AIDS-free – the AIDS-free generation. I want to thank Sir Elton for his tremendous leadership almost from the beginning of the challenge of HIV/AIDS. And his foundation, the Elton John AIDS Foundation, has been critical in bringing hope and help to a lot of people.

So it’s my pleasure today to be able to announce a $7 million partnership between PEPFAR and the Elton John Foundation which will help bring additional assistance to people and help us meet this goal of an AIDS-free generation. And I want to thank him very, very much for his extraordinary leadership. We’re going to continue to work together to bring this help to all those folks, particularly in the LGBT community, who need this particular assistance. And we think it’ll make a difference, as he has through the years. So thank you, sir.

SIR ELTON JOHN: Thank you. I’d like to thank Secretary Kerry for taking the time to see me, for his tireless work from the word “go” to create an AIDS-free world. He has been relentless in that. And also, hearing the Obama Administration’s loud, loud voice that everyone in the world should be – we should be living in an AIDS-free world, and that people, no matter who they love, who they are, should have a right to be AIDS-free.

To be able to combine with PEPFAR, from our foundation’s point of view, is a dream come true, because together, you double the effect. I think from the beginning of the AIDS crisis, there were so many different foundations, and what’s happened is that now, there’s a few of us left. We’re probably the smallest of them all, but we combine with PEPFAR and everybody else. We all work together to ensure that in this day and age, nobody gets left behind no matter what their sexuality, their color, or whatever. It’s important. If people get left behind, the disease will get left behind, and we will face an enormous uphill battle.

So this partnership that we’re doing today is an incredibly important step to, again, ensuring that people in the future will be living in an AIDS-free society. That’s been my goal ever since we started this foundation, and I know it’s Secretary Kerry’s goal as well and the Obama Administration’s goal. Together, we’re fighting it, and I’m very optimistic that we can make a huge difference. This is a very, very big deal. We’re opening this and doing this in South Africa, and – this first joint venture and it’s a historic adventure – a venture and an adventure.

So thank you, Senator Kerry, for your help; thank you, PEPFAR; and together, I think we will do great work, and we have a lot more work to do, but this is a good start.

SECRETARY KERRY: Thank you, sir, very, very much. Thank you. Nice comments.

SECRETARY OF STATE KERRY MAKES REMARKS AT UNAIDS

FROM:  THE STATE DEPARTMENT 

Remarks at UNAIDS

Remarks

John Kerry

Secretary of State

UN Headquarters

New York City

September 25, 2014

Well, thank you very much. Thank you for a generous introduction. Mr. Deputy Secretary General, thank you for your leadership and thank you for your important words here today. And thank you to the many activists out here, those of you who are championing this effort on the frontlines. We certainly welcome Victoria Beckham. Thank you for taking this on.

And I want to note that my old friend and our leader, Eric Goosby, Dr. Eric Goosby, is here. Happy to see him and all his great work. And I’m happy to see – (applause). I’m happy to see a colleague of mine who I got to serve with for a few years before I came onto this, but delighted to see Senator from Delaware Chris Coons here, his passionate voice in the Senate for this – (applause). And all of you, thank you for – now I’m getting whispered who I have to start – my good friend Michel is saying got to recognize – (laughter) there, there. If I do that, I’m never going to get through this. (Laughter.)

Mr. Deputy Secretary General, three years ago you set a tremendous goal for all of us. You said, "Zero new HIV infections, zero discrimination, and zero AIDS." And that goal has been set for us to achieve by 2020. In the refusal to allow AIDS to ravage yet another generation, you have showed an even bigger determination than we might have anticipated to meet our global responsibilities. And I want to thank you for the tremendous efforts by setting that target for all of us. And I believe it’s achievable, notwithstanding the difficulties that Jan just mentioned to all of us.

I want to thank President Burkhalter of Switzerland and President Mahama of Ghana and President Zuma of South Africa, and my good old friend Michel Sidibe, the executive director of UNAIDS, for their commitment to helping to write a new chapter in the fight against AIDS.

It’s more than fair to say that the work that we’re doing together here is work that was once just a distant dream. And we are making an AIDS-free generation a closer reality for a lot of folks all around the world.

Now I think about what the word " AIDS" meant when I became a United States Senator in 1985. Back then it was a death sentence. Back then many people in positions of responsibility – and I knew them, some of them – were not even comfortable saying the word or talking about it in a meeting or being present when it was discussed.

I think about what the word " AIDS" meant on a global scale back in the 1990s, back when Senator Bill Frist and I first began working together on this issue and when we started to join three words together in a sentence: " AIDS in Africa." It meant a looming death sentence for an entire continent, and thank God people of conscience and conviction decided that was unacceptable.

The truth is that in many ways, we’ve ended 1985’s meaning of " AIDS" as we knew it. It’s not an unspoken word, nor is it an automatic death sentence. And thanks to the President’s Emergency Plan for AIDS Relief, which grew out of our initial efforts in the Senate I am proud to say, we are on the road to do the same globally, notwithstanding pockets of greater emergence or pockets of resistance. But the reason we’re on the road is we know what we can achieve. We’ve seen what we’re able to do. We now have to complete the task to end the era of AIDS, period, full stop end the era. (Applause.)

Last year, I was honored to stand with President Obama as he announced that PEPFAR had not only met but exceeded his goal. That’s what I mean about we know we have the capacity: 6.7 million people are now receiving life-saving treatment, and that’s an astounding number, a fourfold increase since the beginning of this Administration, since Barack Obama came into office. And today, more than one million babies have been born HIV-free because of PEPFAR’s support. Now, these are a lot more than just numbers, and I think everybody in this room knows that better than any other people. Every one of these men, women, children has a unique contribution to make, and every one of those babies can now grow up to be a person, healthy, go to school, contribute to the workforce, realize dreams, and maybe even have sons and daughters of their own. Their lives remind us of what we have achieved, but more importantly, they remind us still of the miles we have yet to go in order to achieve the full-fledged AIDS-free generation.

So first, we need to continue to make strategic and creative investments that are based on the latest science and best practices. In a tight budget environment – and everybody faces that – every dollar, yen, and euro counts. And that’s why we need to focus on data, on mutual accountability, transparency for impact, and put our weight behind HIV prevention, treatment, and care interventions that work. We also need to continue to set benchmarks, and I’m very pleased that PEPFAR’s investment supports UNAIDS’s 90-90-90 targets. (Applause.) PEPFAR is laser-focused on achieving ambitious targets in the areas of high HIV prevalence, and the challenge is obviously big and it’s obviously important.

Second, we need to focus on the impact of HIV/AIDS on children, young women, and vulnerable populations. And that’s why the United States announced a new partnership last month between PEPFAR and the Children’s Investment Fund Foundation called Accelerating Children’s HIV/AIDS Treatment. This ambitious partnership will help 300,000 more children living with HIV to get the treatment that they need, and I’m proud to announce today that we are making nearly 500 million in PEPFAR funds available this year to support efforts for children, young women, and vulnerable populations. (Applause.)

Third, we need to double down on our new country health partnerships, which are focused on using data to change people’s lives on the ground. South Africa, Rwanda, Namibia are on the front lines of the transformation from direct aid to providing support for locally run, self-sustaining investments, and we need to back these efforts every step of the way.

Finally, we need to ensure that the post-2015 development agenda reflects the United States’s continued commitment to ending the HIV/AIDS epidemic and creating an AIDS-free generation. I want to emphasize: The United States commitment to fighting HIV/AIDS is undiminished, just as our work is unfinished. And our commitment has only been strengthened by the progress that we’ve made, the lives we’ve saved, and the fact that we’ve learned we know what to do, we just have to do it. That’s a story worth telling and it’s a story that compels all of us to continue.

So I will never forget just a few months ago walking into the Gandhi Memorial Hospital in Addis Ababa. And as I passed the front gate in the back with a group of doctors, nurses, and patients all assembled, I saw this big sign on the wall that read, " Ethiopia and the United States of America: Investing in a Healthy Future Together." That sign tells it all, and that sign is replicated all across communities in one place or another where this kind of help is coming to people. We know – we know that achieving an AIDS-free generation will continue to pose an incredible test. But we also know that with our work together, we can pass this test, we can see this fight across the finish line. And I’m convinced with the folks here and this commitment we are going to do just that. Let’s not stop. Let’s get the job done. Thank you. (Applause.)

NSF EXAMINES HIV BUDDING FROM CELLS

FROM:  NATIONAL SCIENCE FOUNDATION 

Catching HIV budding from cells: it all comes down to ALIX

Study shows last-minute role of specific protein named ALIX

The secrets of the AIDS virus may all come down to a protein named ALIX.

Researchers have devised a way to watch newly forming AIDS particles emerging or "budding" from infected human cells without interfering with the process.

The method shows that a protein named ALIX (which stands for "alg-2 interacting protein x") gets involved during the final stages of virus replication, not early on, as was believed. ALIX assists in separating new virus buds from a cell. These buds repeat the replication process and further infect their host.

"We watch one cell at a time" and use a digital camera and special microscope to make movies and photos of the budding process, says virologist Saveez Saffarian, a scientist at the University of Utah, and co-author of a paper on HIV budding published this week in the journal PLOS ONE.

"We saw ALIX recruited into HIV budding for the first time," he says. "Everybody knew that ALIX was involved in HIV budding, but nobody could visualize the recruitment of ALIX into the process."

The finding has no immediate clinical significance for AIDS patients because ALIX is involved in too many critical functions like cell division to be a likely target for new medications, Saffarian says.

"We know a lot about the proteins that help HIV get out of the cell, but we don't know how they come together to help the virus emerge," he says. "In the next 10 to 20 years, we will know a lot more about this mechanism."

Saffarian conducted the research with the paper's first author Pei-I Ku, as well as researchers Mourad Bendjennat, Jeff Ballew and Michael Landesman. All are with the University of Utah.

The research was funded by the National Science Foundation (NSF).

"This project has led to the development of an important technique in basic research in cell biology and virology," says Parag Chitnis, director of NSF's Division of Molecular and Cellular Biosciences.

"It's uncovering a new understanding of the viruses involved in human diseases," says Chitnis. "This is an excellent example of how purely basic research can lead to the fundamental understanding of topics of societal need."

Watch, don't touch, as HIV buds

Biochemical methods used for years involve collecting millions of viruses in lab glassware and conducting analyses to reveal the proteins that make up the virus--for example, by using antibodies that bind to certain proteins and using other proteins to make the first proteins fluoresce so they can be seen.

"You're not doing it one virus at a time," Saffarian says. "The problem is that you don't see the differences among similar viruses. And you don't see the timing of how various proteins come and go to help the virus get out of the cell."

Other methods freeze or otherwise fix cells as new HIV particles emerge, and use an electron microscope to photograph freeze-frame views of viral replication.

Saffarian employs technology known as "total internal reflection fluorescence microscopy" that looks at the dynamic processes in cells.

The method has been used to make images of the budding of HIV and a similar horse virus, EIAV.

But Saffarian says that the EIAV study didn't show ALIX becoming involved in HIV budding, and that it wrongly indicated that ALIX got involved early in the EIAV budding process, suggesting it did the same in HIV budding.

Ku, Saffarian and colleagues combined their microscopy method with an improved way of genetically linking a green fluorescent "label" to ALIX proteins in cloned cells so they could see the proteins without harming their normal function.

The researchers tried numerous so-called "linkers" and found the one that let them see the ALIX proteins as they became involved in HIV budding.

Neither the microscope technology nor labeling proteins with green fluorescence are new, but "what we did that is new is to connect these fluorescence proteins to ALIX using many different kinds of linkers," says Saffarian, to find one that let the ALIX protein function properly.

The problem with research that indicated ALIX was involved early in the budding process was that only one linker was used, and it impaired ALIX's normal function, the scientists say.

Looking at proteins forming HIV

When HIV replicates inside a human cell, a protein named Gag makes up most of the new particles--there are 4,000 copies of the Gag protein in one HIV particle--although other proteins get involved in the process, including ALIX.

Experiments like those by Saffarian use "virus-like particles," which are HIV particles stripped of their genetic blueprint or genome so they don't pose an infection risk in the lab.

"Virus-like particles maintain the same geometry and same budding process as infectious HIV," Saffarian says.

During budding, Gag proteins assemble on the inside of a cell membrane--along with ALIX in the late stages--and form a new HIV particle that pushes its way out of the cell--the process by which AIDS in an infected person spreads from cell to cell.

To look at the budding process, Ku and Saffarian placed human cells containing the particles in a small amount of liquid growth medium in a petri dish and placed it under the microscope, which is in a glass chamber kept at body temperature so the cells can remain alive for more than 48 hours.

A solid-state blue laser was aimed at the sample to make the green-labeled ALIX and red-labeled Gag proteins glow or fluoresce so they could be seen as they assembled into a virus particle.

With red-labeled Gag proteins and green-labeled ALIX proteins, "we could see ALIX come in at the end of the assembly of the virus particle," says Saffarian. Some 100 ALIX proteins converged with the roughly 4,000 Gag molecules and assembled into a new HIV particle.

Enter ALIX

ALIX then brought in two other proteins, which cut off the budding virus particle from the cell when it emerged. ALIX's position during the pinching off of new particles hadn't been recognized before.

The researchers watched the virus particles bud one cell at a time: about 100 particles emerged during a two-hour period. Most of the ALIX proteins left when HIV assembly was complete and returned to the liquid inside a cell.

Saffarian says the discovery that ALIX doesn't get involved until the late stages of HIV budding suggests the existence of a previously unrecognized mechanism that regulates the timing of ALIX and other proteins in assembling new HIV particles.

"We discovered that the cellular components that help with the release of the virus arrive in a much more complex timing scheme than predicted based on the biochemical data," he says.

"The outcome of this study is promising because it uncovers a new regulatory mechanism for recruitment of cellular components to HIV budding sites, and opens the door to exciting future studies on the mechanism of HIV budding."

SECRETARY OF STATE KERRY'S REMARKS ON WORLD AIDS DAY 2013

FROM:  U.S. STATE DEPARTMENT 
World AIDS Day 2013
Remarks
John Kerry
Secretary of State
Washington, DC
November 29, 2013

On World AIDS Day, we come together as a global community to honor the many lives we have lost, and to reaffirm our support for the millions of individuals and families who are still living with and affected by HIV/AIDS around the world.

On this day, we also gain strength by celebrating the important strides that we have taken over the past year, and recommit ourselves to the work still ahead to achieve an AIDS-free generation.

This year marks an extraordinary decade of progress. Ten years ago, when the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) was launched by President Bush and with strong bipartisan support of the U.S. Congress, an AIDS diagnosis was a virtual death sentence in much of Africa. The epidemic was threatening the very foundation of societies – creating millions of orphans, stalling economic development, and leaving countries stuck in poverty.

Today, landmark scientific advances, coupled with success in implementing effective programs have put an AIDS-free generation within sight. In sub-Saharan Africa, where the epidemic has hit the hardest, new HIV infections are down by nearly 40 percent since 2001, and AIDS-related mortality has declined by nearly one-third since 2005. This progress is thanks in large part to the unique efforts of and partnership between PEPFAR, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and host countries.

The United States is proud of its longstanding leadership role in these efforts. Through research, funding, direct support for HIV services, we have always led by example in this fight, and asked others to join us.

This June, in marking PEPFAR’s tenth anniversary, I was pleased to announce the one-millionth baby born HIV-free due to PEPFAR-supported prevention of mother-to-child transmission programs. I also was greatly encouraged to report that 13 countries (including 11 in sub-Saharan Africa) have now reached the programmatic “tipping point” in their AIDS epidemic – the point where the annual increase in adults on treatment is greater than the number of annual new adult HIV infections.

And in September, I was honored to host a session with top African leaders and senior global health stakeholders to launch the innovative concept of PEPFAR Country Health Partnerships with South Africa, Rwanda, and Namibia, which will further our efforts to advance country ownership and strengthen sustainability. These successes were further amplified by the U.S. Congress’ bi-partisan and bi-cameral effort in the passage of the PEPFAR Stewardship and Oversight Act on November 19.

The Act reaffirms the United States’ continued commitment to this historic health program and to the fight against global AIDS.

Achieving an AIDS-free generation is a shared responsibility. Partnerships with host government, civil society, the faith community, the private sector, and multilateral organizations are vital to a robust and sustained global AIDS response.

On this World AIDS Day, as we reflect on the extraordinary progress we have made together, it is important to remember that our work is far from finished.

With a sustained focus on strengthened results and shared responsibility, I know that we can get there

LANL RESEARCHERS STUDY HIV VIRUS SPREAD WITH COMPUTER MODELING

FROM:  LOS ALAMOS NATIONAL LABORATORY
HIV Virus Spread and Evolution Studied Through Computer Modeling

LOS ALAMOS, N.M., November 19, 2013—Researchers at Los Alamos National Laboratory are investigating the complex relationships between the spread of the HIV virus in a population (epidemiology) and the actual, rapid evolution of the virus (phylogenetics) within each patient’s body.

“We have developed novel ways of estimating epidemics dynamics such as who infected whom, and the true population incidence of infection versus mere diagnoses dates,” said Thomas Leitner, principal investigator. “Obviously, knowledge about these things is important for public health monitoring, decision making and intervention campaigns, and further to forensic investigations.”

The team models the uninfected population using traditional differential equations on the computer; this is done for computational speed, because an agent-based component is much more demanding. Once a person is infected, he/she becomes an “agent” in computer modeling terms, and the model starts following their behavior individually, as well as the viral HIV evolution within the person.

Agent-based Modeling Clarifies Infection History

This new modeling approach distinguishes between susceptible and infected individuals to capture the full infection history, including contact tracing data for infected individuals. The uninfected individuals are modeled at a population level and stratified by transmission risk and social group. The social network in this model forms – and can change – during the simulation. Thus, the model is much more realistic than traditional models.

The advantage of this epidemiological model, Leitner said, is that “it allows us to simulate many possible outcomes of epidemics with known parameters of human interactions, where social networks form as part of the agent interactions. It is a flexible system that has the ability to describe realistic human populations.”

Within a National Institutes of Health-supported project “Reconstructing HIV Epidemics from HIV Phylogenetics,” the team has published 10 papers describing new mathematical models and results from real data addressing these issues. Most recently, they published a Nature correspondence on the limitations of HIV forensics and the need for better standards.

Who Infected Whom

A key question is on the fundamental limitations to the inference of who infected whom, based on a concept known as the pre-transmission interval (which this group first described back in 1999). Another publication, published in Epidemics, developed a new hybrid model to simulate and analyze the spread of HIV or other pathogens spread in a human population. The work also appeared in PLoS-ONE Public Library of Science online publication.

As an example, the team modeled a Latvian HIV-1 epidemic, and they showed that injecting drug users fueled the heterosexual population, thereby sustaining the overall epidemic. The researchers are now expanding this hybrid model to also include HIV genetic evolution, which occurs in every infected individual.

The researchers have shown that in fast HIV epidemics – such as among individuals injecting themselves with drugs – HIV viral evolution is slow, resulting in little diversification at the population level. Meanwhile, slower-spreading epidemics display more HIV evolution over the same amount of time.

New Field of Phylodynamics Evolves

Understanding HIV’s genetic evolution will soon allow investigations of how accurately researchers can reconstruct different epidemiological scenarios using pathogen genetic materials, an important and growing field called phylodynamics.

The team also has developed a new mathematical model that facilitates estimation of when a person was infected with HIV based on a previously used biomarker (BED IgG).

“This is important because most HIV infected persons are not discovered shortly after infection rather, they are often discovered long after, often years after infection, said Leitner. “Thus, to estimate true incidence, that is when infections actually occurred, cannot be done based on diagnosis dates.”

Using Swedish surveillance data, the team has shown that the common assumption that infection occurred on average half way between last negative test and first positive test, is wrong. Instead, the actual infection is strongly skewed towards the first positive sample.

This finding should have large impact on epidemiological models used worldwide by public health organizations, Leitner says. “Currently, we have further developed this model to also correct for unknown cases, such as infected people not yet discovered but who contribute to new infections and thereby the true incidence of the disease.”

The Team Behind the Insights

Researchers include Frederik Graw, Thomas Leitner, Ruy M. Ribeiro, and Helena Skar (Los Alamos National Laboratory) and Jan Albert (Karolinska Institute and Karolinska University Hospital). The National Institutes of Health funded the research.

LANL SAYS HIV VACCINE SHOWS PROMISE IN MONKEYS

FROM:  LOS ALAMOS NATIONAL LABORATORY 
New Global HIV Vaccine Design Shows Promise in Monkeys
Preclinical study provides strong rationale for clinical trials

LOS ALAMOS, N.M., October 30, 2013—The considerable diversity of HIV worldwide represents a critical challenge for designing an effective HIV vaccine. Now, it appears that that a vaccine bioinformatically optimized for immunologic coverage of global HIV diversity, called a mosaic vaccine and designed by Bette Korber and her team at Los Alamos National Laboratory, may confer protection from infection.

“This is the first time the mosaic antigen inserts were used in a challenge study. In a challenge study, vaccine-elicited protection from infection is tested, versus testing a vaccine for its ability to stimulate good immune responses,” says Bette Korber of Los Alamos.

These vaccines are specifically designed to present the most common forms of parts of the virus that can be recognized by the immune system. This new insight regarding a mosaic vaccine’s ability to protect from infection is the result of work by a scientific team led by Beth Israel Deaconess Medical Center (BIDMC), and including Los Alamos researchers. The study, which was conducted in monkeys, is newly published in the journal Cell.

“To our knowledge, this study represents the first evaluation of the protective efficacy of a candidate global HIV antigen strategy in nonhuman primates,” says lead author Dan H. Barouch, MD, PhD, the director of the Center for Virology and Vaccine Research at BIDMC and professor of medicine at Harvard Medical School. “In this study, we show for the first time that bioinformatically optimized HIV vaccine antigens can afford partial protection in rhesus monkeys against challenges with a stringent simian-human immunodeficiency virus.”

Key defense against HIV infection studied

Barouch and his team studied the immunogenicity of HIV mosaic Env/Gag/Pol antigens administered to monkeys using viral vectors. (Env, Gag, and Pol are three major HIV proteins that help viruses “bind to” or enter host cells and infect them.) Mosaic proteins resemble these natural proteins, therefore increasing efficacy against the HIV diversity. After immunization, the monkeys were repetitively exposed to a simian-human immunodeficiency virus that carried the human Env (envelope, or binding) protein, and the investigators evaluated the ability of the vaccines to block infection by repeatedly exposing the vaccinated animals to the virus.

Although most animals immunized with the mosaic HIV vaccine became infected by the end of the study, the researchers observed an 87 to 90 percent reduction in monkeys’ probability of becoming infected each time they were exposed to the virus. In contrast, monkeys that received sham vaccines became infected quickly.

“These findings indicate that these optimized vaccine antigens can afford partial protection in a stringent animal model,” says Barouch.

The investigators found that the immunized monkeys mounted antibody responses against diverse strains of HIV noting, “Protection was dependent on several different types of antibody responses, suggesting that the coordinated activity of multiple antibody functions may contribute to protection against difficult-to-neutralize viruses.” The monkeys also mounted cellular immune responses to multiple regions of the virus.

Highly infective virus presents challenge

The researchers note that most previous HIV vaccine candidates have typically only been tested for protection against easy-to-neutralize viruses rather than against a difficult-to-neutralize virus like the one used in this study. Also, the viral challenge in the study was approximately 100-fold more infectious than typical sexual HIV exposures in humans.

“These data suggest a path forward for the development of a global HIV vaccine and give us hope that such a vaccine might indeed be possible,” said Barouch. “We are planning to advance this HIV vaccine candidate into clinical trials next year,” he adds.

The research team

Study coauthors include BIDMC investigators Kathryn E. Stephenson, Erica N. Borducchi, Kaitlin Smith, Kelly Stanley, Anna G. McNally, Jinyan Liu, Peter Abbink, Lori F. Maxfield and Michael S. Seaman. Other team members include Anne-Sophie Dugast, Galit Alter, Melissa Ferguson, Wenjun Li, Patricia L. Earl, Bernard Moss, Elena E. Giorgi, James J. Szinger, Leigh Anne Eller, Erik A. Billings, Mangala Rao, Sodsai Tovanabutra, Eric Sanders-Buell, Mo Weijtens, Maria G. Pau, Hanneke Schuitemaker, Merlin L. Robb, Jerome H. Kim, Bette T. Korber and Nelson L. Michael.

This work was supported by the U.S. Military Research and Material Command and the U.S. Military HIV Research Program; the National Institutes of Health; the NIAID Division of Intramural Research; the Ragon Institute of MGH, MIT, and Harvard; and the Bill and Melinda Gates Foundation.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and currently ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox.

SECRETARY OF STATE KERRY'S REMARKS AT PEPFAR 10TH ANNIVERSARY CELEBRATION

FROM: U.S. DEPARTMENT OF STATE
Remarks at the President's Emergency Plan for AIDS Relief (PEPFAR) 10th Anniversary Celebration
Remarks
John Kerry
Secretary of State
Dean Acheson Auditorium
Washington, DC
June 18, 2013

Thank you very, very much everybody. What a pleasure to be here. This is a really great celebration. This is special. And if anybody here – I know you’re here because you are touched by it – but what a wonderful thing to celebrate the 10-year anniversary of this remarkable intervention that represents the best of the human spirit, and also I think in many ways, the best of American leadership. It’s something we can really be proud of, and we can be possibly not prouder at all of any effort by any individual than the remarkable effort, the amazing job of developing the PEPFAR programs and taking on one of the greatest health challenge crises of our time. I cannot thank enough the leadership of Ambassador Eric Goosby, who has been spectacular in this effort. (Applause.) Thank you. Thank you.


And I want to thank Tatu. Thank you so much for being here with us. I couldn’t be more pleased than to welcome you and your daughter, Faith, here to the State Department. I think you are an inspiration to everybody in this room and to everybody who knows your story, which everybody will learn more of. But you’re a living example of the impact and meaning of this program, and we thank you for coming here to share with us.

Also, when it comes to vision and leadership, I’d be remiss if I did not recognize Dr. Tony Fauci. Tony has been there since the very beginning, and he has taught us all that if we follow the science, we can truly achieve an AIDS-free generation. And I’m not sure there would be a PEPFAR today if it were not for the leadership of Tony, and we owe him all our thanks, so thank you very much. (Applause.)

And I know full well after 29 years on the Hill that without the right senators and congressmen and women behind this kind of effort, it doesn’t happen. And when this started up, it started up with a lot of courage by individuals who were willing to step up. It didn’t exactly have the unanimous consent not only of the people in the Congress initially, but in the country. So I want to thank Senators Mike Enzi and Ben Cardin for their leadership, and thanks for being here today; I know you’re going to hear from them. And I also want to thank my good friend and colleague Senator Johnny Isakson and the other members of Congress who are here. We salute you all for coming and sharing in this celebration, and that is what it is.

Everybody knows that as you look at Congress today, not every day produces the kind of exceptional bipartisan cooperation that created the celebration we’re here to enjoy today. This is one issue where I can happily say that partisanship has really almost always taken a backseat. And in fact, the success of this effort shows what can happen when you reach across the aisle and you do wind up working together.

I want to thank Richard Nchabi Kamwi for – he’s the Health Minister from Namibia – I want to thank him for being here with us today. Namibia has been hugely impacted by this disease, but through the Minister’s efforts, and our partnership with his country, we are seeing extraordinary progress.

And to everyone else here, I know that so many of you here are the stakeholders in this effort and you’ve worked hard on it, and I thank you for what you’ve done and I welcome you here at the State Department on this tremendous occasion.

I want to acknowledge one person who, sadly, is not here today, and that’s Michael Taylor Riggs. Michael was a former congressional staffer whose hard work and dedication helped to make PEPFAR a reality. And as many of you know, Michael passed away last month at the age of 42. And we miss him, and we thank him for his leadership. And while we celebrate today’s anniversary, I think all of us are thinking of Michael as well as the millions whose lives this terrible disease touched: the mothers and fathers who lost children, the children who were left orphaned, the friends and loved ones left behind, the communities that were devastated, from San Francisco to Soweto.

I met a number of these young people who were affected by this disease when Teresa, my wife and I, visited the Umgeni Primary School outside of Durban. And I’ll never forget the visit, walking around these mud huts with a grandmother who was coughing badly from HIV infection, and young kids whose – the only – the gap between them was generations wide. And we saw these orphans who were robbed of their parents, who were forced to take on the burden of adulthood at the age of 13, 14, 15, and caring for their younger siblings.

We were heartbroken at hearing what these children had been through, and you couldn’t help but feel this agony and this total disruption of the way life is supposed to be. But we were also inspired. We saw in their faces the amazing resilience of humanity, and it said something about all of us, and to all of us as well. Because when we all looked lost, when this disease appeared to be unstoppable, history will show that humanity and individual humans rose to the challenge. Action was taken. Innovations were discovered. Hope was kindled, and generations were saved.

The success of PEPFAR, as well as efforts by the entire global community, including the great work done by the Global Fund, represents in truth a victory for the human spirit. And with the Global Fund replenishment happening this year, now is the time for all donors to join with the United States to support and strengthen the fund. The fight against HIV and AIDS shows what we can accomplish when we make the effort together, join hands, overcome the ideology and the politics, and really dedicate our hearts to win.

None of this was easy, and frankly it’s really worth remembering for a moment how bleak things looked at a certain point in time. A decade ago, when the world finally began to reckon with the full magnitude of this crisis, many experts thought it was too late, and with nearly 30 million people infected with HIV/AIDS in 2002, an entire generation seemed lost. When I looked at the enormity of the challenge at that point in time, candidly it was hard not to be overwhelmed to some degree, and perhaps even a tiny bit pessimistic.

But I also felt that we had to do something, and so did many of my fellow senators, I am so happy to tell you, especially Bill Frist and ultimately Jessie Helms. I was proud to serve with Senator Frist as a founding co-chair of the bipartisan HIV/AIDS taskforce, a group that was instrumental in helping us to be able to prepare and lay the groundwork and pass the first AIDS legislation in the United States Congress – unanimously, I might add, in the Senate, thank to Jesse Helms’ and Bill Frist’s efforts – so that that was signed by President Bush in 2003. That translated ultimately into PEPFAR.

This landmark legislation created the world’s largest and most successful foreign assistance program, and today a disease that seemed unstoppable is in retreat. Globally, new HIV infections have declined nearly 20 percent over the past decade. In Sub-Saharan Africa, both the number of new infections and AIDS-related deaths are down by almost one-third over the last decade. Last year alone, PEPFAR supported HIV testing and counseling for nearly 50 million people, and while just 300,000 people in low and middle income countries were receiving anti-retroviral treatment 10 years ago, today PEPFAR is directly supporting more than 5 million people on treatment.

Because of these successes, I am honored to make a very special announcement today, an announcement that we could literally only have dreamed about 10 years ago. Thanks to the support of PEPFAR, we have saved the one millionth baby from becoming infected with HIV. That is a remarkable step. (Applause.)

And as you know, preventing mother-to-child transmission has been a central pillar of our fight against this disease, and just this month we reached the truly landmark moment on the HIV/AIDS timeline. Imagine what this means – one million babies, like Tatu’s daughter Faith, can grow up happy and healthy, go to school, realize their dreams, break out of this cycle, maybe even have sons and daughters of their own, free from the burden and the fear of HIV.

That is not the only good news. I’m also pleased to report that in 13 countries, we have now passed a programmatic tipping point. Today, more people are newly receiving treatment than are newly infected. We are at this point, thanks to the combined and coordinated efforts of all partners in the fight of global – against global AIDS. That is what has brought us to this moment.

But in order for more countries to pass this tipping point and keep going in the right direction, we still need to reach those who are at the greatest risk of HIV infection. That’s why last July, the United States announced the creation of a new $20 million fund to support key populations, people who are too often stigmatized, at risk, and neglected. And that means particularly men who have sex with men, it means people who inject drugs, and it means sex workers. And it’s my pleasure today to announce that the recipients of this funding, Cambodia, Ghana, Nepal, Senegal, Swaziland, Zimbabwe, and two regional programs, are going to have the benefit of this going forward.

This has been a decade of remarkable progress, my friends. But obviously, our work is not done. Millions still become infected every year and millions are still dying. But we can now say with confidence something we could perhaps only have dreamed of before, as I said, and that is we can achieve an AIDS-free generation, and that is within our grasp now.

So to get there we’re going to have to stay at it. Under President Obama’s leadership, we have redoubled our efforts. Through PEPFAR, the U.S. now directly supports three times more people on antiretroviral drugs today than we did in 2008.

Where we once saw a situation spiraling out of control, today we see a virtuous cycle beginning to form, with more people receiving treatment and fewer people passing on the virus. Fewer infections means it is now easier to actually focus treatment efforts. And with fewer people sick and dying, we are seeing healthier, more productive populations. That’s the virtuous cycle. The economies of Sub-Saharan Africa are growing at a substantial rate, and a generation is now able to look to the future with hope.

As the progress continues, PEPFAR, over its next decade, will gradually evolve as our fight against this disease evolves, and that is going to happen both by necessity and by design. Achieving an AIDS-free generation is a shared responsibility and it is going to be a shared accomplishment. That is why PEPFAR is working to gradually and appropriately transfer responsibilities to host countries. This means that PEPFAR will shift from merely providing aid to co-investing in host countries’ capacity.

Ten years after this program began, rest assured that the commitment of President Obama, the State Department, myself, this country’s commitment to fighting HIV/AIDS is as undiminished as our work is unfinished. Our commitment has only been strengthened by the progress that we’ve made and the lives that we’ve saved and this story that we are able to tell today. This story compels us to continue.

What has been achieved here is a lesson for all of us. And I think it is, in fact, a lesson that people should believe in humanity. To never doubt what we can achieve is one of the lessons of today, to know that we can do the remarkable, that we can find solutions to what seems to be unsolvable, that we can overcome the insurmountable and we can leave politics and ideology at the wayside in order to choose life and possibilities for people everywhere.

Because of this faith, because of this program, because of your efforts, because a mother like Tatu could live to see her child grow up to change the world – that is why we will continue

Thank you. Thank you, Eric. Thank you, senators and congressmen and women. And thank you, all of you who have worked at this extraordinary effort. It’s a story worth telling. Appreciate it. (Applause.)

LOS ALAMOS NATIONAL LABORATORY LOOKS AT HOW HIV ATTACKS

FROM: LOS ALAMOS NATIONAL LABORATORY
Research Deciphers HIV Attack Plan
Scientists get inside look at how AIDS virus grooms its assault team

LOS ALAMOS, N.M., March 29, 2013—A new study by Los Alamos National Laboratory and University of Pennsylvania scientists defines previously unknown properties of transmitted HIV-1, the virus that causes AIDS. The viruses that successfully pass from a chronically infected person to a new individual are both remarkably resistant to a powerful initial human immune-response mechanism, and they are blanketed in a greater amount of envelope protein that helps them access and enter host cells.

These findings will help inform vaccine design and interpretation of vaccine trials, and provide new insights into the basic biology of viral/host dynamics of infection.

During the course of each AIDS infection, the HIV-1 virus evolves within the infected person to escape the host’s natural immune response and adapt to the local environment within the infected individual. Because HIV evolves so rapidly and so extensively, each person acquires and harbors a complex, very diverse set of viruses that develops over the years of their infection. Yet when HIV is transmitted to a new person from their partner, typically only a single virus from the diverse set in the partner is transmitted to establish the new infection.

The key discoveries here are the specific features that distinguish those specific viruses which successfully move to the new host, compared with the myriad forms in the viral population present in a chronically infected individual.

"The viruses that make it through transmission barriers to infect a new person are particularly infectious and resilient," said Los Alamos National Laboratory scientist Bette Korber. "Through this study we now better understand the biology that defines that resilience."

The team set out to determine whether the viruses that were successfully transmitted to a new patient might share distinct biological properties relative to those typically isolated from people with long-term, chronic infection. To do this, the group at U Penn cloned a set of intact viruses from acute infection, and a set of viruses from chronically infected people, and characterized them by measuring quantities that might be related to the virus's ability to successfully establish a new infection. They discovered several clear correlations. For example, transmitted viruses were both more infectious and contained more protective "envelope" per virus; envelope is the protein the virus uses to enter host cells.

The team identified an additional interesting property that could be a general characteristic of new viral infections: the transmitted HIV was capable of replicating and growing well in the presence of alpha interferon. Alpha interferon production is part of our innate human immune response to a new infection. As soon as a new viral infection is initiated in our bodies, local immune cells at the site of infection start secreting molecules called cytokines that have general antiviral activity and can inhibit the production of the newly infected virus. Alpha interferon is one of these potent cytokines.

In the early days of an HIV infection, this innate immune response increases to an intense level, called a "cytokine storm," which gradually recedes during infection. For a newly transmitted HIV to successfully establish infection, it must grow and expand in the new host while facing this cytokine storm. Although typical chronic viruses are sensitive to and inhibited by alpha interferon, transmitted HIV-1 viruses grew well in the presence of interferon.

U.S. VA SUPPORTS WORLD AIDS DAY

Photo:  U.S. Naval Hospital Ship Mercy.  Credit:  U.S. Navy

FROM: U.S. VETERANS ADMINISTRATION

December 1 is World AIDS Day
The U.S. Preventive Services Task Force recently released its recommendations that all Americans ages 15 to 65 should be tested for HIV at least once in their lifetime.

VA is ahead of the curve and has recommended routine HIV testing for all Veterans since 2009. VA policy is to test every Veteran at least once in their lifetime.

Currently, over 1.2 million Veterans, representing 20 percent of Veterans in care, have a documented HIV test in their electronic medical record. Routine HIV screening allows for care for HIV positive Veterans and reduces the potential for the virus to be transmitted to others.

VA’s Office of Public Health is encouraging VA staff to offer every Veteran an HIV test. Working together, we can create an AIDS-free generation!

To reinforce the importance of World AIDS Day, VA is issuing a unique and comprehensive HIV Prevention Manual, which is a compilation of VA policies and strategies to address primary and secondary HIV prevention.

Designed as a tool for front-line health care providers, it is an extremely valuable resource.

On World AIDS Day, VA joins the AIDS community in its "Facing AIDS" initiative, a campaign to help reduce stigma and promote HIV testing by putting a face to those with HIV and the people who support them.
"An estimated 1.2 million Americans are living with HIV, and yet one out of five doesn’t know it," according to Dr. Maggie Czarnogorski, Deputy Director of VA’s HIV, Hepatitis, and Public Health Pathogen Program. "World AIDS Day is an opportunity to take action. VA is the largest provider of care to those living with HIV/AIDS in the United States. By diagnosing HIV infection as soon as possible, Veterans can receive excellent care and remain healthy for many years to come."

Join VA in recognizing World AIDS Day. Say yes to the test!