Positively Aware Magazine. Current HIV news and updates.

Positively Aware, The HIV News Journal published by the Test Positive Aware Network

Positively Aware Online News Brief. Current HIV News and events

POSITIVELY AWARE 3/05/2012

Number of people on the ADAP waiting list, 4,521

There’s Nothing Like the Drug Guide

The Positively Aware 16th Annual HIV Drug Guide is now available in print, online, and in digital form. Always a favorite with providers and consumers alike, this year’s Guide provides the most up-to-date information on the 30 HIV drugs that are currently on the market, as well as the four that are expected to be approved later this year. Contributors this year include pharmacist Renata Smith, assistant professor in HIV/Infectious Diseases at the University of Illinois at Chicago, activist Joey Wynn from Broward House in Florida, PA favorite Dr. Joel Gallant of Johns Hopkins University School of Medicine, and PA associate editor Enid Vázquez as you’ve never seen her before!

Dr. Gallant writes about “What Lies Ahead” in HIV treatment and care; editor Jeff Berry shares his own experience with changing his regimen after several years, as well as providing a “road map” to using the Guide and an article on co-pay and patient assistance programs; and art director Rick Guasco finds a way to bring optimism and hope, not to mention visual interest, to an otherwise rather dry topic.

The usual format of each drug having its own page remains, but this year, you can access each specific drug’s page by adding the name of the drug to the end of PA’s URL (as in www.positivelyaware.com/atripla). Also included are the Drug Guide “centerfold,” a fold-out chart picturing all the drugs with basic dose information, quick reference charts listing side effects and drug interactions, as well as the popular co-pay and patient assistance programs chart.

To receive bulk shipments, contact distribution@tpan.com.

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National Women & Girls HIV/AIDS Awareness Day

National Women and Girls HIV/AIDS Awareness Day is observed on March 10 every year and is a nationwide observance that encourages awareness of HIV/AIDS and its impact on women and girls. It is coordinated by the U.S. Department of Health and Human Services' Office on Women's Health (OWH). It helps organizations across the country come together to offer support, encourage discussion, and teach women and girls about prevention of HIV, the importance of getting tested for HIV, and how to live with and manage HIV/AIDS.

OWH encourages organizations to hold events throughout the month of March. To find out more, go to womenshealth.gov/NWGHAAD/about.

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CROI Preview

Over 4,000 leading researchers and clinicians from around the world will gather in Seattle, Washington, March 5-8, for the 19th Conference on Retroviruses and Opportunistic Infections (CROI). CROI is a scientifically focused meeting of the world’s leading researchers working to understand, prevent, and treat HIV/AIDS and its complications. The goal of CROI is to provide a forum for translating laboratory and clinical research into progress against the epidemic.

A complete list of all presentations is available at the CROI website, www.retroconference.org, but topics to be covered include sessions on PrEP (pre-exposure prophylaxis) using tenofovir in both pill and microbicide gel form; breakthroughs in hepatitis C treatment; treatment issues for women and children; the four drugs in the pipeline for approval in 2012 (see the Positively Aware 16th Annual HIV Drug Guide at www.positivelyaware.com or http://issuu.com/positivelyaware); and co-morbidities like cancer, metabolic disorders and cardiac problems now occurring in the aging HIV-positive population.

Matt Sharp, long-time activist and former Director of Education at TPAN, will participate in a symposium on “Pathways Toward a Cure: Viral Latency and Reservoirs. Sharp, along with PA Editor Jeff Berry, David Evans, Lynda Dee, Richard Jefferys, Nelson Vergel and Jeff Taylor, have organized a daylong Community Cure Workshop in Seattle that immediately precedes the conference, in which members of the community will hear from leading researchers and pharmaceutical companies on advances in cure research. The workshop is sponsored by the AIDS Treatment Activists Coalition, Project Inform, and Treatment Action Group.

Watch the E-News next week for updates from our reporters in the field and read comprehensive coverage in the May/June issue of Positively Aware.

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Bionor Pharma’s Vaccine Research Moves Forward

Swiss pharmaceutical company Bionor Pharma announced on February 15 that researchers have completed a final review of the company's lead therapeutic HIV vaccine, Vacc-4x, and its ability to reduce HIV viral load compared to placebo. These final conclusions from the Phase 2b, placebo-controlled, double-blind, international, multicenter trial confirm initial findings of a statistically significant difference in viral load set point between Vacc-4x and placebo groups at the end of the study. The full results in addition to the final review of the immunological assessment are being prepared for publication in an international peer reviewed journal.

Researchers from the Ragon Institute, Harvard, and MIT published findings in 2011 confirming the existence of conserved regions on p24, a core protein of HIV, and emphasizing their potential as targets for an HIV vaccine. Bionor had identified these domains over a decade earlier, and began developing the vaccine based on these findings. Today Bionor’s Vacc-4x is the most studied immunotherapeutic product targeting p24.

Vacc-4x is designed to generate immune responses to conserved domains of p24 that are common to all strains of HIV. Sustained immune responses to p24 have previously been shown to delay HIV disease progression.

Final review of Phase 2b data confirms a statistically significant 64% reduction of viral load “set point” (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo, indicating a possible new option for patients and doctors. The HIV viral load set point in patients given Vacc-4x was 60% lower than the level before starting with standard antiretroviral treament, or ART. In the placebo group, no change compared to pre-ART was observed. 

"These final results confirm that Vacc-4x lowers viral load in patients with HIV who have remained off ART for at least six months," said Vidar Wendel-Hansen, MD, PhD, Chief Medical Officer, Bionor Pharma, "and suggests a correlation between this effect and the vaccine-induced immune responses to p24." 

Based on the conclusive Phase 2b data, Bionor is studying several paths to guide the direction towards a Phase 3 pivotal trial, the final study before regulatory review and market entry:

  • Vacc-4x revaccination of patients from the phase 2b study, to further reduce the viral load set point (planned study 1H 2012). Such an approach may eventually lead to a "functional cure," meaning that HIV viral load is gradually reduced to lower levels following successive ART-free periods.
  • Vacc-4x in combination with Revlimid (lenalidomide), an immunomodulatory drug, for patients with unmet medical needs. Based on the confirmed ability for Vacc-4x to lower viral load in HIV patients, Bionor will study the effect of combining Vacc-4x with Revlimid for patients who are well controlled on ART but fail to improve CD4 T-cell counts.
  • Vacc-4x in combination with Vacc-C5, to reduce viral load and the spread of infection. Vacc-C5 is designed to induce antibodies to HIV that can reduce HIV associated immune hyperactivation which leads to AIDS. Preclinical studies have shown that Vacc-C5 successfully induced antibodies against HIV in rabbits and sheep. Bionor intends to conduct the first human clinical study of Vacc-C5 in the spring of 2012. Subsequent to the Vacc-C5 Phase 1/2 trial, Bionor intends to combine Vacc-4x with Vacc-C5, a treatment that can potentially revolutionize the management of HIV infections and could form the basis for both a therapeutic and a preventative vaccine.

Bionor is furthermore investigating different options for administration of its vaccines.
An ongoing trial at Oslo University Hospital aims to reveal whether Vacc-4x given by nasal administration can provide equivalent effect compared to delivery by needle injection. Such administration will be important for cost and availability in both Western and developing countries. All patients have been successfully included in the trial and the results are expected in the first half of 2012.

More information about Bionor Pharma, its research, and products is available at www.bionorpharma.com.

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Which Anti-HIV Drug Combinations Work Best and Why?

Using a mathematical formula that carefully measures the degree to which HIV infection is stalled by antiretroviral therapy, HIV/AIDS experts at Johns Hopkins have calculated precisely how well dozens of anti-HIV drugs work, alone or in any of 857 likely combinations, in suppressing the virus. Results of the team's latest research reveal how some combinations work better than others at impeding viral replication, and keeping the disease in check. The findings were published in the journal Nature Medicine online February 19.

"Our study results should help researchers and clinicians develop simpler treatments, using either existing or new drugs, for people who are just starting therapy or people who have already tried and developed resistance to another combination," says senior study investigator and infectious disease specialist Robert Siliciano, MD, PhD, a professor at the Johns Hopkins University School of Medicine and a Howard Hughes Medical Institute investigator.

Siliciano and colleagues constructed the measurement tool, called the instantaneous inhibitory potential, or IIP, in the laboratory several years ago by analyzing the shape of drug dose-response curves in human immune system cells infected with HIV. They found that the curves' steepness reflects the extent to which small increases in the amount of drugs can further suppress attempts by the virus to bounce back, reproduce, and spread.

Researchers found that the steepest curves occurred when the drug targeted a stage in HIV's life cycle in which many copies of viral enzymes were needed. Citing protease inhibitors as an example, Siliciano says several copies of protease enzyme are needed to cleave the virus into hundreds of working parts before HIV can infect a new immune system cell. He goes on to say that "a level of inter-enzyme cooperation" is happening, specific to each stage of HIV replication.

"Our research shows that drugs like protease inhibitors really work like an on-off switch," says Siliciano. "Above a certain concentration, these drugs completely turn off viral replication. When you have only one copy of a viral enzyme needed in any key part of HIV's life cycle, a little more drug won't give you a lot more suppression; but, when you have more than one copy of enzyme needed for viral replication, then the dose-response curve for the drug will be a lot steeper, and a little more drug will completely shut off viral replication, which is what we want.”

The latest study findings, along with other recent studies, provide valuable information to physicians about the potential strength of different combination drug therapies, and can help in streamlining and tailoring highly active antiretroviral therapy (HAART) to as few possible drugs as needed.

Siliciano points out that any drug combination which suppresses viral replication to the degree that only one out of every 100,000 lymphocytes exposed to the drugs is likely to become infected is sufficient to keep the disease in check, as long as people take their medication as prescribed.

"This means that overall access to anti-HIV medications could also improve as we develop simpler combinations of fewer drugs to achieve near total suppression," says Siliciano.

Scientists have focused for decades on multiple drugs of different classes targeting different enzymes that are key to the HIV life cycle, thinking that multiple barriers along the chain could best halt replication. Although the strategy worked, until now, there was no theory to explain why some drug combinations worked well and others did not. Siliciano says that as a result of the Hopkins team's latest research and another of their recent findings, published in Science Translational Medicine in July, experts can finally demonstrate how different drug combinations disrupt and halt viral replication.

"It's gratifying to finally have a consistent metric for evaluating HAART medications that offers reliable information on how well they work in stopping HIV replication, and which also gives us a baseline target for suppression at less than one in 100,000 immune cells becoming infected in the presence of any drug combination," he adds.

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Galen to Market DaunoXome for Advanced HIV-Associated Kaposi’s Sarcoma

Galen, Ltd., a Northern Ireland Pharmaceutical company with a U.S. subsidiary, has acquired the chemotherapy agent DaunoXome (daunorubicin citrate liposome injection) from Gilead Sciences, Inc. Galen US, Inc. will market DaunoXome in the United States.

DaunoXome is an anthracycline chemotherapy agent that was first approved in the United States in 1996. It is indicated as a first-line cytotoxic therapy for advanced HIV-associated Kaposi’s sarcoma (KS) and has been shown to be as effective as a triple chemotherapy regimen in this disease. KS is a type of cancer that affects both the skin and organs inside the body, such as the lungs, liver, and digestive tract in patients with HIV.

“HIV-associated KS is an AIDS-defining illness, which has considerable impact on patient prognosis. For some HIV patients with advanced or poorly controlled KS, chemotherapy may be required alongside highly active antiretroviral therapy, to effectively target the cancer. DaunoXome provides a much needed option for physicians needing to treat advanced HIV-associated KS patients with such chemotherapy regimens,” says Dr Anil Tulpule, Associate Professor of Medicine at the Norris Cancer Center, Los Angeles, California.

Speaking about the acquisition of DaunoXome, President of Galen, Mark Scrutton, commented, “We are delighted that we are now able to supply DaunoXome in the United States for the treatment of patients with this devastating disease. DaunoXome marks our first step into the oncology arena and this exciting, new acquisition provides us with the opportunity to offer more widely a much-needed therapy for patients with advanced HIV-associated KS.”

For further information please click here for the full DaunoXome package insert or visit www.DaunoXome.com.

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Condom Use Explored in Series of Studies

An unprecedented collection of condom use studies, published in a special online issue in advance of the print issue of the journal Sexual Health, provides a global perspective on condom use problems and errors, along with new research on factors influencing correct condom use, how condom use programs can be more effective, and the promotion of the female condom. Problems with the correct use of the male condom, such as not wearing a condom throughout sex or putting it on upside down, are common in the U.S. and have become a major concern of public health officials. The new research shows that countries around the world are facing similar challenges.

Led by The Kinsey Institute’s Condom Use Research Team (CURT), more than 20 researchers from around the world examined such issues as safe-sex behaviors by American adults, counterfeit condoms in China, and use of female condoms in South Africa.

"The articles in the special issue illustrate both commonalities and differences relative to the use and promotion of male condoms around the world," said William L. Yarber, professor of applied health science at Indiana University and member of CURT. "It provides a resource for sexual health professionals to use for strategizing ways to increase cultural and individual acceptance of condom use."

CURT, which has studied condom use for a decade, is a research team of scholars from Indiana University, the University of Kentucky, the University of Guelph in Ontario, Canada, and the University of Southampton in the United Kingdom.

The CURT researchers suggest that closing the gap between the ideal way condoms should be used and the more typical manner is critical to reducing unplanned pregnancies and the spread of sexually transmitted infections such as HIV. Condoms are inexpensive compared to costly HIV/AIDS medications, which often are inaccessible to people most in need.

"While we'd like to think the AIDS epidemic is going away, it's not. In the U.S, it's getting worse," said Richard Crosby, a member of CURT, professor at the University of Kentucky and lead editor for Sexual Health’s special issue. "We keep looking to medical doctors for the solution to the epidemic, but it's the wrong paradigm. We can prevent small pox, SARS, cholera, and a host of other infectious diseases. The prevention of the disease is the modern solution to the AIDS pandemic, and we need to begin applying that solution in earnest."

The special issue represents the first time condom use research from around the globe has been compiled in one place. CURT researchers want to get the information into the hands of global AIDS prevention organizations, such as the World Health Organization and the U.S. Centers for Disease Control and Prevention.

Crosby said that making condoms accessible to people who need them is important, but improved clinic-based counseling, public education, and Internet-based education efforts are all key requirements to their correct use. This involves talking openly about such things as erections, semen, lubricant and other aspects of sex that can make people uncomfortable.

"We chronically underestimate how complicated condom use can be," he said. "It involves the use of a condom, while negotiating the condom use and sex with a partner all at the same time. There is a complex triad of the sex act, condom use, and partner dynamics that must constantly be navigated by condom users."

The research articles highlight problems and barriers to effective condom use and make suggestions for improving access to condoms, addressing cultural issues that can interfere with their efforts, specific populations that should receive more attention programmatically, and areas where more research is needed.

The special issue can be found online at publish.csiro.au/nid/166/issue/5934.htm

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Legislation Watch

By Sue Saltmarsh

A spot of sanity amidst the absurd flap over coverage of contraception mandated in the Affordable Care Act—the Senate voted 51-48 on March 1 to kill the Blunt amendment to S. 1813, a bill providing for highway construction. Senator Roy Blunt, Republican of Missouri, proposed the amendment which granted health insurance plans and employers the right to refuse to provide or pay for coverage of “specific items or services” if the coverage would be “contrary to the religious beliefs or moral convictions of the sponsor, issuer or other entity offering the plan.” One must wonder if there’s a way to prove that any company (especially insurers) actually has religious, let alone moral, convictions?

Senator Olympia Snowe of Maine was the only Republican to vote against the amendment, while Democrats Bob Casey (PA), Joe Manchin (WV), and Ben Nelson (NE) inexplicably voted for it.

Snowe recently announced that she would not run again when her term is up, stating the current polarization in Congress as her reason. “I do find it frustrating…that an atmosphere of polarization and 'my way or the highway' ideologies have become pervasive in campaigns and in our governing institutions," she said. An increasingly “endangered species” as a moderate, reasonable Republican, the Senate will be diminished by her absence.

Public objection to this bill, along with several other pieces of legislation in various states which attack women and reproductive rights, was fast and strong. More than 20 national women’s groups and medical organizations, including NOW, the American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists, condemned the amendment as too broad and noted the dangers of allowing employers to avoid covering not just contraception, but any medical treatment or procedure they may object to. It was easy to imagine those who’d claim that their “religious” view that homosexuality is an “abomination” or drug addiction a sin was justification for refusing to cover the cost of HIV meds.

One must wonder if Republicans are, like lemmings, committing mass political suicide by rushing toward the dangerous cliff’s edge of alienating people with legitimate medical needs, as well as all but the most fundamentalist women voters.

In the midst of that absurdity, at least someone was looking out for the needy among us. On February 27, Democratic Representative Diana Degette from Colorado introduced H.R. 4091, a bill to assist low-income individuals in obtaining medically recommended dental care. It’s been referred to the Committee on Energy and Commerce.

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