Welcome to The Body PRO Newsletter, a bi-weekly review of the latest breaking news and research in HIV medicine, aimed specifically at informing healthcare professionals.
Ask Your Colleagues: How do I decide whether to use tipranavir or darunavir in a treatment-experienced patient with resistance to multiple protease inhibitors? Ben Young, M.D., responds.
This Week: Staccato Data Counter SMART Findings; New CME/CE; and More
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August 10, 2006
In This Newsletter:
  • HIV Treatment & Patient Care
  • XVI International AIDS Conference
  • HIV/HAART-Related Complications
  • HIV Transmission/Testing
  • HIV Pathogenesis
  • HIV News & Views
  • HIV-Related Policy/Advocacy in the U.S.
  • HIV Outside the U.S.
  •   HIV TREATMENT & PATIENT CARE

    New CME/CE Activity: Optimizing Therapy for Patients With Multidrug-Resistant HIV
    Ten years since the birth of HAART, the very concept of HIV treatment has undergone a revolution, as patients in developed countries benefit from ever-more-potent regimens. But as every clinician knows, there is one group of patients whose viral load is under tenuous control and whose regimen is composed of drugs with limited activity. The increasingly complex interplay of resistance mutations and medication options has made the management of these treatment-experienced patients more and more challenging. In this free, three-hour activity, Charles Hicks, M.D., Angela D.M. Kashuba, Pharm.D., and Sharon Walmsley, M.D., examine how to exploit pharmacokinetics to optimize exposure to drug therapy, discuss the latest data on antiretrovirals in development, and analyze recent research regarding antiretroviral treatment failure and the management of treatment-experienced patients. Click Here

    This activity is only one of a growing number of free CME/CE activities available at The Body PRO. Visit CME/CE Central for a complete list of available activities!


    HIV JournalView: Expert Analysis of the Recently Published HIV Research
    In the new May/June 2006 issue of The Body PRO's illuminating HIV JournalView, David Wohl, M.D., examines research on the quantifiable benefits of HIV care; predicting response to ritonavir (Norvir)-boosted atazanavir (Reyataz); the need for baseline resistance testing; widespread belief in HIV conspiracy theories; adherence and risk-reduction interventions; and recent patterns in body fat changes among HAART patients. Click Here


    New Staccato Data May Breathe Life Back Into CD4-Guided Treatment Interruptions
    Newly published results from the Staccato study suggest that CD4+ cell count-guided HIV treatment interruptions may still have a place in patient care. Contrary to the findings of the much larger SMART trial, the randomized, 430-patient Staccato trial found that patients who stopped treatment with a CD4+ cell count over 350 cells/mm3 and a viral load below 50 copies/mL did not experience a greater number of AIDS-defining adverse events than patients who continued therapy. (In fact, no patients in the Staccato trial experienced an AIDS-defining event, although the median follow-up was much shorter than it was in the SMART trial.) Through a median 21.9 months of follow-up, patients in the treatment interruption arm experienced more candidiasis and had a lower CD4+ cell count than patients on continued therapy, but also experienced less diarrhea and neuropathy. Rates of resistance appeared similar between the two groups. “Staccato indicates that ritonavir-boosted protease-inhibitor-based HAART can be interrupted without undue harm, provided that CD4 counts are monitored," the authors concluded. The Staccato study results appear in the Aug. 5 issue of The Lancet; free registration is required to read the abstract. Click Here

    The Staccato results comprise one article within a special, HIV-focused issue of The Lancet (free registration required to browse) that has been published in advance of the XVI International AIDS Conference. The issue was born out of a partnership with (PRODUCT) RED, an international alliance of companies that seeks to devote a portion of its profits to the Global Fund to Fight AIDS, Tuberculosis and Malaria. The special issue includes dozens of research articles, commentaries, editorials, book reviews and other opinion pieces.


    Early HIV Treatment May Improve Gut Health, Study Suggests
    Even when antiretroviral therapy suppresses plasma HIV viral load, the virus can continue to replicate in gut-associated lymphoid tissue, according to the results of a 10-patient study by University of California researchers that was published in the August 2006 issue of the Journal of Virology. The researchers noted, however, that patients who initiated HIV treatment during the primary stage of infection showed less inflammation and a greater revival of the mucosal immune system in their gut than patients who began treatment after their CD4+ cell count had dropped below 350. The findings suggest that gut biopsies, though a potential burden for patients, could nonetheless provide a measure of HAART efficacy, the authors assert. Click Here


    Moving Toward Access to Treatment in Microbicide Trials
    Is it ethical to conduct a clinical trial of an experimental HIV prevention method in an area where access to HIV treatment is not readily available? The debate over this question has already led to the cancellation of a few trials, including several international pre-exposure prophylaxis studies involving tenofovir (Viread). In hopes of balancing a need to explore new frontiers in prevention with a fundamental commitment to insuring patient health and safety, experts have discussed several options for conducting such trials, including the possibility of only holding HIV prevention trials in countries with established treatment programs, or requiring trial sponsors to pay for the health care of any patient who contracts HIV during the trial. Anna Forbes of the Global Campaign for Microbicides discusses these options in this opinion piece, which appears in the July 2006 issue of PLoS Medicine. Click Here

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      XVI INTERNATIONAL AIDS CONFERENCE

    The Body PRO Gears Up for AIDS 2006: Research, Podcasts and More!
    The largest HIV conference in the world, the International AIDS Conference, will take place from Aug. 13-18 in Toronto, Canada -- and The Body PRO will be on hand to provide extensive, authoritative reports of breaking research! The Body PRO's coverage of the XVI International AIDS Conference (AIDS 2006) will include podcast interviews with researchers, clinicians and other attendees, alongside our traditional coverage of important research presentations. We will also feature live Webcasts of key conference events from kaisernetwork.org! Bookmark our conference home page and check back throughout the conference for the very latest. Click Here


    AIDS 2006 Will Be a Full House; HIV-Infected People Welcome in Canada
    In less than one week, Toronto, Canada, will become a temporary home for more than 25,000 of the world's HIV scientists, physicians, patients and activists, all of whom will be attending the XVI International AIDS Conference (AIDS 2006). "We fully expect this [conference] will be possibly the largest ever," said Darryl Perry, one of the officials organizing the conference. Even Canada's immigration officials have done their part to ensure success: Since May 2005, short-term visa applications have omitted HIV-related questions, allowing HIV-infected persons from abroad to freely visit Canada on short trips without disclosing their status. "This is an important change that'll benefit people coming to the conference," said Perry, "and it's a lasting change we are very proud of." By contrast, the United States is one of a handful of countries that forbid the entry of all HIV-infected foreigners. Click Here

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      HIV/HAART-RELATED COMPLICATIONS

    FDA Issues Health Warning on Raw Oysters From U.S. Pacific Northwest
    The U.S. Food and Drug Administration (FDA) has advised consumers to avoid eating raw oysters harvested in the U.S. Pacific Northwest as a result of increased reports of gastrointestinal illnesses associated with the naturally occurring bacteria Vibrio parahaemolyticus in oysters harvested from the area. The threat is especially pertinent for immunocomprized individuals, including HIV-infected patients. Until the threat has passed, consumers are advised to thoroughly cook oysters harvested from the Pacific Northwest before eating. Click Here


    Patient Death Halts Trial of Experimental Lipohypertrophy Treatment; Other Studies Continue
    No approved treatment exists for HIV-related lipohypertrophy, but clinical trials are currently investigating the use of growth hormone releasing factor to potentially reverse visceral fat gain. One of these experimental treatments, a phase 2 drug known as CJC-1295, recently hit a wall when an HIV-infected study participant died after receiving an injection of the drug, leading the study to be halted shortly after it began. However, clinical trials of other lipohypertrophy treatments continue, including a once-daily drug known as TH-9507 that is now in phase 3 study. Click Here


    Severe Immune Suppression May Spur Osteonecrosis in HIV-Infected Patients
    Although research indicates that osteonecrosis incidence is higher among HIV-infected people than HIV-uninfected people, researchers remain unsure as to why. However, a new study by Spanish researchers suggests that bone death risk may be elevated among patients with advanced HIV disease. The study of 10,000 Spanish HIV-infected patients found 54 cases of osteonecrosis; the researchers noted that patients with osteonecrosis had an average CD4+ cell count of 90, and that most had previously experienced an AIDS-defining illness. The data suggest that severe immune suppression may be a major cause of the complication. Click Here


    Depression, Fear of Disclosure Appear Common Among HIV-Infected Americans Over 50
    HIV-infected New Yorkers over age 50 are 13 times more likely to be severely depressed than the general New York City population, according to a large survey by the AIDS Community Research Initiative of America. The survey of 1,000 older HIV-infected patients also found that many respondents might lack the support they need out of a fear of disclosure: Less than half of respondents said their family knew they had HIV, and only 35% said they had told their friends. More dramatically, most respondents (82%) also said they were unemployed. The findings point to the need for a strengthening of support services available specifically for HIV-infected people over 50, the study's authors conclude. Click Here

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      HIV TRANSMISSION/TESTING

    Sexual Risk Behaviors More Likely Among Female Injection Drug Users With HIV
    Many HIV-infected women who use injection drugs fail to routinely use condoms with their HIV-uninfected partners, according to a multicity U.S. study. The findings highlight the many ways in which drug use may increase HIV transmission risk between HIV-infected patients and their uninfected partners. The study also noted that women who used condoms inconsistently were more likely to use drugs and alcohol during sex, have negative beliefs about condoms and feel less personal responsibility to protect others. "HIV-positive women may need structural interventions such as better access to drug treatment," said lead investigator Mary H. Latka, M.P.H., Ph.D. The study appears in the June 2006 of JAIDS. Click Here


    Most Young Assault Victims Don't Complete PEP, Study Finds
    Young women who are victims of sexual assault usually fail to finish their prescribed 28-day course of post-exposure prophylaxis (PEP), according to a study by researchers from the Boston University School of Medicine and Children's Hospital Boston. Only 38% of study participants who were prescribed PEP returned for a follow-up visit, and only 13.4% completed the full treatment course. The researchers concluded that young sexual assault victims should still be offered PEP, but added that more must be done to ensure adherence: "Patient education and a comprehensive follow-up system with extensive outreach and case management are necessary to encourage post-exposure prophylaxis adherence and return for follow-up care among adolescent sexual assault survivors," they wrote. The study appears in the July 2006 issue of the Archives of Pediatrics & Adolescent Medicine. Click Here


    Gates Foundation Doubles HIV Vaccine Funding to $528 Million
    The Bill & Melinda Gates Foundation is attempting to revolutionize the manner in which HIV vaccine research is conducted under a new series of HIV vaccine development grants totaling $287 million. Rather than giving money to far-flung, independent research teams throughout the world, the grants aim to bring the world's researchers together to share resources and collaborate on creating more effective vaccines. The 165 researchers who receiving foundation funding will be required to collaborate and share the results of their research. In addition, the researchers may patent their findings as long as they make their vaccines available at low costs to people in developing countries. Click Here


    Baltimore Launches HIV Nucleic Acid Testing Program
    Baltimore, Md., health clinics have implemented nucleic acid testing, which can detect HIV one to two weeks after infection by amplifying gene fragments of the HIV to detect minute amounts of viral genetic material in pooled plasma samples. If a pool tests positive for HIV, individual samples can be detected and removed for further processing, and the donor can be deferred and notified. Several studies, most notably a series of studies led by the University of North Carolina and the North Carolina Department of Health and Human Services, have suggested that the use of nucleic acid testing in conjunction with partner tracing programs can potentially help public health officials and clinicians identify local HIV transmission "hot spots" and intervene during the patients' earliest stage of infection, when they are most contagious. Click Here

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      HIV PATHOGENESIS

    Scientists Explore HIV Link Between Humans, Chimpanzees
    HIV initially spread from chimpanzees to humans when they were exposed to the virus during hunting and butchering. Could other diseases, or new strains of HIV itself, similarly pass from simians to humans? A team of researchers at the Johns Hopkins' Bloomberg School of Public Health plans to find out, in hopes of identifying emerging strains of HIV and other diseases before they develop into the next global pandemic. The team, led by epidemiologist Nathan Wolfe, last year found that one in six people in Cameroon who were in regular contact with primate blood had been exposed to SIV, the simian strain of HIV. The findings are unsettling, Wolfe said. "We don't know whether HIV is done emerging. It may be the case that novel forms of HIV continue to enter the population." Click Here


    HIV May Be Result of Gene Mutation, Study Says
    HIV could be the result of a gene mutation that occurred when the simian immunodeficiency virus (SIV) -- believed to be the progenitor of HIV -- jumped from apes to humans, according to a study published in the June 13 issue of the journal Cell, Reuters reports. Frank Kirchhoff, of the University of Ulm in Germany, and colleagues studied a gene called nef that is found in both HIV and SIV. In SIV, nef prevents CD4+ cells from self-destructing. In HIV, the virus selectively infects CD4+ cells and causes them to self-destruct. According to researchers, the findings show that nef genes in HIV might have lost the characteristic that prevents CD4+ cells from self-destructing and that protects apes' immune systems. Researchers also found that the much rarer HIV-2 strain of the virus functions similarly to SIV. Click Here

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      HIV NEWS & VIEWS

    Howard Grossman, M.D., Resigns as Director of AAHIVM
    The American Academy of HIV Medicine (AAHIVM) has announced the resignation of its executive director Howard Grossman, M.D. Dr. Grossman had served in the position since November 2004, but said in a statement that he wished "to pursue other professional opportunities and to fulfill family obligations." While it conducts a new executive search, AAHIVM has named Brian Hujdich as its interim executive director. Click Here


    Larry Kramer Calls for New "Nuremberg Trials" to Document "Real History" of HIV
    When AIDS activist Larry Kramer was invited to speak at a special "AIDS at 25" panel discussion hosted by the New York Times, the newspaper probably had no idea that Kramer would blast the paper itself for "its own huge role in allowing this plague to progress." And that's not all Kramer said: as always, this prominent, long-time advocate was blunt and provocative. Read his prepared remarks for this discussion for a poignant look into the heart of a man who will never stop fighting for the justice he feels the HIV community still fails to receive in the United States. Click Here

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      HIV-RELATED POLICY/ADVOCACY IN THE UNITED STATES

    Gay Physician Replaces Drug Company CEO as Head of U.S. Global AIDS Efforts
    The U.S Senate has confirmed Mark Dybul, M.D., a gay physician, to become the new head of the United States' Office of the U.S. Global AIDS Coordinator, which leads the government's HIV-fighting efforts in the developing world. Dr. Dybul, who has been acting head of the office, now officially replaces Randall Tobias, a business executive who was named Pharmaceutical Industry CEO of the Year in 1995. Dybul, by contrast, is a clinician and researcher who has long worked for the U.S. Department of Health and Human Services. Click Here

    For more on Dr. Dybul and his nomination to the post he now holds, you can read this Washington Blade article or this brief bio at the U.S. Department of State's Web site.


    Massachusetts Legislature Trumps Governor's Veto, Legalizing Syringe Sales
    On July 13, Massachusetts joined 47 other U.S. states in legalizing non-prescription, pharmacy-based sales of hypodermic needles. "[W]e will have less hepatitis C infection in the state, and we will have less prevalence of HIV/AIDS. Those are two things we know are going to happen," remarked Sen. Robert O'Leary (D-Barnstable), who first sponsored the legislation four years ago. O'Leary also said studies of other states with similar programs do not show an increase in drug use or discarded needles. The legislature narrowly overrode Republican Gov. Mitt Romney's veto of the bill. Click Here

    Click here for coverage of Gov. Romney's initial veto and the response it received.

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      HIV OUTSIDE THE UNITED STATES

    Nine Pharmaceutical Firms Agree to Review Global Antiretroviral Prices
    At a meeting aimed to encourage drug makers to widen access to antiretroviral treatment in low- and middle-income countries, United Nations Secretary-General Kofi Annan urged the companies to lower their drug prices, as well as develop more medications and diagnostic tools for children living with HIV. Annan said the companies agreed to prioritize the research and development of pediatric antiretrovirals and diagnostic tools; register their drugs and diagnostic tools in as many countries as possible, including developing countries; sustain negotiations with third-party manufacturers to make antiretrovirals and diagnostics more affordable; and invest more in researching and developing new HIV-related drugs and diagnostics, such as vaccines and microbicides. Not all HIV medication manufacturers were part of this agreement, however. Click Here


    A Silver Lining on South Africa's Dark Cloud: HIV Incidence May Be Leveling
    It's astonishing when a 30 percent HIV incidence rate among pregnant women is considered good news. But in South Africa -- one of the focal points of the global pandemic -- that's exactly the case. A new survey released by the South African Department of Health shows that 30 percent of pregnant women were diagnosed with HIV in 2005, which is only a slight increase over 2004. In addition, the overall HIV prevalence rate among teenagers was down from 2004 to 15.9 percent. "This is encouraging to note," said Health Minister Manto Tshabalala-Msimang, "but a great deal of work still needs to be done to ensure that new infections no longer take place at all in South Africa." Overall, the survey estimated that 5.54 million South Africans were living with HIV. Click Here

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    Also Worth Noting

    Lipoatrophy Center
    Refer Your Patients to The Body's Lipoatrophy Center

    Kathleen Mulligan, Ph.D.
    Kathleen Mulligan, Ph.D., is one of several clinicians interviewed for The Body's newly launched Lipoatrophy Resource Center. Dr. Mulligan helped organize the first International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV.
    Lipoatrophy ranks as one of the greatest concerns for HIV-infected patients who are receiving, or about to initiate, antiretroviral therapy. The newly launched Lipoatrophy Resource Center at The Body, The Body PRO's sister site for the general public, provides the Web's most comprehensive collection of information on this difficult adverse effect.

    At The Body's Lipoatrophy Resource Center, patients can read -- and download podcasts of -- interviews with top physicians and HIV-infected people who have experience with lipoatrophy. They can also browse through a trove of useful information about this complication, including the latest news, research updates, overviews, comparisons of facial fillers, tips on how to get insurance coverage for lipoatrophy surgery and compelling accounts of what it's like to live with lipoatrophy.