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This Week: Brecanavir Development Axed; Ryan White Renewal Passed; and More
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December 21, 2006
In This Newsletter:
  • HIV Treatment & Complications
  • Ryan White & ADAP
  • HIV Transmission
  • HIV Policy in the U.S.
  • HIV Outside the U.S.
  •   HIV TREATMENT & COMPLICATIONS

    Development Halted for Brecanavir, a Phase 2 Protease Inhibitor
    Clinical development of the experimental protease inhibitor brecanavir has been halted, according to an announcement from GlaxoSmithKline. "We have been unable to develop a viable oral dosage formulation capable of delivering the desired drug levels in patients with multi-drug resistant HIV," the announcement states. Earlier clinical trials involving brecanavir had found that the drug exhibited powerful antiviral activity against both wild-type and highly drug-resistant HIV; the drug's relatively low dosage also raised hopes that it might be less toxic than many other antiretrovirals. Click Here


    Expanded Access Program to Begin for CCR5 Inhibitor
    An international expanded access program is slated to commence in early 2007 for maraviroc, a CCR5 inhibitor in late-stage development. The program, which will enroll patients from more than 30 nations, will make the drug available at no charge to HIV-infected patients with multidrug resistance. Click Here


    Interaction Warning: Ritonavir and Blood-Pressure Drug Nifedipine
    The calcium channel blocker nifedipine (known by the brand names Adalat, Nifedical and Procardia) may cause a dangerous, and potentially life-threatening, interaction when taken concurrently with ritonavir (Norvir), according to a case report in the Jan. 2, 2007 issue of AIDS. The report outlines the case of an HIV-infected patient from Spain who experienced kidney failure and an extreme drop in blood pressure, among other symptoms, due to an interaction between nifedipine and the lopinavir/ritonavir (Kaletra) in his HAART regimen. Symptoms rapidly resolved upon discontinuation of either medication, the researchers noted. Click Here

    The case report can be accessed directly by clicking here.


    HIV Impairs Immune Response to HCV; Nadir CD4 Above 300 May Be Protective
    HIV/hepatitis C (HCV)-coinfected patients appear to be more likely than HCV-monoinfected patients to experience recurrence of HCV viremia after initial control, according to researchers in Massachusetts. In a study published on Dec. 12 in the online edition of PLoS Medicine, the researchers write that control over HCV viremia in coinfected patients is lost when CD4+ cell count falls, which indicates that HIV impairs the immune response to HCV. Although this is a small study, the researchers note that the results highlight the importance of testing all HIV-infected patients for HCV and of regularly testing all coinfected patients for a rise in HCV levels. They add that these HIV/HCV-coinfected patients might also benefit from earlier initiation of antiretroviral therapy to treat their HIV infection; patients with a nadir CD4+ cell count above 300 cells/mm3 appeared more likely to spontaneously control their HCV infection. Click Here


    Tropism Shift Tied to Relatively Successful Treatment in Naive Patient With Heavy Resistance
    Achieving a successful treatment outcome for a patient with an HIV strain resistant to almost all antiretrovirals may seem intimidating, but according to French researchers, it is an achievable goal. In a case report published in the Jan. 2, 2007 issue of AIDS, the researchers report that a salvage regimen was able to provide some immunological benefit through nearly three years of follow-up; the patient experienced no opportunistic infections or other symptoms, his CD4+ cell count held above 300 cells/mm3, and his viral load remained at or below 10,000 copies/mL. According to the researchers, “the relative benefit of this incomplete viral suppression could be caused by the decrease in viral replication capacity (probably driven by the additional selection of M184V), by residual drug activity, and by the shift to CCR5-only tropism.” Click Here

    The case report can be accessed directly by clicking here.


    Researchers Identify Potential Treatment for Metabolic Complications
    Metabolic complications remain one of the primary adverse-effect concerns among HIV-infected patients. Research into treatments for this array of complications is ongoing; in fact, researchers in Boston, Mass., report in the November 2006 issue of the Journal of Clinical Endocrinology & Metabolism that promising, early results have been found in an early study of acipimox, which is already used outside the United States (under the brand name Olbetam) to treat hypercholesterolemia and diabetes. In the small study, the Boston researchers found that acipimox had a beneficial impact on a range of lipid levels in HIV-infected men and women with high baseline triglycerides and abnormal body fat distribution. Click Here


    The GEMINI Study: Are Saquinavir + Ritonavir and Lopinavir/Ritonavir Twins?
    Several new trials seek to compare the safety and efficacy of the dominant protease inhibitor on the market, lopinavir/ritonavir (Kaletra), with other boosted protease inhibitors. Preliminary data from the GEMINI Study, for instance, indicate that lopinavir/ritonavir and saquinavir (Invirase) + ritonavir (Norvir) match up well in terms of efficacy, but that saquinavir + ritonavir appears to cause fewer lipid abnormalities. The Body PRO's Graeme Moyle, M.D., reports from the 8th International Congress on Drug Therapy in HIV Infection. Click Here

    For additional, in-depth coverage of key research presented at this conference, click here!

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      RYAN WHITE & ADAP

    Ryan White CARE Act Reauthorization Is Signed Into Law
    After being held up for a full year due to disagreements between Republicans and Democrats, the long-awaited reauthorization of the Ryan White CARE Act was finally signed into law on Dec. 19. Both houses of the U.S. Congress approved a compromise bill to renew the act, which provides more than $2 billion for an array of HIV-related support and treatment programs throughout the United States. In the compromise, legislators essentially agreed not to make any fundamental changes to the act -- including a highly controversial revision proposed by Republicans that may have dramatically shifted funds from urban areas to rural areas. Click Here


    Funding Lost, Funding Gained: Impact of Ryan White CARE Act Reauthorization
    How will individual states fare under the compromise bill to renew the Ryan White CARE Act? Some states stand to benefit, others may lose. South Carolina, for example, is slated to receive an increase in funding, which will help cover a $3 million budget shortfall in its AIDS Drug Assistance Program (ADAP). This increase is desperately needed, as four people have already died while on a waiting list to receive ADAP-funded antiretrovirals. Maryland, on the other hand, could lose 5% of its $36 million in HIV funding next year. Click Here


    Ryan White CARE Act Reauthorization Could Improve HIV Services in Rural South
    Poor HIV-infected patients living in rural areas often face challenges traveling to and from their health care provider. This situation may improve under the newly passed compromise bill to reauthorize the Ryan White CARE Act. Patients living in the rural South will likely see a much-needed increase in funding, which could be used for transportation and improved treatment access. Kathie Hiers, CEO of AIDS Alabama, said the additional $7 million Alabama is scheduled to receive would be used not only for transportation programs, but to increase the number of medications covered by Alabama's AIDS Drug Assistance Program. According to Hiers, Alabama’s current list has 35 medications, compared with 500 in New York. Click Here


    Hundreds on ADAP Waiting Lists in United States
    Although the U.S. Congress has finally agreed to reauthorize the Ryan White CARE Act, many low-income and uninsured HIV-infected patients in the United States are still going without HIV treatment due to a lack of government funding. As of Nov. 15, there were 340 people on AIDS Drug Assistance Program (ADAP) waiting lists in three states, and other ADAPs have had to impose various restrictions. "Even with the changes in the reauthorized program, ADAPs will continue to tread water unless sufficient funding to stabilize the programs is provided," warned Julie Scofield, the executive director of the National Alliance of State and Territorial AIDS Directors, which provided the report on the current state of the country's ADAPs. Click Here

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      HIV TRANSMISSION

    Male Circumcision Dramatically Reduces HIV Risk for Heterosexual Men, Studies Find
    Interim results from two major studies on male circumcision in Kenya and Uganda have so conclusively supported the protective benefits of circumcision against heterosexual HIV transmission among men that the studies have been prematurely terminated. The massive studies -- which cumulatively enrolled 7,780 HIV-uninfected men in areas where heterosexual sex was the primary mode of HIV transmission -- found that HIV incidence dropped approximately 50% among men who received circumcision compared to those who did not. The researchers noted that the study only involved circumcisions that were performed by trained medical professionals, and included adequate followup care to ensure that the patient fully healed. Click Here

    For more information on these studies, read this Q & A document prepared by the U.S. National Institute of Allergy and Infectious Diseases, or this NIAID release announcing the studies' discontinuation.


    Missed Chances for Early HIV Diagnosis Abound in South Carolina
    The U.S. Centers for Disease Control and Prevention now recommends that all patients between the ages of 13 and 64 receive routine HIV testing. New data from a study in South Carolina showcases just how important this testing is: The study found that more than 40% of patients diagnosed with HIV in South Carolina were also diagnosed with AIDS within one year; nearly 17% were diagnosed with AIDS within 30 days. The majority of these late testers were not generally considered "high-risk" patients; only a third were injection drug users or men who had sex with men. Click Here


    AHF Ad Campaign Warns of Link Between Viagra, Meth and HIV
    The Los Angeles-based AIDS Healthcare Foundation (AHF) launched an advertising campaign against pharmaceutical company Pfizer because it said the company's ads for the erectile dysfunction drug Viagra (known generically as sildenafil) promote recreational use. AHF said it was particularly concerned that the drug has become popular among men who have sex with men who use methamphetamine, which has been associated with high-risk sexual behavior and increased risk of HIV infection. Pfizer denied that the ads encourage recreational use of the drug and said its advertising states that the drug does not protect against sexually transmitted infections. Click Here

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      HIV POLICY IN THE UNITED STATES

    New Jersey Lawmakers Approve Bill to Offer Clean Needles, Expand Drug Treatment Programs
    The New Jersey state legislature has approved a measure that will establish needle-exchange programs in six cities and provide $10 million to drug treatment programs in the state. "The science is clear: Needle exchange programs reduce sharing of contaminated needles, reduce transmission of HIV and hepatitis C and serve as gateways to treatment,” said Gov. Jon Corzine, who has promised to sign the bill. The $10 million drug treatment program will allow the state to provide "motivational counseling" for up to 1,500 intravenous drug-users, open four sites for outpatient illicit drug addiction treatment, increase access to long-term residential treatment and maintain "sober houses" to encourage illicit drug-free living. New Jersey is currently the only state that does not allow injection drug users to obtain clean needles through community-based needle-exchange programs or with a prescription. Click Here


    President Bush Eases U.S. Ban on Some HIV-Infected Visitors
    On World AIDS Day, U.S. President George W. Bush announced that he will issue an executive order allowing HIV-infected people to enter the U.S. on short-term visas without having to seek special permission. Since 1987, people living with HIV have been officially banned from entering the United States as tourists or immigrants, with some limited exceptions. Under the new rule proposed by Bush, HIV-infected people would obtain a "categorical waiver" for business or tourist visas for visits of no more than 60 days. It is not yet clear whether visitors would still be required to declare their HIV status, and the executive order would not alter policies toward long-term visitors or immigrants. Click Here


    Democrats Seek to Investigate PEPFAR Faith-Based and Abstinence-Only Initiatives
    The United States requires HIV programs it funds in developing countries to offer abstinence-only education, but Democrats in the U.S. Congress may be seeking to change this policy. Democratic lawmakers want to investigate funding for faith-based HIV and abstinence-until-marriage initiatives receiving money under the President's Emergency Plan for AIDS Relief (PEPFAR), which is scheduled to be reauthorized in 2007. By law, at least one-third of the HIV prevention funds that countries receive through PEPFAR -- a $15 billion, five-year program -- must be used for abstinence-until-marriage programs. Rep. Barbara Lee (D-Calif.) also said last week that she wants to follow up on reports that the Bush administration has given 98.3% of faith-based foreign-aid money to Christian groups, while groups of other faiths have received a pittance by comparison. Click Here

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      HIV OUTSIDE THE UNITED STATES

    Indian HIV Treatment Program Reaches Less Than 10% of HIV-Infected People
    Fewer than 10% of HIV-infected people in India are receiving free antiretrovirals through India's state-run National AIDS Control Organization, according to the organization. The agency revealed this fact while addressing India’s Supreme Court, where several advocacy groups brought a suit alleging a paucity of government progress in treating its HIV-infected population. According to the United Nations, India's HIV prevalence stands at 5.7 million, a higher figure than in any other country in the world. Currently, government-run health centers provide antiretrovirals to only 46,000 HIV-infected Indians, although the Indian government had aimed to offer antiretroviral drugs to 100,000 people by the end of 2005. Click Here


    India's Law Against Homosexuality Faces Renewed Challenge
    The United States still has much progress to make in improving gay rights, but the situation could be worse. In India, for instance, a law known as Section 377 effectively outlaws homosexuality, stating that any "carnal intercourse against the order of nature with man, woman or animal" is punishable by up to 10 years in prison. Recently, a five-year-old lawsuit against Section 377, which was originally thrown out of court, was brought up for review once again by order of the Supreme Court of India. Supporters of the law say it is used to prosecute sexual offenses against children, but opponents argue that it can also be used to incriminate gay adults in consensual relationships. That can only increase stigma for many gay and bisexual men -- UNAIDS believes the number to be anywhere between 5 million and 15 million -- who as a result may be extremely difficult to reach through HIV prevention outreach efforts. Click Here


    Antiretrovirals Now Reach Two Million in Developing World, but Far More Remain Untreated
    The number of people receiving antiretrovirals in developing countries doubled from 2005 to 2006, according to newly released statistics. That brings to approximately two million the number of people now receiving HIV treatment, according to United Nations officials. Much of the credit for that increase belongs to the United States' President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which together provide antiretrovirals to 1.2 million people living with HIV. However, despite this progress, HIV continues to spread faster than the drugs used to treat it, and the world's leaders have fallen short of their pledges to make HIV treatment virtually universal within the next several years. Click Here


    Using HIV as a Weapon of War
    Sexual violence is an ancient instrument of war, but with the spread of HIV, that violence has become particularly deadly. According to a report published in The Lancet from the African Commission on Human and Peoples' Rights, the Democratic Republic of Congo has accused neighboring countries of deliberately sending as many as 2,000 HIV-infected soldiers to Congo's eastern province to spread HIV through rape. The war in Congo is still ongoing, and Africa's human rights commission has been powerless to investigate the alleged crimes or enforce penalties. According to Amnesty International, more than 40,000 women have been raped in the course of the conflict. Click Here


    HIV Stories From Latin America: Three Women Speak About Their Struggle
    Justa Suazo, Laura Perez Ottonello and Sandra Zambrano are three Latin-American women whose lives have been turned upside-down by HIV -- but who have responded with incredible strength and resilience. For instance, two years after Justa, a 36 year-old woman from Honduras, was diagnosed with HIV, she joined a support group called the Association of People Living with HIV/AIDS. Now she is one of the group's national leaders. Or take Laura: Fifteen years ago, she learned that she had gotten HIV from her husband, who had been cheating on her. Today she has a three-year-old granddaughter and is president of the Uruguay Network of People Living with HIV. As Sandra explains, "The epidemic has made us stronger." Click Here

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    Also Worth Noting

    Get the Credit You Deserve: Free CME/CE Credit at The Body Pro's CME/CE Central!
    New Activities:
    Overcoming Treatment Challenges in the Treatment-Experienced Patient With HIV, by Daniel S. Berger, M.D., Valery Hughes, R.N., M.S., C.-F.N.P., and Kathleen E. Squires, M.D. (1.5 hours)
    NNRTIs: The Next Generation Approaches, by Brian A. Boyle, M.D., J.D., and Calvin J. Cohen, M.D., M.S. (1.0 hours)
    Also Available:
    Challenging Cases in HIV: Implications of Anemia, by Douglas T. Dieterich, M.D., and David H. Henry, M.D. (1.0 hours)
    Update on Management of the HIV/Hepatitis B- or HIV/Hepatitis C-Coinfected Patient, by Maurizio Bonacini, M.D. (1.5 hours)
    Optimizing Therapy for Patients With Multidrug-Resistant HIV, by Charles Hicks, M.D., Angela D.M. Kashuba, B.Sc.Phm., Pharm.D., D.A.B.C.P., and Sharon Walmsley, M.D. (3.0 hours)
    New Developments in HIV Drug Resistance and Options for Treatment-Experienced Patients, by Bonaventura Clotet, M.D., Ph.D., and Cal Cohen, M.D., M.S. (2.0 hours)
    And More!

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