New State-Of-The Art Treatment Guidelines for HIV-Infected Adults and Adolescents Released

On Dec. 1, the National Institutes of Health joins the global community in commemorating World AIDS Day. On this occasion, we remember the more than 25 million people who have lost their lives to this terrible disease, and dedicate ourselves to meeting the needs of the many millions more who are living with HIV/AIDS. We also recognize their families, caregivers, and communities, who are coping every day with the burden of this disease.

“World AIDS Day is a time for all of us to take stock of the important progress that has been made against this global scourge and to recommit ourselves to addressing the extraordinary and unprecedented challenges that remain to prevent and treat HIV/AIDS here in the United States and around the world, “says NIH Director Francis Collins, M.D., Ph.D.

The Joint United Nations Program on HIV/AIDS (UNAIDS) estimates that more than 33.4 million people are living with HIV/AIDS. In 2008, about 2.7 million people were newly infected and 2.0 million died of AIDS-related illnesses. The World Health Organization recently reported that AIDS is the leading killer of women of reproductive age around the world.

In the United States, more than 1.1 million people are estimated to be HIV-infected; someone is infected with the virus every 9 and a half minutes. HIV/AIDS in the United States disproportionately affects racial minorities and men who have sex with men. HIV/AIDS is not only a young person’s disease: approximately one-quarter of HIV-infected adults in the United States are at least 50 years old, and individuals 50 years of age and older account for approximately 10 percent of all new HIV infections.

Since the first cases of what is now known as AIDS were reported in the United States more than 28 years ago, NIH has established the largest HIV/AIDS research program in the world. NIH supports and conducts basic, clinical, behavioral, and translational research to better understand the biology of the virus and how it affects the body, and to develop effective new therapies and tools of prevention.

NIH-funded research has led to pivotal scientific advances against HIV/AIDS: the discovery and development of antiretroviral drugs that have turned HIV infection from a death sentence into a chronic disease for those who can access and tolerate these drugs; HIV prevention strategies, including groundbreaking techniques for the prevention of mother-to-child transmission of HIV; and the development of treatments for many HIV-associated co-infections, co-morbidities, malignancies and clinical complications. Most of these advances would not have been possible without hundreds of thousands of dedicated volunteers participating in NIAID-sponsored clinical trials. For this, we thank them.

Despite these important advances, the epidemic continues to expand, and improved prevention strategies and therapeutic regimens are urgently needed. For example, a growing proportion of patients receiving long-term therapy are demonstrating treatment failure, experiencing serious drug toxicities and side effects, and developing drug resistance. Recent epidemiologic studies and clinical reports of HIV-infected individuals have shown an increased incidence of malignancies, premature aging, and cardiovascular, neurological, and metabolic complications associated with long-term HIV disease and therapy.

Because HIV/AIDS research encompasses a broad array of co-infections, co-morbidities, malignancies and complications, no other disease so thoroughly transcends every area of basic scientific investigation and clinical medicine. HIV/AIDS research is conducted and supported by every one of the 27 NIH institutes and centers.

This complex and multifaceted trans-NIH research program is coordinated by the Office of AIDS Research (OAR) (http://www.oar.nih.gov/), part of the NIH Office of the Director. The OAR strategic plan (http://www.oar.nih.gov/strategicplan/), is developed with broad input from scientists from NIH, other government agencies, non-governmental organizations and community representatives. It establishes the scientific priorities for NIH investments in HIV/AIDS-related research and the scientific foundation for implementing the goals of President Obama’s National HIV/AIDS Strategy: reduce HIV incidence; increase access to care and optimize health outcomes; and reduce HIV-related health disparities.

“AIDS is a complicated disease that impacts the individual, families, communities, and society as a whole,” says Jack Whitescarver, Ph.D., NIH associate director for AIDS Research and director of the Office of AIDS Research. “Our unified and collaborative trans-NIH research program allows us to define the highest priorities for research that will address the HIV/AIDS epidemic at each of these levels.”

The National Institute of Allergy and Infectious Diseases (NIAID) accounts for approximately half of AIDS-related spending at NIH. NIAID Director Anthony S. Fauci, M.D., notes that “despite the many advances against HIV/AIDS, much remains to be accomplished. In particular, we urgently need improved prevention strategies and a cure for HIV infection, and NIH is funding hundreds of studies to achieve these goals.”

For example, numerous studies are under way to test topical microbicides — creams, gels or other substances for application to the vagina or rectal mucosa to prevent HIV infection. Clinical trials are also testing the efficacy of pre-exposure prophylaxis (PrEP), a daily regimen of one or two antiretroviral drugs that is designed to prevent infection in uninfected individuals who are at high risk for the virus. NIH also plans to test the feasibility of a potential HIV prevention strategy known as test and treat that involves community-wide HIV testing and immediate treatment for people found to be infected.

A vaccine against HIV remains a key NIH priority. The HIV vaccine field recently was encouraged by data from a large clinical trial in Thailand in which a two-stage HIV vaccine regimen demonstrated the first signal from any human study that a protective vaccine for HIV may be possible.

The development of state-of the-art practice guidelines and their effective dissemination are integral to HIV prevention and treatment efforts, and critical in light of the continuing advent of new and complex antiretroviral treatment regimens, issues related to adherence to prescribed treatments, and the need to translate research results into practice. In this regard, NIH supports several working groups to develop such guidelines for the U.S. Department of Health and Human Services. On Dec. 1, the latest update of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents is being released. The update is being made available on AIDSInfo.gov (http://www.aidsinfo.nih.gov/). The guidelines provide current treatment information for health care providers and patients based on the most recent clinical data. The guidelines and related information about medications, clinical trials, and fact sheets are available on the Web site and can be downloaded to a PDA for immediate availability at the point of care.

“We face a time of extraordinary scientific opportunities and challenges, and are committed to harnessing the breadth of expertise across the NIH to continue to lead the world’s effort to finding solutions to this pandemic,” says Dr. Collins. “We do so in collaboration with other government agencies, foundations, and organizations, but especially in partnership with the dedicated volunteers who participate in our clinical research studies. On this World AIDS Day, and every day, we thank them for their generosity.”

Web Resources:

Information about the AIDS research programs of the NIH Institutes and Centers can be found at http://www.oar.nih.gov/hivaids/institutes.asp.

The National Library of Medicine has an array of critical resources regarding AIDS at http://sis.nlm.nih.gov/hiv.html.

Information about AIDS clinical trials can be found at http://www.aidsinfo.nih.gov/

Information about HIV Vaccine research is available at http://bethegeneration.nih.gov/

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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