The U.S. Food and Drug Administration (FDA) has three important advisory committee meetings scheduled in May that may impact HIV prevention, detection, and treatment.

On May 10, 2012, FDA’s Antiviral Advisory Committee will discuss expanding the indication of Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet, made by Gilead Sciences, Inc., to include use for Pre-Exposure Prophylaxis (PrEP), to reduce the risk of sexually acquired HIV–1 infection.  Truvada is currently approved for treatment of HIV infection.  Read more on this page.

On May 11, 2012, the Antiviral Drugs Advisory Committee will discuss a new drug application (NDA) for a fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naive or have no known genetic substitutions associated with resistance to the individual drug components. More details available on this page.

Finally, on May 15, 2012, the FDA Blood Products Advisory Committee will meet to discuss the evaluation of data related to the safety and effectiveness of the OraQuick In-Home HIV Test. This is the first application for FDA approval of a home-use rapid test for detection of infection with HIV. Details about this meeting are found on this page.

The public is invited to comment on these topics and to attend FDA advisory committee meetings; see the links above for details about each meeting.

Read more about the FDA’s HIV/AIDS activities.

The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents released updated Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents last week. Revisions to the October 14, 2011, version of the guidelines include both new sections and key updates to existing sections, including:

• New section on HIV and the older patient
• New table on cost of antiretroviral drugs
• Updated recommendations on initiation of antiretroviral therapy (ART) in treatment-naive individuals
• Expanded discussion of use of hormonal contraceptives in HIV-infected women
• Preliminary recommendations on coadministration of the newly approved hepatitis C virus (HCV) NS3/4A protease inhibitors (PIs) boceprevir and telaprevir
• Recommendations on “when to start” ART in HIV-infected individuals diagnosed with tuberculosis but not receiving ART
• Discussion of the role of effective ART in preventing HIV transmission

For a complete preview of key updates to the guidelines, please see What’s New in the Guidelines?  To view or download the guidelines, go to the Adult and Adolescent Treatment Guidelines section of AIDSinfo.

AIDSinfo Announces New Process and Format for Release of Guidelines
With the release of the updated adult and adolescent antiretroviral treatment guidelines, NIH’s AIDSinfo introduced a new process and format for production and release of guidelines disseminated via the AIDSinfo website. According to an announcement from AIDSinfo, the new process and format will allow the guidelines panels to review, update, and release individual sections of guidelines as often as necessary to coincide with the latest emerging research. Thus, release of a revised section will not be delayed until the entire guidelines are updated/reviewed (for example, on an annual basis). Henceforth individual sections of guidelines will include both a “last updated” date and a “last reviewed” date. “Last updated” will indicate the last date changes were made to a section; “last reviewed” will indicate the last date section contents were reviewed and judged current and appropriate. Although all guidelines will continue to be available in PDF format, the PDF versions of the guidelines will include a cover page with a disclaimer stating that the guidelines are only guaranteed current on the date printed or saved to the user’s computer. Users are encouraged to check the AIDSinfo website frequently for notice of subsequent updates and access to the most up-to-date guidelines.

Your Feedback Is Important
The Panel on Antiretroviral Guidelines for Adults and Adolescents welcomes feedback on the latest revisions to the adult and adolescent treatment guidelines. The panel also invites feedback on the new process and format for release of the guidelines. Please send your comments with the subject line “Adult and Adolescent Guidelines Comments” to ContactUs@aidsinfo.nih.gov by April 10, 2012.

At the recent 19th Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Ron Valdiserri, Deputy Assistant Secretary of Health for Infectious Diseases, spoke with Dr. Jonathan Mermin, Director of CDC’s Division of HIV/AIDS Prevention. They discussed some of the significant findings from the conference including advances related to pre-exposure prophylaxis (PrEP) and the growing discussions of an AIDS-free generation.  Watch their conversation below.

It is understandable why advances in the development of anti-HIV drugs have so dominated media stories about the AIDS epidemic in recent years. The advent of highly active antiretroviral therapy has had such a tremendous impact on HIV morbidity and mortality that early commentators of the phenomenon often referred to “the Lazarus effect” when describing the profound improvements in health and vitality resulting from these new therapies.

Less visible and not as well recognized by the general public–but equally impressive in their own right– are the progressive improvements that have taken place in laboratory science since the first test to diagnose HIV was licensed in 1985.

A symposium this week at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) was devoted to this very topic. Dr. Bernie Branson from CDC explained that 3rd and 4th generation HIV laboratory tests have become progressively more sensitive, narrowing further and further the “window period”– that is, the interval of time between infection with HIV and the ability of a laboratory test to diagnose infection. In fact, CDC is working on a new HIV testing algorithm that recognizes this improved sensitivity and will recommend a more streamlined approach to HIV diagnostic testing.

Of course, advances in HIV testing technology are only beneficial to the degree that they are put into practice. Namely, ensuring that HIV testing is widely available and that test results empower/enable the person being tested to make positive health choices. This includes prompt referral to care for those who are found to be infected with HIV and ongoing prevention support for high-risk seronegative persons.

Dr. Blayne Cutler from the New York City Department of Health shared New York City’s successful experience with expanding access to HIV testing. Employing a multi-pronged strategy that included incentives (for example, performance contracts), social marketing campaigns, targeted technical assistance, and legislative change, their efforts have resulted in over 700,000 HIV tests being performed and 2,000 new HIV diagnoses.

Other panel presentations included Ms. Nduku Kilonzo who spoke about her experiences scaling-up HIV counseling and testing services in Kenya and Dr. Patrick Sullivan who described various aspects of HIV results disclosure, including couples testing programs for gay men.

Other presentations at CROI dealt with the important issue of promoting early HIV diagnosis and facilitating linkage into life-saving care. Please take the time to visit the CROI website and read these abstracts . Several of the presentations are also available as webcasts, audio files, and slide sets, which you can find on the CROI website . You may find some useful ideas and approaches to help with your own local efforts to address the National HIV/AIDS Strategy’s goal of increasing the percentage of undiagnosed infected persons who are tested and promptly referred into care.

At the 19th Conference on Retroviruses and Opportunistic Infections (CROI) [external disclaimer] this week, Dr. Ron Valdiserri, Deputy Assistant Secretary of Health for Infectious Diseases, spoke with Dr. Michael Horberg, Director of HIV/AIDS for Kaiser Permanente and a member of the Presidential Advisory Council on HIV/AIDS (PACHA). They discussed the paper Dr. Horberg is presenting at CROI on the impact of missed office visits on HIV outcomes and mortality. This paper offers important insight into our efforts to address improvements in the continuum of HIV care. Watch their convseration below.

The 19th Conference on Retroviruses and Opportunistic Infections  (CROI) officially opened in Seattle on Monday afternoon, March 5th. Over 4,200 researchers, providers, community leaders, and advocates from 83 countries gathered at the Washington State Convention Center to hear the opening plenary session. The first presentation was from Dr. Dennis Burton, an internationally renowned expert in HIV virology who shared newly emerging information about neutralizing antibodies to HIV that are providing scientists new insights into developing a vaccine for HIV. Next, Drs. Quarraisha and Salim Abdool Karim shared an overview of two decades of their groundbreaking prevention research in South Africa that led to the development of an effective vaginal microbicide to help protect young women from HIV infection.

The theme of prevention carried over into the plenary session on Tuesday, March 6 during which Dr. Wafaa El Sadr talked about antiretroviral therapy (ART) as an important prevention strategy. Dr. El Sadr reminded conference participants that there is no easy or single solution to achieving the promise of ART for prevention. Instead, she advocated for further research into novel strategies for expanding early diagnosis of HIV, actively linking persons into care, and developing tools, systems and processes that help people stay in care. Dr. El Sadr recognized the strength of community partnerships, including partnerships with people living with HIV/AIDS, as an essential ingredient in moving forward with a “vibrant” research agenda.

Later in the morning, a series of oral abstracts on PrEP (pre-exposure prophylaxis), microbicides and male circumcision were presented.  Follow-up questions to PrEP researchers emphasized the importance of developing alternatives to daily dosing strategies and the need to better understand the factors and variables that influence adherence.

It is simply not possible to share all of the important information coming out of this meeting.  As such, I would like to remind all of you that the CROI abstracts are available online as well as webcasts and podcasts of many sessions. I urge you to visit the CROI site and learn more about the amazing work that is being presented here in Seattle.

Dr. Ronald Valdiserri

The President has committed to supporting a National HIV/AIDS Strategy (NHAS) that is “grounded in the best science.” Scientific research efforts have greatly expanded our understanding of HIV/AIDS and produced a large number of critical tools and interventions to help us diagnose, prevent, and treat HIV. The past year has been particularly productive with important scientific advances in the area of treatment as prevention, among others.

These findings, and many others yet to come, are essential to our HIV/AIDS work and we cannot achieve the vision of the NHAS without continued and sustained progress in biomedical, behavioral, and social science. Nor can we afford to neglect the policy, operational and social questions that often emerge as a result of new research findings.

To learn more about rapidly evolving fields of HIV/AIDS research, I will be attending—along with colleagues from HHS, including Dr. Andrew Forsyth, Senior Science Advisor in the Office of HIV/AIDS Policy—the 19th Conference on Retroviruses and Opportunistic Infections (CROI) from March 5-8, 2012 in Seattle, Washington. CROI is a scientifically focused meeting of the world’s leading researchers working to understand, prevent, treat– and ultimately cure — HIV/AIDS and its complications. The goal of CROI is to provide a forum for translating laboratory and clinical research into progress against the AIDS epidemic. Over 4,000 leading researchers and clinicians from around the world convene in a different location each year for the Conference.

I hope you will have an opportunity to read this blog next week, as I look forward to sharing some of the important information being discussed. The conversation at CROI will be a tantalizing preview of the  important research findings and policy issues that will be discussed at the International AIDS Conference in Washington, DC, this summer.

Over the past year and a half, many of you followed the AIDS.gov blog post series Future Directions for NIAID HIV Research by Dr. Carl Dieffenbach, Director of the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID) at NIH. Last week, NIAID advanced those efforts by issuing several requests for applications (RFAs) to establish leadership groups for clinical research networks focused on distinct areas of HIV/AIDS research.

NIAID is looking to expand upon the success of its six current HIV/AIDS clinical trials networks to create an infrastructure capable of performing both HIV/AIDS research and research involving non-HIV/AIDS infectious diseases.

The leadership groups to be funded will have overall responsibility for developing, implementing and adapting clinical research agendas to address NIAID’s HIV/AIDS scientific priorities in the following areas:
•    Therapeutics for HIV/AIDS and HIV-associated infections in adults
•    HIV/AIDS and HIV-associated infections in pediatric and maternal populations
•    Integrated strategies to prevent HIV infection
•    Vaccines to prevent HIV infection
•    Microbicides to prevent HIV infection

The new RFAs are part of NIAID’s larger effort to revamp its existing HIV/AIDS clinical trials networks. Applications for each of the five RFAs are due Sept. 28, 2012. Awards are expected to be made in 2013. Read full details at NIAID.

Next: Funding Announcements for Clinical Trials Units and TA for Applicants
In connection with its larger clinical trials network restructuring effort, NIAID plans to publish this spring a Funding Opportunity Announcement (FOA) designed to solicit applications for the Clinical Trials Units (CTUs) that will populate the revamped clinical research networks. To assist potential CTUs applicants, NIAID will host three workshops focused on the grant application and review process. The first of these workshops will be held July 28-29, 2012, in Washington, D.C. The two remaining workshops, which will be held later in 2012, will be conducted in South America and Africa. Stay tuned to the NIAID clinical trial restructuring Web site for registration and additional information about these upcoming workshops.

Since early in the HIV/AIDS epidemic, the National Institute of Allergy and Infectious Diseases (NIAID) has involved community representatives and advocates in the research process.   The nature and scope of the community’s involvement have grown over the years, but the rationale behind these efforts remains the same:  the people who might benefit from the research should have a voice in the process, and community engagement helps ensure that the research is both relevant and ethical.  While there are many ways to establish community-researcher partnerships, the Community Advisory Board (CAB) model is the primary way in which NIAID and its funded researchers work together with interested, nonscientific community representatives.

NIAID established its first CAB in 1990 in response to HIV/AIDS activists’ demands, and soon thereafter, CABs became a requirement for each of the NIAID-funded HIV/AIDS clinical trials networks and sites.  Currently, there are 138 CABs that interact with one or more of the NIAID-funded clinical trials sites.  The CABs facilitate a two-way dialogue between the research staff and the broader community.  This serves to increase community understanding of why a given trial may be conducted – what researchers hope to learn and how it fits into the overall research plan.  The exchange also helps research staff gain insight into community needs, concerns and culture, which can facilitate more effective and meaningful communication with the broader community, and may enable staff to better assess the importance and feasibility of any given study in that community. In addition to the local CABs, each of NIAID’s six HIV/AIDS clinical trials networks has a CAB with global representation. These CABs interact with the scientific leadership and provide input into the scientific agenda, network operations, and the prioritization and design of specific studies.

When the HIV/AIDS clinical trials networks were restructured in 2006, NIAID established a cross-network group called Community Partners (CP) whose goal is to help ensure effective representation of and timely communication among the global communities where the clinical trials networks operate. This group also works to 1) harmonize best practices for community involvement across the HIV/AIDS networks and affiliated sites, 2) identify the communities’ scientific priorities, and 3) develop effective training tools and evaluation measures.

NIAID has several other means of fostering community engagement. Since 2006, the NIAID HIV Vaccine Research Education Initiative (NHVREI) has worked to increase awareness of and engagement in HIV vaccine research among highly HIV-affected populations within the United States, and more recently has begun to address other prevention research. Through partnerships with local community-based organizations and national and regional non-governmental organizations and associations, NHVREI works to improve knowledge of and attitudes toward HIV vaccine research, enhance partnerships between communities and researchers, and create support for current and future HIV vaccine trials.   Since this project is winding down, NIAID has established a way to ensure that the important work of the NHVREI not only continues but also expands to fully encompass other biomedical prevention research, such as microbicides and pre-exposure prophylaxis.

The Legacy Project, which began within the HIV Vaccine Trials Network, is now a project that spans all six clinical trials networks.  The Legacy Project works to build trust within communities in the United States that have been historically distrustful of and underrepresented in clinical trials research, namely African Americans and Latinos.  Coordinated by the Office of HIV/AIDS Network Coordination, the Legacy Project strives to ensure cultural competency and responsiveness of research by developing partnerships with key stakeholders in these communities.

As the clinical trials networks are restructured in 2013, NIAID will continue to encourage and support community engagement activities through the CABs, CP and the partnerships developed through the Legacy Project and projects like the NHVREI.  NIAID remains committed to increasing the community’s understanding and awareness of HIV/AIDS biomedical research and ensuring that the community always has a seat at the table.

Co-authored by Scott Proestel, M.D., Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH

On September 18, 2011, we mark the fourth observance of National HIV/AIDS and Aging Awareness Day.  The remarkable success of antiretroviral therapies in prolonging the lives of HIV-infected individuals who have access to and can tolerate these drugs has led to many more HIV-infected people living into middle and old age.  In 2008, an estimated 29 percent of HIV-infected adults in the U.S. were at least 50 years of age, and in 2009, individuals in that age group accounted for 17% of all new HIV diagnoses.  Both of these percentages have been increasing in recent years.  As the benefits of improved therapies for HIV continue to accrue, research into the complex relationship between aging and HIV becomes increasingly critical.

A major goal of HIV and aging research at the National Institutes of Health (NIH) is to achieve greater understanding of how premature aging of the immune system may be occurring in people living with HIV, and clarifying the fundamental mechanisms of inflammation.  Understanding the complex interaction between HIV and aging will require considerable effort on multiple fronts. The NIH Institutes and Centers support a broad range of research on HIV and aging.  For example, this past April, three NIH Institutes (National Institute on Aging, National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke) announced that they will fund research into the effects of HIV on the brain in aging populations taking antiretroviral therapy.  Within the National Institute of Allergy and Infectious Diseases (NIAID) programs, research on HIV and aging is ongoing in the Women’s Interagency HIV Study (WIHS)and the Multicenter AIDS Cohort Study (MACS) . These long term follow-up studies of HIV infected women (WIHS) and men (MACS) have defined some of the important differences in HIV risk, pathogenesis and treatment response between the sexes. The International Epidemiologic Database to Evaluate AIDS (IeDEA) provides domestic and international information about the epidemic including pathogenesis differences between HIV infected adults who are growing older and newly infected older individuals. In addition, studies conducted by the Centers for AIDS Research (CFAR), AIDS Clinical Trials Group (ACTG) , and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) are pursuing HIV and aging-related scientific questions.

The NIH Office of AIDS Research, which has responsibility for overall planning and coordination of NIH AIDS research, has made AIDS and aging research a priority in the annual Trans-NIH Plan for HIV-Related Research, and has supported a number of initiatives to catalyze this area of science.  In close collaboration with a number of NIH Institutes with research portfolios in HIV/AIDS, OAR has been exploring new ways to sponsor further research on HIV and aging.  OAR has established a Working Group on HIV and Aging comprised of experts in both HIV/AIDS and geriatrics, as well as representatives from the HIV affected community to identify new scientific opportunities and priorities in this field of research.

While the NIH continues to expand research on HIV and aging, multiple other Federal agencies, foundations, and advocacy groups are also making critical contributions in this important area, as well as directly supporting the needs of older individuals living with HIV.  Only by addressing these needs can we truly achieve the vision of the President’s National HIV/AIDS Strategy:

The United States will become a place where new HIV infections are rare and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.