INFORMATION ON HIV/AIDS TREATMENT, PREVENTION AND RESEARCH FROM DHHS

“On April 8, 2014 FDA approved updates to the Isentress (raltegravir) label to include information regarding co-adminsitration of raltegravir with boceprevir or telaprevir.

“In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of telaprevir or boceprevir. No dose adjustment is required for Isentress or boceprevir or telaprevir.”

The revised label is available at the FDA website.

More information is available:

“On April 7, 2014, FDA approved new changes to the Prezista (darunavir) label to update the following sections:

  • “WARNING AND PRECAUTIONS, Severe Skin Reactions,  ADVERSE REACTIONS, Postmarketing Experience, and PATIENT COUNSELING INFORMATION sections of the labeling were updated with information regarding rash with eosinophilia and systemic symptoms.
  • “DRUG INTERACTIONS, Established and Other Potentially Significant Drug Interaction and CLINICAL PHARMACOLOGY, Table 15 subsections of the labeling were updated with information regarding dolutegravir. …
  • “CLINICAL PHARMACOLOGY, Microbiology subsection of labeling was updated to rilipivirine to the list of drugs that did not show antagonism with darunavir. 
  • “Prezista 400 mg tablets were removed from the HOW SUPPLIED/STORAGE AND HANDLING section because this dosage strength is no longer marketed in the US.”

The revised label is available at the FDA website.

More information is available:

  • April 3, 2014: Future HIV Vaccine Research Must Consider Both Protective Immune Responses and Those That Might Increase Susceptibility to Infection

    “Last year, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, held a scientific meeting to examine why certain investigational HIV vaccines may have increased susceptibility to HIV infection. In a new perspectives article appearing in the journal Science, HIV research leaders from NIAID (Anthony S. Fauci, M.D., and Carl W. Dieffenbach, Ph.D.) and its grantees at Emory University (Eric Hunter, Ph.D.) and the University of California, San Francisco (Susan Buchbinder, M.D.), summarize the findings and considerations for future HIV vaccine research.”

     
  • March 31, 2014: HIV-Infected Men at Increased Risk for Heart Disease, Large Study Finds

    “The buildup of soft plaque in arteries that nourish the heart is more common and extensive in HIV-infected men than HIV-uninfected men, independent of established cardiovascular disease risk factors, according to a new study by National Institutes of Health grantees. The findings suggest that HIV-infected men are at greater risk for a heart attack than their HIV-uninfected peers, the researchers write in Annals of Internal Medicine.”

The HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission announces the release of the updated Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States.

For a complete preview of key updates to the guidelines, please see What's New in the Guidelines. Additions and revisions are also highlighted in yellow throughout the text and tables of the guidelines.

To view or download the guidelines, go to the Perinatal Guidelines section of AIDSinfo. Separate PDF files of the tables or recommendations can also be downloaded from the page.

Your Feedback Is Welcome

Feedback on the latest revisions to the Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States is welcome. Please send your comments with the subject line “Comments on Perinatal Guidelines” to ContactUs@aidsinfo.nih.gov by April 11, 2014.

“What immune response should a vaccine elicit to prevent HIV infection? Two studies published online today [March 19, 2014] bring scientists closer to answering this question by identifying previously unrecognized attributes of antibodies that appear to have reduced the risk of HIV infection in the only clinical trial to show efficacy, albeit modest, of an experimental vaccine regimen in people.

Earlier analyses of the results of that trial, known as RV144, suggested that antibodies to sites within a part of the HIV envelope called V1V2 correlated with reduced risk of HIV infection. These antibodies belong to a class called immunoglobulin G, or IgG. The new studies by two independent laboratories both found that only one subclass of V1V2-directed IgG antibodies—the IgG3 subclass—is associated with antiviral responses linked to the reduced risk of HIV infection seen in RV144. …  

“More research is needed to determine whether V1V2-directed IgG3 antibodies actually protected some vaccinees from HIV infection, as well as whether there was a relationship between the fast decline in IgG3 antibodies and the sharp drop in efficacy of the investigational RV144 vaccines. Information from the current and ongoing studies will help scientists refine their efforts to design and test HIV vaccines that build on the success of RV144.” 

More information is available:
March 20 is National Native HIV/AIDS Awareness Day—an annual observance that highlights the impact of HIV/AIDS on American Indian, Alaska Native, and Native Hawaiian communities.

According to the Centers for Disease Control and Prevention (CDC), approximately 20% of HIV-infected people in the United States do not know that they are infected; however, among American Indians and Alaska Natives the figure is closer to 25%. Compared to members of other ethnic or racial groups, American Indians and Alaska Natives who receive a diagnosis of HIV infection or AIDS have one of the shortest survival times. This may be due to HIV infections diagnosed late in the course of the disease or limited access to health care.

Visit our National Native HIV/AIDS Awareness Day page [en español] to learn how the HIV/AIDS epidemic is affecting native communities.
  • March 5, 2014: Genetic Modification of Cells Proves Generally Safe as HIV Treatment Strategy

    “Scientists today report initial results from humans on the safety and tolerability of a novel strategy to curb HIV disease by removing key cells from HIV-infected individuals, genetically modifying the cells to resist HIV infection and returning them to those individuals. The basic and pre-clinical research on this strategy, which eventually might help people control the virus without drugs, was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.”

     
  • March 3, 2014: Study of Antibody Evolution Charts Course Toward HIV Vaccine

    “In an advance for HIV vaccine research, a scientific team has discovered how the immune system makes a powerful antibody that blocks HIV infection of cells by targeting a site on the virus called V1V2. Many researchers believe that if a vaccine could elicit  potent antibodies to a specific conserved site in the V1V2 region, one of a handful of sites that remains constant on the fast-mutating virus, then the vaccine could protect people from HIV infection.”

Each year, March 10 is set aside to observe National Women and Girls HIV/AIDS Awareness Day. The purpose of this day is to recognize the impact of HIV on women and girls and encourage action to reduce the burden of HIV/AIDS among women and girls. According to the Centers for Disease Control and Prevention (CDC), at the end of 2010, 1 in 4 people living with a diagnosis of HIV infection in the United States were women. 

Explore our National Women and Girls HIV/AIDS Awareness Day webpage [en español] to learn more about the annual observance and to find HIV/AIDS-related information specific to women and girls.

  • February 25, 2014: NIH Expands Focus of Research Funding Opportunity Targeting HIV Reservoirs

    “The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health, both part of the National Institutes of Health, recently expanded the scientific scope of an HIV-cure related funding announcement to allow for a broader range of studies and approaches.

    “Specifically, the funding opportunity 'Targeting Persistent HIV Reservoirs,' which was originally issued February 17, 2012, has been significantly expanded to allow for 'proposed basic research into the cellular and molecular mechanisms of HIV latency and persistence.' …

    “The funding opportunity is part of the larger NIH HIV Cure Initiative designed to fuel research toward finding a cure for HIV. NIAID and NIMH will accept applications through April 25, 2014. For more information about the specific changes to the RFA, see the Notice of Change of Program Priorities to be Supported by PAR-12-109 ‘Targeting Persistent HIV Reservoirs (TaPHIR) (R21/R33).’ View the complete RFA.”
     
  • February 24, 2014: Youth Born With HIV May Have Higher Heart Disease Risk, NIH Network Study Shows

    “Nearly half of adolescents who have had HIV since birth may be at increased risk for cardiovascular disease — including heart attack and stroke — later in life, according to a National Institutes of Health network study.

    “The findings are the latest results from the Pediatric HIV/AIDS Cohort Study (PHACS), a multi-site, long-term follow-up study of children and youth who have had HIV since birth, sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and supported by eight other institutes at NIH.”

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