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

"On September 24, 2014, FDA approved Tybost (cobicistat) 150 mg tablets. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection."

For more information on cobicistat, view the FDA press release.

"On September 24, 2014, FDA approved Vitekta (elvitegravir) 85 mg and 150 mg tablets. Vitekta is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor indicated in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults."

For more information on elvitegravir, view the FDA press release.

The labeling for both drugs will be available soon at the FDA website
The Centers for Disease Control and Prevention (CDC) is seeking public comments on a newly developed draft clinical quality measure for HIV infection screening. The measure aligns with the U.S. Preventive Services Task Force (USPSTF) recommendations that all individuals between the ages of 15 and 65 be screened for HIV. The measure was developed in collaboration with clinicians and quality experts. The goal is to develop a measure that will be nationally endorsed through the National Quality Forum (NQF) and included in the Centers for Medicare and Medicaid Services (CMS) programs.

Public comments will be accepted through October 20, 2014. For information on how to submit comments, please view the public notice on the CMS website.
CDC recently launched HIV Treatment Works, a new national campaign focused on encouraging people infected with HIV to get into care and adhere to treatment. The website includes information and resources for people living with HIV, including information on treatment adherence and tips for healthy living. Visit the HIV Treatment Works website to find an HIV care provider, an HIV support group, or mental health provider.

For more information, view the CDC press release
September 27 is the annual observance of National Gay Men’s HIV/AIDS Awareness Day, which serves to highlight the continuing impact of the HIV/AIDS epidemic among gay men. Gay and bisexual men are more severely affected by HIV than any other group in the United States. According to CDC, gay, bisexual, and other men who have sex with men (MSM) represent approximately 2% of the U.S. population but accounted for 63% of estimated new HIV infections in 2010.

Explore our National Gay Men’s HIV/AIDS Awareness Day webpage [en español] to learn more about this observance and to find information on HIV/AIDS and gay men.
On August 28, 2014, FDA approved updates to the label for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir 300 mg) fixed-dose combination tablets. The label was updated with efficacy, resistance, and safety data from two clinical trials; renal information; and drug interaction information.

The updated labeling for Stribild is available at the FDA website

More information is available: 
National HIV/AIDS and Aging Awareness Day is a day set aside each year to recognize the impact of HIV/AIDS among older adults. According to the Centers for Disease Control and Prevention (CDC), adults aged 55 and older accounted for 19% of the estimated 1.1 million people living with HIV infection in the United States in 2010. Older Americans are more likely than younger Americans to be diagnosed with HIV infection late in the course of their disease, which may mean a later start to treatment, possibly causing more damage to their immune system. This can lead to poorer prognoses and shorter HIV-to-AIDS intervals.

Visit our National HIV/AIDS and Aging Awareness Day webpage [en español] to learn more about this observance and to find information on HIV/AIDS and aging.
"An NIH-led team of scientists has discovered a new vulnerability in the armor of HIV that a vaccine, other preventive regimen or treatment could exploit. The site straddles two proteins, gp41 and gp120, that jut out of the virus and augments other known places where broadly neutralizing antibodies (bNAbs) bind to HIV. This newly identified site on the viral spike is where a new antibody found by the scientists in an HIV-infected person binds to the virus. Called 35O22, the antibody prevents 62 percent of known HIV strains from infecting cells in the laboratory and is extremely potent, meaning even a relatively small amount of it can neutralize the virus."

More information is available:
"On August 22, 2014, FDA approved a new fixed-dose combination product: TRIUMEQ, a combination of dolutegravir (integrase strand transfer inhibitor), abacavir sulfate and lamivudine (both nucleoside analogue reverse transcriptase inhibitors) for the treatment of HIV-1 infection. 
  • "TRIUMEQ alone is not recommended for use in patients with current or past history of resistance to any components of TRIUMEQ.
  • "TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. See full prescribing information for dolutegravir. 
"The recommended dosage regimen of TRIUMEQ in adults is one tablet once daily orally with or without food."

The complete label for Triumeq is available at the FDA website.

For more information, view the FDA press release.
"On August 20, 2014, the Intelence (etravirine) label was updated to include information regarding coadministration of etravirine with the following drugs:
  • "dolutegravir, dolutegravir/darunavir/ritonavir, dolutegravir/lopinavir/ritonavir
  • "atazanavir/ritonavir
  • "boceprevir"
The updated labeling for etravirine is available at the FDA website.

More information is available:

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