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Issue No. 51  | December 14, 2012
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Recent Labeling Updates from FDA

The U.S. Food and Drug Administration (FDA) recently announced the following labeling updates:

  • Edurant (Rilpivirine)

    “On December 7, 2012, FDA approved changes to the Edurant (rilpivirine) package insert. The major changes include restricting the indication to treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL, updating the package insert with the 96 week results from the Phase 3 trials and adding a new Warning and Precaution for hepatotoxicity.”

    For more information, read the FDA press release.  
     
  • Hepsera (Adefovir Dipivoxil)

    “On November 29, 2012, FDA approved a labeling change for Hepsera (adefovir dipivoxil) package insert to include the following information under Section 5.5, Coadministration with Other Products, and to Section 17.1, Patient Counseling Information/Instructions for Safe Use.

    “Hepsera should not be used concurrently with Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disporoxil fumarate combination tablet).

    “Hepsera is nucleotide analogue for the treatment of chronic hepatitis B infection ... .”

    For more information, read the FDA press release.


Study Examines Effects of Aging, Smoking, and HIV Infection on Carotid Intima-Media Thickness

“[The objective of this study is to] investigate the effects of aging and smoking on carotid intima-media thickness (cIMT) among patients with and without HIV. …

“Data on 166 male and female participants with stable HIV-infection and 152 healthy HIV-uninfected participants were analyzed. Among the HIV-infected and HIV-uninfected participants, a significant association was observed between age and cIMT [r=0.51, P<0.0001 (HIV), r=0.39, P<0.0001, (non-HIV)], and between smoking burden and cIMT [r=0.42, P<0.0001 (HIV), r=0.24, P=0.003 (non-HIV)]. In multivariate regression modeling among all participants (HIV and non-HIV), a significant three-way interaction was observed between age, smoking burden, and HIV status with respect to cIMT (P<0.010), controlling for sex, race, and traditional cardiovascular disease (CVD) risk factors, such that increased cIMT was associated with increased smoking burden and age to a greater degree among HIV-infected vs. HIV-uninfected participants. Among HIV-infected participants a significant interaction between smoking burden and age with respect to cIMT was seen (P=0.027) controlling for race, sex, CVD risk factors, immunological function, and antiretroviral therapy use. …

“A significant interaction between HIV, age, and smoking on cIMT was observed, suggesting that HIV-infection modifies the relationship of age and smoking on cIMT in this population. These findings emphasize the need to encourage smoking cessation in this population, due to its deleterious effect on subclinical atherosclerosis in older HIV-infected patients.”

More information is available:


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