|
Issue No.
2
| January 15, 2010
|
|
|
AIDSinfo.nih.gov is pleased to provide you with a weekly update of highlights about what has happened in the world of HIV/AIDS treatment, prevention, and research. We hope you find this encapsulated view of HIV/AIDS news useful. |
 |
|
 |
|
Atripla (Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate) Product Label Updated
“On January 7, 2010, FDA approved an updated Atripla label including new efficacy, safety and resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on their HAART Regimen) in which HIV-1 infected adults on a stable antiretroviral regimen were either switched to Atripla or remained on their background regimen to compare the effectiveness (efficacy, safety, and tolerability) of Atripla to that of subjects continuing unmodified HAART as measured by the proportion of subjects who maintain HIV-1 RNA <200 copies/mL on their original assigned regimen at Week 48 based on the time-to-loss of virologic response (TLOVR) analysis.
“Other revisions were made to the label for consistency between Sustiva, Viread, Truvada and Emtriva labels.”
The complete revised labeling will be available at the FDA Web site.
More information is available:
New Study Results Available for Women and Infants Transmission Study (WITS)
“Detectable HIV-1 RNA at delivery is the strongest predictor of mother-to-child transmission. The risk factors for detectable HIV, including type of regimen, are unknown. We evaluated factors, including highly active antiretroviral (HAART) regimen, associated with detectable HIV-1 RNA at delivery in the Women and Infants Transmission Study (WITS).... Data from 630 HIV-1-infected women who enrolled from 1998 to 2005 and received HAART during pregnancy were analyzed. Multivariable analyses examined associations between regimens, demographic factors, and detectable HIV-1 RNA (>400 copies/milliliter) at delivery.... Overall, 32% of the women in the cohort had detectable HIV-1 RNA at delivery. Among the subset of 364 HAART-experienced women, a lower CD4 cell count at enrollment [adjusted odds ratio (AOR) = 1.20 per 100 cells/muL, confidence interval (CI) 1.04 to 1.37] and higher HIV-1 RNA at enrollment (AOR = 1.52 per log10 copies/milliliter, CI 1.32 to 1.75) were significantly associated with detectable HIV-1 RNA levels at delivery. For the 266 HAART-naive women, both lower CD4 cell count at enrollment (AOR = 1.24 per 100 cells/muL, CI 1.05 to 1.48) and higher HIV-1 RNA at enrollment (AOR = 1.35 per log10 copies/milliliter, CI 1.12 to 1.63) were associated with detectable HIV-1 RNA at delivery.… Lack of viral suppression at delivery was common in the WITS cohort, but differences by antiretroviral regimen were not identified. Despite a transmission rate below 1% in the last 5 years of the WITS cohort, improved measures to maximize HIV-1 RNA suppression at term among high-risk women are warranted.”
More information is available:
Winter 2010 Issue of mental health AIDS Released
The quarterly biopsychosocial research update on HIV and mental health, mental health AIDS, is sponsored by the Center for Mental Health Services (CMHS) of the Substance Abuse and Mental Health Services Administration (SAMHSA) and is disseminated free-of-charge through the SAMHSA Web site in both PDF and HTML formats.
The Winter 2010 issue features the Toolbox "Lending an Existential Ear to the Elemental Issues in HIV-Related Therapy."
"Existential psychotherapy is grounded in 'a theoretical framework that concerns itself with articulating the fundamental dimensions, meanings, and dilemmas of human existence.' This framework is 'especially well suited to the work of psychotherapy with individuals living with HIV disease' and 'can inform any number of techniques, including those drawn from a cognitive-behavioral, interpersonal, or psychodynamic approach.' This tool box centers on several studies that were existential in focus and conducted largely among people of color living with HIV. These studies are bracketed by an applied understanding of the theory and practice of existential psychotherapy in the context of HIV disease."
More information is available:
|
|
|
|
|
|
