FDA Updates Atripla Labeling
“FDA recently approved updates to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label to include the following changes:
Lists Stribild as one of the drugs that should not be coadministered with Atripla
Adds drug interaction information for raltegravir, boceprevir and telaprevir
Strengthens Warnings and Precautions: Rash section
Updates the Use in Specific Populations: Nursing Mothers section
Updates Tables 7 and 8 with didanosine drug interaction data based upon recent changes to the prescribing information for Sustiva, Truvada and Viread.”
The updated labeling...
Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health and Human Services (DHHS) - April 19, 2013 Category: Infectious Diseases Source Type: news
ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1
ViiV Healthcare presents 24-week interim results from Phase III SAILING study at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) (Source: GSK news)
Source: GSK news - March 6, 2013 Category: Pharmaceuticals Source Type: news
FDA Updates Lopinavir/Ritonavir (Kaletra) Labeling to Include New Drug Interaction Information
"On January 17, 2013, FDA approved revisions to the Kaletra (lopinavir/ritonavir) labels to include new drug interaction information. The following updates were included.
"Anticoagulants: Rivaroxaban. Avoid concomitant use of rivaroxaban and Kaletra. Coadministration of Kaletra and rivaroxaban is expected to result in increased exposure of rivaroxaban which may led to risk of increased bleeding
"Anticonvulsants: Lamotrigine and valproate. Coadministration of Kaletra and lamotrigine or valproate may decrease the exposure of lamotrigine or valproate. A dose increase of the lamotrigine or valproate may be nee...
Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health and Human Services (DHHS) - January 22, 2013 Category: Infectious Diseases Source Type: news
Systematic review and meta-analysis of clinical use of HIV integrase inhibitors
Source: PLoS One
Area: News
Integrase inhibitors have swiftly been adopted as part of current antiretroviral regimens. This systematic review and meta-analysis was carried of current evidence regarding the use of these agents in various clinical settings.
A search was conducted of the literature from April 2006 until November 2012, for RCTs and non-RCTs, and cohort studies. A total of 48 unique studies (including 15 abstract-only reports) were included on the use of integrase inhibitors in antiretroviral therapy-naive patients and treatment-experienced patients with either virological failure or switching to in...
Source: NeLM - News - January 17, 2013 Category: Drugs & Pharmacology Source Type: news
RCT: Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from SPRING-2 study
Source: Lancet
Area: News
The Lancet has featured the results of the SPRING-2 phase III study evaluating a new once-daily HIV integrase inhibitor dolutegravir, in comparison with raltegravir as initial treatment for adults with HIV-1.
The 96-week, double-blind, active-controlled, non-inferiority study involved 822 patients aged ?18 years with HIV-1 infection and HIV-1 RNA concentrations of 1000 copies per mL or greater, who were randomised to receive dolutegravir 50 mg once daily (n=411) or raltegravir 400 mg twice daily (n=411). The primary endpoint was the proportion of participants with HIV-1 RNA less than ...
Source: NeLM - News - January 8, 2013 Category: Drugs & Pharmacology Source Type: news
Changes in CV Biomarkers in Patients Switching ART RegimensChanges in CV Biomarkers in Patients Switching ART Regimens
Switching from ritonavir-boosted protease inhibitors to raltegravir leads to significant changes in plasma lipids and CV biomarkers. What does this mean for HIV patients' CV health? AIDS (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - January 1, 2013 Category: Infectious Diseases Tags: HIV/AIDS Journal Article Source Type: news
