Lupin gets USFDA nod for HIV drug
Drug firm Lupin has received tentative approval from the US health regulator to market a generic version of Prezista tablets, used in treating HIV infection. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 30, 2014 Category: Pharmaceuticals Source Type: news
Reduced Darunavir Dose Maintains HIV SuppressionReduced Darunavir Dose Maintains HIV Suppression
A 600-mg dose of darunavir is as effective as the approved 800-mg dose in maintaining HIV suppression, researchers from Spain report. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 29, 2014 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news
View AIDSinfo Patient Fact Sheets on Three Recently Approved HIV Medications
AIDSinfo invites you to view our patient fact sheets on three medications recently approved by the FDA. The three medications are all indicated for use in the treatment of HIV infection in adults. The patient fact sheets include information on dosage forms and strengths, possible side effects, and instructions on how to take and store the medications.
Fact sheet on abacavir/dolutegravir/lamivudine (brand name: Triumeq)
Triumeq is a combination medicine that can be used alone as a complete treatment regimen or with other HIV medicines.
Fact sheet on cobicistat (brand name: Tybost)
Cobicistat is ...
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) - October 24, 2014 Category: Infectious Diseases Source Type: news
EMA Panel Endorses Darunavir/Cobicistat Combo for HIVEMA Panel Endorses Darunavir/Cobicistat Combo for HIV
Rezolsta is intended for the treatment of antiretroviral therapy-naive and antiretroviral therapy-experienced adults with no darunavir-resistance-associated mutations. International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 29, 2014 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news
FDA Approves Two Medications to Treat HIV Infection: Cobicistat (Brand Name: Tybost) and Elvitegravir (Brand Name: Vitekta)
"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 an...
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) - September 26, 2014 Category: Infectious Diseases Source Type: news
FDA Updates Etravirine Labeling
"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:
FDA: Press release
AIDSinfo: Patient fact sheet on etravirine (Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health an...
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) - August 29, 2014 Category: Infectious Diseases Source Type: news
ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1
An investigational two drug-regimen of maraviroc dosed once daily, combined with darunavir/ritonavir (DRV/r) showed inferior efficacy compared to emtricitabine/tenofovir (FTC/TDF) with DRV/r. (Source: GSK news)
Source: GSK news - July 22, 2014 Category: Pharmaceuticals Source Type: news
FDA Updates Darunavir (Prezista) Labeling
“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, M...
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 11, 2014 Category: Infectious Diseases Source Type: news
Janssen Files NDA For New HIV Combo Drug
Janssen Research & Development (Janssen) announced that it has filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose antiretroviral combination tablet containing its protease inhibitor Prezista (darunavir) with Gilead Sciences’ cobicistat, an investigational pharmacokinetic enhancer for use in combination with other human immunodeficiency virus (HIV-1) medicines. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 3, 2014 Category: Pharmaceuticals Source Type: news
Raltegravir Combo Gives New Anti-HIV Alternative
BOSTON (MedPage Today) -- The use of a two-drug anti-HIV therapy of raltegravir (Isentress) plus darunavir (Prezista) appeared to be non-inferior to tenofovir/emtricitabine (Truvada) plus darunavir, researchers reported here. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - March 6, 2014 Category: Consumer Health News Source Type: news
New 96-Week ACTG Study Results Presented at CROI 2014; First Large Study Comparing ISENTRESS® (raltegravir) Regimen to Two Protease Inhibitor Regimens in Previously Untreated Adults with HIV-1
Dateline City:
BOSTON
BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
said today that in a new 96-week, open-label AIDS Clinical Trials Group
(ACTG) study designed to compare three different NNRTI-sparing HIV
regimens in treatment-naïve patients – one containing Merck’s
twice-daily ISENTRESS® (raltegravir) and two containing
different once-daily ritonavir-boosted protease inhibitors, atazanavir
and darunavir -- all three regimens achieved high and equivalent levels
of...
Source: Merck.com - Research and Development News - March 5, 2014 Category: Pharmaceuticals Tags: Research and Development News Source Type: news
New 96-Week ACTG Study Results Presented at CROI 2014; First Large Study Comparing ISENTRESS® (raltegravir) Regimen to Two Protease Inhibitor Regimens in Previously Untreated Adults with HIV-1
Dateline City:
BOSTON
BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
said today that in a new 96-week, open-label AIDS Clinical Trials Group
(ACTG) study designed to compare three different NNRTI-sparing HIV
regimens in treatment-naïve patients – one containing Merck’s
twice-daily ISENTRESS® (raltegravir) and two containing
different once-daily ritonavir-boosted protease inhibitors, atazanavir
and darunavir -- all three regimens achieved high and equivalent levels
of ...
Source: Merck.com - Product News - March 5, 2014 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
Janssen seeks EMA approval for fixed-dose combination of HIV medicine darunavir with cobicistat
Janssen-Cilag (Janssen), a subsidiary of the Johnson & Johnson pharmaceutical firm, has filed a marketing authorisation application with the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 15, 2013 Category: Pharmaceuticals Source Type: news
Dolutegravir vs Darunavir: Positive Data From FLAMINGODolutegravir vs Darunavir: Positive Data From FLAMINGO
Dr. Paul Sax discusses results of the FLAMINGO study comparing dolutegravir vs ritonavir-boosted darunavir in treatment-naive patients with HIV. Medscape HIV/AIDS (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 26, 2013 Category: Consumer Health News Tags: HIV/AIDS Commentary Source Type: news
New HIV Drug Matches Old Standard (CME/CE)
DENVER (MedPage Today) -- The recently approved anti-HIV medication dolutegravir (Tivicay) has equivalent efficacy to boosted darunavir (Prezista), a researcher said. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - September 13, 2013 Category: Consumer Health News Source Type: news
