FDA Approves Two Medications to Treat HIV Infection: Evotaz and Prezcobix
On January 29, 2015, FDA sent e-mails noting the approval of two HIV medications to treat HIV infection:   "On January 29, 2015, FDA approved Evotaz, a fixed dose combination tablet containing 300 mg of atazanavir and 150 mg of cobicistat. Evotaz is indicated in combination with other antiretroviral agents for the treatment of … human immunodeficiency virus (HIV 1) infection in adults."   "On January 29, 2015, FDA approved Prezcobix a fixed dose combination tablet containing 800 mg of darunavir and 150 mg of cobicistat.   "Prezcobix is indicated in combination with other antiretrov...
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 30, 2015 Category: Infectious Diseases Source Type: news

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 a pharmacoki...
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 and Human Services (DHHS))
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, Microbi...
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 efficacy, as measured by time t...
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 efficacy, as measured by time to...
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 16, 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

ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naïve Adults with HIV-1
ViiV Healthcare today announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study. (Source: GSK news)
Source: GSK news - September 12, 2013 Category: Pharmaceuticals Source Type: news

Prezista Extends HIV Suppression in Children (CME/CE)
KUALA LUMPUR (MedPage Today) -- Children with human immunodeficiency virus (HIV) maintain viral control over 48 weeks when treated with the protease inhibitor darunavir/ritonavir (Prezista) along with an optimized background regimen, researchers reported here. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - July 6, 2013 Category: Consumer Health News Source Type: news

Generic Competition Pushing Down HIV Drug Prices, But Patents Keep Newer Drugs Unaffordable
Myanmar 2012 © Greg Constantine A patient collects her medication from the pharmacy at an MSF clinic in Yangon, where MSF treats HIV/AIDS and TB. Report Download Report [2.05 MB] Report Download Report [4.86 MB] KUALA LUMPUR/NEW YORK, JULY 2, 2013—The price of first- and second-line antiretrovirals (ARVs) to treat HIV are falling because of increased competition among generic producers, but newer ARVs continue to be priced astronomically high, according to the annual report Untangling the Web of ARV Price Reductions, released today by the international medical humanitarian orga...
Source: MSF News - July 3, 2013 Category: Global & Universal Source Type: news

Recent HIV/AIDS News
April 30, 2013: U.S. Preventive Services Task Force Issues Final Recommendation Statement on Screening for HIV “The U.S. Preventive Services Task Force (Task Force) today released its final recommendation statement on screening for HIV. The Task Force recommends that clinicians screen all people aged 15 to 65, as well as younger adolescents and older adults who are at an increased risk for HIV infection.” Read the AIDS.gov blog post.   April 25, 2013: Prezista (Darunavir) Labeling Changes “On April 24, 2013, FDA approved revisions to the Prezista (darunavir) tablet and oral suspens...
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) - May 3, 2013 Category: Infectious Diseases Source Type: news

Recent News from NIH and FDA
NIH-sponsored researchers announced the following news at the Conference on Retroviruses and Opportunistic Infections (CROI) this week: March 4, 2013: Daily-Use HIV Prevention Approaches Prove Ineffective Among Women in NIH Study “Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa.” Read the NIH press release.   March 3, 2013: Toddler ‘Functionally Cured’ of HIV Infection, NIH-Supported Investigators Report “A two-year-old child born with HIV infection and treated with a...
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 5, 2013 Category: Infectious Diseases Source Type: news

Correction to the Perinatal Guidelines Issued
On April 3, 2013, an error in the references in the Darunavir section was corrected. Reference 4 was updated. To view the correction notice, please click here. (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))
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 5, 2013 Category: Infectious Diseases Source Type: news

FDA Updates Darunavir Tablet and Oral Suspension Labeling with Pediatric Dosing Information
“On February 1, 2013, FDA approved revisions to the Prezista (darunavir) tablet and oral suspension label to include once daily dosing in treatment-naïve subjects 3 to less than 18 years of age and once daily dosing in treatment-experienced subjects 3 to less than 18 years of age with no darunavir resistance associated substitutions.” The updated labeling will be available at the FDA website. More information is available: FDA: Press release AIDSinfo: Darunavir (Prezista) patient drug summary (Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Servi...
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) - February 7, 2013 Category: Infectious Diseases Source Type: news

HIV/AIDS Update - Prezista (darunavir) tablet and oral suspension: pediatric dosing
On February 1, 2013, FDA approved revisions to the Prezista (darunavir) tablet and oral suspension label to include once daily dosing in treatment-naïve subjects 3 to less than 18 years of age and once daily dosing in treatment-experienced... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 4, 2013 Category: Pharmaceuticals Source Type: news

European Commission Approves PREZISTA® (Darunavir) 800mg Tablet Once A Day Reducing The Number Of Pills Taken By People Living With HIV
Janssen R&D Ireland has announced that the European Commission (EC) has approved a new PREZISTA(R) (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated mutations[i].[1] Darunavir is always taken in combination with ritonavir and other HIV medicines together with food... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 17, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news

Single once daily darunavir (Prezista®) 800mg tablet approved in EU
Source: BioSpace Area: News The European Commission has approved a new darunavir (Prezista®) 800mg tablet allowing patients to take one darunavir tablet once a day (in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-experienced and treatment-naïve patients with no darunavir resistance-associated mutations). This new tablet strength allows patients taking darunavir once daily to reduce the number of darunavir tablets by half. (Source: NeLM - News)
Source: NeLM - News - January 17, 2013 Category: Drugs & Pharmacology Source Type: news

European commission approves PREZISTA®
Janssen R&D Ireland has announced that the European Commission (EC) has approved a new PREZISTA® (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. (Source: Pharmacy Europe)
Source: Pharmacy Europe - January 16, 2013 Category: Drugs & Pharmacology Source Type: news

European Commission Approves PREZISTA(R) (darunavir) 800 mg Tablet Once a Day Reducing the Number of Pills Taken by People Living With HIV
CORK, Ireland, January 16, 2013 (HSMN NewsFeed) --Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA® (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Dar... Biopharmaceuticals, HIV/AIDS, RegulatoryJanssen, PREZISTA, darunavir (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 16, 2013 Category: Pharmaceuticals Source Type: news

Long-term Results With DRV/r vs LPV/rLong-term Results With DRV/r vs LPV/r
How does once-daily darunavir/ritonavir compare with lopinavir/ritonavir in HIV-1-infected treatment-naive patients? HIV Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 7, 2013 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news