Fixed dose combination

New Findings on Gilead’s Biktarvy® Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults

Retrieved on: 
Saturday, July 4, 2020
AIDS, Health, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Health, Articles, Bictegravir/emtricitabine/tenofovir alafenamide, Fixed dose combination, HIV/AIDS, HIV, Exacerbation, Hepatitis

These data were evaluated as part of a pooled analysis of four international trials and will be presented during the 23rd International AIDS Conference (AIDS 2020: Virtual).

Key Points: 
  • These data were evaluated as part of a pooled analysis of four international trials and will be presented during the 23rd International AIDS Conference (AIDS 2020: Virtual).
  • The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.
  • Important Safety Information for Biktarvy, including a Boxed Warning on the risk of post-treatment acute exacerbation of hepatitis B.
  • At week 48, the proportion with HIV RNA

Gilead Sciences Demonstrates Commitment to Scientific Innovation In HIV With New Prevention, Treatment and Cure Research Data Presented At AIDS 2020: Virtual

Retrieved on: 
Wednesday, July 1, 2020
Biotechnology, Hospitals, Pharmaceutical, Health, Esters, Chemistry, Articles, Organophosphates, Tenofovir alafenamide, Fixed dose combination, Gilead Sciences, Bictegravir/emtricitabine/tenofovir alafenamide, HIV/AIDS

Biktarvy and Descovy do not prevent other sexually transmitted infections or cure HIV or AIDS.

Key Points: 
  • Biktarvy and Descovy do not prevent other sexually transmitted infections or cure HIV or AIDS.
  • Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults

Retrieved on: 
Monday, March 9, 2020
Health, FDA, Infectious diseases, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Combination drugs, Bictegravir/emtricitabine/tenofovir alafenamide, Fixed dose combination, Reverse-transcriptase inhibitor

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.

Key Points: 
  • The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.
  • The data presented at CROI 2020 are part of our relentless pursuit to address unmet needs in HIV treatment.
  • The study showed noninferior antiviral efficacy for people switching to Biktarvy from a variety of regimens, including in patients with pre-existing NRTI resistance.
  • The double-blind Phase 3 studies 1489 and 1490 randomized 1274 treatment-nave adults to assess the safety and efficacy of Biktarvy.

ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting, injectable treatment regimen in adults living with HIV-1

Retrieved on: 
Monday, March 9, 2020
Health, Consumer, General Health, Research, Science, Gay & Lesbian, Chemical compounds, Hepatotoxins, Drugs, Organic compounds, RTT, Fixed dose combination, Abacavir/dolutegravir/lamivudine, Integrase inhibitors, Lamivudine, Rilpivirine, Dolutegravir/lamivudine, Cabotegravir

The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96.

Key Points: 
  • The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96.
  • Week 96 results from the global phase III FLAIR study continued to build on the previously reported non-inferiority of long-acting cabotegravir and rilpivirine to daily oral Triumeq at Week 48.
  • The study found that rates of virologic suppression (HIV-1 RNA
  • No new confirmed virologic failure (CVF) was reported between Week 48 and Week 96 among individuals who received long-acting cabotegravir and rilpivirine.

Biktarvy: Drug Insights and Sales Forecasting, 2019-2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, December 27, 2019
Health, Pharmaceutical, Bictegravir/emtricitabine/tenofovir alafenamide, Fixed dose combination

The "Biktarvy - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biktarvy - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.
  • Biktarvy - Drug Insight, 2019 report provides comprehensive information of the drug, Biktarvy.
  • It further provides Biktarvy`s patents (US & EU) and its API manufacturers details in the United States, Europe, China and India.
  • The report also throws light on Biktarvy market competition and emerging therapies in the same space as Biktarvy.

Epzicom - Drug Insight Report, 2019-2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, November 11, 2019
Health, Pharmaceutical, Fixed dose combination, Hepatotoxins, Abacavir/lamivudine, RTT, SWOT analysis, SWOT

The "Epzicom - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Epzicom - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.
  • Epzicom - Drug Insight, 2019 highlights the drug marketed details and the Global API Manufacturers details across the globe along with their location.
  • The report covers the Global Market Assessment of the Epzicom covering the historical global sales and also provides the Epzicom sales estimation during the forecasted period (2019-2021).
  • In addition to this, the report also provides the SWOT analysis for Epzicom and emerging therapies in this space.

Parker Waichman LLP and The Drakulich Firm File TDF Lawsuit

Retrieved on: 
Thursday, August 29, 2019
Gilead Sciences, Hepatotoxins, Fixed dose combination, RTT, Drugs, Medicine, Medical specialties, Tenofovir disoproxil, Elvitegravir/cobicistat/emtricitabine/tenofovir, Efavirenz/emtricitabine/tenofovir, Emtricitabine/tenofovir, Emtricitabine/rilpivirine/tenofovir

The drug is manufactured by Gilead Sciences Inc. ("Gilead"), of Forest City, California, under numerous brand names, such as Truvada, Viread, Atripla, Complera and Stribild.

Key Points: 
  • The drug is manufactured by Gilead Sciences Inc. ("Gilead"), of Forest City, California, under numerous brand names, such as Truvada, Viread, Atripla, Complera and Stribild.
  • The lawsuit additionally claims, among other allegations, that Gilead then hid those risks from doctors and patients so it could continue to raise its market share of sales of TDF.
  • Parker Waichman has represented clients in injury lawsuits for decades.
  • If you or someone you know is interested in filing a TDF lawsuit, please contact Parker Waichman LLP at the firm's website at www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Retrieved on: 
Friday, August 9, 2019
Biotechnology, Pharmaceutical, Health, Infectious diseases, Hospitals, Clinical trials, Drugs, Hepatotoxins, Organic compounds, Chemistry, Integrase inhibitors, Gilead Sciences, Fixed dose combination, RTT, Bictegravir, Tenofovir alafenamide, Emtricitabine, Tenofovir disoproxil

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.

Key Points: 
  • Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
  • In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
  • The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003.
  • Biktarvy received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2018.

Lawsuits against drugmaker Gilead over HIV medications containing TDF to be coordinated before a single judge in California, following motion by Grant & Eisenhofer

Retrieved on: 
Thursday, August 8, 2019
Gilead Sciences, Hepatotoxins, Fixed dose combination, RTT, Drugs, Medicine, Medical specialties, Tenofovir disoproxil, Elvitegravir/cobicistat/emtricitabine/tenofovir, Efavirenz/emtricitabine/tenofovir, Emtricitabine/tenofovir, Emtricitabine/rilpivirine/tenofovir

Elizabeth Graham of Grant & Eisenhofer delivered arguments for plaintiffs before Judge Freeman on July 30 in petitioning for the case coordination.

Key Points: 
  • Elizabeth Graham of Grant & Eisenhofer delivered arguments for plaintiffs before Judge Freeman on July 30 in petitioning for the case coordination.
  • Having cases coordinated before a single judge prevents inconsistent rulings, and plaintiffs' claims are addressed in a unified manner," said Ms. Graham.
  • The case is styled as: Gilead Tenofovir Cases and Coordinated Actions, Judicial Council Coordination Proceeding No.
  • Those who believe they may have been injured by Gilead TDF antiviral medications, Viread, Truvada, Atripla, Complera and/or Stribild, can seek additional details at the following toll-free number: 888-984-7988 or visit masstortreport.com.

AHF Challenges Gilead to Charge $1 per-pill for Descovy for PrEP Use

Retrieved on: 
Thursday, August 8, 2019
Public policy, Government, Healthcare reform, AIDS, Pharmaceutical, General Health, Health, Other Policy Issues, Esters, Medicine, Organic compounds, Pre-exposure prophylaxis, Prevention of HIV/AIDS, AHF, Tenofovir alafenamide, Gilead Sciences, AIDS Healthcare Foundation, Fixed dose combination, Hepatotoxins

As part of its rationale for the pricing request, AHF cited the billions of dollars Gilead has already made on its roster of HIV/AIDS medications.

Key Points: 
  • As part of its rationale for the pricing request, AHF cited the billions of dollars Gilead has already made on its roster of HIV/AIDS medications.
  • Now that it's well on its way to gaining final FDA approval for wider use as PrEP, AHF challenges its manufacturer, Gilead, to charge just one-dollar per pill for Discovy, said Michael Weinstein, president of AHF.
  • So, Gilead should do the right thing and price Descovy for PrEP use at one-dollar per pill.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare
    View source version on businesswire.com: https://www.businesswire.com/news/home/20190807005946/en/