Tenofovir disoproxil

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations

Retrieved on: 
Tuesday, November 29, 2022

The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.

Key Points: 
  • The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.
  • Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic.
  • Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in pediatric HIV research.
  • In 2021, an estimated 800,000 children under the age of 19 living with HIV were still not receiving HIV treatment.

U.S. Food and Drug Administration Approves Vemlidy® (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients

Retrieved on: 
Wednesday, November 2, 2022

While pediatric hepatitis B prevalence has dropped significantly in the U.S., children who develop chronic hepatitis B following an acute infection can experience lifelong health impact, said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

Key Points: 
  • While pediatric hepatitis B prevalence has dropped significantly in the U.S., children who develop chronic hepatitis B following an acute infection can experience lifelong health impact, said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
  • Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection.
  • VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 12 years of age and older with compensated liver disease.
  • Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance.

DiRx Partners With Hepatitis B Foundation to Offer Low-cost Medications

Retrieved on: 
Thursday, April 14, 2022

Access to proper health care for people living with hepatitis B is one of our highest priorities, and that includes helping to ensure they can afford their medications, Chari Cohen, DrPH, MPH, senior vice president of the Hepatitis B Foundation, said.

Key Points: 
  • Access to proper health care for people living with hepatitis B is one of our highest priorities, and that includes helping to ensure they can afford their medications, Chari Cohen, DrPH, MPH, senior vice president of the Hepatitis B Foundation, said.
  • DiRx will provide people living with hepatitis B in the U.S. with a new option for obtaining the medications they require, so we very much appreciate the companys offer to partner with our organization.
  • In addition to these critical medications for hepatitis B, DiRx carries more than 1,200 FDA-approved generic medicines with prices as low as $3 per month, including shipping.
  • About the Hepatitis B Foundation: Hepatitis B Foundation is the nations leading nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education, and patient advocacy.

Chronic Hepatitis B Virus Infection Pipeline Market Research Report 2022: Comprehensive Insights About 40+ Companies and 40+ Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 16, 2022

The "Chronic Hepatitis B Virus Infection - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chronic Hepatitis B Virus Infection - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • The "Chronic Hepatitis B Virus Infection - Pipeline Insight, 2022," report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Chronic Hepatitis B Virus Infection pipeline landscape.
  • This segment of the Chronic Hepatitis B Virus Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • The companies which have their Chronic Hepatitis B Virus Infection drug candidates in the mid to advanced stage, i.e.

Arbutus Reports Fourth Quarter and Year End 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 3, 2022

WARMINSTER,Pa., March 03, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reports its fourth quarter and year end 2021 financial results and provides pipeline updates.

Key Points: 
  • WARMINSTER,Pa., March 03, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reports its fourth quarter and year end 2021 financial results and provides pipeline updates.
  • 2021 was a transformative year for Arbutus as we greatly expanded our development efforts in Hepatitis B and coronavirus infections, including SARS-CoV-2, said William Collier, Arbutus President and Chief Executive Officer.
  • Arbutus has commenced IND-enabling studies for AB-101 and intends to complete those studies in the second half of 2022.
  • Arbutus, and Genevant, do not seek an injunction or otherwise seek to impede the sale, manufacture or distribution of MRNA-1273.

Gilead Presents Long-Term Switch Data Reinforcing Biktarvy® as a Treatment Option for a Broad Range of People Living With HIV

Retrieved on: 
Thursday, October 21, 2021

In addition to helping create a world with no new HIV infections, we also strive to ensure the people living with HIV can realize long-term treatment success.

Key Points: 
  • In addition to helping create a world with no new HIV infections, we also strive to ensure the people living with HIV can realize long-term treatment success.
  • The data further establish the robust and durable efficacy profile of Biktarvy as a treatment option for virologically suppressed people living with HIV with known resistance.
  • Additionally, at EACS 2021, Gilead will share new findings on long-acting HIV treatment strategies, as well as updates from the companys continued pursuit of a cure for HIV.
  • Biktarvy, Descovy, Descovy for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

Exavir Therapeutics announces publication of preclinical data for novel tenofovir prodrug, XVIR-210, in Nature Communications, demonstrating long-acting exposures sufficient for antiviral activity against HIV and HBV

Retrieved on: 
Thursday, September 16, 2021

NEW YORK and OMAHA, Neb., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Exavir Therapeutics, a company dedicated to transforming the lives of patients living with or at risk for acquiring HIV and other viral infections, announced today the publication of preclinical data for XVIR-210, an investigational agent being developed as a long-acting antiviral for chronic HBV treatment, HIV treatment and prophylaxis, and HIV-HBV co-infection.

Key Points: 
  • We now have a second agent,XVIR-210,that can provide long-acting exposures of a backbone antiviral therapy, tenofovir.
  • As discussed in the publication, a single injection of XVIR-210, Exavirs proprietary nano-formulated tenofovir prodrug, provided therapeutic exposures of tenofovir to rats for over two months.
  • Widespread tissue biodistribution of tenofovir, and its active metabolite, tenofovir diphosphate, were observed in target tissues of interest for HIV and HBV infection, namely liver and lymphatic tissues.
  • Exavir Therapeutics is a preclinical stage biotechnology company dedicated to eliminating HIV and other viral infections with a broad modality-agnostic approach, beginning with long-acting antiviral therapeutics.

Arbutus Biopharma and Antios Therapeutics Announce Clinical Collaboration Agreement to Evaluate AB-729 in Combination with ATI-2173 in Subjects with Chronic Hepatitis B Virus Infection

Retrieved on: 
Tuesday, June 29, 2021

ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial.

Key Points: 
  • ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial.
  • Our collaboration with Arbutus will test that hypothesis in combination with AB-729, an RNAi drug candidate, and Viread, a nucleotide analogue.
  • The combination clinical trial cohort will include 10 subjects with chronic HBV infection assigned 8:2 to active drug (ATI-2173+AB-729) or matching placebos.
  • Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection.

Teva Launches First Generic Versions of HIV-1 Treatments TRUVADA® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets in the U.S.

Retrieved on: 
Friday, October 2, 2020

Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection.

Key Points: 
  • Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection.
  • Contraindications: Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
  • The time from initiation of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.
  • Use emtricitabine and tenofovir disoproxil fumarate tablets to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative.