NRTI

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

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Lunedì, Febbraio 26, 2024
AIDS, FDA, Health, Hospitals, Pharmaceutical, Biotechnology, Infection, Division, Week, Doctor of Philosophy, Gilead Sciences, HIV-1, Drug resistance, MD, PWH, Science, Food, DHHS, Boxed warning, Hospital, Life, Risk, Safety, NRTI, RNA, History, Public, Guideline, DTG, Harvard Medical School, Mutation, Tablet, HIV, Vaccine

HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

Key Points: 
  • HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.
  • The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.
  • “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH.
  • There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

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

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Martedì, Gennaio 2, 2024
Medical Subject Headings, Condom, Marketing, HIV-1, Tenofovir disoproxil, INN, Risk, Immune system, Health care, HIV/AIDS, Infection, Mylan, ATC, AIDS, International, Emtricitabine, Blood, Language, European Medicines Agency, Food, HIV, Tablet, Select, Subtypes of HIV, Patient, Cell, NRTI, Anatomy, Medicine, IIA, Pre-exposure prophylaxis, Generic drug

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

Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

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Martedì, Gennaio 2, 2024
Patient, Medical Subject Headings, HIV, Diarrhea, Marketing, Zidovudine, Lethargy, Agency, INN, Risk, Immune system, Fever, Fatigue, ATC, AIDS, International, Cough, HLA, Headache, CD4, Ageing, Nausea, Blood, Somatic symptom disorder, Profile, Rash, Language, Liver, Allergy, Hypersensitivity, European Medicines Agency, Infection, Tablet, Myalgia, Select, Cell, Human, Lamivudine, NRTI, Anatomy, Vomiting, IIA, Periodic breathing, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 as Therapies for Chronic Hepatitis B and Hepatitis D

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Sabato, Giugno 24, 2023
Learning, Auckland City Hospital, Viremia, University, Conditional sentence, Safety, NRTI, HDV, Clinical trial, Pharmacokinetics, PEG, Hepatitis B, Small RNA, Congress, Hong Kong, Spectrochimica Acta Part B, Hepatology, Patient, European Association for the Study of the Liver, Division, SAN, Clinical research, Poster, HBV, Vaccine, Tea, Medical device, Pharmaceutical industry, Health insurance, Medicine, HBsAg, Gastroenterology

SAN FRANCISCO, June 24, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from its robust hepatitis B and D virus (HBV and HDV) portfolio that were presented at the EASL™ (European Association for the Study of the Liver) Congress.

Key Points: 
  • These data further support the clinical development of these investigational medicines for the treatment of HDV.
  • “I am very excited by the progress we are making toward our goal of achieving HBV functional cure.
  • Our data to-date with VIR-2218 and PEG-IFN-⍺ support our hypothesis of using a cocktail of antivirals combined with immunomodulators.
  • The majority of adverse events were consistent with the known effects of PEG-IFN-⍺ and resolved after the end of treatment.

Vir Biotechnology Announces First Patient Dosed in New Phase 2 Chronic Hepatitis B Virus Trial Evaluating Combinations of VIR-2218, VIR-3434, PEG-IFNα and an NRTI

Retrieved on: 
Giovedì, Maggio 11, 2023
NRTI, HDV, Hepatitis B virus, Inflammation, Monoclonality, Small RNA, SAN, Clinical research, HBV, Safety, Pharmaceutical industry, Vaccine

SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in the Phase 2 STRIVE sub-protocol clinical trial evaluating the safety and efficacy of regimens containing combinations of VIR-3434, VIR-2218, pegylated interferon alpha (PEG-IFNα) and a nucleoside reverse transcriptase inhibitor (NRTI) in hepatitis B virus (HBV) immune-active, treatment-naïve adults. The STRIVE sub-protocol trial is the first to initiate under Vir’s new PREVAIL platform trial evaluating VIR-2218 and VIR-3434 with other therapies, including PEG-IFNα and an NRTI, in people at various stages of chronic HBV infection. Initial data from the STRIVE sub-protocol trial are expected in the first half of 2024.

Key Points: 
  • The STRIVE sub-protocol trial is the first to initiate under Vir’s new PREVAIL platform trial evaluating VIR-2218 and VIR-3434 with other therapies, including PEG-IFNα and an NRTI, in people at various stages of chronic HBV infection.
  • Initial data from the STRIVE sub-protocol trial are expected in the first half of 2024.
  • Under the PREVAIL platform trial, the THRIVE sub-protocol trial will evaluate the safety and efficacy of regimens containing VIR-3434 and an NRTI with or without VIR-2218.
  • VIR-2218 and VIR-3434 are also being evaluated for the treatment of chronic HBV in adults who are already virally suppressed by an NRTI in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial.

Brii Biosciences Presents Promising Clinical Data to Support Ongoing Development of Novel HIV Therapeutic Candidates at IDWeek 2022

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Mercoledì, Ottobre 19, 2022
Therapy, AN2, Infection, MAD, Pharmacology, HIV/AIDS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Adult, Patient, NNRTI, NCE, MPH, Multimedia, HIV-1, HIV, Food, Hepatitis B, Company, Social stigma, Islatravir, NRTI, XDR, SAD, 2021 Essex County Council election, CNS, MDR, PK, FDA, COVID-19, Pharmacokinetics, Central nervous system, Leadership, Pharmaceutical industry, Vaccine, Tolerability, Rilpivirine, Safety

Results from both studies show that once-weekly BRII-732 and BRII-778 are safe and well-tolerated, generating important data to support the ongoing development of a potential first-in-class oral once-weekly combination therapy to treat HIV.

Key Points: 
  • Results from both studies show that once-weekly BRII-732 and BRII-778 are safe and well-tolerated, generating important data to support the ongoing development of a potential first-in-class oral once-weekly combination therapy to treat HIV.
  • The findings from these studies were presented in two poster sessions at IDWeek 2022.
  • These data reinforce potential development of BRII-732 as part of a combination antiretroviral therapy, inclusive of once-weekly dosing.
  • In addition, three of the Brii's strategic development partners are presenting a total of 16 abstracts at IDWeek 2022 related to assets under co-development with the Company.

Inflammasome Therapeutics’ CEO to Be Featured Speaker at Upcoming Virtual Summit on Inflammasomes

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Venerdì, Novembre 12, 2021
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Population, University, View, Boehringer Ingelheim, Degenerative disease, National academy, Therapy, IgG4-related ophthalmic disease, III, Center, Reverse transcriptase, CEO, RNA, Bill & Melinda Gates Medical Research Institute, Inflammasome, Ashton, Research, Therapeutic Targets Database, AMD, PNAS, NRTI, Severe cognitive impairment, Macular degeneration, Nature Communications, Effectiveness, Science Advances, GA, National, Toxicity, Review, AIDS, Geographic atrophy, MS, Bill, Pharmaceutical industry, Medical device

Paul Ashton, president and CEO of Inflammasome Therapeutics ( https://inflam.com ), a private company developing therapies for prevalent, degenerative diseases, will be one of the featured speakers at the Inflammasome Therapeutics Summit.

Key Points: 
  • Paul Ashton, president and CEO of Inflammasome Therapeutics ( https://inflam.com ), a private company developing therapies for prevalent, degenerative diseases, will be one of the featured speakers at the Inflammasome Therapeutics Summit.
  • This digital event, November 16-18, marks its third year as the only industry-dedicated forum that focuses specifically on inflammasome regulation and novel inflammasome therapeutics.
  • Dr. Ashton will present Insights and Learnings from Clinical Investigations of Inflammasome Activation in the Ophthalmic Setting, at 12:30 p.m.
  • Inflammasome Therapeutics is commercially developing Kamuvudines, and the company has said that it plans to bring one or more of its Kamuvudines into the clinic next year.