Subtypes of HIV

ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV

Retrieved on: 
Lundi, avril 8, 2024
Research, Infectious Diseases, FDA, LGBTQ+, AIDS, Pharmaceutical, Consumer, Health, Science, Other Science, ARV, Week, DANCE, ViiV Healthcare, Pfizer, TANGO, HIV, GSK, Ageing, Safety, Subtypes of HIV, Shionogi, Food, Pharmaceutical industry

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1
    In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people.
  • Lynn Baxter, Head of North America at ViiV Healthcare, said: "This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment.
  • As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”
    The approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults).1 Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to ≤500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48.1 The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.1 Exposures for components of Dovato were higher but were not clinically significant.1

Wistar Scientists Discover Link Between Leaky Gut and Accelerated Biological Aging

Retrieved on: 
Vendredi, février 23, 2024
Methylation, Dysbiosis, Culture, Penn Center, Health, Bacteria, University, Subtypes of HIV, Life Length, Wistar Institute, Bangladesh Technical Education Board, Ileum, Infection, NIH, AIDS, Glass, Metabolomics, Nucleotide, DSM-IV codes, Biomedical Research, HIV/AIDS research, Wistar, University of Pittsburgh, DNA, Immune system, National Institutes of Health, Leiden University Medical Center, Weill Cornell Medicine, Hannum, Research, Inflammation, Blood, Ageing, Cancer, Cell biology, Microbiome, Rush University, HIV, DNA methylation, Vaccine

Dr. Abdel-Mohsen investigates what drives this rapid aging and how to create ways to slow down biological aging and improve health.

Key Points: 
  • Dr. Abdel-Mohsen investigates what drives this rapid aging and how to create ways to slow down biological aging and improve health.
  • A prime suspect in this aging puzzle is the gut microbiome and its potential leakage into the bloodstream.
  • The Abdel-Mohsen lab investigates how gut leakage can impact the immune system and lead to chronic inflammation, which may accelerate aging.
  • Their analysis revealed a significant connection between disrupted gut microbiomes, increased intestinal permeability (leaky gut), and faster biological aging.

ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV

Retrieved on: 
Mercredi, février 28, 2024
Health, Infectious Diseases, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Subtypes of HIV, ARV

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of Dovato.

Key Points: 
  • Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of Dovato.
  • Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol.
  • Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage.
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance, and adverse reactions in a breastfed infant.

ViiV Healthcare announces new packaging option now available in the U.S. for Dovato (dolutegravir/lamivudine)

Retrieved on: 
Mardi, février 6, 2024
AIDS, Consumer, Health, Pharmaceutical, LGBTQ+, Subtypes of HIV, HIV, Pfizer, Shionogi, ViiV Healthcare, ARV, GSK

The sheets allow people living with HIV to view the number of pills left and track their doses.

Key Points: 
  • The sheets allow people living with HIV to view the number of pills left and track their doses.
  • The FDA approved the Dovato blister pack on November 3, 2023.
  • ViiV Healthcare plans to offer the Dovato blister pack in some European markets in 2024.
  • ViiV Healthcare will continue to offer Dovato in the 30-count pill bottle.

Uvax Bio Announces Dosing of First Participant in Phase 1 Clinical Trial Evaluating Two Vaccines to Prevent HIV-1 Infection

Retrieved on: 
Mardi, janvier 30, 2024
AIDS, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, HIV-1, Subtypes of HIV, Animal, HIV, Computational biology, Safety, UFO, Immunization, Serum, Env, Vaccine

“UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery.

Key Points: 
  • “UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery.
  • Uvax Bio expects to report topline data from the Phase 1 trial in the fourth quarter of 2024.
  • The novel protein nanoparticle vaccine candidates are designed for active immunization and are intended to prevent HIV-1 infection.
  • Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA

Retrieved on: 
Mardi, janvier 2, 2024
FDA, PDUFA, News, Letter, HIV, TSX, Subtypes of HIV, Patient, ARV, Senior, Pharmaceutical industry

MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review.

Key Points: 
  • MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review.
  • In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.
  • The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo® treatment regimen.
  • “The intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo® treatment and without the need for regular IV placement,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.

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: 
Mardi, janvier 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

Theratechnologies Announces FDA Approval of Trogarzo® 90-Second Intravenous (IV) Push Loading Dose

Retrieved on: 
Mercredi, décembre 13, 2023
FDA, News, HIV, Subtypes of HIV, TSX, Patient, ARV, Senior, Pharmaceutical industry

MONTREAL, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk).

Key Points: 
  • MONTREAL, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk).
  • The label update follows FDA approval of the IV push maintenance dose in October 2022.
  • With the new label, Trogarzo® administration can now take only 90 seconds for the loading dose, as opposed to a 30-minute infusion, and 30 seconds for a maintenance dose every two weeks.
  • Theratechnologies is currently finalizing its application to the FDA for an intramuscular (IM) method of administration of the Trogarzo® maintenance dose.

Theratechnologies Announces Results from Trogarzo® (Ibalizumab-uiyk) Intramuscular Administration Study

Retrieved on: 
Vendredi, octobre 13, 2023
Partnership, TSX, Pharmacokinetics, Itch, Food, Safety, Subtypes of HIV, ART, FDA, MDR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Injection, Hand, Medical device, Pharmaceutical industry

MONTREAL, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced results from a study evaluating an intramuscular (IM) method of administration for Trogarzo® (ibalizumab-uiyk), a monoclonal antibody antiretroviral therapy (ART) for the treatment of heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.

Key Points: 
  • The TMB-302 study, conducted in partnership with TaiMed Biologics, enrolled 21 subjects (7 HIV-positive and 14 HIV-negative) to assess the pharmacokinetics, efficacy, and safety of IM administration of Trogarzo® as compared to intravenous (IV) infusion.
  • Viral suppression, a key secondary clinical endpoint, was maintained in all HIV-positive subjects throughout the IM phase and the overall study.
  • With the TMB-302 data in hand, Theratechnologies is seeking expert advice prior to completing a regulatory submission of the Trogarzo® IM administration maintenance dose to the U.S. Food and Drug Administration (FDA).
  • The FDA is currently reviewing the Company’s submission for the loading dose of the Trogarzo® IV push method of administration and a decision is expected in mid-December.

Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV

Retrieved on: 
Mardi, septembre 5, 2023
HIV/AIDS, CHAI, Joint United Nations Programme on HIV/AIDS, HIV, MPP, Food and Drug Administration, ARV, Subtypes of HIV, ViiV Healthcare, Medicines Patent Pool, Tablet, Patient, PEPFAR, President's Emergency Plan for AIDS Relief, WHO, Abacavir/dolutegravir/lamivudine, FDA, Safety, UNAIDS, Food, World Health Organization, Pharmaceutical industry, Viatris

PITTSBURGH and BANGALORE, India, Sept. 5, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients.

Key Points: 
  • According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), treatment coverage for children and adolescents lags behind adults.
  • Some 660,000 children living with HIV – about 43 percent of the estimated total 1.5 million [1.2 million–2.1 million] children living with HIV – did not receive antiretroviral (ARV) therapy in 2022.
  • Accordingly, children accounted for 13 per cent of AIDS-related deaths in 2022, even though they comprise only about 4 percent of people living with HIV.
  • The approval of this single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg - will reduce the pill burden for children living with HIV."