Coinfection

Yes! We Can End TB & AIDS, Says AHF

Retrieved on: 
Friday, March 22, 2024
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We Can End TB & AIDS’ commemorations to honor the millions of lives lost to TB while urging leaders at all levels of government to prioritize TB prevention, testing, and treatment efforts.

Key Points: 
  • We Can End TB & AIDS’ commemorations to honor the millions of lives lost to TB while urging leaders at all levels of government to prioritize TB prevention, testing, and treatment efforts.
  • View the full release here: https://www.businesswire.com/news/home/20240322482439/en/
    AIDS Healthcare Foundation (AHF) country teams, which have prioritized screening for TB in clinics—along with preventing and treating HIV/TB co-infection—will hold World TB Day commemorations around the globe.
  • Integrating TB prevention and care into HIV programs, which AHF has done, is essential for comprehensive healthcare.
  • We Can End TB & AIDS.’”
    According to the World Health Organization, TB claimed 1.3 million lives in 2022, including 167,000 people living with HIV, with an estimated nearly 11 million people falling ill to TB worldwide.

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024
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“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024
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Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

60 Degrees Pharma Announces IRB Approval of Phase IIA Study to Evaluate Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease; Type C Meeting Re-Scheduled by FDA to January 17, 2024

Retrieved on: 
Tuesday, December 26, 2023
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The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse.

Key Points: 
  • The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse.
  • Additionally, the U.S. Food and Drug Administration (FDA) rescheduled the Company’s previously announced January 15 Type C meeting to January 17, 2024, due to a federal holiday.
  • The agenda and all material submitted by SXTP to FDA in support of the Type C meeting remain unchanged.
  • Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

Mpox (Monkeypox) Vaccine Triggers Equally Strong Immune Response in Smaller Than Usual Doses and in People With or Without HIV

Retrieved on: 
Thursday, December 14, 2023
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Because of limited space between skin layers, intradermal injections can only accommodate small doses, while larger doses generally require subcutaneous injections.

Key Points: 
  • Because of limited space between skin layers, intradermal injections can only accommodate small doses, while larger doses generally require subcutaneous injections.
  • The smaller doses, about one-fifth of the usual full dose and spread out by as long as three months, were designed to stretch the short supply of vaccine available after an outbreak in May 2022.
  • The IgG antibodies were detected in some cases more than six months after a second and final dose of the vaccine.
  • The mpox vaccine is now routinely recommended by the Centers for Disease Control and Prevention (CDC) for people at risk.

QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA

Retrieved on: 
Thursday, September 21, 2023
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QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.
  • The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance through the FDA’s De Novo process and is now the first rapid antigen test also to receive CLIA waiver.
  • With the CLIA waiver, the Sofia 2 SARS Antigen+ FIA is deemed to be so simple and at such low risk of error that it no longer requires administration by trained clinical laboratory personnel, opening broader use in virtually any point-of-care setting equipped with Sofia 2 instruments.
  • “As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, and the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA, it is gratifying to also be the first to receive a full CLIA waiver for our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho.

Breaking Research Sheds Light on COVID, Flu, and RSV Co-infections

Retrieved on: 
Tuesday, July 25, 2023
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ANAHEIM, Calif., July 25, 2023 /PRNewswire/ -- Today, at the 2023 AACC Annual Scientific Meeting & Clinical Lab Expo, scientists will present new data about rates of co-infections with SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) in the United States, providing one of the first snapshots of the interplay among these common but potentially deadly viruses. Their work could lead to better diagnosis and patient management for all three illnesses.

Key Points: 
  • The findings could have implications for how clinicians approach respiratory disease testing during future epidemics and seasonal outbreaks.
  • Household respiratory viruses such as RSV pose major burdens on public health systems.
  • But researchers have lacked the data to define rates of co-infections during this outbreak of RSV, which until recently had no vaccine.
  • The scientists tested the samples for RSV, SARS-CoV-2, and influenza A/B with the Roche cobas® and Cepheid Xpert® platforms.

New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic

Retrieved on: 
Monday, July 24, 2023
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The data were presented at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023), taking place July 23-26 in Brisbane, Australia.

Key Points: 
  • The data were presented at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023), taking place July 23-26 in Brisbane, Australia.
  • No adverse events (AEs) leading to premature discontinuation and no drug-related AEs were observed in the pregnant women or neonates.
  • “The clinical profile of Biktarvy is further supported by safety data and no mother-to-child transmission in this study and data showing that normal dosing may be appropriate.
  • Indications and Important Safety Information, including Boxed Warning on post treatment acute exacerbation of hepatitis B, for Biktarvy.

Advancing Research, Awareness, Screening and Linkage to Care to Eliminate Hep D in the U.S. is Critical

Retrieved on: 
Tuesday, June 27, 2023
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FAIRFIELD, N.J., June 27, 2023 /PRNewswire/ -- In a newly published article in the open journal, Hepatology Communications, the authors outline five urgent priority areas to address hepatitis delta (HDV)—the most aggressive form of viral hepatitis. The recommendations offered in "Advancing research, awareness, screening, and linkage to care to eliminate HDV in the U.S." were the result of an American Liver Foundation and Hepatitis B Foundation joint roundtable on Hep D held in May 2022, and call on lawmakers to identify the unmet needs of this patient population and suggest strategies to better support and engage the larger community around the prevention, diagnosis, and management of hepatitis delta.

Key Points: 
  • The recommendations offered in " Advancing research, awareness, screening, and linkage to care to eliminate HDV in the U.S ."
  • The five priority areas identified in the article are to generate accurate prevalence data, increase awareness, simplify screening and testing, facilitate research on linkage to care and follow-up and improve communication and outreach.
  • "It remains an enigma in the eyes of the public, healthcare providers, community groups and policy makers and that must change."
  • "This publication focuses on additional needs that must also be addressed to more optimally serve this neglected patient population."

Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Retrieved on: 
Friday, May 19, 2023
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Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay.

Key Points: 
  • Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay.
  • The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect™ collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, saving time and reducing the potential for error, repetitive stress injuries and exposure to viruses.
  • Since the beginning of the COVID pandemic, Hologic has shipped more than 200 million SARS-CoV-2 laboratory diagnostic tests worldwide.
  • FDA clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay follows the July 2022 announcement of CE marking for the same test in Europe , furthering Hologic’s position as one of the world’s largest molecular diagnostic companies.