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National Center for Biotechnology Information. PubChem Compound Summary for CID 134694278, Albuvirtide. Accessed April 5, 2023
Have all the materials ready before starting the dose preparation to minimize the overall preparation time. Use aseptic technique when preparing and administering the dose. Froma100 mL infusion bag (bottle) of 0.9% sodium chloride solutionwithdraw 12mLto discard.The remaining 88mL of 0.9%sodium chloride solution will be used for the AIKENING TMreconstitution. TALENT investigated the novel long-acting injectable combination dual therapy to treat people living with HIV (PLHIV) whohave failed initial treatment
Step 1: Determine number of AIKENING TMvial(s) needed for infusion based on assigned dosage (see table above). For 0.32 gdose, two vials are needed. As a long-acting antiretroviral therapy, AIKENING TM may allow HIV-1-infected patients who have difficulty with daily oral therapy to maintain viral suppression within a relatively long dosing window. AIKENING TM could ensure durable suppression of viral load and minimize the risk of HIV drug resistance, especially for people who have pill fatigue. AIKENING TM CLINICAL DATA TRIAL Design
The prepared dose should be administered as soon as possible (or within 30 minutes after end of reconstitution). Discard the dose if the infusion is not started within 30 min after the end of dose preparation and re-prepare the dose with a fresh vial.
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Thein vivoantiviral activity of subcutaneous injection of Albuvirtidewas evaluatedin SCID-hu Thy/Liv mice model that was constructed by transplantation of human fetal thymus and liver into immunodeficient CB-17-SCID mice and inoculation with HIV-1. Albuvirtideshowed strong antiviral activity in mice at a dose of 10 mg/kg whether Albuvirtide was administered by subcutaneous injectiononce a day or every other day (equalto around 2 and 4 half-lifeintervals of mouse albumin, respectively). The percentages of patientswith HIV-RNA <50 copies/ml after treatment for 48 weeks were 80.4% and 66.0%, respectively in the treatment group and the control group in the FAS analysis set, and the bilateral 95% CI of treatment difference between the two groups was -3.0% ~ 31.9%, meeting the criterion for non-inferioritywith a prespecified margin of 12%. It indicated that efficacy of the treatment groupwas non-inferior to that of the control group (see Table 3).The percentages of subjects with HIV-RNA <50 copies/ml were 94.9% and 74.4%, respectively (P <0.05,with statistical significance)in the treatment group and the control group in the PPS analysis set, indicating that the efficacy in the treatment group was superior to that of the control group.
Dr. Changjin Wang, CEO of Frontier added: “AT04, with its novel mechanism of action, can be uniquely positioned in the treatment of hypercholesterolemia which is associated with an elevated risk of cardiovascular disease, the leading cause of death worldwide and in China. We are excited about working with AFFiRiS’ team and committed to accelerating the development of AT04 in China.” Selected Study Results: Results published in AIDS Research and Therapy (2016) showed that there was little to no drug-drug interaction between albuvirtide and lopinavir/ritonavir. Additionally, albuvirtide combined with lopinavir/ritonavir was safe and effective in reducing viral load levels, with the higher albuvirtide dose tested having greater anti-HIV activity than the lower albuvirtide dose tested. 5 In October 2021, in the “13th National AIDS and Hepatitis C Conference of the Chinese Medical Association”, organized by the AIDS Group of the Chinese Society of Infectious Diseases, Chinese Medical Association, the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS (2021 Edition) (hereinafter referred to as the 2021 Guidelines) was released. The first Guidelines for Diagnosis and Treatment of HIV/AIDS in China was formulated in 2005, led by the AIDS and Hepatitis C Group of the Chinese Society of Infectious Diseases, Chinese Medical Association. It was updated in 2011, 2015 and 2018 respectively. The 2021 Guidelines were based on the 4th Edition Guidelines in 2018 and revised with reference to the latest research progress in China and abroad.Hansen, E.; Zadura, L.; Frankowski, S.; Wachowicz, M. Upgrading of an activated sludge plant with floating biofilm carriers at Frantschach Swiecie S.A. to meet the new demands of year 2000. Water Sci. Technol. 1999, 40, 207–214. [ Google Scholar] [ CrossRef] AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of chronic diseases, based on its proprietary patented AFFITOME ® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing specific immunotherapies. In addition to its active immunotherapy AT04, AFFiRiS’ pipeline also includes the monoclonal antibody mAB C6-17 targeting mutated huntingtin (mtHTT) protein, which causes Huntington’s disease.
Frontier is an innovation-driven biopharmaceutical company. Through more than a decade of committed effort, Frontier Biotech has built an extraordinary team with international vision and deep expertise in new drug development and established a fully integrated state-of-the-art long-acting peptide new drug innovation platform with global intellectual properties. In addition to the launch of Aikening ®, a Category 1 product and the first long-acting HIV fusion inhibitor in the world, Frontier Biotech is advancing an array of clinical assets through our R&D pipeline. This includes multiple programs reaching Phase 1 and 2 clinical trials in China and the United States. Purpose: The purpose of this study is to establish the optimal dosage of a regimen consisting of albuvirtide plus the investigational broadly neutralizing antibody (bNAb) 3BNC117. The study will also evaluate the safety and effectiveness of this regimen as maintenance therapy. 8Step 2: Inject 1.2 mL of 5%sodium bicarbonate solution into each vial, shake or vortex the vial thoroughly to form solution. Study Purpose: The purpose of this open-label trial was to evaluate 1) the drug-drug interaction between albuvirtide and lopinavir/ritonavir and 2) the short-term safety and efficacy of albuvirtide plus lopinavir/ritonavir. Selected Study Results: Results presented at IAS 2021 showed that albuvirtide plus lopinavir/ritonavir was noninferior to two NRTIs plus lopinavir/ritonavir in suppressing viral load in participants who had treatment failure on standard first-line ART. 10 The TALENT study (TALENT) findings, which were presented at the 11th International AIDS Society (IAS) Conference on HIV Science, showed that a two-drug regimen was as effective and safe as multi-drug therapies
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