Delving into the Latest Updates on Albuvirtide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Labuvirtide, 艾博卫泰

+ [1]

Target

gp41

Action

inhibitors

Mechanism

gp41 inhibitors(Transmembrane glycoprotein gp41 inhibitors), HIV fusion inhibitors

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication

Acquired Immunodeficiency Syndrome

Originator Organization

Frontier Biotechnologies, Inc. (China)

Active Organization

Frontier Biotechnologies, Inc. (China)

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (23 May 2018),

HIV Infections

RegulationSpecial Review Project (China)

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Structure/Sequence

Molecular FormulaC204H306N54O72

InChIKeyDJIGFNCGXOAXOW-WTPNCWHFSA-N

CAS Registry2395796-76-4

Sequence Code 76457

Source: *****

Upon confirming an HIV diagnosis, patients need to start life-long antiretroviral therapy (ART) as soon as possible. During HIV treatment, ART drugs can cause intolerable adverse reactions, leading to poor medication compliance, treatment failure, and advancement of the HIV stage. Herein, we report a case of AIDS intolerant to multiple antiviral drugs due to side effects that we finally stabilized with the Albuvirtide (ABT) and Dolutegravir (DTG) combination. A 48 -year-old woman developed intractable nausea, vomiting and abdominal discomfort within one month of starting ART. Over the course of four years, she was switched to four different ART regimens due to her intolerance of severe adverse effects, mainly gastrointestinal symptoms, rash, and lethargy. Over four years, she failed to attain viral suppression due to poor drug compliance. After several ART changes, we started her on the Long-acting antiretroviral therapy (LA ART), Albuvirtide, combined with Dolutegravir, which she tolerated well. The patient's general condition improved significantly and attained marked virologic suppression. The patient's condition has been well controlled for nearly two years with good adherence. This case emphasizes the influence of ART treatment options on medication compliance and the outcome of HIV infection.

01 Feb 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Article

Author: Qin, Huiling ; Xie, Dong ; Yao, Cheng ; Yu, Shuchang ; Ye, Jun ; Liu, Yuantao ; Hu, Wei ; Hu, Min ; Zhang, Wei

Albuvirtide (ABT) is the first long-acting HIV fusion inhibitor developed in China, blocking the invasion of HIV-1 virus into target cells. This study aimed to compare the pharmacokinetics (PK), tolerability, and safety of ABT following a single intravenous (IV) bolus injection or intravenous drip in healthy Chinese subjects. A single-center, randomized, open-label, single-period, parallel phase I clinical trial was conducted. Thirty subjects were randomly divided into three groups in a ratio of 1:1:1. After an overnight fast, all subjects received a single dose of 320 mg ABT either by intravenous drip for 45 min (group A) or bolus injection for 0.5 min (group B), or bolus injection for 3 min (group C). ABT plasma concentrations were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Non-compartmental analysis was used to evaluate PK parameters. The median time to reach maximum concentration was 0.75 h in group A and 0.16 h in both groups B and C. Elimination half-life, mean residence time, apparent clearance, and apparent volume of distribution were similar among the three groups. The 90% confidence intervals (CI) of geometric mean ratios of PK parameters for groups B and C relative to group C were within 85-120%. All adverse events (AEs) reported in this study were mild, according to the CTCAE guidelines and the study investigator's judgement. ABT bolus injections for 0.5 min and 3 min are expected to be well tolerated and to exhibit similar PK characteristics as IV drip for 45 min, offering potential clinical benefits.

10 Nov 2023·Medicine

Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS

Article

Author: Zhou, Ruifeng ; Yao, Yuan ; Yin, Ke ; Liu, Huanxia ; Lu, Chunrong ; Yang, Tongtong ; Cheng, Jing ; He, Shenghua ; He, Yuanhong

Treatment options for hospitalized people living with HIV/AIDS (PLWHA) with opportunistic infections and comorbidities are limited in China. Albuvirtide (ABT), a new peptide drug, is a long-acting HIV fusion inhibitor with limited drug-drug interactions and fast onset time. This single-center, retrospective cohort study investigated the effectiveness and safety of ABT plus dolutegravir (DTG) therapy in a real-world setting. We performed a chart review on the electronic patient records for hospitalized PLWHA using ABT plus DTG between April and December 2020. The clinical outcomes were retrospectively analyzed. Among 151 PLWHA (mean age 47.6 ± 15.9 years), 140 (93%) had at least 1 episode of bacterial and/or fungal infections and 64 (42%) had other comorbidities including syphilis, hepatitis B, and/or hypertension. ABT plus DTG was given to 87 treatment-naïve (TN) and 64 treatment-experienced (TE) PLWHA. Regardless of treatment history, mean HIV-1 RNA levels significantly decreased from 4.32 log10copies/mL to 2.24 log10copies/mL, 2.10 log10copies/mL and 1.89 log10copies/mL after 2, 4 and 8 weeks of treatment, respectively (P < .0001). Compared with baseline mean CD4 + T-cell counts of 122.72 cells/μL, it increased to 207.87 cells/μL (P = .0067) and 218.69 cells/μL (P = .0812) after 4 and 8 weeks of treatment. Except for limited laboratory abnormalities such as hyperuricemia, increased creatinine level, and hyperglycemia observed after treatment, no other clinical adverse events were considered related to ABT plus DTG. Data suggests that ABT plus DTG is safe and effective for critically-ill hospitalized PLWHA. In view of the rapid viral load suppression and restoration of CD4 + count within 8 weeks of treatment, its clinical application warrants further investigation.

100 Deals associated with Albuvirtide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J05A	DB15166

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	China	Frontier Biotechnologies, Inc. (China)	23 May 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 2	China	Frontier Biotechnologies, Inc. (China)	19 Feb 2014

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	HIV Infections	-	艾可宁	(eighgpviaq) = 受试者接受基于艾可宁®的强化方案治疗12周后，可以明显改善CD4+T淋巴细胞计数，较对照组具有显著的优效性。 tgilwdbeby (fvpurdpjbu ) View more	Positive	29 Jul 2024
				对照组
Company_Website Manual	Not Applicable	HIV Infections	10	艾博韦泰+多替拉韦	(gnabbtgwqn) = None gywztemghf (lxfzenyfjk ) View more	Positive	28 Jun 2024
NCT02369965 (TALENT, NEWS) Manual	Phase 3	HIV Infections	418	Lopinavir/Ritonavir+艾可宁	lrozodlcwx(ffbnqakwyo) = fftbkcpyjt bctkdgqzbm (kasrycrpoe )	Non-inferior	13 Jun 2022
				Lopinavir/Ritonavir+NRTI	lrozodlcwx(ffbnqakwyo) = onxjlmmluv bctkdgqzbm (kasrycrpoe )

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