Aikening (albuvirtide) / Frontier Biotech - LARVOL DELTA

Therapeutic efficacy of albuvirtide-based antiretroviral therapy in people living with HIV who have low-level viremia and non-AIDS-defining malignancies: two case reports. (PubMed, Retrovirology) - "These cases suggest potential benefits of ABT-containing ART regimens in PLWH who have LLV and concurrent NADCs. While two cases cannot establish definitive conclusions, they highlight the need for larger studies investigating the role of ABT in this complex clinical scenario."

Journal • Breast Cancer • Human Immunodeficiency Virus • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CD4

Safety and efficacy of pharmacotherapy containing the second-generation INSTIs and chemotherapy drugs in AIDS-related diffuse large B-cell lymphoma: a single-center retrospective analysis. (PubMed, Oncol Res Treat) - "Second-generation INSTIs seem to be a safe and effective first-line treatment option for AR-DLBCL patients undergoing chemotherapy, regardless of the chemotherapy type."

Journal • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Thrombocytopenia • Tuberculosis • CD4 • CD8

A Multicenter Study of Albuvirtide Combined With 3BNC117 in Multidrug-Resistant HIV-1 Infection (CROI 2025) - "In the eight-week analysis after ABT+3BNC117 cessation in 14 participants, 92.8% had a viral load below 50 RNA copies/mL. Conclusions In patients with MDR HIV-1 infection who have advanced disease and limited treatment therapeutic options, the combination of ABT+3BNC117 had significant antiviral activity during a 34-week study period."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Safety and efficacy of switching to 4-weekly albuvirtide plus daily dolutegravir in virologically suppressed HIV-1 adults: a 24-week study. (PubMed, AIDS) - "Switching to 4-weekly ABT plus daily DTG demonstrated good safety, favorable pharmacokinetics, maintained virological suppression, and improved immune recovery. These findings support ABT's potential as a long-acting agent for simplifying HIV treatment."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Efficacy and safety of an Albuvirtide-based regimen for preventing mother-to-child transmission of multidrug-resistant HIV: a case report. (PubMed, BMC Pregnancy Childbirth) - "In our case, ABT-based antiretroviral regimen was effective in suppressing viral load (VL) in pregnancy, and there is no reported safety issues for the mother or the baby. Albuvirtide use in pregnancy might represent a strategy to avoid in utero transmission of MDR-HIV, but further investigation is warranted."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Drug-Drug Interaction Between Rifampicin and Albuvirtide: A Phase 1, Randomized, Open-Label Study. (PubMed, J Clin Pharmacol) - "The time to reach Cmax (Tmax) of both ABT and RIF demonstrated no statistically significant difference, whether administered alone or concurrently. The pharmacokinetics profiles of both RIF and ABT changed to some extent when co-administered, while no clinically significant impact on these two drugs was observed, indicating that ABT and RIF can be used together without necessitating dose adjustments."

Journal • P1 data • Human Immunodeficiency Virus • Infectious Disease

Efficacy and Safety of add-on treatment with albuvirtide every 4 weeks for HIV-1 infected incomplete immune responders (ChiCTR) - P4 | N=66 | Recruiting | Sponsor: WUHAN JINYINTAN HOSPITAL(Wuhan Infectious Disease Hospital); WUHAN JINYINTAN HOSPITAL(Wuhan Infectious Disease Hospital)

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Evaluation of 28-week Antiretroviral Treatment with Albuvirtide and Cabotegravir in HIV Patients with Stable Virologic Suppression: Efficacy, Pharmacokinetics, and Safety (ChiCTR) - P=N/A | N=10 | Not yet recruiting | Sponsor: Guangzhou Eighth Peoples Hospital Guangzhou Medical University; Guangzhou Eighth Peoples Hospital Guangzhou Medical University

New trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Improved immunological recovery after ART intensification with Albuvirtide in immunological non-responders living with HIV (AIDS 2024) - "Significant CD4+ cell count increase suggests ABT enhances immune function in INRs. Immune reconstitution achieved by ABT could be attributed to its antiviral properties as well as its ability to increase thymic cell output and decrease."

Human Immunodeficiency Virus • Infectious Disease • CASP3 • CD31 • PECAM1

Enhanced immune reconstitution with albuvirtide in HIV-infected immunological non-responders. (PubMed, Front Cell Infect Microbiol) - "The proportion of caspase 3+CD45RA+CD31+CD4+ T cells was significantly lower in participants with satisfactory immune response (sIR) to ABT (p<0.05). Significant CD4+T cell count increase suggests ABT enhances immune function in INRs which may be attributed to its antiviral properties as well as its ability to increase thymic cell output and decrease cell apoptosis."

Journal • Human Immunodeficiency Virus • Infectious Disease • CASP3 • CD31 • PECAM1

Gendered Inclusion in Studies Evaluating Injectable HIV Treatment and PrEP: A Scoping Review (CROI 2024) - "In female participants, LA-I cabotegravir (CAB) is superior to oral PrEP...PrEP studies evaluated CAB 8 (57%), rilpivirine (RPV) 2(14%) and mono-clonal antibodies 4 (29%). Treatment studies evaluated CAB+RPV, lenacapavir, albuvirtide and monoclonal antibodies, [18 (67%), 5 (18%), 3 (11%), 1 (4%), respectively]...The number of female participants in studies on LA-I treatment have significantly increased, but remain unacceptably low at 19% (2022/3) and do not reflect the global population. Gender-targeted PrEP studies have been effective at increasing numbers of females recruited. Transgender and NBP remain very poorly represented."

Review • Human Immunodeficiency Virus • Infectious Disease

Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS. (PubMed, Medicine (Baltimore)) - "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."

Journal • Cardiovascular • Diabetes • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • CD4

Effects of albuvirtide intensification on CD4 T cell reconstitution in acquiring HIV clients with incomplete immune reconstitution (EACS 2023) - "Conclusions : Data suggested Intensive treatment with Albuvirtide was safe and effective for HIV-acquired subjects with incomplete immune reconstitution. In view of restoration of CD4+ counts in 12-week of treatment, Albuvirtide may improve the immune function recovery."

Human Immunodeficiency Virus • Infectious Disease • CD4

Effects of albuvirtide intensification on CD4 T cell reconstitution in acquiring HIV clients with incomplete immune reconstitution (EACS 2023) - "Conclusions : Data suggested Intensive treatment with Albuvirtide was safe and effective for HIV-acquired subjects with incomplete immune reconstitution. In view of restoration of CD4+ counts in 12-week of treatment, Albuvirtide may improve the immune function recovery."

Human Immunodeficiency Virus • Infectious Disease • CD4

Rescue therapy with an albuvirtide-based antiretroviral regimen in an HIV-infected child with multidrug resistance and multiple opportunistic infections: a case report. (PubMed, AIDS Res Ther) - "The case reported here could suggest that an ABT-based antiretroviral therapy might be beneficial and without relevant toxicity in children with MDR HIV. Infectiologists specializing in managing HIV should be prepared to manage an increasing number of children with MDR HIV. ABT might be a new treatment option for MDR HIV infection in children."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • CD4

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "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."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

After the honeymoon with CFTR-modulators, a rude awaikening with sudden and exceptionally severe infection. (ECFS 2023) - No abstract available

Infectious Disease

Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Frontier Biotechnologies Inc. | Not yet recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Comparing albuvirtide plus ritonavir-boosted lopinavir regimen to two nucleotide reverse transcriptase inhibitors plus ritonavir-boosted lopinavir in HIV-infected individuals who failed initial treatment: a retrospective comparative cohort study. (PubMed, Ann Transl Med) - "Conversion to ABT + LPV/r therapy appears to be an effective and safe strategy. This treatment regimen has great potential to be generalized in the HIV-infected population, although further testing in a larger patient population is required to verify these results."

Journal • Retrospective data • Human Immunodeficiency Virus • Immunology • Infectious Disease • Pain • CD4

Safety and efficacy of pharmacotherapy containing INSTIs and chemotherapy drugs in people living with HIV and concomitant colorectal cancer. (PubMed, AIDS Res Ther) - "DTG- or BIC-containing regimens are good options for patients with HIV and concomitant CRC."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Solid Tumor • CD4

Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority TALENT study. (PubMed, J Infect) - No abstract available

Head-to-Head • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Peptide-Based HIV Entry Inhibitors. (PubMed, Adv Exp Med Biol) - "In particular, the peptide-based anti-HIV drugs enfuvirtide and albuvirtide were approved for clinical use by the U.S. FDA and CFDA in 2003 and 2018, respectively. Therefore, they are particularly useful for HIV-infected patients who have failed to respond to the highly active antiretroviral drugs (ARD) targeting the late stage of HIV replication, such as reverse transcriptase inhibitors and protease inhibitors. In this chapter, we will focus on the past, current, and future trends in research and development of peptide-based HIV entry inhibitors."

Journal • Human Immunodeficiency Virus • Infectious Disease

Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Frontier Biotechnologies Inc.

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Albuvirtide-based dual therapy for hospitalised AIDS patients is safe and effective: a real-world cohort study (EACS 2021) - "ABT-dual included combinations with dolutegravir (DTG) in 88 treatment-naïve (TN) and 69 treatment-experienced (TE) patients, and with lopinavir/ritonavir (LPV/r) for 3 TE patients. Data suggests that ABT-dual is safe and effective for hospitalised AIDS patients. In view of the rapid viral load suppression and restoration of CD4+ count in 8 weeks of treatment, its clinical application warrants further investigation."

Clinical • Real-world evidence • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • CD4

Albuvirtide-based dual therapy for hospitalised AIDS patients is safe and effective: a real-world cohort study (EACS 2021) - "ABT-dual included combinations with dolutegravir (DTG) in 88 treatment-naïve (TN) and 69 treatment-experienced (TE) patients, and with lopinavir/ritonavir (LPV/r) for 3 TE patients. Data suggests that ABT-dual is safe and effective for hospitalised AIDS patients. In view of the rapid viral load suppression and restoration of CD4+ count in 8 weeks of treatment, its clinical application warrants further investigation."

Clinical • Real-world evidence • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • CD4