Aikening (albuvirtide) / Frontier Biotech - LARVOL DELTA

Safety and Virological Outcomes of a Modified Albuvirtide Intensification Regimen with Standard ART in People with HIV. (PubMed, Infect Drug Resist) - "Among patients with baseline HIV-RNA above 20 copies/mL, the viral load decreased from 2.55 to 1.43 log10 copies/mL. Preliminary results demonstrate that 4-week ABT antiviral intensification regimen is feasible and exhibits potential antiviral activity."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Adjunctive albuvirtide is associated with improved immune recovery in treatment-naive patients with advanced HIV disease receiving bictegravir/emtricitabine/tenofovir alafenamide: a retrospective propensity score-matched cohort study. (PubMed, Front Immunol) - "The retrospective design, limited matched sample, residual confounding, and 24-week follow-up preclude causal inference. These findings require confirmation in prospective randomized trials."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Efficacy and Safety of Albuvirtide Plus Dolutegravir or Dolutegravir/Lamivudine in Hospitalized People with Advanced AIDS: A Retrospective Real-World Study. (PubMed, AIDS Res Hum Retroviruses) - "No significant differences in efficacy or safety were found between the ABT + DTG and ABT + DTG/3TC regimens. In a real-world setting, ABT-based regimens containing DTG (with or without 3TC) demonstrated high efficacy and excellent safety in hospitalized people with advanced AIDS, supporting its use in this difficult-to-treat population."

Journal • Real-world evidence • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

OPT-ARL: Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Shanghai Public Health Clinical Center

New trial • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Oncology

Efficacy, Influencing Factors, and Changes in Cardiovascular Disease Risk Associated with the Use of Albuvirtide (ABT) to Promote Immune Reconstitution in Treated HIV-1-Infected Patients with Immunological Non-responder (ChiCTR) - P=N/A | N=70 | Sponsor: Guangzhou Eighth Peoples Hospital Guangzhou Medical University; Guangzhou Eighth Peoples Hospital Guangzhou Medical University

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

A clinical study of pegylated interferon alfa-2b combined with Albuvirtide (ABT) for functional cure in HIV-1 infection (ChiCTR) - P=N/A | N=16 | Sponsor: Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University

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

Albuvirtide-based regimens for advanced- stage HIV and Talaromyces marneffei co-infection: A longitudinal case series. (PubMed, Int J STD AIDS) - "The study included treatment-naive HIV/TM co-infected patients who initiated ABT-based antiretroviral therapy combined with oral background regimens (predominantly dolutegravir/lamivudine or bictegravir/emtricitabine/tenofovir alafenamide). No severe adverse events related to the study drugs were observed.ConclusionFindings from this small case series suggest that ABT-based regimens demonstrated a favorable safety profile and achieved rapid viral suppression during the critical advanced stage of HIV/TM co-infection. These findings suggest that adding parenteral ABT to oral background regimens provides a feasible and intensified treatment strategy to stabilize critically ill patients, particularly those with potential gastrointestinal dysfunction."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Efficacy and Safety of Albuvirtide Intensification for Low-Level Viremia in People Living with HIV-1: A Retrospective Pilot Study. (PubMed, Int J Infect Dis) - "Albuvirtide intensification effectively suppressed LLV and restored immune homeostasis. The regimen induced a favorable immune profile characterized by selective CD4⁺ recovery without CD8⁺ expansion, supporting ABT as a valuable strategy for managing complex LLV cases."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Albuvirtide plus 3BNC117 provides a promising combination strategy for multidrug-resistant HIV-1 infection: a prospective, open-label, multicenter phase 2 trial. (PubMed, BMC Infect Dis) - P2 | "In patients with MDR HIV-1 infection who have limited treatment therapeutic options, the combination of ABT+3BNC117 plus an OBR was observed to have significant antiviral activity during a 34-week study period."

Journal • P2 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety and efficacy of albuvirtide and dolutegravir for HIV postexposure prophylaxis in men who have sex with men: a prospective non-randomized cohort study. (PubMed, BMC Infect Dis) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Safety, pharmacokinetics, and efficacy of albuvirtide administered by intravenous bolus every 4 weeks in combination with oral dolutegravir in virologically suppressed adults living with HIV: A 24-week study. (PubMed, Int J Infect Dis) - "In this small-sample, open-label study, the combination of 4-weekly ABT with daily DTG demonstrated excellent short-term efficacy, a favorable safety profile, and desirable pharmacokinetic properties over 24 weeks. These preliminary findings support further investigation of this novel long-acting regimen in larger, controlled clinical trials."

Clinical • Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CD4

Management of HIV-related Progressive Multifocal Leukoencephalopathy: insights from metagenomic next-generation diagnosis and pembrolizumab-lenalidomide therapy, a case report (EACS 2025) - "The individual received intensified cART (dolutegravir, lamivudine, zidovudine, albuvirtide), a 21-day course of lenalidomide (25 mg/day), and four pembrolizumab infusions (100 mg/dose). This case emphasizes the diagnostic value of brain tissue mNGS for PML when CSF testing is inconclusive. The pembrolizumab-lenalidomide regimen showed tolerability and potential efficacy in restoring anti-JCV immunity, supported by improved clinical outcomes and immune markers. However, long-term benefits and mechanisms require validation in larger cohorts."

Case report • Clinical • IO biomarker • Human Immunodeficiency Virus • Infectious Disease • CD4 • CXCL8 • IL6

Confronting Dual Therapeutic Hurdles in Advanced HIV: A Case Report on INSTIs Resistance and Talaromyces marneffei Coinfection. (PubMed, Int Med Case Rep J) - "Antiretroviral therapy (ART) was switched from elvitegravir to zidovudine, lamivudine, dolutegravir, and albuvirtide. Antifungal therapy adjusted from voriconazole to itraconazole...This case emphasizes genotype resistance testing-guided ART modification and rigorous opportunistic infection management in drug-resistant HIV patients. Coordinated care and timely interventions can enhance the outcomes in high-risk cases."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Research on the Psychological Status of Patients With HIV-1 Infection (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Shanxi Bethune Hospital

New trial • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

Evaluation of 28-week Antiretroviral Treatment with Albuvirtide and Cabotegravir in HIV Patients with Stable Virologic Suppression: Efficacy, Pharmacokinetics, and Safety (ChiCTR) - P4 | N=10 | Completed | Sponsor: Guangzhou Eighth Peoples Hospital Guangzhou Medical University; Guangzhou Eighth Peoples Hospital Guangzhou Medical University | Not yet recruiting ➔ Completed | Phase classification: PN/A ➔ P4

Phase classification • Trial completion • Human Immunodeficiency Virus • Infectious Disease

Integrating multi-dimensional data to reveal the mechanisms and molecular targets of baikening granules for treatment of pediatric influenza. (PubMed, Front Mol Biosci) - "BKN may alleviate pediatric influenza via key components targeting core targets (PPARG, MMP2, GSK3B, PARP1, CCNA2, and IGF1) and hub genes (OTOF, IFI27), with the involvement of feature genes-related pathways. These results have potential consequences for future research and clinical practice."

Journal • Asthma • Cough • Immunology • Infectious Disease • Influenza • Pediatrics • Pertussis • Pulmonary Disease • Respiratory Diseases • CCNA2 • IFI27 • IGF1 • MMP2 • PARP1 • PPARG

Safety and efficacy of four-weekly Albuvirtide plus Dolutegravir in virologically suppressed adults living with HIV-1: a pooled analysis based on two prospective studies (IAS-HIV 2025) - "Whether ABT is administered by intravenous infusion or bolus injection, the drug concentration within the body remains above the effective concentration. Additionally, good safety and efficacy have been initially observed, warranting further validation of the clinical efficacy of this regimen."

Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Salvage therapy with an Albuvirtide-based antiretroviral regimen for multi-drug resistant HIV and drug-resistant HBV with renal impairment: a case report. (PubMed, Virol J) - "This case underscores the potential value of individualized treatment strategies for patients with multidrug-resistant HIV and HBV co-infection complicated by renal impairment. The observed virological control following the use of novel agents such as Albuvirtide (ABT), in combination with second-generation integrase strand transfer inhibitors (INSTIs) like DTG, alongside renal-sparing antivirals, highlights the importance of designing optimized regimens based on resistance profiles and renal function. This personalized and adaptive therapeutic approach may offer clinical benefits in similarly complex scenarios."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Nephrology • Renal Disease

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