Albuvirtide
A long-acting HIV fusion inhibitor licensed in China
Albuvirtide is a long-acting peptide that stops HIV-1 from fusing with human cells, the same step targeted by enfuvirtide. Developed in China and given by intravenous infusion, it is licensed only in China, where a phase 3 trial found it non-inferior to standard nucleoside drugs as part of second-line treatment.
What is it?
HIV enters cells by fusing its envelope with the cell membrane. Enfuvirtide, approved in the US in 2003, blocks that step but must be injected twice daily. Albuvirtide was designed as a long-acting fusion inhibitor and, according to a 2024 pharmacokinetic study, is the first developed in China; later studies describe it as licensed only there.
Its pivotal phase 3 trial enrolled antiretroviral-experienced adults. At 48 weeks, 80.4% of those given albuvirtide with lopinavir/ritonavir had HIV RNA below 50 copies/mL, against 66.0% on a nucleoside-based regimen, meeting non-inferiority, with superiority in the per-protocol analysis and similar rates of severe adverse events. An earlier study combining it with lopinavir/ritonavir found a clear dose-response. A pharmacokinetic study of the same combination found that lopinavir/ritonavir barely changed albuvirtide exposure, but albuvirtide lowered lopinavir and ritonavir exposure by roughly a third, which the authors judged may not reduce the regimen's effectiveness.
Smaller Chinese studies have explored it in people whose CD4 counts fail to recover on treatment, where intensive albuvirtide raised CD4 counts by 45 cells/µL against a fall of 5 in controls, and in hospitalised patients and those with opportunistic infections. It is not approved outside China.
At a Glance
Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.
Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Published Research
Studies of albuvirtide, from their PubMed abstracts.
Phase 3 in treatment-experienced adults
In antiretroviral-experienced adults, 80.4% on albuvirtide plus lopinavir/ritonavir and 66.0% on a nucleoside regimen had HIV RNA below 50 copies/mL at 48 weeks, meeting non-inferiority, with superiority per protocol and similar grade 3-4 adverse events.
Dose-finding with lopinavir/ritonavir
At week 7, HIV RNA fell by 1.9 and 2.2 log10 copies/mL at 160 and 320 mg, and fell below 50 copies/mL in 1 of 9 and 5 of 9 patients, showing a clear dose-efficacy relationship.
Interaction with lopinavir/ritonavir
In 10 people with HIV, adding lopinavir/ritonavir left albuvirtide exposure essentially unchanged (AUC ratio 1.09), but lowered lopinavir exposure (AUC ratio 0.63) and ritonavir exposure (0.62); the authors judged this may not reduce effectiveness.
Poor immune recovery
In 50 people whose CD4 counts had not recovered on treatment, intensive albuvirtide raised CD4 counts by 45 cells/µL at 12 weeks against a fall of 5 in controls, and the difference persisted at 24 weeks.
Advanced HIV with Talaromyces infection
A case series from two hospitals in Guangxi evaluated albuvirtide-based regimens, described as licensed only in China, in treatment-naive patients with advanced HIV and Talaromyces marneffei co-infection.
Infusion vs bolus in healthy volunteers
In 30 healthy Chinese adults given a single 320 mg dose, peak concentration came at 0.75 hours after a 45-minute drip and 0.16 hours after a bolus, while elimination half-life, clearance and volume of distribution were similar across methods.
Hospitalised patients, with dolutegravir
In 151 hospitalised people with HIV, 93% with bacterial or fungal infections, albuvirtide plus dolutegravir lowered mean HIV RNA from 4.32 to 2.24 log10 copies/mL after 2 weeks and further at 4 weeks, in both treatment-naive and experienced patients.
Side Effects & Contraindications
Reported Side Effects
From the studies above.
Contraindications & Cautions
No US label; it is not approved in the US.
Legal Status
Albuvirtide is licensed in China but not in the US.
Frequently Asked Questions
?How is albuvirtide different from enfuvirtide?
Both block HIV fusion with cells; albuvirtide is long-acting and given by infusion, whereas enfuvirtide is injected under the skin twice a day.
?Is albuvirtide approved in the US?
No. It is licensed only in China.
?How well does it work?
In its phase 3 trial, 80.4% of patients on albuvirtide plus lopinavir/ritonavir had undetectable virus at 48 weeks against 66.0% on a nucleoside regimen.
?Can it be given as a quick injection instead of a drip?
In healthy volunteers, a bolus injection reached peak levels sooner than a 45-minute drip, but half-life, clearance and distribution were similar, suggesting the faster method gives comparable exposure.
References
- [clinical-trial] Su B, et al. "Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study." Chin Med J (Engl), 2020;133(24):2919-2927. PMID: 33252379.
- [clinical-trial] Zhang H, et al. "Combination of long-acting HIV fusion inhibitor albuvirtide and LPV/r showed potent efficacy in HIV-1 patients." AIDS Res Ther, 2016;13:8. PMID: 26865854.
- [pubmed] Yang W, et al. "Evaluation of pharmacokinetic interactions between long-acting HIV-1 fusion inhibitor albuvirtide and lopinavir/ritonavir, in HIV-infected subjects, combined with clinical study and simulation results." Xenobiotica, 2017;47(2):133-143. PMID: 27052428.
- [clinical-trial] Fan L, et al. "Enhanced immune reconstitution with albuvirtide in HIV-infected immunological non-responders." Front Cell Infect Microbiol, 2024;14:1397743. PMID: 38975330.
- [pubmed] Yu X, et al. "Albuvirtide-based regimens for advanced- stage HIV and Talaromyces marneffei co-infection: A longitudinal case series." Int J STD AIDS, 2026;37(8):846-852. PMID: 41947318.
- [pubmed] Qin H, et al. "Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection." Naunyn Schmiedebergs Arch Pharmacol, 2024;397(2):913-922. PMID: 37535074.
- [pubmed] Liu H, et al. "Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS." Medicine (Baltimore), 2023;102(45):e35344. PMID: 37960773.
Sources & Citations
Studies were read from their PubMed records, October 3, 2026.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.