Drug Database: Albuvirtide

What is albuvirtide?What is albuvirtide?

What is albuvirtide?

Albuvirtide is an investigational drug that is being studied to treat HIV.³  Albuvirtide has also been evaluated for use as part of HIV post-exposure prophylaxis (PEP) regimens.⁵

Albuvirtide belongs to a group of HIV drugs called fusion inhibitors.² Fusion inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body. 

To learn about how investigational drugs are tested during clinical trials, read the HIVinfo  What is an Investigational HIV Drug? and HIV and AIDS Clinical Trials fact sheets.

Select clinical trials of albuvirtideSelect clinical trials of albuvirtide

Select clinical trials of albuvirtide

Study Name: ChiCTR-TRC-13003140

Phase: 2
Status: This study has been completed.
Location: China
Purpose: The purpose of this study was to evaluate 1) the drug-drug interaction between albuvirtide and lopinavir/ritonavir (brand name: Kaletra) and 2) the short-term safety and effectiveness of albuvirtide plus lopinavir/ritonavir in participants who had never taken HIV medicines.⁶
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.⁶

Study Names: TALENT; NCT02369965

Phase: 3
Status: This study has been completed.
Location: China
Purpose: The purpose of this study was to compare the effectiveness of albuvirtide plus lopinavir/ritonavir to the effectiveness of two nucleoside reverse transcriptase inhibitors (NRTIs) plus lopinavir/ritonavir in participants who have previously had treatment failure.⁷
Selected Study Results: Results presented at IAS 2021 showed that albuvirtide plus lopinavir/ritonavir was as effective as two NRTIs plus lopinavir/ritonavir in suppressing viral load.⁸
Additional Published Material:

• Chin Med J (Engl) article, 2020: 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

Study Name: NCT03719664

Phase: 2
Status: The status of this study is unknown.
Location: 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 long-acting maintenance therapy.⁹

Study Name: NCT04819347

Phase: 2
Status: The status of this study is unknown.  
Location: China
Purpose: The purpose of this study is to evaluate the safety of combination therapy with albuvirtide plus 3BNC117 and determine whether this combination can control viral load levels after an analytical treatment interruption of antiretroviral therapy (ART).¹⁰

Study Name: NCT04560569

Phase: 2
Status: The status of this study is unknown.
Location: United States
Purpose: The purpose of this study is to evaluate the safety and effectiveness of combination therapy with albuvirtide plus 3BNC117 in participants with multidrug-resistant HIV.¹¹

Study Name: ChiCTR2100053311

Phase: 4
Status: This study has been completed.
Location: China
Purpose: The purpose of this study was to evaluate the effect of intensive albuvirtide treatment on immune function in individuals with incomplete immune recovery on suppressive ART.^12,13
Selected Study Results: Results presented at AIDS 2024 and published in Frontiers in Cellular and Infection Microbiology (2024) showed that at Week 12 of the study, CD4 counts increased significantly in the intensive albuvirtide treatment group compared to the control group.^13,14

For more details on the studies listed above, see the Health Professional version of this drug summary.

A study evaluating the safety and efficacy of a switch to once-monthly albuvirtide plus daily dolutegravir in adults with viral suppression was also conducted. Results were published in AIDS (2025).¹⁵

What side effects might albuvirtide cause?What side effects might albuvirtide cause?

What side effects might albuvirtide cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of albuvirtide listed above.

ChiCTR-TRC-13003140

In this Phase 2 study, none of the participants had serious side effects. Some participants had mild side effects including nausea, diarrhea, rash, and increased triglyceride levels. None of the participants had injection site reactions.⁶

TALENT (NCT02369965)

In this Phase 3 study, the safety profile between the albuvirtide plus lopinavir/ritonavir group was similar to that of the two NRTIs plus lopinavir/ritonavir group. Two participants in each group discontinued treatment because of side effects. Common drug-related side effects across both groups included diarrhea, nausea, and increased triglycerides. There were no drug-related serious side effects associated with albuvirtide. No injection site reactions were reported with albuvirtide use.^8,16

ChiCTR2100053311

In this study, participants with viral suppression on ART were assigned to either once-weekly intravenous albuvirtide added to their current ART regimen or continue on their current ART regimen. Through 12 weeks of treatment, there were no albuvirtide-related side effects or serious side effects reported. No participants experienced injection site reactions. The most common laboratory abnormality among participants receiving albuvurtide was elevated triglycerides.^12,13

Because albuvirtide is still being studied, information on possible side effects of the drug is not complete. As testing of albuvirtide continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying albuvirtide?Where can I get more information about clinical trials studying albuvirtide?

Where can I get more information about clinical trials studying albuvirtide?

More information about albuvirtide-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

ReferencesReferences

References

1. National Center for Biotechnology Information. PubChem Compound Summary for CID 134694278, Albuvirtide. Accessed March 3, 2025
2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Accessed March 3, 2025
3. Jefferys R. Antiretroviral therapy. Treatment Action Group Pipeline Report 2024. Accessed March 3, 2025
4. Frontier Biotechnologies Inc. website. Our Story: Frontier Biotechnologies Inc. Accessed March 3, 2025
5. Nie J, Sun F, He X, et al. Tolerability and adherence of antiretroviral regimens containing long-acting fusion inhibitor albuvirtide for HIV post-exposure prophylaxis: a cohort study in China. Infect Dis Ther. 2021;10(4):2611-2623. doi:10.1007/s40121-021-00540-5. Accessed March 3, 2025
6. Zhang H, Jin R, Yao C, 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. Accessed March 3, 2025
7. Frontier Biotechnologies Inc. Efficacy and safety of albuvirtide for injection combined with LPV/r for treatment of HIV-1-infected patients failed first-line antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 18, 2015. NLM Identifier: NCT02369965. Accessed March 3, 2025
8. Wu H, Yao C, Zhang T, et al. Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in treatment-experienced HIV-1 infected patients: Week 48 analysis from the randomized controlled phase 3 TALENT study. Poster presented at: IAS Conference on HIV Science; July 18-21, 2021. Accessed March 3, 2025
9. Frontier Biotechnologies Inc. A Phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 22, 2018. NLM Identifier: NCT03719664. Accessed March 3, 2025
10. Frontier Biotechnologies Inc. The Phase 2, two arms, one site, safety and antiviral activity of combination therapy with albuvirtide and 3BNC117 in virologically suppressed subjects with HIV-1 infection after analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 22, 2021. NLM Identifier: NCT04819347. Accessed March 3, 2025
11. Frontier Biotechnologies Inc. A multicenter, two-arm, 24-week study of albuvirtide in combination with 3BNC117 in patients with multi-drug resistant (MDR) HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 17, 2020. NLM Identifier: NCT04560569. Accessed March 3, 2025
12. Chinese Clinical Trial Registry. ChiCTR number: ChiCTR2100053311; Study on albuvirtide intensification of antiretroviral therapy in HIV infected patients with poor immune restoration. Accessed March 3, 2025
13. Fan L, Hu Y, Li R, et al. Enhanced immune reconstitution with albuvirtide in HIV-infected immunological non-responders. Front Cell Infect Microbiol. 2024;14:1397743. doi:10.3389/fcimb.2024.1397743. Accessed March 3, 2025
14. Fan L, Hu Y, Li R, et al. Improved immunological recovery after ART intensification with Albuvirtide in immunological non-responders living with HIV. Abstract presented at: International AIDS Conference; July 22-26, 2024; Munich, Germany and Virtual. Abstract TUPEB103. Accessed March 3, 2025
15. Xie X, Fu Y, Gan L, et al. Safety and efficacy of switching to 4-weekly albuvirtide plus daily dolutegravir in virologically suppressed HIV-1 adults: a 24-week study. AIDS Lond Engl. Published online January 27, 2025. doi:10.1097/QAD.0000000000004130. Accessed March 3, 2025
16. Wu H, Yao C, Zhang T, et al. Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in treatment-experienced HIV-1 infected patients: week 48 analysis from the randomized controlled phase 3 TALENT study. Abstract presented at: IAS Conference on HIV Science; July 18-21, 2021; Virtual. Abstract PEB148. Accessed March 3, 2025