Drug information

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Pronounce:
Other Names
Entyvio (brand product for the treatment of ulcerative colitis and Crohn’s disease), VDZ
Drug Class
a4ß7 Integrin Antagonist
Molecular Formula

C6528 H10072 N1732 O2042 S42

Registry Number
943609-66-3 (CAS)
Chemical Name

Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer's patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer

Organization
Takeda Pharmaceuticals America, Inc.
Phase of Development

Vedolizumab is in Phase 2 development for HIV treatment.

(Compound details obtained from ChemIDplus Advanced,1 Treatment Action Group website,and Entyvio Full Prescribing Information3)

 
What is vedolizumab?What is vedolizumab?

What is vedolizumab?

Vedolizumab is currently approved by the U.S. Food and Drug Administration (FDA) under the brand name Entyvio for the treatment of ulcerative colitis and Crohn’s disease.3  Vedolizumab is also being studied as an investigational drug to treat HIV infection.2

As an investigational HIV drug, vedolizumab belongs to a group of drugs called α₄β₇ integrin antagonists. αβ integrin antagonists block an immune cell receptor called αβ.3 The αβ receptor is thought to have an important role in directing HIV into gut tissues.4

Researchers are currently studying whether vedolizumab can help people with HIV maintain control of their viral load levels.5–7 

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 vedolizumabSelect clinical trials of vedolizumab

Select clinical trials of vedolizumab

Study Name: NCT03577782
Phase: 2
Status: This study has been completed.
Location: Spain
Purpose: The purpose of this study was to evaluate the safety of vedolizumab and whether vedolizumab plus antiretroviral therapy (ART) could help people who had never taken HIV medicines control their viral load levels during a structured treatment interruption of ART.2,5,8
Selected Study Results: Results presented at GeSIDA 2019 (abstract PO-48) showed that although vedolizumab was safe and well tolerated when given in combination with ART to participants in the early stages of HIV infection, it was unable to substantially control viral load levels after participants underwent a structured treatment interruption of ART.8

Study Names: HAVARTI; NCT03147859
Phase: 2
Status: This study is currently recruiting participants.
Location: Canada
Purpose: The purpose of this trial is to evaluate vedolizumab’s safety and ability to control viral load levels in individuals with chronic HIV infection undergoing a structured treatment interruption of ART.6
Selected Study Results: Results presented at CROI 2019, showed that vedolizumab given at two different doses and administered both before and after a structured treatment interruption of ART was generally safe. No drug-related severe side effects were reported. No participants had sustained viral suppression after treatment interruption of ART. Notably, the higher dose of vedolizumab appeared to have a significantly greater effect on reducing viral rebound compared with the lower dose of vedolizumab.9

Study Names: EHVA T02/ANRS VRI07; NCT04120415
Phase: 2
Status: See the ClinicalTrials.gov record for this study’s status.
Location: Not available
Purpose: The purpose of this study is to evaluate the ability of vedolizumab given with and without the therapeutic HIV vaccine MVA HIV-B in controlling viral load levels in people undergoing a structured treatment interruption of ART.7

A Phase 1 study (NCT02788175) evaluating the effectiveness of vedolizumab on controlling viral rebound in individuals undergoing a structured treatment interruption of ART has also been completed.10 

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

 

What side effects might vedolizumab cause?What side effects might vedolizumab cause?

What side effects might vedolizumab 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 vedolizumab listed above.

NCT03577782:

In this Phase 2 study, ten participants were enrolled, and six participants completed 24 weeks of treatment with vedolizumab plus ART, followed by interruption of treatment. Vedolizumab was reported as being well tolerated. No serious side effects occurred throughout the study period.5,8

HAVARTI (NCT03147859):

In this Phase 2 study, eight adults with HIV received intravenous infusions of vedolizumab. Vedolizumab was administered both before and after a structured treatment interruption of ART. No drug-related severe side effects were reported. Influenza and severe short-term hepatitis each occurred in one participant.6,9

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

Additional information on side effects known to be associated with vedolizumab can be found in the FDA-approved Full Prescribing Information for Entyvio.

 

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

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

More information about vedolizumab-related research studies is available from ClinicalTrials.gov.

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. United States National Library of Medicine. ChemIDplus Advanced: Vedolizumab. https://chem.nlm.nih.gov/chemidplus/rn/943609-66-3. Accessed February 1, 2022
  2. Treatment Action Group website. Research toward a cure trials. https://www.treatmentactiongroup.org/cure/trials/. Accessed February 1, 2022
  3. Takeda Pharmaceuticals America, Inc. Entyvio: full prescribing information, August 25, 2021. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c. Accessed February 1, 2022
  4. Uzzan M, Tokuyama M, Rosenstein AK, et al. Anti-α4β7 therapy targets lymphoid aggregates in the gastrointestinal tract of HIV-1–infected individuals. Sci Transl Med. 2018;10(461). doi:10.1126/scitranslmed.aau4711
  5. Hospitales Universitarios Virgen del Rocío. Phase II clinical trial to analyze the safety and efficacy of vedolizumab combined with antiretroviral therapy to achieve permanent virological remission in HIV-infected subjects without previous antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 12, 2018. NLM Identifier: NCT03577782. https://clinicaltrials.gov/ct2/show/NCT03577782. Accessed February 1, 2022
  6. Ottawa Hospital Research Institute. Vedolizumab treatment in antiretroviral drug treated chronic hiv infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 3, 2017. NLM Identifier: NCT03147859. https://clinicaltrials.gov/ct2/show/NCT03147859. Accessed February 1, 2022
  7. ANRS, Emerging Infectious Diseases. EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: a Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic Infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 30, 2019. NLM Identifier: NCT04120415. https://www.clinicaltrials.gov/ct2/show/NCT04120415. Accessed February 1, 2022
  8. Jimenez-Leon MR, Gasca Capote C, Espinosa N, et al. Safety and efficacy of vedolizumab combined with antiretroviral therapy to achieve permanent virological remission in HIV-infected subjects without previous antiretroviral therapy. Presented at: XI Congreso Nacional GeSIDA; December 10-13, 2019; Toledo, Spain. Abstract PO-48. http://web.archive.org/web/20220120023739/https://congresogesida.es/images/site/CONGRESO_GeSIDA_2019_web.pdf. Accessed February 1, 2022
  9. McGuinty M, Angel J, Kumar A, et al. Seeking suppression in HAVARTI: viremia & T cells after vedolizumab & ATI in HIV/ART. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2019; Seattle, WA. Poster 393. https://2jg4quetidw2blbbq2ixwziw-wpengine.netdna-ssl.com/wp-content/uploads/sites/2/posters/2019/1430_McGuinty_0393.pdf. Accessed February 1, 2022
  10. National Institute of Allergy and Infectious Diseases (NIAID). An exploratory, open-label study of vedolizumab (anti-alpha4beta7 antibody) in subjects with HIV infection undergoing analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 28, 2016. NLM Identifier: NCT02788175. https://clinicaltrials.gov/ct2/show/NCT02788175. Accessed February 1, 2022

 

 

Last Reviewed: February 1, 2022