Drug information

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Pronounce:
Other Names:
LEN, GS-6207, GS-CA2
Drug Class:
Capsid Inhibitors
Organization:
Gilead Sciences, Inc.
Phase of Development:

Lencacapvir is in Phase 2/3 development for HIV treatment.

(Compound details obtained from NIAID Therapeutics Database1 and ClinicalTrials.gov2)

What is lenacapavir?What is lenacapavir?

What is lenacapavir?

Lenacapavir is an investigational drug that is being studied to treat HIV infection2,3

Lenacapavir belongs to a group of HIV drugs called capsid inhibitors.1 Capsid inhibitors interfere with HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication.  Capsid inhibitors can disrupt HIV capsid during multiple stages of the viral life cycle. This prevents HIV from multiplying and can reduce the amount of HIV in the body.4,5 

Lenacapavir may work against HIV strains that are resistant to other HIV drugs.6

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

Which clinical trials are studying lenacapavir?Which clinical trials are studying lenacapavir?

Which clinical trials are studying lenacapavir?

Study Names: CALIBRATE; GS-US-200-4334; NCT04143594
Phase: 2
Status: This study is ongoing, but not recruiting participants.
Locations: United States, Dominican Republic, and Puerto Rico
Purpose: The purpose of this study is to evaluate the safety and efficacy of lenacapavir when given in combination with other antiretroviral agents in adults with HIV who have never taken HIV medicines.3

Study Names: CAPELLA; GS-US-200-4625; NCT04150068
Phase: 2/3
Status: This study is ongoing, but not recruiting participants.
Locations: Multiple countries, including United States 
Purpose: The purpose of this study is to evaluate the safety and efficacy of lenacapavir when given as an add-on to a failing antiretroviral therapy (ART) regimen in participants who have HIV with drug resistance. Afterwards, the efficacy of lenacapavir given in combination with optimized background therapy will be assessed.2

A Phase 1b trial (NCT03739866) evaluating the safety, pharmacokinetics and antiviral activity of subcutaneous lenacapavir in adults with HIV was completed.7 

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

What side effects might lencapavir cause?What side effects might lencapavir cause?

What side effects might lencapavir cause?

One goal of HIV research is to identify new drugs that have fewer side effects.  In the CAPELLA (NCT04150068) study discussed under the previous question, a total of 72 participants received lenacapavir. None of the participants had a drug-related serious side effect, and no one stopped lenacapavir treatment because of a side effect. Excluding injection site reactions, common side effects that occurred during the study included headache, nausea, cough, diarrhea, back pain, fever, rash, and urinary tract infections.8

Almost half of the participants in the study experienced at least one injection site reaction related to subcutaneous lenacapavir. Injection site reactions included swelling, redness, lumps (nodules), and pain. Most of the injection site reactions were mild and went away within days, but nodules (all of which were mild) lasted for a few months. No participants stopped treatment because of injection site reactions.8

Severe laboratory abnormalities, including those related to kidney function and blood sugar levels, occurred in 21% of participants who received lenacapavir. Some of these abnormalities, however, were temporary or unconfirmed, and some cases of abnormal blood sugar levels were related to underlying diabetes.8

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

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

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

More information about lenacapavir-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

References

  1. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed March 26, 2021
  2. Gilead Sciences. A Phase 2/3 study to evaluate the safety and efficacy of long acting capsid inhibitor GS-6207 in combination with an optimized background regimen in heavily treatment experienced people living with HIV-1 infection with multidrug resistance. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 28, 2019. NLM Identifier: NCT04150068. https://clinicaltrials.gov/ct2/show/NCT04150068. Accessed March 26, 2021
  3. Gilead Sciences. A Phase 2 randomized, open label, active controlled study evaluating the safety and efficacy of long-acting capsid inhibitor GS-6207 in combination with other antiretroviral agents in people living with HIV. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 28, 2019. NLM Identifier: NCT04143594. https://clinicaltrials.gov/ct2/show/NCT04143594. Accessed March26, 2021
  4. Collins S and Clayden P. HIV pipeline 2020: new drugs in development. HIV Treatment Bulletin. 2020 Mar; 21(1) Suppl: 1-13. https://i-base.info/htb/wp-content/uploads/2020/03/i-Base-HIV-pipeline-March-2020.pdf. Accessed March 26, 2021
  5. Carnes SK, Sheehan JH, Aiken C. Inhibitors of the HIV-1 Capsid, A Target of Opportunity. Curr Opin HIV AIDS. 2018;13(4):359-365. doi:10.1097/COH.0000000000000472
  6. Rhee, M. Lenacapavir (GS-6207): a first-in-class long acting HIV capsid inhibitor. HIV DART; December 10, 2020; Virtual Meeting. National AIDS Treatment Advocacy Project (NATAP): HIV Articles; 2020. https://www.natap.org/2020/HIV/121520_02.htm. Accessed March 26, 2021
  7. Gilead Sciences. A Phase 1b randomized, double-blinded, placebo controlled, multi-cohort study of the safety, pharmacokinetics, and antiviral activity of GS-6207 administered subcutaneously in HIV-1 infected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 2, 2018. NLM Identifier: NCT03739866. https://clinicaltrials.gov/ct2/show/NCT03739866. Accessed March 26, 2021
  8. Segal-Maurer S , Castagna A , Berhe M, et al. Potent antiviral activity of lenacapavir in Phase 2/3 in heavily ART-experienced PWH. Conference on Retroviruses and Opportunistic Infections (CROI); March 6-10, 2021; Virtual. Levin: Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2021. https://www.natap.org/2021/CROI/croi_47.htm. Accessed March 26, 2021

Last Reviewed: March 26, 2021