Last reviewed · How we verify
Long-acting Cabotegravir injection
Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.
Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 infection in treatment-naive and treatment-experienced adults (long-acting injectable formulation for maintenance therapy).
At a glance
| Generic name | Long-acting Cabotegravir injection |
|---|---|
| Sponsor | MU-JHU CARE |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Cabotegravir binds to the active site of HIV integrase and inhibits the strand transfer step of viral integration into the host genome. The long-acting injectable formulation provides sustained plasma concentrations over weeks to months, enabling less frequent dosing compared to daily oral antiretrovirals. This mechanism maintains suppression of HIV replication and reduces viral load in treated individuals.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults (long-acting injectable formulation for maintenance therapy)
Common side effects
- Injection site reactions (pain, induration, erythema)
- Headache
- Fatigue
- Nausea
- Pyrexia
- Diarrhea
Key clinical trials
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
- Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs (PHASE4)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 (PHASE3)
- Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana (PHASE4)
- HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
- Combined Injectable Treatment for HIV and OUD (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |