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Drug information

Drug's link(s)
Generic name

Cabotegravir

Brand names

Apretude, Vocabria

Compound type

Small molecule

Drug class/category

integrase strand transfer inhibitor; INSTI)

Summary

Cabotegravir (CAB), also known as GSK1265744, is a HIV-1 integrase strand transfer inhibitor (INSTI). Long-acting versions of CAB (CAB-LA) are currently administered once monthly or every-2-months as a intramuscular (IM) injection containing an extended-release drug particle nanosuspension, with an optional ~30 day oral-lead in period. CAB-LA administered by IM injection requires approximately one week to achieve maximal plasma drug concentration. CAB is metabolised in the body by the enzyme UGT1A1; with the average half-life of IM CAB-LA ranging from 5.6 to 11.5 weeks.

Approval status

An injectable formulation of cabotegravir is approved for use for HIV PrEP and as part of a regimen, for HIV treatment

Regulatory authorities

Cabotegravir LA, both as suspension for intramuscular injection 600mg/3ml (200mg/ml) and as 30 mg tablet is included in WHO PQ: https://extranet.who.int/prequal/sites/default/files/document_files/EOI_23rd%20HIV_9July_2025_clean_PQ.pdf Cabotegravir for PrEP is included in WHO guidelines. CAB+RPV LA injectable for treatment, is also recommended by WHO to be used as an alternative switching option for adults and adolescents with undetectable HIV viral load on oral ART and without active hepatitis B infection : https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/guidelines ViiV Healthcare and Medicines Patent Pool have signed a voluntary licensing agreement to enable access to long-acting injectable cabotegravir for HIV PrEP and HIV treatment

Therapeutic area(s)

  • HIV
Use case(s)
  • Pre-Exposure Prophylaxis (PrEP)
  • Treatment

Administration route

Oral, Intramuscular, Subcutaneous

Associated long-acting platforms

Aqueous drug particle suspension

Use of drug

Ease of administration
  • Administered by a nurse
  • Administered by a specialty health worker
  • Administered by a community health worker
  • Self-administered
  • To be determined
Frequency of administration
  • Daily
  • Monthly
  • Every 2 months
  • Other/Variable/Unknown : Other investigated formulations may provide additional dosing frequencies
  • Every 4 months
User acceptance
For prevention, CAB-LA is well accepted across key populations: in HPTN 083 (MSM/transgender women) and HPTN 084 (African cisgender women, including adolescent girls), adherence to scheduled injections was high and most participants preferred injectable over oral PrEP, citing discretion and freedom from daily pill-taking, though injection-site pain and clinic dependence were recurring concerns. For treatment, ATLAS and FLAIR showed that CAB+RPV LA produced significantly greater gains in treatment satisfaction and acceptance than daily oral ART, with ≥97% preferring injections over previous tt.

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Additional information

Cabotegravir LA, both as suspension for intramuscular injection 600mg/3ml (200mg/ml) and as 30 mg tablet is included in WHO PQ: https://extranet.who.int/prequal/sites/default/files/document_files/EOI_23rd%20HIV_9July_2025_clean_PQ.pdf

Cabotegravir for PrEP is included in WHO guidelines. CAB+RPV LA injectable for treatment, is also recommended by WHO to be used as an alternative switching option for adults and adolescents with undetectable HIV viral load on oral ART and without active hepatitis B infection : https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/guidelines

ViiV Healthcare and Medicines Patent Pool have signed a voluntary licensing agreement to enable access to long-acting injectable cabotegravir for HIV PrEP and HIV treatment : https://medicinespatentpool.org/

Developer(s)

ViiV Healthcare
Originator
United Kingdom

ViiV Healthcare

ViiV Healthcare is a pharmaceutical company that specializes in the development of therapies for HIV infection. The company is headquartered in Brentford in the United Kingdom and was initially formed in November 2009 as a part of a joint venture between GlaxoSmithKline and Pfizer.

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

Mannitol (E421), polysorbate 20, macrogol 3350, water for injectable preparations ad solutionem pro 1 ml.

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Delivery device(s)

No delivery device

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided