Who is eligible for cabotegravir (HIV-1 integrase strand transfer inhibitor)?

From the Guidelines

Cabotegravir is eligible for individuals at risk of sexually acquiring HIV, including adults and adolescents weighing at least 35 kg, as a long-acting injectable for HIV pre-exposure prophylaxis (PrEP) 1.

Key Eligibility Criteria

• Individuals at risk of sexually acquiring HIV
• Adults and adolescents weighing at least 35 kg
• No history of treatment failure or known resistance to integrase inhibitors
• Not recommended for patients with severe hepatic impairment or those with known resistance to integrase strand transfer inhibitors

Formulations and Uses

• Available as a long-acting injectable (brand name Apretude) for HIV pre-exposure prophylaxis (PrEP) in individuals at risk of sexually acquiring HIV
• Also available as part of a complete regimen (paired with rilpivirine, brand name Cabenuva) for treatment of those already diagnosed with HIV who are virologically suppressed on a stable antiretroviral regimen

Administration and Monitoring

• Intramuscular gluteal injections with 600 mg of cabotegravir every 8 weeks after an initial 4-week interval between the first 2 injections 1
• Rapid point-of-care HIV testing should be done on the day of each injection prior to the provision of the injection 1
• Sexually transmitted infection testing as with oral PrEP but every 4 months (every second injection) 1
• Liver enzyme tests should be administered every 6 months 1

From the FDA Drug Label

INDICATIONS AND USAGE HIV-1 Treatment: VOCABRIA is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. HIV-1 Pre-Exposure Prophylaxis: VOCABRIA is indicated for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition.

Eligible Patients for Cabotegravir:

• Adults and adolescents 12 years of age and older weighing at least 35 kg who are virologically suppressed and have no history of treatment failure or resistance to cabotegravir or rilpivirine for HIV-1 treatment.
• Adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition for HIV-1 Pre-Exposure Prophylaxis. Key points to consider:
• Age: 12 years of age and older
• Weight: at least 35 kg
• HIV-1 status: virologically suppressed for treatment, or at risk for HIV-1 acquisition for PrEP
• Resistance: no known or suspected resistance to cabotegravir or rilpivirine
• Treatment history: no history of treatment failure 2

From the Research

Eligibility Criteria for Cabotegravir

• Cabotegravir is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing ≥ 35 kg who have a negative HIV-1 test prior to initiation 3, 4, 5.
• The medication is approved for use in individuals who are HIV-negative but at risk of HIV-1 infection 5.
• Cabotegravir is also used as a complete long-acting regimen for the maintenance of HIV-1 virological suppression in adults living with HIV, in combination with rilpivirine, dosed every 2 months 6, 7.

Target Population

• At-risk adults and adolescents weighing ≥ 35 kg 3, 4, 5.
• Individuals who are HIV-negative but at risk of HIV-1 infection 5.
• Adults living with HIV who are virologically suppressed and seeking an alternative to daily oral antiretroviral therapy 6, 7.

Special Considerations

• Cabotegravir is not indicated for individuals who are HIV-positive or have unknown HIV status 3, 4, 5.
• The medication should only be initiated in individuals with a negative HIV-1 test prior to initiation 3, 4, 5.