What is Cabenuva (cabotegravir and rilpivirine)?

What is Cabenuva (cabotegravir and rilpivirine)?

Cabenuva is the first complete long-acting injectable antiretroviral regimen for HIV-1 treatment, consisting of cabotegravir and rilpivirine, administered monthly or every 2 months as an alternative to daily oral therapy for virologically suppressed adults. 1, 2

Composition and Administration

• Cabenuva contains two active ingredients: cabotegravir (an integrase strand transfer inhibitor) and rilpivirine (a non-nucleoside reverse transcriptase inhibitor) in extended-release injectable formulations 1, 2
• Administered as two separate intramuscular injections by healthcare providers either monthly or every 2 months 3
• Before starting injections, patients may receive an optional oral lead-in with VOCABRIA (oral cabotegravir) and EDURANT (oral rilpivirine) to assess tolerability 4

Indications

• Approved for the treatment of HIV-1 infection in adults to replace current antiretroviral therapy in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) 1, 2
• Used as a maintenance therapy after achieving viral suppression with other antiretroviral regimens 5
• Not recommended for initial therapy in treatment-naïve patients according to current guidelines 6

Efficacy

• Clinical trials (ATLAS and FLAIR) demonstrated that Cabenuva is non-inferior to daily oral antiretroviral therapy in maintaining viral suppression 1, 2
• The ATLAS-2M study showed that dosing every 8 weeks (2 months) is non-inferior to every 4 weeks (monthly) dosing 2
• The SOLAR trial demonstrated non-inferior efficacy of Cabenuva compared to bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) with HIV-1 RNA ≥50 copies/mL in 1% vs <1% of patients, respectively 5

Benefits and Advantages

• Reduces dosing frequency from daily to monthly or every 2 months, potentially improving adherence 2, 3
• May address challenges associated with daily oral therapy such as:
  • Reducing HIV-related stigma and fear of treatment disclosure 3
  • Eliminating daily reminders of HIV status 3
  • Minimizing risk of treatment-related toxicity due to suboptimal adherence 2
• High patient satisfaction and treatment preference compared to daily oral regimens 3

Limitations and Considerations

• Not recommended during pregnancy due to inadequate data to support use 6
• If pregnancy is diagnosed in an individual receiving Cabenuva, switching to an oral triple-drug regimen is recommended 6
• Not recommended with rifampin due to drug-drug interactions 6
• Requires regular clinic visits for administration by healthcare providers 3
• Injection site reactions are common (reported by 70% of patients) though most (98%) are mild to moderate 5

Special Populations

• Adolescents: Safety, tolerability, and pharmacokinetics have been assessed in virologically suppressed adolescents aged 12 to younger than 18 years weighing ≥35 kg 4
• Pregnancy: Not recommended to initiate during pregnancy due to inadequate data 6
• Tuberculosis treatment: Not recommended with rifampin due to drug-drug interactions 6

Practical Management

• Missed doses can be managed according to specific protocols to maintain therapeutic drug levels 3
• If discontinuation is necessary, transition to an alternative oral antiretroviral regimen is recommended 3

Cabenuva represents a significant advancement in HIV treatment by offering a long-acting injectable alternative to daily oral therapy, potentially addressing adherence challenges while maintaining effective viral suppression.