CABOTEGRAVIR/ RILPIVIRINE INJ,SUSP,SA
Clinical Criteria Summary
Document 326: HIV PrEP Clinical Recommendations for Use DEC 2025
Indications & Target Populations
- HIV preexposure prophylaxis (PrEP) for men who have sex with men (MSM), transgender women (TGW), cisgender men, and cisgender women at risk for HIV sexual acquisition.
- Patients at very high risk of transmission (e.g., frequent condom-less sexual encounters, partners with uncontrolled HIV infection).
Renal & Skeletal Considerations
- Alternative to oral PrEP for patients with renal dysfunction.
- Unlikely to impact renal function or bone mineral density.
- Appropriate alternative for patients with osteoporosis or osteopenia.
Adherence & Behavioral Factors
- Beneficial for patients unable to adhere to daily oral dosing due to unstable housing, stigma, cognitive difficulties, uncontrolled mental illness, or substance use disorders.
- Requires patient agreement to comply with a strict every-2-month injection and testing schedule.
- Long half-life may pose a risk if therapy is abruptly discontinued while continuing high-risk behaviors (subtherapeutic concentrations may persist for up to 1 year, increasing resistance risk).
Contraindications & Drug Interactions
- Should not be used in patients receiving strong CYP inducers.
- Indicated for patients with contraindications or intolerance to tenofovir or emtricitabine.
Monitoring & Testing Requirements
- HIV must be excluded at baseline and at least every 2 months while on therapy.
- Adherence counseling and support required; patients educated on side effects, particularly during the first month of therapy.
- Additional monitoring (e.g., sexually transmitted infections, serum lipids, weight) per CDC/USPSTF guidelines.
Administration & Prescribing Requirements
- Long-acting intramuscular injection formulation.
- Oral lead-in is optional but may be used to assess early tolerance prior to long-lasting injection; oral CAB must be procured from Theracom.
- Prior authorization (PA-F) on the VA National Formulary (VANF).
- Must be prescribed by Infectious Diseases, HIV, or other PrEP providers with training/experience in managing HIV PrEP patients.
Document 100: Cabotegravir Rilpivirine CABENUVA CFU Update Feb 2026
Exclusion Criteria
- Known hypersensitivity to any component of the treatment regimen
- Coadministration with strong UGT1A1 and/or CYP3A4 inducers (e.g., rifamycins, dexamethasone, anticonvulsants that induce UGT/CYP)
- Baseline resistance mutations to either CAB or RPV
- History of significant INSTI or NNRTI resistance associated mutations (with the exception of K103N)
- Pregnant or planning to become pregnant
- Active hepatitis B virus (HBV) infection not on active HBV therapy
- Unable to discontinue use of PPI therapy while on ORAL RPV induction/bridge therapy
Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care HIV/ID provider or locally designated expert
- A specific indication for CAB/RPV injection exists, SUCH AS difficulty managing oral medication (e.g., cognitive deficits, homelessness), concern for oral absorption of antiretrovirals, or concern for severe stigma with discovery of oral medications
- Documented history of adherence to HIV-related clinic appointments for at least 3 months
- Provider documents that the patient agrees to show up for clinic injections and understands that failure to do so will impact clinic schedules, increase risk of treatment failure and MAY result in changing back to an oral and potentially salvage regimen
Additional Inclusion Criteria (ONE must be selected)
- Virologically controlled (HIV-1 RNA<50 copies/mL) on a stable oral standard antiretroviral regimen for ≥ 3 months
- Detectable viremia (HIV-1 RNA >50 copies/mL) with a high risk of HIV disease progression and its complications (CD4 count <200 /uL or AIDS-defining illness) and documented adherence issues to oral ART despite reinforcement efforts and clinical support