CABOTEGRAVIR/ RILPIVIRINE INJ,SUSP,SA
Clinical Criteria Summary
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 cabotegravir or rilpivirine
- History of significant INSTI or NNRTI resistance-associated mutations (with the exception of K103N)
- Prior virologic failure to any previous antiretroviral regimen (defined as HIV-1 RNA >400 copies per mL after initial viral suppression)
- 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 rilpivirine induction/bridge therapy
Inclusion Criteria
- Virologically controlled (HIV-1 RNA <50 copies/mL) on a stable oral standard antiretroviral regimen for ≥ 6 months with two or more HIV-1 RNA labs <50 copies/mL in the past 12 months (one in the previous 6–12 months, and one 0–6 months)
- 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 the past year
- Provider documents that the patient agrees to reliably show up for clinic injections and understands that failure to do so will impact clinic schedules and may result in changing back to an oral regimen
Supplemental Clarifications
- A change in a prior antiretroviral regimen due to adverse events, safety concerns, ease, or convenience is NOT considered evidence of virologic failure, provided the patient remained suppressed through the change.