What labs should be monitored while on Cabenuva (rilpivirine and cabotegravir)?

Laboratory Monitoring for Cabenuva (Cabotegravir and Rilpivirine)

Monitor HIV RNA levels at 4-6 weeks after starting therapy, then every 3 months until suppressed for at least 1 year, followed by every 6 months thereafter, along with baseline and periodic liver function tests, complete blood count, and renal function assessments. 1

Baseline Laboratory Testing (Prior to Initiation)

Before starting Cabenuva, the following laboratory tests are essential:

• HIV RNA level to confirm viral suppression (<50 copies/mL), as Cabenuva is only indicated for virologically suppressed patients 1
• CD4+ cell count to assess immune status 1
• Hepatic function panel including ALT, AST, alkaline phosphatase, total and direct bilirubin, and albumin to screen for pre-existing liver disease 1, 2
• Complete blood count (CBC) to establish baseline hematologic parameters 1
• Renal function tests including creatinine and calculated glomerular filtration rate (GFR) 1
• Lipid panel and glucose level for general health assessment 1
• Pregnancy test in individuals of childbearing potential 1
• Viral hepatitis screening (hepatitis A, B, and C) to identify co-infections 1
• ART resistance testing (reverse transcriptase-protease genotype) if not previously documented 1

Monitoring During Treatment

Early Treatment Phase (First 4-6 Weeks)

• HIV RNA levels should be measured at 4-6 weeks after starting Cabenuva to assess early virologic response and adherence 1
• Adherence and tolerability assessment should be performed at this visit 1

Ongoing Monitoring Schedule

For virologically stable patients:

• HIV RNA levels every 3 months until suppressed for at least 1 year, then can be extended to every 6 months if the patient remains clinically stable and adherent 1
• CD4+ cell counts every 6 months until consistently above 250 cells/μL for at least 1 year; after that, no further CD4+ assessments are warranted unless virologic failure occurs 1
• Liver function tests should be monitored periodically, as hepatotoxicity has been reported with cabotegravir 2
• Complete blood count and hepatic function panel as clinically indicated 1

At Every Clinical Encounter

• Evaluation for medication toxicity including assessment for depressive symptoms, as depressive disorders have been reported with cabotegravir plus rilpivirine 1, 2
• Screening for sexually transmitted infections (STIs) at all exposed mucosal sites if potential exposures exist 1
• General health maintenance assessments including age- and risk-appropriate cancer screening 1

Management of Abnormal Results

Virologic Failure

• If HIV RNA levels have not decreased to below 200 copies/mL after 12-24 weeks of therapy and adherence is adequate, resistance genotyping based on the regimen is advised 1
• Eight confirmed virological failures occurred in clinical trials, with five of eight having archived NNRTI resistance-associated mutations to rilpivirine at baseline 3

Hepatotoxicity

• Discontinue Cabenuva immediately if hepatotoxicity is suspected 2
• Clinical and laboratory monitoring should be intensified if liver enzyme elevations occur 2

Common Pitfalls to Avoid

• Failing to confirm viral suppression before initiating Cabenuva, as it is only indicated for virologically suppressed patients with no history of treatment failure 2
• Not screening for archived NNRTI resistance in patients with prior treatment experience, as this increases risk of virologic failure 3
• Inadequate monitoring for depressive symptoms, which have been reported with this regimen and require prompt evaluation 2
• Missing the 4-6 week HIV RNA check, which is critical for early detection of treatment failure or adherence issues 1
• Overlooking drug-drug interactions that may reduce cabotegravir exposure, particularly with UGT1A1 inducers 2