Management of Antiretroviral Therapy Interruption With Missed Biktarvy for 1 Month
Biktarvy should not be doubled to make up for missed doses after a prolonged interruption. [1] Biktarvy should be restarted as soon as possible with clinical follow-up and laboratory assessment to evaluate for viral rebound and treatment failure. [3], [5]
Immediate Actions After the Missed Month
Biktarvy should be resumed as soon as possible after realizing the interruption. [5] Two doses should not be taken at the same time to compensate for missed doses. [1] A prescriber should be contacted promptly to confirm the restart plan and assess need for additional evaluation. [5]
Medication Restart Strategy
Biktarvy should be taken as a single daily dose on the regular dosing schedule after restart. [1] Changes to the regimen should not be made without prescriber direction. [1]
Laboratory Evaluation After Treatment Interruption
HIV viral load testing should be obtained after restarting to assess for rebound viremia and return to virologic suppression. [3], [4] CD4 count should be measured as part of monitoring after treatment interruption and restart. [3], [4]
Monitoring Schedule for Viral Load and CD4 Count
After modification of antiretroviral therapy, HIV viral load should be performed within 4 to 8 weeks after the change. [3] HIV RNA should be repeated every 4 to 8 weeks if detectable after encouraging adherence or changing therapy until viral suppression is achieved. [3]
Assessment for Drug Resistance and Virologic Failure
If HIV RNA remains elevated after restart and adherence support, virologic failure evaluation should be performed. [4] Genotypic drug-resistance testing should be performed while the person remains on the failing regimen or within 4 weeks of discontinuation of a non–long-acting regimen. [4] Resistance testing may still provide useful information after longer discontinuations, while recognizing that previously selected mutations can be missed due to lack of drug-selective pressure. [4]
Hepatitis B Considerations
HBV coinfection status should be considered when restarting or discontinuing Biktarvy because HBV can worsen after stopping products containing emtricitabine and/or tenofovir. [1] If HBV coinfection is present, close monitoring of hepatic function for several months after stopping antiretroviral therapy should be ensured. [1]
Adherence Support and Prevention of Further Interruptions
Adherence interventions should be implemented with the goal of uninterrupted ART delivery and sustained viral suppression. [5] Barriers to medication access and ongoing adherence should be addressed during the restart period to prevent recurrence of interruption. [5]
When Urgent Clinical Reassessment Is Needed
Urgent evaluation should be pursued for symptoms suggestive of severe hepatotoxicity or lactic acidosis during or after restarting. [1]
Key Clinician Checklist for the Restart Visit
HIV viral load and CD4 count should be ordered after restart. [3], [4] Hepatitis B infection history should be reviewed or HBV testing confirmed if not previously documented. [1] Adherence barriers should be assessed, and a plan to prevent future interruptions should be documented. [5] Resistance testing should be planned if viral load rebound persists after restart and adherence support. [4]