Should a transgender male on Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) with elevated HIV RNA levels consider changing their medication?

Do Not Change Medication – Repeat HIV RNA and Assess Adherence First

This patient does not meet criteria for virologic failure and should not change their Biktarvy regimen at this time. The current HIV RNA of 159 copies/mL represents a single detectable measurement that requires confirmation before any treatment modification 1.

Defining Virologic Failure

Virologic failure is defined as HIV RNA >200 copies/mL on at least two consecutive measurements 1. This patient's current value of 159 copies/mL:

• Falls below the threshold for confirmed virologic failure
• Represents only a single measurement
• Does not automatically indicate treatment failure

The 2020 IAS-USA guidelines explicitly state that virologic failure requires a confirmed HIV RNA level above 200 copies/mL on 2 consecutive measurements 1.

Immediate Management Steps

1. Repeat HIV RNA Testing Within 4 Weeks

• Obtain a confirmatory HIV RNA measurement within 4 weeks 1
• A single detectable value between 50-200 copies/mL may represent a "blip" rather than true virologic failure 1
• Virologic blips (isolated increases to <1000 copies/mL with return to undetectable levels) rarely progress to virologic failure, and switching ART in this setting is not recommended 1

2. Assess Medication Adherence

• Poor adherence is the most common cause of detectable viremia 1
• Evaluate barriers to adherence including:
  • Medication access and affordability
  • Dosing schedule conflicts
  • Side effects or tolerability issues
  • Psychosocial factors 1

3. Rule Out Intercurrent Infections or Vaccination

• Recent infections or vaccinations can cause transient increases in HIV RNA 1
• These do not represent true virologic failure

Why Biktarvy Should Be Continued

High Efficacy Profile

• Biktarvy is listed as a generally recommended initial regimen (evidence rating AIa) by the IAS-USA Panel 2
• Clinical trials demonstrate 89-93% of participants achieve HIV-1 RNA <50 copies/mL at week 48 3, 4
• At 144 weeks, 82-84% maintain viral suppression 5

Exceptional Resistance Barrier

• No treatment-emergent resistance to bictegravir has been observed in clinical trials through 144 weeks 3, 4, 5
• Bictegravir has a high genetic barrier to resistance 2
• This is particularly important for integrase inhibitor-based regimens 1

Safety and Tolerability

• Biktarvy demonstrates minimal drug-drug interactions 2
• Low discontinuation rates due to adverse events (0-2% in clinical trials) 3, 4, 5
• Well-tolerated with few treatment-related adverse events 6, 7

When to Consider Changing Therapy

Only proceed with resistance testing and regimen change if:

1. Confirmed virologic failure occurs: HIV RNA >200 copies/mL on two consecutive measurements separated by at least 4 weeks 1

2. If confirmed failure develops, obtain HIV genotype testing including integrase resistance testing while the patient remains on the failing regimen 1

3. For integrase inhibitor failure with resistance mutations: Consider dolutegravir 50 mg twice daily with at least one other active drug, or a boosted PI regimen with 2 NRTIs (at least one fully active) 1

Special Considerations for Transgender Patients

• No specific modifications to HIV treatment guidelines are needed based on transgender status alone 1
• Ensure no drug-drug interactions with gender-affirming hormone therapy
• Biktarvy's minimal interaction profile makes it particularly suitable when multiple medications are used 2

Monitoring Plan

• Repeat HIV RNA in 4 weeks 1
• If repeat value is <50 copies/mL, resume routine monitoring every 3-6 months 1, 8
• If repeat value remains 50-200 copies/mL, continue current regimen with intensive adherence support and close monitoring 1
• Only if HIV RNA rises to >200 copies/mL on repeat testing should resistance testing and regimen change be considered 1