Switching from Biktarvy to Apretude: Timing and Considerations
Patients should not be switched from Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to Apretude (cabotegravir) the next day, but rather should begin oral Apretude-based regimen at least 1 month before the next scheduled injection would have been due to prevent periods of functional monotherapy. 1
Proper Switching Protocol
- A thorough review of the patient's ART history, prior resistance testing, comorbidities, potential drug interactions, and presence of hepatitis B coinfection is mandatory before making any treatment changes 1, 2
- For patients switching from Biktarvy to injectable cabotegravir (Apretude), the long half-life of cabotegravir requires proper transition to prevent development of resistance 1
- The recommended approach is to maintain the oral regimen (Biktarvy) while initiating the new treatment protocol for Apretude 1
Key Considerations Before Switching
- HIV viral load assessment is recommended 1 month after switching regimens to ensure virologic suppression has been maintained 2
- For patients with chronic hepatitis B virus (HBV) coinfection, switching from Biktarvy to Apretude requires continuation of HBV treatment, as Apretude does not provide treatment for or protection against HBV infection 2
- Patients with documented or suspected resistance to cabotegravir should not be switched to Apretude due to increased risk of treatment failure 2
Risk Factors for Virologic Failure with Apretude
- Clinical trials have shown a 1-2% incidence of virologic failure with emergence of 2-class resistance even with adherence to scheduled injections 2
- Risk factors for virologic failure include:
- Rilpivirine-associated resistance at baseline
- Viral subtype A6
- Body mass index greater than 30 2
Monitoring After Switch
- Check viral load at 1 month post-switch to ensure continued viral suppression 1, 2
- Continue monitoring viral load every 3 months for the first year after switching 1, 2
- Patients unable to attend their scheduled injections need additional close attention and interventions to bring them back to care 2
Common Pitfalls to Avoid
- Never discontinue Biktarvy without immediately starting an effective alternative regimen due to the risk of developing resistance 1
- Do not switch to Apretude if there is a history of resistance to cabotegravir 2
- For patients with chronic HBV, do not switch to a regimen without anti-HBV activity (Biktarvy contains tenofovir alafenamide which is active against HBV) 1, 2
Evidence from Clinical Trials
- The SOLAR study demonstrated that switching from Biktarvy to long-acting cabotegravir plus rilpivirine maintained virologic suppression with non-inferior efficacy (HIV-1 RNA ≥50 copies/mL, 1% vs <1%) 3
- However, more participants in the long-acting group had adverse events leading to withdrawal (6% vs 1%) 3
- Injection site reactions were reported by 70% of participants receiving long-acting therapy, though most (98%) were grade 1 or 2 3
In conclusion, while switching from Biktarvy to Apretude is possible and can maintain virologic efficacy, it requires careful planning and cannot be done with just a next-day switch. The transition must follow proper protocols to ensure continued viral suppression and prevent development of resistance.