Can Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) be used for Post-Exposure Prophylaxis (PEP)?

Biktarvy for HIV Post-Exposure Prophylaxis (PEP)

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) is an effective and well-tolerated option for HIV post-exposure prophylaxis (PEP) and can be recommended as a preferred regimen based on recent evidence showing high completion rates and favorable safety profiles.

Current PEP Recommendations and Regimens

Preferred PEP Regimens

According to the most recent guidelines, preferred regimens for PEP include:

• Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) is now a preferred regimen for most adults and adolescents requiring PEP 1
• Dolutegravir plus (tenofovir alafenamide or tenofovir disoproxil fumarate) plus (emtricitabine or lamivudine) 1
• Previously, recommended regimens included lopinavir/ritonavir-based or PI-based regimens 2

Key Principles for PEP Administration

• PEP should be initiated as soon as possible, ideally within 24 hours but no later than 72 hours after exposure 1
• A complete 28-day course of antiretroviral medications is recommended 2, 1
• The first dose should not be delayed due to pending laboratory test results 1

Evidence Supporting Biktarvy for PEP

Safety and Tolerability

Recent studies specifically evaluating Biktarvy for PEP have shown:

• High completion rates of 96.4% in a Chinese study 3 and 90.4% in a Boston study 4
• Mild side effects profile, primarily consisting of nausea/vomiting (15.4%), fatigue (9.6%), and diarrhea (7.7%) 4
• No serious adverse events or significant hepatic or renal toxicity 4, 3
• Better tolerability compared to historical PEP regimens 4

Advantages of Biktarvy for PEP

• Single-tablet regimen (STR) - improves adherence and completion rates
• Once-daily dosing - more convenient than multiple daily doses
• High genetic barrier to resistance - important when source patient's resistance profile is unknown
• Fewer drug-drug interactions compared to PI-based regimens

PEP Implementation Algorithm

1. Exposure Assessment:

   • Determine if exposure presents substantial risk for HIV transmission
   • Ideally initiate within 24 hours, but no later than 72 hours post-exposure

2. Baseline Testing:

   • Rapid HIV test or laboratory-based antigen/antibody combination test
   • Serum creatinine level
   • Hepatitis B surface antigen
   • Hepatitis C antibody
   • STI screening as appropriate

3. PEP Regimen Selection:

   • First choice: Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) once daily for 28 days
   • Alternative: Dolutegravir plus (tenofovir alafenamide or tenofovir disoproxil fumarate) plus (emtricitabine or lamivudine)

4. Follow-up:

   • 24-hour follow-up (remote or in-person)
   • Clinical follow-up at 4-6 weeks and 12 weeks post-exposure
   • HIV testing at follow-up visits

Special Considerations and Cautions

• Renal function: Monitor creatinine clearance, especially in patients with pre-existing renal disease
• Pregnancy: Assess pregnancy status in women of childbearing potential
• Drug interactions: Review potential interactions with current medications
• Transition to PrEP: Consider PrEP for individuals with ongoing HIV risk after completing PEP 1

Conclusion

Biktarvy represents a significant advancement in PEP regimens due to its single-tablet formulation, once-daily dosing, excellent tolerability profile, and high completion rates. The most recent evidence strongly supports its use as a preferred option for HIV PEP.