Biktarvy for HIV Post-Exposure Prophylaxis Protocol
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a preferred regimen for HIV post-exposure prophylaxis (PEP), administered as a single tablet once daily for 28 days. 1, 2
Recommended Protocol
- Initiate Biktarvy as soon as possible after exposure, ideally within 1-2 hours, but no later than 72 hours post-exposure 1, 2
- Administer as a single tablet once daily for a complete 28-day course 1, 2
- Biktarvy can be taken with or without food 3
- Do not delay the first dose while waiting for laboratory test results 1
Baseline Assessment Before Starting PEP
- Perform HIV testing (rapid or laboratory-based antigen/antibody combination test) 1, 4
- Screen for sexually transmitted infections 1
- Assess pregnancy status in women of childbearing potential 1
- Test for hepatitis B and C 1, 3
- Evaluate baseline renal function with creatinine assessment 1, 3
Follow-up Monitoring
- Schedule follow-up at 24 hours (in person or remote) after initiating PEP 1
- Conduct HIV testing at 4-6 weeks and 12 weeks after exposure 1
- Monitor for adverse effects and adherence throughout the 28-day course 1
- Discontinue PEP if the source is determined to be HIV-negative at any point 1
Special Considerations
- For pregnant individuals, dolutegravir with TAF/FTC is the preferred regimen rather than Biktarvy 2
- For children ≥14 kg and ≥2 years of age, Biktarvy is available in pediatric formulation (30 mg BIC/120 mg FTC/15 mg TAF) 2, 3
- For patients with severe renal impairment (CrCl <30 mL/min), Biktarvy is not recommended 3
- For patients with severe hepatic impairment (Child-Pugh Class C), Biktarvy is not recommended 3
Alternative Regimens When Biktarvy Is Not Available/Appropriate
- Dolutegravir plus emtricitabine/tenofovir alafenamide (Descovy) 1, 4
- TDF/FTC with boosted darunavir or TDF/FTC/cobicistat/elvitegravir 1
Common Pitfalls to Avoid
- Delaying initiation beyond 72 hours significantly reduces effectiveness 1, 2
- Mistaking PEP for a single-dose intervention rather than a full 28-day course 2
- Failing to check for drug interactions, particularly with medications containing polyvalent cations 2
- Not transitioning high-risk individuals to PrEP after completing PEP 1, 4
- Discontinuing treatment prematurely due to mild side effects 1
Transition to PrEP
- Assess ongoing HIV risk at the completion of the 28-day PEP course 1
- For individuals with continued risk, create a PEP-to-PrEP transition plan 1, 4
- Ensure no gap between PEP completion and PrEP initiation for those with ongoing risk 4
Biktarvy offers several advantages as a PEP regimen including once-daily dosing, high tolerability, and the convenience of a single-tablet regimen, which may improve adherence to the complete 28-day course 2, 5. Animal studies have demonstrated high efficacy of bictegravir/emtricitabine/tenofovir alafenamide combinations for post-exposure prophylaxis 5.