Can HIV‑positive individuals (adults and adolescents ≥ 12 years or ≥ 30 kg) safely take Viktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as part of antiretroviral therapy?

Can HIV-Positive People Take Viktarvy?

Yes, HIV-positive individuals can and should take Viktarvy (bictegravir/emtricitabine/tenofovir alafenamide)—it is FDA-approved and guideline-recommended as a complete treatment regimen for HIV-1 infection in adults and children weighing at least 14 kg. 1

Guideline-Based Recommendations for Initial Treatment

Viktarvy (BIC/TAF/FTC) is a preferred first-line regimen for treatment-naïve HIV-positive adults and adolescents. 2

• The 2025 International Antiviral Society-USA (IAS-USA) guidelines recommend bictegravir/emtricitabine/tenofovir alafenamide as a generally recommended initial regimen with AIa evidence rating 2
• The 2018 IAS-USA guidelines similarly listed BIC/TAF/FTC among generally recommended initial regimens 2
• This single-tablet regimen provides once-daily dosing with high efficacy and tolerability 3, 4

Who Can Take Viktarvy

Treatment-Naïve Patients

• Viktarvy is approved for adults and children ≥14 kg with no prior antiretroviral treatment history 1
• No HLA-B*5701 testing is required (unlike abacavir-containing regimens), making it suitable for rapid-start treatment 5
• Can be initiated before resistance testing results are available in most cases 2

Treatment-Experienced Patients

• Viktarvy can replace current regimens in virologically suppressed patients (HIV-1 RNA <50 copies/mL) with no known resistance to bictegravir or tenofovir 1
• Phase 3 trials demonstrated non-inferiority to dolutegravir-based therapy through 96 weeks with no emergent resistance 3

Pediatric Populations

• Approved for children aged ≥2 years weighing ≥14 kg 1, 6, 7
• Adolescents aged 12-18 years and weighing ≥35 kg achieved similar efficacy to adults with 88% maintaining viral suppression at week 96 3
• Children aged 6-12 years weighing ≥25 kg demonstrated maintained virological suppression in 98% at week 48 6
• Younger children (≥2 years, 14-25 kg) receive a lower-dose formulation (30 mg/120 mg/15 mg) with comparable safety and efficacy 7

Special Populations and Considerations

Pregnancy

• Dolutegravir-based regimens are preferred over bictegravir during pregnancy due to more extensive safety data 2
• BIC/TAF/FTC is listed as an alternative regimen in pregnancy (BIIa evidence rating) 2
• Bictegravir exposures are lower during pregnancy compared to postpartum, but this is not considered clinically significant in virologically suppressed pregnant individuals 1
• If a patient is stable on Viktarvy and becomes pregnant, switching to dolutegravir-based therapy is recommended, though continuation with closer monitoring is an option after counseling 2

Hepatitis B Co-infection

• Viktarvy is an excellent choice for HIV/HBV co-infection because it contains both tenofovir alafenamide and emtricitabine, which are active against HBV 5
• This fulfills the dual treatment requirement without additional medications 5

Renal Impairment

• Viktarvy can be used in patients with creatinine clearance ≥30 mL/min 5
• This represents an advantage over some other regimens that require CrCl ≥50 mL/min 5
• Tenofovir alafenamide has improved renal safety compared to tenofovir disoproxil fumarate 2

Tuberculosis Co-treatment

• BIC/TAF/FTC is NOT currently recommended with rifampin due to drug-drug interactions and inadequate data (AIII evidence rating) 2
• If tuberculosis treatment is needed, switch to dolutegravir (50 mg twice daily) with TAF/FTC or efavirenz-based regimens 2

Important Contraindications and Cautions

When NOT to Use Viktarvy

Do not use if:

• Known resistance to bictegravir or tenofovir is present or suspected 1
• Concurrent rifampin therapy is required 2
• Creatinine clearance is <30 mL/min 5

Situations Requiring Alternative Regimens

Consider dolutegravir-based therapy instead if:

• Pregnancy is confirmed or planned (dolutegravir is preferred) 2
• Prior exposure to long-acting cabotegravir as PrEP (use boosted darunavir initially until resistance testing excludes InSTI resistance) 2
• Active tuberculosis requiring rifampin treatment 2

Clinical Efficacy and Safety Profile

Efficacy Data

• At week 96,88% of treatment-naïve patients on BIC/TAF/FTC achieved HIV-1 RNA <50 copies/mL, demonstrating non-inferiority to dolutegravir/abacavir/lamivudine 3
• No treatment-emergent resistance to any component of Viktarvy was observed in phase 3 trials 3, 6
• Bictegravir has a high genetic barrier to resistance 6, 4, 5

Tolerability

• Viktarvy was better tolerated than dolutegravir/abacavir/lamivudine with fewer drug-related adverse events (28% vs 40%) 3
• Most common adverse events were nausea (11%), diarrhea (15%), and headache (13%) 3
• No participants discontinued due to adverse events in the bictegravir group compared to 2% in the dolutegravir group at week 96 3
• In pediatric populations, the regimen was well tolerated with most adverse events grade 2 or less 6, 7

Practical Prescribing Algorithm

For newly diagnosed HIV-positive patients:

1. Confirm HIV-1 diagnosis with appropriate testing 2
2. Obtain baseline labs (CBC, chemistry, HIV RNA, CD4 count, resistance testing, HBsAg, HCV antibody) 2
3. Start Viktarvy immediately without waiting for resistance results in most cases (one tablet once daily) 2
4. Adjust regimen if resistance testing reveals bictegravir or tenofovir resistance 1

For treatment-experienced patients:

1. Confirm viral suppression (HIV-1 RNA <50 copies/mL) 1
2. Review treatment history and prior resistance testing 1
3. Switch to Viktarvy if no known resistance to bictegravir or tenofovir 1
4. Monitor HIV RNA at 1 month post-switch to ensure maintained suppression 2

Common Pitfalls to Avoid

• Do not use Viktarvy for HIV prevention (PrEP)—it is only approved for treatment 1
• Do not continue Viktarvy if rifampin is started—switch to dolutegravir twice daily or efavirenz-based regimen 2
• Do not assume pregnancy safety is equivalent to dolutegravir—counsel patients and consider switching 2
• Do not prescribe if CrCl <30 mL/min—this is outside the approved indication 5