BIKTARVY
Combination product
Pronunciation: bik-TEG-ra-veer and em-tri-SIT-a-been and ten-OF-oe-veer al-a-FEN-a-mide (bik-TAR-vee)
Combination of Bictegravir, Emtricitabine and Tenofovir alafenamide.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Components (3)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| HIV-1 infection (complete regimen) | Adults & peds >=25 kg; CrCl >=30 mL/min, or virologically-suppressed adults on chronic hemodialysis | 1 tab (BIC 50/FTC 200/TAF 25 mg) QD | 1 tab QD | 1 tab QD |
| HIV-1 infection | Peds 14 to <25 kg; CrCl >=30 mL/min | 1 tab (BIC 30/FTC 120/TAF 15 mg) QD | 1 tab QD | 1 tab QD |
| HIV-1 infection | Pregnant, virologically-suppressed on stable regimen | 1 tab (BIC 50/FTC 200/TAF 25 mg) QD | 1 tab QD | 1 tab QD |
Renal Not recommended if CrCl 15 to <30, or <15 not on chronic hemodialysis, or <15 with no antiretroviral history; virologically-suppressed adults on chronic hemodialysis may use standard dose (give after dialysis)
Hepatic No adjustment for mild-moderate (Child-Pugh A/B); not recommended in severe (Child-Pugh C)
Instructions
- Take once daily with or without food
- Test for hepatitis B before or when initiating
- For children unable to swallow whole tablet, may split and take all parts within ~10 minutes
Available strengths
- tab 30/120/15, 50/200/25 mg
Contraindications
- Coadministration with dofetilide (risk of increased dofetilide levels)
- Coadministration with rifampin (decreased bictegravir levels; loss of efficacy/resistance)
Cautions
- Severe acute exacerbation of hepatitis B on discontinuation
- Loss of virologic response/adverse reactions from drug interactions
- Immune reconstitution syndrome
- New onset or worsening renal impairment
- Lactic acidosis/severe hepatomegaly with steatosis
Adverse reactions
- Diarrhea
- Nausea
- Headache
Pregnancy Recommended only in virologically-suppressed individuals; APR data show no drug-associated increase in major birth defects; monitor viral load closely (lower exposures in pregnancy).
Lactation Breastfeeding not recommended (HIV-1 transmission risk); BIC, FTC, TAF and tenofovir present in human milk.
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 30/120/15 mg | tab | 30 qd | — | $4,099.65 | not offered |
| 50/200/25 mg | tab | 30 qd | — | $4,101.85 | not offered |
Part D rank #220.