BOXED WARNING Severe acute HBV exacerbations reported after discontinuation in HBV-infected individuals (monitor hepatic function ≥several months; anti-HBV therapy may be warranted). For PrEP: prescribe only to confirmed HIV-negative individuals (test immediately before and at least q3mo during use); drug-resistant HIV-1 has emerged when PrEP was used during undetected acute HIV-1 infection.
FDA dosing
Population
Start
Target
Max
HIV-1 treatment (with other antiretrovirals)
Adults & peds ≥35 kg
1 tab (FTC 200 mg/TDF 300 mg) QD, with or without food
1 tab (FTC 200 mg/TDF 300 mg) QD, with or without food
Same
1 tab QD
Renal Treatment: CrCl ≥50 no adjustment; CrCl 30–49 1 tab q48h (monitor closely); CrCl <30 or hemodialysis not recommended. PrEP: not recommended if CrCl <60. No pediatric renal-dosing data
Hepatic Undefined
Renal dosing intervals use CrCl calculated with ideal (lean) body weight
Instructions
Test for HBV before or when initiating
Assess serum creatinine, estimated CrCl, urine glucose and protein before initiation and during use (plus serum phosphorus in CKD)
PrEP: confirm HIV-negative immediately before starting, at least q3mo during use, and on diagnosis of any STI; do not start with signs/symptoms of acute HIV-1 unless negative status confirmed
PrEP: use as part of comprehensive prevention strategy; effectiveness strongly correlated with daily adherence
Available strengths
tab 100/150, 133/200, 167/250, 200/300 mg
Contraindications
PrEP: unknown or positive HIV-1 status
Cautions
Severe acute HBV exacerbation on discontinuation in HBV-infected individuals — monitor months after stopping
PrEP in undetected HIV-1 infection selects drug resistance — TRUVADA alone is not a complete treatment regimen
New or worsening renal impairment incl. acute renal failure and Fanconi syndrome; avoid concurrent/recent nephrotoxic agents (e.g., high-dose/multiple NSAIDs)
Bone mineral density decreases and mineralization defects (osteomalacia with proximal renal tubulopathy); consider BMD assessment with fracture history/osteoporosis risk
Lactic acidosis/severe hepatomegaly with steatosis, incl. fatal cases — suspend if suspected
PrEP (>2% and > placebo): headache, abdominal pain, weight decreased
Skin hyperpigmentation (FTC, 3%)
Pregnancy APR observational data: no increased risk of major birth defects (FTC 2.3%, TDF 2.1% vs 2.7% background); for at-risk women, consider continuing/initiating PrEP during pregnancy (HIV acquisition risk rises in pregnancy)
Lactation HIV-1 treatment: do not breastfeed (CDC — HIV transmission risk). PrEP: weigh benefits/risks; do not breastfeed if acute HIV-1 suspected; FTC detectable (low) in infant plasma, tenofovir undetectable