Truvada

E409694

Truvada is a prescription antiretroviral medication widely used both to treat HIV infection and as pre-exposure prophylaxis (PrEP) to help prevent HIV in high-risk individuals.

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All labels observed (2)

Statements (48)

Predicate Object
instanceOf HIV medication
antiretroviral medication
brand-name drug
fixed-dose combination drug
approvedBy Food and Drug Administration
surface form: U.S. Food and Drug Administration
ATCCode J05AR02
boxedWarning risk of acute exacerbations of hepatitis B after discontinuation
risk of lactic acidosis and severe hepatomegaly with steatosis
commonSideEffect diarrhea
headache
nausea
containsDoseStrength emtricitabine 200 mg
tenofovir disoproxil fumarate 300 mg
contraindication severe renal impairment
developer Gilead Sciences (board member)
surface form: Gilead Sciences
dosageForm tablet
drugClass nucleoside reverse transcriptase inhibitor
nucleotide reverse transcriptase inhibitor
FDAApprovalIndication pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection
treatment of HIV-1 infection in combination with other antiretrovirals
FDAApprovalYear 2004
hasActiveIngredient emtricitabine
tenofovir disoproxil fumarate
hasGenericName Truvada self-linksurface differs
surface form: emtricitabine and tenofovir disoproxil fumarate
hasPatentHolder Gilead Sciences (board member)
surface form: Gilead Sciences
indication post-exposure prophylaxis for HIV (off-label in some settings)
pre-exposure prophylaxis for HIV-1 (PrEP)
treatment of HIV-1 infection
isGenericAvailable true
isNotEffectiveAgainst established HIV infection when used alone
isOnWHOEML yes
isUsedWith other antiretroviral agents
legalStatusEU prescription-only
legalStatusUS prescription-only
marketingAuthorizationHolder Gilead Sciences (board member)
surface form: Gilead Sciences
pregnancyCategoryUS B (historical classification)
prevents sexual transmission of HIV-1 when used as PrEP with adherence
requiresCombinationForTreatment yes
requiresMonitoring HIV status before and during PrEP
renal function
routeOfAdministration oral
seriousSideEffect decreased bone mineral density
renal impairment
takenFrequency once daily
targets HIV-1
surface form: HIV-1 reverse transcriptase
usedForPopulation adolescents at high risk of HIV infection (meeting weight and other criteria)
adults at high risk of HIV infection
usedInProgram HIV prevention programs worldwide

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

Gilead Sciences (board member) product Truvada
subject surface form: Gilead Sciences
Truvada hasGenericName Truvada self-linksurface differs
this entity surface form: emtricitabine and tenofovir disoproxil fumarate