referred to as emtricitabine or FTC, Emtriva belongs
to the nucleoside reverse transcriptase inhibitor
(NRTI) class of anti-HIV drugs. The US Food and
Drug Administration (FDA) approved Emtriva on
July 2, 2003 for use in combination with other
antiretroviral agents for the treatment of HIV
infection in adults aged 18 and older.
is not a cure for HIV infection and its use does
not prevent infection with HIV.
and effectiveness of Emtriva in children and infants
have not been established.
is Emtriva Used in HIV Infection?
HIV treatment-experienced patients, the use of
Emtriva may be considered for adults whose virus
is expected to be susceptible to Emtriva. This
is determined by genotypic or phenotypic testing.
Are There Non HIV-Related Uses of Emtriva?
are also studying Emtriva for the treatment of
chronic hepatitis B virus (HBV) infection.
How is Emtriva Dosed in
comes in capsule form and may be taken with or
recommended dose of Emtriva is 200 mg once daily.
Patients with decreased kidney function may need
to take Emtriva less frequently. Some patients
may benefit from different doses of Emtriva .
patients with baseline creatinine clearance less
than 50 ml/min, the dosing interval of Emtriva
should be adjusted. The dosing interval recommendations
are: creatinine clearance 30 to 49 ml/min, 200
mg every 48 hours; creatinine clearance 15 to
29 ml/min, 200 mg every 72 hours; and creatinine
clearance less than 15 ml/min, 200 mg every 96
Store at 25 C (77 F); excursions permitted to
15 C to 30 C (59 C to 86 F)
are the Contraindications for Taking Emtriva?
is contraindicated in patients with previously
demonstrated hypersensitivity to any of the components
of the drug product. Individuals should tell their
doctor about any medical problems they have before
are the Side Effects and Toxicities of Emtriva?
most frequently reported adverse effects of Emtriva
are headache, nausea, skin rash, and skin discoloration
on palms and soles.
acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with
the use of nucleoside analogues alone or in combination,
including with Emtriva. In some patients coinfected
with HIV and hepatitis, exacerbation of hepatitis
B has been reported after discontinuing treatment
of body fat, peripheral wasting, facial wasting,
breast enlargement, and cushingoid appearance
have been observed in patients receiving antiretroviral
therapy, including Emtriva.
What are the Drug and Food Interactions with Emtriva?
can be taken with or without food: the AUC was
unchanged and Cmax decreased by 29% when the drug
was administered with a 1,000-calorie, high-fat
has been evaluated in healthy volunteers in combination
with Viread (tenofovir), Crixivan (indinavir),
Famvir (famciclovir), and Zerit (stavudine). Results
showed no interactions except for a small increase
in plasma trough concentrations of Emtriva when
it is administered concurrently with tenofovir.
What are Some Aspects of the Pharmacology of Emtriva?
a synthetic nucleoside analogue of cytosine, undergoes
phosphorylation by means of cellular enzymes.
The product of phosphorylation, emtricitabine
5'-triphosphate, inhibits viral DNA synthesis
by competing with the natural substrate deoxycytidine
5'-triphosphate for incorporation into viral DNA
and terminating the DNA chain at the point of
is rapidly and extensively absorbed following
oral administration, reaching peak plasma concentrations
(Cmax) at 1 to 2 hours post-dose.
is in FDA Pregnancy Category B. Animal studies
revealed no increased incidences of fetal variations
or malformations in mice and rabbits at 60- and
120-fold higher exposures, respectively, than
the human exposure at the recommended daily dose.
However, there have been no adequate well-controlled
studies in pregnant women. Results of animal studies
are not always predictive of human response and
emtricitabine should be used during pregnancy
only if clearly needed. It is not known whether
emtricitabine is distributed into human milk.
plasma half-life of Emtriva is approximately 10
isolates with reduced susceptibility to emtricitabine
have been recovered from some patients treated
with emtricitabine alone or in combination with
other antiretroviral agents.
has been noted among some nucleoside analogues.
Emtricitabine-resistant isolates were cross-resistant
to lamivudine (Epivir; Epivir-HBV) and zalcitabine
(Hivid) but retained susceptibility to abacavir
(Ziagen), didanosine (Videx), stavudine (Zerit),
tenofovir (Viread), and zidovudine (Retrovir),
as well as to the non nucleoside reverse transcriptase
inhibitors (NNRTIs) delavirdine (Viracept), efavirenz
(Sustiva), and nevirapine (Viramune).
and Distributes Emtriva?
Sciences Inc, 333 Lakeside Dr, Foster City, CA,