FDA Approves
Protease Inhibitor Fosamprenavir (Lexiva) for Treatment of HIV in Children
The
U.S. Food and Drug Administration (FDA) has approved a liquid formulation of the
protease
inhibitor fosamprenavir (Lexiva) for use in HIV patients age 2 to 18 years. Following
is the text of GlaxoSmithKline’s announcement of the approval:
The
new oral suspension [of fosamprenavir], used in combination
with other HIV antiretroviral therapies, provides a therapeutic alternative for
the treatment of children
with HIV, a patient population with comparatively fewer treatment options than adults.
GlaxoSmithKline [GSK] currently manufactures five of the twelve medications approved
for the management of HIV disease in patients under 18.
“Many
advances have been made in HIV treatment for pediatric patients, but children
do not have the same treatment options as adults, necessitating the development
of new antiretroviral therapies with pediatric indications and formulations,”
said Judith Millard, PhD, Director, HIV, InfectiousDiseaseMedicineDevelopmentCenter
at GlaxoSmithKline. “The development and approval of the pediatric formulation
for Lexiva underscore GSK’s commitment
to improving pediatric HIV care.”
The
safety, pharmacokinetic profile, and anti-viral activity of Lexiva Oral Suspension and
Tablets were evaluated in pediatric patients aged 2 to 18 years. Eighteen protease-inhibitor-naďve
pediatric patients received Lexiva Oral Suspension twice daily without ritonavir
in combination with two other HIV medicines.
At week 24, 67 percent of these patients (12/18) achieved HIV RNA < 400 copies/mL,
and the median increase from baseline in CD4 +cell count was 353 cells/mm3.
Of
the patients receiving Lexiva Oral Suspension or Tablets with ritonavir twice
daily in combination with two other HIV medicines, 27 were protease-inhibitor
naive and 30 were protease-inhibitor experienced. At week 24, 70 percent of the
protease-inhibitor naive patients (19/27) and 57 percent of the protease-inhibitor
experienced patients (17/30) achieved HIV RNA <400 copies/mL; median increases
from baseline in CD4+ cell counts were 131 cells/mm3 and 149 cells/mm3
in protease inhibitor-naďve and experienced patients, respectively.
The
most common adverse
reactions in adults associated with Lexiva include diarrhea, rash,
nausea, vomiting, and headache. The adverse reaction profile seen in pediatric
patients taking Lexiva is similar to that observed in adult patients with the
exception of vomiting.
Vomiting
from any cause occurred more frequently among pediatric patients receiving Lexiva
twice daily, with and without ritonavir, compared
with adults receiving Lexiva twice daily.
Dose
information
Lexiva
Oral Suspension will be available in a strength of 50 mg/mL. Pediatric patients
should take Lexiva Oral Suspension twice daily with food. Adults should take the
Oral Suspension without food. Therapy-naive patients 2 to 5 years of age should
take Lexiva Oral Suspension without ritonavir. Lexiva Oral Suspension may be taken
with or without ritonavir by therapy-naive patients 6-18 years of age. Therapy-experienced
patients 6-18 years of age should take Lexiva Oral Suspension with ritonavir.
There
are insufficient data to recommend
dosing of Lexiva in therapy-experienced patients 2 to 5 years of age. The recommended
dosage of Lexiva in patients 2 years and older should be calculated based on body
weight (kg) and should not exceed the recommended
adult dose.
Lexiva
Indication and Background
Lexiva
is indicated for the treatment of HIV infection in combination
with other antiretroviral medications. The following points should be considered
when initiating therapy with Lexiva plus ritonavir (Lexiva/r) in PI-experienced patients:
the PI-experienced patient study was not large enough to reach a definitive conclusion
that Lexiva/r and lopinavir/ritonavir (Kaletra) are clinically equivalent. Once-daily administration
of Lexiva plus ritonavir is not recommended
for adult PI-experienced patients or any pediatric patients.
Important
Safety Information about Lexiva
HIV medicines do not cure HIV infection/AIDS or prevent
passing HIV to others.
Patients
should not take Lexiva if they have had an allergic reaction to Lexiva or Agenerase(amprenavir). High blood sugar, diabetes or worsening of diabetes,
and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors.
When a patient starts taking HIV medicines, his immune system may get stronger
and could begin to fight infections that have been hidden in his body, such as
pneumonia, herpes virus,
or tuberculosis.
If
a patient has new symptoms after starting his HIV medicines, he should tell his
doctor. Changes in body fat may occur in some patients taking antiretroviral therapy.
The cause and long-term health effects of these conditions are not known at this
time.
Skin
rashes can occur in patients taking Lexiva.
06/22/07
Source GlaxoSmithKline.
Lexiva Approved for Treatment of HIV in Pediatric
Patients. Press Release. June 20, 2007.
Index
of All HIV and AIDS Articles by Topic ( A to Z)
The
U.S. Food and Drug Administration (FDA) has approved a liquid formulation of the
