A previous study had shown a 30% reduction in blood concentration of amprenavir
when Zantac (another drug for reducing stomach acidity) was given one hour before Lexiva .
LEXIVA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of this product or to amprenavir
No relevant effects of TDF on plasma amprenavir
(APV) PK were demonstrated when once daily TDF 300mg was given in combination with once daily LEXIVA/r 1400/100 or 1400/200.
Comparator PIs included lopinavir, saquinavir, amprenavir
and indinavir; however, lopinavir was selected for 50% of patients in the comparator PI arm.
FDA Pregnancy Categories of Antiretroviral Drugs Nucleoside Nonnucleside Reverse Reverse Trancriptase Trancriptase Protease Category Inhibitors Inhibitors Inhibitors B didanosine atazanavir emtricitabine nelfinavir tenofovir ritonavir saquinavir C abacavir efavirenz amprenavir
lamivudine (3TC) nevirapine undinavir stavudine (d4T) lopinavir/ritonavir zalcitadine (ddC) zidovudine (AZT) D Fusion Miscellaneous Category Inhibitors Agents B enfurtide C D Hydroxyurea Note: No antiretroviral agents in pregnancy category A or X.
Lexiva is converted into amprenavir
(Agenerase), a previously approved protease inhibitor, in the body.
Researchers in Denmark report that the protease inhibitor amprenavir
(Agenerase) lowers the levels of delavirdine (Rescriptor).
When LEXIVA was simultaneously co-administered with Nexium there was no effect on amprenavir
(the active molecule LEXIVA) steady-state plasma levels.
The Food and Drug Administration (FDA) has approved an official recommended dose for combining the protease inhibitors amprenavir
(Agenerase) and ritonavir (Norvir).
Patients with a current regimen can continue the regimen unless the drugs have a specific contraindication in pregnancy such as efavirenz and amprenavir
, which are associated with congential abnormalities.
T20-206 was an open label, randomized Phase II controlled study of T-20 comparing three doses of T-20 in combination with a regimen of oral antiretrovirals (abacavir, amprenavir
, ritonavir and efavirenz) in 71 nNRTI-naive and protease inhibitor (PI)- and nucleoside reverse transcriptase inhibitor (NRTI)-experienced HIV patients.
These data complement findings from a clinical study of LEXIVA/r in protease inhibitor experienced patients wherein plasma amprenavir
trough concentrations were similar for subjects receiving tenofovir as compared to subjects not receiving tenofovir," said Doug Manion, M.