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Lexiva (Fosamprenavir Calcium) - Summary

 
 



LEXIVA SUMMARY

LEXIVA (fosamprenavir calcium) is a prodrug of amprenavir, an inhibitor of HIV protease.

LEXIVA® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.

The following points should be considered when initiating therapy with LEXIVA plus ritonavir in protease inhibitor-experienced patients:

•The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent

[see Clinical Studies ]

.•Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients

[see Dosage and Administration (2.1, 2.2), Clinical Studies (14.2, 14.3)]

.•Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months

[see Clinical Pharmacology].

 


See all Lexiva indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Lexiva (Fosamprenavir)

Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. [2010.09]
PURPOSE: ritonavir (RTV) effectively boosts most protease inhibitors but is associated with significant dose-dependent adverse events (AEs). In an effort to better manage toxicities through a reduced dose of RTV, this study compared fosamprenavir (FPV) boosted with RTV 100 mg (FPV/r100) or with RTV 200 mg (FPV/r200) daily...

Impact of low abundance HIV variants on response to ritonavir-boosted atazanavir or fosamprenavir given once daily with tenofovir/emtricitabine in antiretroviral-naive HIV-infected patients. [2010.04]
Population genotyping (PG) can underestimate resistance if resistance-containing low abundance variants go undetected. PG and clonal analysis (CA) results were compared in virologic failures (VFs) from a 48-week clinical trial that evaluated once-daily fosamprenavir/ritonavir (FPV/r) 1400 mg/100 mg or atazanavir/ritonavir (ATV/r) 300 mg/100 mg, each combined with tenofovir/emtricitabine, in antiretroviral-naive patients.

Steady-state amprenavir and tenofovir pharmacokinetics after coadministration of unboosted or ritonavir-boosted fosamprenavir with tenofovir disoproxil fumarate in healthy volunteers. [2010.03]
Objective An open-label, three-period pharmacokinetic study was conducted to investigate the drug interaction potential between fosamprenavir (FPV) and tenofovir disoproxil fumarate (TDF). Methods Thirty-six healthy subjects received TDF 300 mg once daily (qd) for 7 days (period 1), and then were randomized to 14 days of either FPV 1400 mg twice daily (bid) or FPV/ritonavir (RTV) 700/100 mg bid alone or with TDF (period 2)...

The effect of tenofovir disoproxil fumarate on whole-body insulin sensitivity, lipids and adipokines in healthy volunteers. [2010]
BACKGROUND: Certain antiretrovirals are known to affect lipid and glucose homeostasis. The aim of this study was to assess the effect on insulin sensitivity (determined by peripheral glucose uptake using a hyperinsulinaemic euglycaemic clamp) of tenofovir disoproxil fumarate (TDF) administration compared with placebo for 2 weeks in HIV-1-seronegative healthy male volunteers. Changes in lipids, adiponectin, leptin, plasminogen activator inhibitor 1 (PAI-1) and the adhesion molecules E-selectin and P-selectin were also assessed... CONCLUSIONS: TDF use for 2 weeks does not affect insulin sensitivity, as assessed by the hyperinsulinaemic euglycaemic clamp in HIV-negative male volunteers. TDF use resulted in modest, but statistically significant, reductions in total and LDL cholesterol.

Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naive HIV-1-infected adult subjects. [2009.11]
PURPOSE: Fosamprenavir/ritonavir 1400 mg/100 mg once-daily regimen may have a more favourable tolerability and lipid profile than the fosamprenavir/ritonavir twice-daily regimen, while maintaining comparable antiviral efficacy... CONCLUSION: Though the study did not continue to stage 2, fosamprenavir/ritonavir once daily demonstrated noninferior antiviral efficacy to fosamprenavir/ritonavir twice daily.

more studies >>

Clinical Trials Related to Lexiva (Fosamprenavir)

Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment [Completed]
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of hepatic impairment to healthy subjects.

Pharmacokinetics of LCQ908 in Patients With Renal Impairment [Completed]
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects

KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks [Completed]
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome [Completed]
The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir [Completed]
The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers. A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.

more trials >>

Reports of Suspected Lexiva (Fosamprenavir) Side Effects

Gastrointestinal Haemorrhage (3)Abortion Spontaneous (2)Herpes Zoster (2)Abdominal Discomfort (2)Angina Pectoris (2)Nausea (2)Maternal Exposure During Pregnancy (2)Confusional State (1)Immune Reconstitution Syndrome (1)Foetal Exposure During Pregnancy (1)more >>


Page last updated: 2011-12-09

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