You have reached the HIVandHepatitis.com legacy site. Please visit our new site at hivandhepatitis.com

 Google Custom Search
Lexiva Tablet

Lexiva (fosamprenavir calcium)

Articles on Lexiva
Full US Prescribing Inormation

Patient Information
Important Safety Information
Drug Interactions
Dosing
Resistance Profile

www.lexiva.com


Articles on Lexiva


FDA and GlaxoSmithKline Warn Fosamprenavir (Lexiva) May Be Linked to Increased Risk of Blood Lipid Elevation and Heart Attacks
12-08-2009

Fosamprenavir (Lexiva) Works Well with 100 mg Ritonavir (Norvir) at 96 Weeks in Treatment-naive Patients

4-03-2009


Efficacy and Safety of Fosamprenavir + Ritonavir (FPV/RTV) 700mg/100mg Twice Daily (BID) Versus FPV/RTV 1400mg/100mg Once Daily (QD) with ABC/3TC QD over 24 Weeks
11-05-2008

Limb and Trunk Fat Changes by Total Body DEXA After 96 Weeks of Treatment with Once Daily (QD) Fosamprenavir (FPV) Boosted with either 100 mg or 200 mg of Ritonavir (/r) plus Abacavir (ABC)/Lamivudine(3TC): COL100758
11-05-2008


Week 96 Virology Analysis of COL100758, a Study of Once-Daily (QD) Fosamprenavir (FPV) Boosted with 100 mg or 200 mg Ritonavir (/r) with Abacavir /Lamivudine (ABC/3TC) in Antiretroviral Naïve HIV-infected Patients
11-05-2008


Long-Term Efficacy and Safety of Abacavir/Lamivudine (ABC/3TC) with Fosamprenavir + Ritonavir Versus Lopinavir/Ritonavir (LPV/r) over 144 Weeks
11-05-2008

Switching from a 200mg-Ritonavir (RTV, r)-Boosted Fosamprenavir (FPV) Regimen (700mg/100mg BID or 1400mg/200mg QD) to a 100mg RTV-Boosted FPV Regimen (1400mg/100mg QD) Yields Similar Efficacy and Safety (the LESS Trial)
11-05-2008

Fosamprenavir (Lexiva) Is Equally Effective with a Lower 100 mg Ritonavir (Norvir) Boosting Dose
11-05-2008


Lexiva - Important Safety Information

• You should not take LEXIVA if you 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 you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your 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. Rarely, rashes were severe or life threatening.
• Opportunistic infections can develop when you have HIV and your immune system is weak. It is very important that you see your healthcare provider regularly while you are taking LEXIVA to discuss any side effects or concerns.
• Most common side effects in clinical studies were diarrhea, headache, nausea, rash, and vomiting. In most cases, these side effects did not cause people to stop taking their medicine.


Lexiva - Drug Interactions

• LEXIVA should not be taken with: AGENERASE® (amprenavir), Halcion® (triazolam), ergot medications (Cafergot®, Migranal®, D.H.E. 45®, and others), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Zocor® (simvastatin), Mevacor®, (lovastatin), Rifadin® (rifampin), Rescriptor® (delavirdine mesylate), or St. John's wort (Hypericum perforatum). If you are taking Norvir® (ritonavir), you should not take Tambocor® (flecainide), or Rythmol® (propafenone hydrochloride).
• Serious and/or life-threatening events could occur between LEXIVA and other medications, including Cordarone® (amiodarone), lidocaine (intravenous only), Elavil® (amitriptyline HCl) and Tofranil® (imipramine pamoate), tricyclic antidepressants, and Quinaglute® (quinidine).
• Women who use birth control pills should choose a different kind of contraception. LEXIVA can affect the safety and effectiveness of birth control pills.
• Patients taking Viagra® (sildenafil citrate) or LEVITRA® (vardenafil HCl) with LEXIVA may be at an increased risk of side effects.
• This list of drug interactions is not complete. Be sure to tell your healthcare provider about all medicines you are taking or plan to take, including over-the-counter drugs, vitamins, and herbals.


Lexiva - Dosing

Your healthcare provider may prescribe LEXIVA for you either once a day or twice a day, based on your HIV treatment history. Often LEXIVA can be taken at the same time you take your other HIV medicines.

When LEXIVA is prescribed with ritonavir, this is known as "boosting" the dose of LEXIVA. Boosting with ritonavir increases the amount of LEXIVA in your body. And boosting may give your healthcare provider the option of prescribing LEXIVA once or twice a day. LEXIVA, with or without ritonavir, is only 4 pills a day.

Whatever regimen you are prescribed, remember: always take your HIV medicines exactly as your healthcare provider tells you to.



*Once daily with ritonavir is not recommended for PI-experienced patients.


Lexiva - Resistance Profile

ART-naive patients
LEXIVA/r, QD — no primary or
secondary protease mutations


APV30002 (SOLO) a randomized, open-label study of LEXIVA/r (1400/200 mg) QD vs NFV (1250 mg) BID in combination with ABC/3TC BID in 649 ART-naive patients.

Because the potential for HIV cross-resistance among protease inhibitors has not been fully explored, it is unknown what effect therapy with LEXIVA will have on the activity of subsequently administered protease inhibitors.

Clinical relevance of resistance data is currently being evaluated.


* Excludes patients without paired genotypes at baseline and at the time that virologic failure was first detected.
† Common natural polymorphisms in the absence of other PRO mutations are excluded: NFV n = 3 [M36 m/l, K20k/m, L10l], LEXIVA/r n = 1 [V77v/i].


ART-naive patients
LEXIVA, BID — limited cross-resistance

APV30001 (NEAT) a randomized, open-label study of LEXIVA (1400 mg) BID vs NFV (1250 mg) BID in combination with ABC/3TC BID in 249 ART-naive patients.

‡ Excludes patients without paired genotypes at baseline and at the time that virologic failure was first detected.

§ Common natural polymorphisms in the absence of other PRO mutations are excluded: LEXIVA n = 1 [A71a/t].



•

 LEXIVA/r provides a high genetic barrier to the development of resistance at 48 weeks

º

 No PRO mutations

º

 Very low incidence of RT mutations — no K65R mutations



LEXIVA, BID — limited cross-resistance
1

APV30001 (NEAT) a randomized, open-label study of LEXIVA (1400 mg) BID vs NFV (1250 mg) BID in combination with ABC/3TC BID in 249 ART-naive patients.


‡
Excludes patients without paired genotypes at baseline and at the time that virologic failure was first detected.
§ Common natural polymorphisms in the absence of other PRO mutations are excluded: LEXIVA n = 1 [A71a/t].

•

 No significant difference in incidence of PRO or RT mutations for LEXIVA vs NFV

•

  At the time of first treatment failure, PRO mutations I54L/M or V32I + I47V were
  selected by LEXIVA. These mutations result in limited cross-resistance to other PIs



PI-experienced patients

LEXIVA/r, BID

•

The following amprenavir resistance-associated mutations were selected either alone or in combination: V32I, M46I/L, I47V, I50V, I54L/M, and I84V

•

Varying degrees of cross-resistance among HIV-1 protease inhibitors have been observed


APV30003 (CONTEXT) a randomized, open-label study of LEXIVA/r (1400/200 mg) QD or LEXIVA/r (700/100 mg) BID vs LPV/r (400 mg/100 mg) BID in combination with 2 NRTIs in 315 PI-experienced patients.