Reyataz (Atazanavir Sulfate) - Summary

REYATAZ SUMMARY

REYATAZ^®
(atazanavir sulfate) Capsules

REYATAZ® (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.

REYATAZ (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 48 weeks duration in antiretroviral-naive and antiretroviral-treatment-experienced patients.

The following points should be considered when initiating therapy with REYATAZ:

• In antiretroviral-experienced patients with prior virologic failure, coadministration of REYATAZ/ritonavir is recommended.
• In Study AI424-045 REYATAZ/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that REYATAZ/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection (see Description of Clinical Studies).
• The number of baseline primary protease inhibitor mutations affects the virologic response to REYATAZ/ritonavir (see CLINICAL PHARMACOLOGY: Microbiology).
• There are no data regarding the use of REYATAZ/ritonavir in therapy-naive patients.

REYATAZ NEWS HIGHLIGHTS

Media Articles Related to Reyataz (Atazanavir)

Herpes Suppression May Not Prevent HIV Infection
Source: MedicineNet Genital Herpes In Women Specialty [2008.06.20]

Complacency about HIV 'more deadly' than disease itself: IFRC (AFP)
Source: Y! Health HIV & AIDS News [2008.11.27]

Universal Testing, Prompt Treatment Could Slash HIV (HealthDay)
Source: Y! Health HIV & AIDS News [2008.11.26]

Long-Term TITAN Study Evaluates PREZISTA(R)/ritonavir Vs. Lopinavir/ritonavir As Part Of HIV Combination Therapy In Treatment-Experienced Adults
Source: Conferences News From Medical News Today [2008.11.19]

Case Of Patient "Cured" Of HIV Baffles Doctors
Source: Lymphoma / Leukemia News From Medical News Today [2008.11.14]

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Published Studies Related to Reyataz (Atazanavir)

Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. [2008.08.23]

No impairment of endothelial function or insulin sensitivity with 4 weeks of the HIV protease inhibitors atazanavir or lopinavir-ritonavir in healthy subjects without HIV infection: a placebo-controlled trial. [2008.08.15]

Effect of atazanavir versus other protease inhibitor-containing antiretroviral therapy on endothelial function in HIV-infected persons: Randomized controlled trial. [2008.07.24]

Atazanavir modestly increases plasma levels of raltegravir in healthy subjects. [2008.07.01]

Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. [2008.02.01]

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Clinical Trials Related to Reyataz (Atazanavir)

Atazanavir Twice Daily [Completed]

Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV [Active, not recruiting]

Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone [Completed]

Drug Interaction Study With Proton Pump Inhibitor [Completed]

Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects [Completed]

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