Reyataz (Atazanavir Sulfate) - Summary

REYATAZ SUMMARY

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.

NEWS HIGHLIGHTS

Published Studies Related to Reyataz (Atazanavir)

Effects of oral posaconazole on the pharmacokinetics of atazanavir alone and with ritonavir or with efavirenz in healthy adult volunteers. [2009.08.01]
BACKGROUND: Patients with HIV/AIDS are at increased risk for opportunistic fungal infections. These patients may require concomitant treatment with antiretrovirals and azole antifungals, and interactions between these classes of drugs should be anticipated... CONCLUSIONS: Frequent monitoring of adverse events and toxicity related to antiviral exposure is recommended in the event of coadministration of posaconazole and ATV with or without ritonavir. In addition, because of decreased posaconazole exposure, coadministration with efavirenz should be avoided unless the benefit to patients outweighs the risk.

Pharmacokinetics of concurrent administration of fosamprenavir and atazanavir without ritonavir in human immunodeficiency virus-negative subjects. [2009.08]
STUDY OBJECTIVE: To quantify the pharmacokinetics of amprenavir and atazanavir (administered as the prodrug fosamprenavir) alone and in combination in human immunodeficiency virus (HIV)-negative subjects... CONCLUSION: Atazanavir 400 mg/day plus fosamprenavir 1400 mg/day significantly decreased concentrations of atazanavir compared with standard dosing regimens of each drug alone. This dosing scheme is not a recommended combination of dual, fully active protease inhibitors.

Improvement in lipid profiles in antiretroviral-experienced HIV-positive patients with hyperlipidemia after a switch to unboosted atazanavir. [2009.06.01]
OBJECTIVE: The primary objective was to compare the change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 12 between patients receiving an atazanavir-containing regimen and those receiving comparator protease inhibitor (PI) regimens. DESIGN: AI424-067 was a 48-week, open-label, randomized, prospective study of 246 patients on PI-based regimens with hyperlipidemia [fasting LDL cholesterol >130 mg/dL (>3.4 mmol/L)] and with HIV RNA <50 copies per milliliter. Patients were randomized to switch to atazanavir (400 mg once daily) on day 1 (immediate switch) or maintain current PI regimen for the first 24 weeks, then switch to atazanavir (delayed switch)... CONCLUSIONS: A switch-either immediate or delayed-from a boosted or unboosted PI to unboosted atazanavir in patients with hyperlipidemia was associated with improvements in plasma lipid parameters without loss of virological suppression.

Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study. [2009.05.01]
OBJECTIVES: To evaluate the efficacy and safety of switching from boosted lopinavir (LPV/r) to boosted atazanavir (ATV/r) in virologically suppressed HIV-1-infected patients versus continuing LPV/r... CONCLUSIONS: Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].

Changes in body composition with ritonavir-boosted and unboosted atazanavir treatment in combination with Lamivudine and Stavudine: a 96-week randomized, controlled study. [2009.05.01]
This 96-week, open-label, randomized study assessed changes in body composition in treatment-naive patients infected with human immunodeficiency virus type 1 who were treated with either atazanavir or ritonavir-boosted atazanavir, in combination with stavudine and lamivudine.

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Clinical Trials Related to Reyataz (Atazanavir)

Atazanavir Twice Daily [Completed]
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

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]
The purpose of this study is to learn how well atazanavir works in combination with ritonavir or saquinavir with tenofovir and a nucleoside to reduce the viral load of treatment experienced subjects with HIV. There is a comparison arm with lopinavir/ritonavir and tenofovir and a nucleoside.

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]
The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.

Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects [Completed]
The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

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