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.
Published Studies Related to Reyataz (Atazanavir)
Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavir. [2011.09]
OBJECTIVES: Treatment of HIV/tuberculosis (TB) co-infected patients is complex due to drug-drug interactions for these chronic diseases. This study evaluates an intermittent dosing regimen for rifabutin when it is co-administered with ritonavir-boosted atazanavir... CONCLUSIONS: The benefits to HIV/TB co-infected patients receiving rifabutin 150 mg three times weekly or every other day may outweigh the risks of neutropenia observed here in non-HIV-infected subjects, provided that patients on combination therapy will be closely monitored for safety and tolerability.
Peripheral and central fat changes in subjects randomized to abacavir-lamivudine or tenofovir-emtricitabine with atazanavir-ritonavir or efavirenz: ACTG Study A5224s. [2011.07.15]
BACKGROUND: We compare the effect of 4 different antiretroviral regimens on limb and visceral fat... CONCLUSIONS: ABC-3TC- and TDF-FTC-based regimens increased limb and visceral fat at week 96, with a similar prevalence of lipoatrophy. Compared to the EFV group, subjects assigned to ATV-r had a trend towards higher mean percentage increase in VAT. CLINICAL TRIALS REGISTRATION: NCT00118898.
Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naive HIV-1-infected patients (the ARTEN study). [2011.07]
OBJECTIVES: Dyslipidaemic effects of antiretrovirals (ARVs) may contribute to increased cardiovascular risk (CR) in HIV-1-infected patients. The ARTEN (atazanavir/ritonavir on a background of tenofovir and emtricitabine vs. nevirapine on the same background, in naive HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naive HIV-1-infected patients. Lipid profiles and CR from baseline to week 48 are reported... CONCLUSIONS: In ARV-naive patients with low CR at the outset, NVP showed a potentially less atherogenic lipid profile compared with ATZ/r. (c) 2011 British HIV Association.
Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. [2011.06.15]
BACKGROUND: Long-term effects of abacavir (ABC)-lamivudine (3TC), compared with tenofovir (TDF)-emtricitabine (FTC) with efavirenz (EFV) or atazanavir plus ritonavir (ATV/r), on bone mineral density (BMD) have not been analyzed... CONCLUSIONS: Compared with ABC-3TC, TDF-FTC-treated participants had significantly greater decreases in spine and hip BMD, whereas ATV/r led to more significant losses in spine, but not hip, BMD than EFV. Clinical Trials Registration. NCT00118898.
Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. [2011.04.05]
BACKGROUND: Limited data compare once-daily options for initial therapy for HIV-1. OBJECTIVE: To compare time to virologic failure; first grade-3 or -4 sign, symptom, or laboratory abnormality (safety); and change or discontinuation of regimen (tolerability) for atazanavir plus ritonavir with efavirenz-containing initial therapy for HIV-1... CONCLUSION: Atazanavir plus ritonavir and efavirenz have similar antiviral activity when used with abacavir-lamivudine or tenofovir DF-emtricitabine. PRIMARY FUNDING SOURCE: National Institutes of Health. (c) 2011 American College of Physicians
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
Reports of Suspected Reyataz (Atazanavir) Side Effects
Foetal Exposure During Pregnancy (102),
Maternal Exposure During Pregnancy (66),
Abortion Spontaneous (64),
Renal Failure Acute (35),
Abortion Induced (33),
Viral Load Increased (31),
Jaundice (23), more >>
Page last updated: 2011-12-09