atazanavir


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Related to atazanavir: Abacavir, Truvada

atazanavir

Reyataz

Pharmacologic class: HIV-1 protease azapeptide inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category B

Action

Selectively inhibits the virus-specific processing of viral Gag and Gag-Pol polyproteins in human immunodeficiency virus (HIV)-1 infected cells, preventing formation of mature virions

Availability

Capsules: 100 mg, 150 mg, 200 mg, 300 mg

Indications and dosages

Treatment-naïve patients with HIV-1 infection in combination with ritonavir

Adults: 300 mg with ritonavir 100 mg P.O. daily. When administered with tenofovir, H2-receptor antagonists, or proton pump inhibitors, give 300 mg with ritonavir 100 mg P.O. daily. When administered with efavirenz, give 400 mg with ritonavir 100 mg P.O. daily. Give 400 mg P.O. daily if patient is unable to tolerate ritonavir.

Adults and children at least age 13 weighing at least 40 kg ( 88 lb) who are unable to tolerate ritonavir: 400 mg (without ritonavir) P.O. daily (For patients at least age 13 and at least 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton pump inhibitors, atazanavir should not be administered without ritonavir.)

Treatment-experienced patients with HIV-1 infection in combination with other antiretrovirals

Adults: 300 mg with ritonavir 100 mg P.O. daily. When administered with an H2-receptor antagonist, give 300 mg with ritonavir 100 mg P.O. daily. When administered with tenofovir and an H2-receptor antagonist, give 400 mg with ritonavir 100 mg P.O. daily.

HIV-1 infection

Children ages 6 to younger than 18 weighing at least 40 kg (88 lb): 300 mg with ritonavir 100 mg P.O. daily

Children ages 6 to younger than 18 weighing at least 20 kg (44 lb) to less than 40 kg: 200 mg with ritonavir 100 mg P.O. daily

Children ages 6 to younger than 18 weighing at least 15 kg (33 lb) to less than 20 kg: 150 mg with ritonavir 100 mg P.O. daily

Dosage adjustment

• Hepatic impairment
• Administration with sildenafil citrate, tadalafil, or vardenafil
• Treatment-experienced pregnant women during second or third trimester, when administered with either an H2-receptor antagonist or tenofovir

Contraindications

• Hypersensitivity to drug or its components
• Administration with alfuzosin, triazolam, oral midazolam, ergot derivatives, rifampin, irinotecan, lovastatin, simvastatin, indinavir, cisapride, pimozide, sildenafil (Revatio), or St. John's wort

Precautions

Use cautiously in:
• hepatic impairment (use not recommended)
• renal impairment (drug shouldn't be administered to HIV treatment-experienced patients with end-stage renal disease managed with hemodialysis)
• conduction abnormalities and coadministration of drugs that may prolong PR interval, especially those metabolized by CYP3A (such as verapamil)
• concomitant use of antiarrhythmics (such as amiodarone, bepridil, systemic lidocaine, quinidine); antidepressants (such as trazodone, tricyclic antidepressants); high doses of ketoconazole and itraconazole (above 200 mg/day); calcium channel blockers; hormonal contraceptives
• concomitant use of endothelin-receptor antagonist (such as bosentan) without ritonavir (use not recommended)
• concomitant use of inhaled nasal steroid (such as fluticasone propionate) and atazanavir without ritonavir
• concomitant use of inhaled nasal steroid (such as fluticasone propionate) and atazanavir with ritonavir (use not recommended unless potential benefit to patient outweighs risk of systemic corticosteroid adverse effects)
• concomitant use of proton pump inhibitors (such as omeprazole) (shouldn't be used in treatment-experienced patients receiving atazanavir)
• concomitant use of opioid (such as buprenorphine) and atazanavir without ritonavir (shouldn't be coadministered)
• administration of drugs highly dependent on CYP2C8 with narrow indices (such as paclitaxel, repaglinide) when atazanavir is administered without ritonavir
• concomitant use of antifungal (such as voriconazole) (shouldn't be administered with atazanavir/ritonavir unless benefit/risk assessment justifies use of voriconazole)
• concomitant use of antigout agent (such as colchicine) (shouldn't be administered with atazanavir to patients with hepatic or renal impairment)
• concomitant use of atazanavir with efavirenz in treatment-experienced patients (don't coadminister)
• concomitant use of inhaled beta agonist (such as salmeterol) (use not recommended)
• pregnant (avoid use without ritonavir) or breastfeeding patients
• patients less than 40 kg (88 lb) receiving concomitant tenofovir, H2-receptor antagonists, or protonpump inhibitors (not recommended)
• children younger than age 13 (avoid use without ritonavir)
• children ages 3 months to 6 years (safety and efficacy not established)
• children younger than age 3 months (avoid use).

Administration

• Perform liver function tests before starting therapy.
• Administer drug with food.

Be aware that drug isn't recommended for treatment-experienced patients with prior virologic failure.

Don't administer to patient with severe hepatic impairment or treatment-experienced patient who is receiving dialysis for end-stage renal disease.

Adverse reactions

CNS: headache, insomnia, dizziness, peripheral neurologic symptoms, depression

CV: cardiac conduction abnormalities

EENT: scleral icterus

GI: nausea, vomiting, diarrhea, abdominal pain

GU: nephrolithiasis

Hematologic: neutropenia, thrombocytopenia, leukopenia, increased bleeding (in patients with hemophilia A and B)

Hepatic: jaundice, hepatotoxicity

Metabolic: hyperbilirubinemia, hyperglycemia, possible exacerbation of or new-onset diabetes mellitus

Musculoskeletal: myalgia

Respiratory: cough

Skin: rash, erythema multiforme, toxic skin eruptions, Stevens-Johnson syndrome

Other: fever, body fat redistribution or accumulation, immune reconstitution syndrome

Interactions

Drug-drug.Antacids, buffered drugs, H2-receptor antagonists, proton pump inhibitors: decreased atazanavir plasma concentration

Antiarrhythmics (such as amiodarone, bepridil, systemic lidocaine, quinidine), tricyclic antidepressants): increased risk of serious or life-threatening adverse reactions

Atorvastatin, rosuvastatin: increased risk of myopathy including rhabdomyolysis

Bosentan: decreased atazanavir level, increased bosentan level

Buprenorphine: increased buprenorphine and its active metabolite norbuprenorphine plasma concentrations, decreased atazanavir level

Calcium channel blockers (such as diltiazem, felodipine, nifedipine, nicardipine, verapamil): increased calcium channel blocker effect

Clarithromycin: increased atazanavir and clarithromycin levels resulting in prolonged QTc interval; significantly reduced active clarithromycin metabolite level

Colchicine: increased colchicine effect

Cyclosporine, sirolimus, tacrolimus: increased immunosuppressant levels

Didanosine (buffered tablets): marked decrease in atazanavir exposure

Drugs primarily metabolized by CYP3A, UGT1A1, other drugs (such as alfuzosin, cisapride, ergot derivatives, indinavir, irinotecan, lovastatin, oral midazolam, pimozide, rifampin, sildenafil [Revatio], simvastatin, triazolam): increased plasma concentration of these drugs resulting in serious or life-threatening adverse reactions

Drugs that prolong PR interval (beta blockers other than atenolol, digoxin, verapamil): expected additive effect of atazanavir

Efavirenz: decreased atazanavir exposure

Ethinyl estradiol with norgestimate: decreased ethinyl estradiol level, increased norgestimate level

Ethinyl estradiol with norethindrone: increased ethinyl estradiol and norethindrone levels

Fluticasone: increased fluticasone plasma concentration

Fluticasone and atazanavir/ritonavir: increased fluticasone plasma concentration resulting in significantly reduced cortisol levels

H2-receptor antagonists: decreased atazanavir plasma concentration resulting in loss of therapeutic effect and development of resistance

Itraconazole, ketoconazole: increased atazanavir area under the curve (AUC) and Cmax, increased itraconazole and ketoconazole effects

Midazolam (parenteral): increased midazolam plasma concentrations, risk of respiratory depression and prolonged sedation

Nevirapine: markedly decreased atazanavir effect; increased nevirapine effect with risk of nevirapine-associated toxicity

Other protease inhibitors: expected increased effect of these drugs

Rifabutin: increased risk of rifabutin-associated adverse reactions

Ritonavir: increased atazanavir effect

Salmeterol: increased risk of cardiovascular adverse reactions including prolonged QT interval, palpitations, and sinus tachycardia

Sildenafil, tadalafil, vardenafil: possible increased phosphodiesterase inhibitor-associated adverse reactions (hypotension, syncope, visual disturbances, priapism)

Tenofovir: decreased atazanavir AUC and Cmin, increased tenofovir level

Trazodone: increased trazodone plasma level

Warfarin: increased risk of serious or life-threatening bleeding

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, amylase, blood glucose, creatine kinase, high-density lipoproteins, lipase, low-density lipoproteins, total bilirubin, total cholesterol, triglycerides: increased levels

Hemoglobin, neutrophils, platelets: decreased levels

Drug-food.Any food: enhanced bioavailability and reduced pharmacokinetic variability

Drug-herbs.St. John's wort: decreased atazanavir plasma concentrations

Patient monitoring

Monitor patient closely and discontinue drug if severe rash occurs (possible sign of Stevens-Johnson syndrome).

Be aware that immune reconstitution syndrome may occur in patients receiving combination antiretroviral therapy. During initial phase of therapy, patient whose immune system responds may develop inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, tuberculosis), which may necessitate further evaluation and treatment.

Temporarily interrupt or discontinue drug if signs or symptoms of nephrolithiasis occur.
• Monitor blood glucose level during therapy; watch for signs or symptoms of new-onset or exacerbation of diabetes mellitus and redistribution or accumulation of body fat.
• Monitor CBC with differential and liver and kidney function tests closely.

Patient teaching

• Instruct patient to take drug by mouth with food, to swallow capsules whole, and not to crush or chew them.
• Instruct patient to take drug 2 hours before or 1 hour after taking antacids or a buffered form of drugs.

Instruct patient to immediately report severe rash, changes in pulse or heart beat, signs or symptoms of kidney stones (pain in the side, blood in urine, or pain when urinating), yellowing of eyes, or signs and symptoms of immune reconstitution syndrome (such as new signs or symptoms of a previously subclinical infection, worsening or progression of a known infection despite treatment, a new infection or illness, or failure of antiretroviral therapy).
• Inform patient that drug may cause increase in blood glucose level and redistribution or accumulation of body fat.
• Advise patient to consult prescriber before using other prescription or over-the-counter drugs or herbs.
• Advise male patient taking sildenafil, tadalafil, or vardenafil to promptly report hypotension, visual changes, or prolonged penile erection to prescriber.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

atazanavir

(a-ta-zan-a-veer) ,

Reyataz

(trade name)

Classification

Therapeutic: antiretrovirals
Pharmacologic: protease inhibitors
Pregnancy Category: B

Indications

HIV infection (with other antiretrovirals).

Action

Inhibits the action of HIV protease, preventing maturation of virions.

Therapeutic effects

↑ CD4 cell counts and ↓ viral load with subsequent slowed progression of HIV and its sequelae.

Pharmacokinetics

Absorption: Rapidly absorbed (↑ by food).
Distribution: Enters cerebrospinal fluid and semen.
Metabolism and Excretion: 80% metabolized (CYP3A); 13% excreted unchanged in urine.
Half-life: 7 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POrapid2.5 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Severe hepatic impairment;Concurrent use of ergot derivatives, midazolam (PO), pimozide, triazolam, alfuzosin, sildenafil (Revatio), rifampin, irinotecan, lovastatin, simvastatin, indinavir, or St. John's wort; Pediatric: ↑ risk of kernicterus in infants <3 mo.
Use Cautiously in: Mild to moderate hepatic impairment;Pre-existing conduction system disease (marked first-degree AV block or second- or third-degree AV block) or concurrent use of other drugs that increase the PR interval (especially those metabolized by CYP3A4, including verapamil or diltiazem);Diabetes mellitus;Hemophilia (↑ risk of bleeding); Pediatric: Children <6 yr (safety not established); Obstetric: Use only if clearly needed;Breast feeding is not recommended if HIV-infected.

Adverse Reactions/Side Effects

When used in combination with other antiretrovirals

Central nervous system

  • headache
  • depression
  • dizziness
  • insomnia

Cardiovascular

  • ↑ PR interval
  • heart block

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • nausea (most frequent)
  • abdominal pain
  • ↑ bilirubin
  • cholelithiasis
  • diarrhea
  • jaundice
  • ↑ liver enzymes
  • vomiting

Dermatologic

  • dress syndrome (life-threatening)
  • erythema multiforme (life-threatening)
  • stevens-johnson syndrome (life-threatening)
  • rash

Endocrinologic

  • hyperglycemia

Genitourinary

  • nephrolithiasis

Metabolic

  • fat redistribution

Musculoskeletal

  • myalgia

Miscellaneous

  • angioedema (life-threatening)
  • fever
  • immune reconstitution syndrome

Interactions

Drug-Drug interaction

Atazanavir is an inhibitor of CYP3A and UGT1A1 enzyme systems. It is also a substrate of CYP3A.↑ blood levels and risk of toxicity from ergot derivatives (ergotamine, ergonovine, dihydroergotamine, methylergonovine ), midazolam (PO), pimozide, triazolam, lovastatin, simvastatin, sildenafil (Revatio), alfuzosin, and irinotecan ; concurrent use is contraindicated.Concurrent use with indinavir may ↑ risk of hyperbilirubinemia; concurrent use is contraindicated.Levels are significantly ↓ by rifampin ; may promote viral resistance; concurrent use is contraindicated.Combination therapy with tenofovir may lead to ↓ virologic response and possible resistance (100 mg ritonavir should be added to boost blood levels and dose of atazanavir ↓ to 300 mg/day).Levels are significantly ↓ by omeprazole ; do not exceed omeprazole dose of 20 mg/day when used with atazanavir and ritonavir in treatment-naive patients (should be taken at least 12 hr before atazanavir and ritonavir); should not be used in treatment-experienced patients.Concurrent use with didanosine buffered tablets will ↓ absorption and levels; give atazanavir with food 2 hr before or 1 hr after didanosine.Efavirenz ↓ levels and may promote viral resistance; 600 mg efavirenz should be given with atazanavir 400 mg/day and ritonavir 100 mg/day to counteract this effect in treatment-naive patients (should not be used with atazanavir in treatment-experienced patients).↑ saquinavir levels.Levels are ↑ by ritonavir ; ↓ atazanavir dose to 300 mg/day.Nevirapine may ↓ levels and atazanavir may ↑ nevirapine levels; avoid concurrent use.Antacids or buffered medications will ↓ absorption; atazanavir should be given 2 hr before or 1 hr after.↑ levels of lidocaine, amiodarone, or quinidine ; blood level monitoring is recommended.↑ risk of bleeding with warfarin.↑ of tricyclic antidepressants ; blood level monitoring is recommended.↑ levels of rifabutin ; ↓ rifabutin dose by 75% (150 mg every other day or 3 times weekly).↑ levels of diltiazem and its active metabolite; ↓ diltiazem dose by 50% and ECG monitoring recommended. Similar precautions may be needed with felodipine, nifedipine, nicardipine, and verapamil.↑ levels of fluticasone ; consider alternative therapy; should not be used when atazanavir used with ritonavir.↓ levels of voriconazole when atazanavir is used with ritonavir; avoid concurrent use. Voriconazole may also ↑ levels of atazanavir (when used without ritonavir).↑ levels of ketoconazole or itraconazole when atazanavir is used with ritonavir.↑ levels of trazodone ; ↓ dose of trazodone.↑ levels of sildenafil, vardenafil, and tadalafil ; ↓ sildenafil dose to 25 mg every 48 hr; ↓ vardenafil dose to 2.5 mg every 72 hr (when atazanavir used with ritonavir) or 2.5 mg every 24 hr (when atazanavir used alone); ↓ tadalafil dose to 10 mg every 72 hr. Exercise caution and monitor for hypertension, visual changes, and priapism.↑ levels and risk of myopathy from atorvastatin or rosuvastatin ; use lowest possible dose of statin; do not exceed rosuvastatin dose of 10 mg/day.Levels may be ↓ by histamine H2 antagonists, promoting viral resistance; separate doses by at least 10 hr.↑ levels of cyclosporine, sirolimus, and tacrolimus ; monitor immunosuppressant blood levels.↑ levels of clarithromycin ; ↓ clarithromycin dose by 50% or consider alternative therapy.May ↓ levels of some estrogens found in hormonal contraceptives ; use alternative nonhormonal method of contraception.May ↑ levels of buprenorphine ; consider ↓ dose of buprenorphine.Concurrent use of other drugs known to ↑ PR interval may ↑ risk of heart block.May ↑ risk of adverse effects with salmeterol ; concurrent use not recommended.May ↑ bosentan levels; initiate bosentan at 62.5 mg once daily or every other day; if patient already receiving bosentan, discontinue bosentan at least 36 hr before initiation of atazanavir and then restart bosentan at least 10 days later at 62.5 mg once daily or every other day; do not use with atazanavir alone (should be used with atazanavir and ritonavir).May ↑ tadalafil (Adcirca) levels; initiate tadalafil (Adcirca) at 20 mg once daily; if patient already receiving tadalfil (Adcirca), discontinue tadalafil (Adcirca) at least 24 hr before initiation of atazanavir and then restart tadalafil (Adcirca) at least 7 days later at 20 mg once daily.May ↑ colchicine levels; ↓ dose of colchicine; do not administer colchicine if patients have renal or hepatic impairment.Concurrent use with telaprevir results in ↓ telaprevir levels and ↑ atazanavir levels.Concurrent use of boceprevir with atazanavir and ritonavir results in ↓ atazanavir and ritonavir levels; concurrent use not recommended.Carbamazepine, phenytoin, and phenobarbiral may ↓ levels; do not give concurrently with atazanvir without using ritonavirConcurrent use of lamotrigine with atazanavir and ritonavir results in ↓ lamotrigine levels; concurrent use not recommended.Concurrent use of voriconazole with atazanavir and ritonavir may result in either ↓ or ↑ voriconazole levels; concurrent use not recommended.St. John’s wort significantly ↓ blood levels; concurrent use is contraindicated.

Route/Dosage

Oral (Adults) Therapy-naive—400 mg once daily or 300 mg once daily with ritonavir 100 mg once daily (must be used with ritonavir in pregnancy); should be used at a dose of 300 mg once daily with ritonavir 100 mg once daily if used concomitantly with tenofovir, H2 receptor antagonist, or proton pump inhibitor; should be used at a dose of 400 mg once daily with ritonavir 100 mg once daily if used concomitantly with efavirenz. Therapy-experienced—300 mg once daily with ritonavir 100 mg once daily; should be used at dose of 400 mg once daily with ritonavir 100 mg once daily if used with tenofovir and a H2 receptor antagonist; in pregnant patients in 2nd or 3rd trimester, should be used at a dose of 400 mg once daily with ritonavir 100 mg once daily if used with tenofovir or a H2 receptor antagonist.
Oral (Children ≥6 yr) 15–19 kg—150 mg once daily with ritonavir 100 mg once daily; 20–39 kg—200 mg once daily with ritonavir 100 mg once daily; ≥40 kg—300 mg once daily with ritonavir 100 mg once daily; ≥13 yr and ≥40 kg and unable to tolerate ritonavir—400 mg once daily; ≥13 yr and ≥40 kg and receiving concomitant tenofovir, H2 receptor antagonists, or proton pump inhibitors—Needs to be administered with ritonavir.

Renal Impairment

Oral (Adults) Therapy-Naive and HD—300 mg once daily with ritonavir 100 mg once daily; Therapy-Experienced and HD—contraindicated.

Hepatic Impairment

Oral (Adults) Moderate hepatic impairment—300 mg once daily (do not use with ritonavir).

Availability

Capsules: 150 mg, 200 mg, 300 mg

Nursing implications

Nursing assessment

  • Assess for change in severity of HIV symptoms and for symptoms of opportunistic infections throughout therapy.
  • Assess for rash which can occur within initial 8 wk of therapy. Usually resolves within 2 weeks without altering therapy. Discontinue therapy if rash becomes severe.
  • Lab Test Considerations: Monitor viral load and CD4 cell count regularly during therapy.
    • May cause ↑ serum amylase, lipase and hyperglycemia.
    • May ↑ liver enzymes.
    • May ↑ creatine kinase.
    • May cause ↓ hemoglobin, neutrophils, and platelets.
    • May cause ↑ in unconjugated bilirubin; reversible on discontinuation.

Potential Nursing Diagnoses

Risk for infection (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Oral: Administer daily with food to enhance absorption. Capsules should be swallowed whole; do not open.

Patient/Family Teaching

  • Emphasize the importance of taking atazanavir with food as directed. Advise patient to read the Patient Information before taking and with each Rx refill; may be updated. Atazanavir must always be used in combination with other antiretroviral drugs. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses as soon as remembered, then return to regular dose schedule. If within 6 hr of next dose, omit dose and take next dose at regular time. Do not double doses.
  • Instruct patient that atazanavir should not be shared with others.
  • Inform patient that atazanavir does not cure HIV or prevent associated or opportunistic infections. Atazanavir does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the HIV virus to others. Advise patient that atazanavir may cause lipodystrophy (redistribution or accumulation of body fat) and the long-term effects of atazanavir are unknown at this time.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially St. John's wort; interactions may be fatal.
  • May cause dizziness. Caution patient to notify health care professional if this occurs and to avoid driving and other activities requiring alertness until response to medication is known.
  • Notify health care professional immediately if yellowing of eyes, change in heart rhythm, or high blood sugar occur.
  • Instruct patient to notify health care professional immediately if signs and symptoms of hepatitis (flu-like symptoms, tiredness, nausea, lack of appetite, yellow skin or eyes, dark urine, pale stools, pain or sensitivity to touch on right side below ribs), skin reactions with symptoms (flu-like symptoms, fever, muscle aches, conjunctivitis, blisters, mouth sores, swelling of face, tiredness), gallbladder disorder (right or middle upper stomach pain, fever, nausea, vomiting, or yellowing of skin and whites of eyes), kidney stones (side pain, blood in urine, pain upon urination), or signs of immune reconstitution syndrome (signs and symptoms of an infection) occur.
  • Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
  • Instruct females using hormonal contraceptives to use an alternative nonhormonal method of contraception. Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding. If pregnant patient is exposed to atazanavir, register patient in Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
  • Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Evaluation/Desired Outcomes

  • Delayed progression of HIV and decreased opportunistic infections in patients with HIV.
  • Decrease in viral load and increase in CD4 cell counts.

atazanavir

an antiretroviral agent.
indication This drug is used to treat HIV-1 infection in combination with other antiretroviral agents.
contraindication Known hypersensitivity to this drug prohibits its use.
adverse effects Adverse effects of this drug include headache, depression, dizziness, insomnia, peripheral neurological symptoms, fatigue, fever, arthralgia, back pain, cough, lipodystrophy, and pain. Life-threatening side effects include hepatotoxicity and Stevens-Johnson syndrome. Common side effects include diarrhea, abdominal pain, nausea, rash, and photosensitivity.

atazanavir

An azapeptide HIV protease inhibitor that selectively inhibits virus-specific processing of gag and gag-pol polyproteins in HIV-infected cells. Once-daily dosage is adequate but the drug is used in combination with other anti-HIV agents. A brand name is Reyataz.
References in periodicals archive ?
Body fat and other metabolic effects of atazanavir and efavirenz, each administered in combination with zidovudine plus lamivudine, in antiretroviral-naive HIV-infected patients.
Atazanavir is a newly approved PI indicated for the treatment of HIV infection.
Safety and efficacy of GS-9350-boosted atazanavir compared to ritonavir-boosted atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naive adults.
Like ritonavir-boosted atazanavir and Kaletra, resistance to ritonavir-boosted fosamprenavir is uncommon in HIV-naive patients.
ARIES is designed as a treatment strategy study [6] to assess the efficacy and safety of a simplification regimen of abacavir/lamivudine and atazanavir after an induction regimen of abacavir/lamivudine and atazanavir/r in treatment-naive HIV patients.
The alternative combinations were FTC, tenofovir and efavirenz, or atazanavir, FTC and ddI-EC.
Atazanavir currently has a category "B label" for use in pregnancy.
A new study has found that if Reyataz (atazanavir), whether taken with or without ritonavir, is used with Prilosec (omeprazole, a proton-pump inhibitor used to reduce stomach acidity, for treating acid-reflux disease or other conditions), the blood level of atazanavir is reduced by three quarters or more, probably making it ineffective and leading to viral resistance.
The newly listed contraindicated regimens are a three-NRTI regimen with abacavir, tenofovir, and lamivudine (because of early virologic nonresponse); a three-NRTI regimen with didanosine, tenofovir, and lamivudine (because of a high rate of virologic failure); the combination of didanosine and stavudine (because of a high incidence of toxicities, including several deaths); the combination of atazanavir and indinavir (both of which can cause high-grade hyperbilirubinemia and jaundice); and emtricitabine plus lamivudine as a two-NRTI backbone (since both drugs have similar resistance profiles and minimal additive antiviral activity).
Data show that Stribild was non-inferior after two years of treatment to two standard of care HIV regimens, Atripla([R]) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Study 102 and a protease-based regimen of ritonavir-boosted atazanavir plus Truvada([R]) (emtricitabine and tenofovir disoproxil fumarate) in Study 103.
It boosts blood levels of atazanavir or darunavir by suppressing CYP3A, an enzyme that metabolizes these drugs in the body.