Reyataz

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AIDS virusReyataz belongs to a class of anti-HIV drugs called Protease Inhibitors (PIs). For a description of the life-cycle of the AIDS virus, and the targets of each class of drugs, click here.

Reyataz is marketed by Bristol-Myers Squibb. They have a useful web site that includes full prescribing information: click here

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Reyataz (atazanavir)

Pronunciation(s): RAY-ah-taz; ah-ta-ZA-na-veer



What is Reyataz?

  • Reyataz is an HIV medication. It is in a category of HIV medicines called protease inhibitors (PIs). Reyataz prevents cells infected with HIV from producing new virus. This reduces the amount of virus in your body.
     
  • Reyataz, manufactured by Bristol-Myers Squibb, was approved for the treatment of HIV by the U.S. Food and Drug Administration (FDA) in 2003.
     
  • Reyataz must be used in combination with at least two other HIV drugs.
     
  • Bristol-Myers Squibb has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Reyataz. To learn more about the PAP for Reyataz, call BMS (888-477-2669). For those with private health insurance, BMS has established a program to help cover up to $200 toward each monthly Reyataz co-payment. To learn more about this co-pay program, call 888-281-8981.

What is already known about Reyataz?
  • For HIV-positive people who have not taken HIV drugs in the past—that is, people starting HIV drug treatment for the first time—the FDA-approved and recommended dose of Reyataz is one 300 mg capsule plus a single 100 mg Norvir (ritonavir) capsule, both taken once a day. For those starting HIV treatment for the first time and unable to tolerate Norvir, Reyataz 400 mg (two 200mg capsules) without Norvir is recommended.
     
  • For HIV-positive people who have taken HIV drugs in the past—for example, people who have experienced a rebound in viral load while taking other HIV medications (especially protease inhibitors)—the FDA-approved dose of Reyataz is one 300mg capsule plus a single 100mg Norvir capsule, both taken once a day.
     
  • Reyataz should be taken with food, preferably a complete nutritious meal, to ensure proper absorption of the drug into the bloodstream.
     
  • Children six years of age or older can take Reyataz. The dose they require will depend on their body weight. To learn about treatment options for children, click here.
     
  • Clinical trials have determined that Reyataz is safe and effective when combined with other drugs, most notably two nucleoside reverse transcriptase inhibitors (NRTIs). Clinical trials have also suggested that Reyataz, combined with Norvir, is an effective option for people who have failed a protease inhibitor-based drug regimen in the past. A number of clinical trials have also demonstrated that Reyataz is less likely to cause increased lipid levels (cholesterol and triglycerides) than other protease inhibitors.
     
  • For HIV-positive adults beginning HIV drug therapy for the first time, Reyataz plus Norvir is listed as a "preferred" protease inhibitor option by the United States Department of Health and Human Services in its treatment guidelines. Reyataz used without Norvir is listed as an "alternative" treatment option (if Reyataz is to be combined with Atripla, Truvada, or Viread, it must be combined with Norvir). To learn more about these recommendations and options, click here.
     
  • If your viral load becomes detectable while taking a drug regimen that contains Reyataz, your doctor can order a drug-resistance test to see which drugs your virus are becoming less sensitive to. If your doctor finds that your virus is becoming resistant to Reyataz, it might be possible to begin taking a low dose of Norvir to boost the amount of Reyataz in the bloodstream. This may help overcome low-level resistance to Reyataz and help push viral load back down to undetectable levels.
     
  • Many of the currently available protease inhibitors are affected by cross-resistance. This means that, if you've tried and failed a drug regimen in the past that contained a protease inhibitor, your virus might be resistant to Reyataz. Similarly, if you take an HIV drug regimen that contains Reyataz and your virus becomes resistant to the drug, your virus might also be resistant to many of the other protease inhibitors available. This is why it is very important to use drug-resistance testing to determine which drugs your virus are no longer responding to if you experience a rebound in your viral load while taking an HIV drug regimen. Drug-resistance testing can also help you figure out which protease inhibitors your virus is still sensitive to.

What about drug interactions?
  • Reyataz is broken down (metabolized) by the liver, like many medications used to treat HIV and AIDS. This means that Reyataz can interact with other medications. Reyataz can lower or raise the levels of other medications in the body. Similarly, other medications can lower or raise the levels of Reyataz in the body. While many interactions are not a problem, some can cause your medications to be less effective or increase the risk of side effects.
     
  • Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John’s Wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take, and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
     
  • The following medications should not be taken while you are being treated with Reyataz:
    HIV protease inhibitors: Crixivan (indinavir)
    Acid reflux/heartburn medications: Propulsid (cisapride)
    Antibiotics: Rifadin (rifampin)
    Cancer chemotherapeutics: Camptosar (irinotecan)
    Antimigraine medications: Methergine, Methylergometrine (methylergonovine); Ergostat, Cafergot, Ercaf, Wigraine (ergotamine); Ergotrate, Methergine (ergonovine); or D.H.E. 45, Migranal (dihydroergotamine)
    Antihistamines: Hismanal (astemizole) or Seldane (terfenadine)
    Steroids: Flonase of Flovent (fluticasone)
    Cholesterol-lowering drugs (statins): Zocor (simvastatin) and Mevacor (lovastatin)
    Antipsychotics: Orap (pimozide)
    Sedatives: Versed (midazolam) and Halcion (triazolam)
    Herbal medications: St. John's wort
    Enlarged prostate: Uroxatral (alfuzosin)
    Pulmonary Hypertension: sildenafil, used as Revatio
     
    If Reyataz is combined with low-dose Norvir, the following medications should also be avoided:
    Antifungals: Vfend (voriconazole)
    Heart medications: Cordarone (amiodarone), Tambocor (flecainide), Vascor (bepridil), Rythmol (propafenone), or Quinaglute/Quinidex (quinidine)
     
  • Anticonvulsants, such as Tegretol (carbamazepine), Luminal (phenobarbital), and Dilantin (phenytoin), may decrease the amount of Reyataz in the bloodstream. It might be necessary to increase your dose of Reyataz if you are taking any of these drugs.
     
  • HIV protease inhibitors can interact with Reyataz. We know that Norvir (ritonavir) increases the amount of Reyataz in the bloodstream. It is also likely that Kaletra which contains lopinavir and ritonavir, will also increase Reyataz levels in the bloodstream. Reyataz increases Invirase (saquinavir), and Lexiva (amprenavir) levels in the bloodstream. Crixivan (indinavir) should not be combined with Reyataz, as both drugs can cause increases in bilirubin levels. Aside from the Reyataz and Norvir combination, no other formal dosing recommendations have been made, but combining Reyataz with other protease inhibitors is not recommended.
     
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs) can also interact with Reyataz. Sustiva (efavirenz) can decrease Reyataz levels in the bloodstream. Reyataz and Sustiva should therefore not be combined in people who are treatment experienced. People who have never taken antiretroviral therapy before may combine Reyataz and Sustiva, however, 100mg of Norvir should be added and the dose of Reyataz should be 400mg. Neither Viramune (nevirapine) nor Intelence (etravirine) should be used with Reyataz, given the likelihood of significant interactions. It is also likely that Rescriptor (delavirdine), a third NNRTI, will increase Reyataz levels in the bloodstream.
     
  • It is also important to be careful when using the nucleotide reverse transcriptase inhibitor (NRTI) Viread (tenofovir) with Reyataz. Viread can decrease Reyataz levels in the bloodstream and Reyataz can increase Viread levels in the bloodstream. If Viread is combined with Reyataz, then 300mg of Reyataz should be used with 100mg of Norvir (to increase Reyataz levels). To make sure that the increased Viread levels do not cause kidney damage (a possible side effect of Viread), blood tests to monitor kidney function should be performed regularly.

    When taking Reyataz with Videx EC (didanosine), Reyataz should be taken with food two hours before or one hour after the Videx EC.
     
  • Reyataz can interact with some antidepressant medications. Reyataz can increase blood levels of tricyclic antidepressants, so caution should be taken if these drugs are used together and providers should monitor blood levels of the antidepressants. Reyataz can also increase blood levels of trazadone. The two drugs should be combined with caution, and lower dose of trazadone may be needed.
     
  • When Reyataz is combined with low-dose Norvir, it could increase blood levels of the antifungal drugs Nizoral (ketoconazole) and Sporanox (itraconazole). High doses of Nizoral and Sporanox should be used with caution if combined with Reyataz and Norvir.
     
  • Reyataz can interact with some medications used to treat TB, MAC and other bacterial infections. Rifadin (rifampin) should not be used with Reyataz. Reyataz can increase Mycobutin (rifabutin) levels (the Mycobutin dose should be reduced to 150mg every other day or three times a week). Reyataz can increase Biaxin (clarithromycin) levels in the bloodstream (the Biaxin dose should be reduced by half or an alternative antibiotic should be tried).
     
  • Reyataz can increase the blood levels of hormonal contraceptives and the two drugs should combined with caution. If an oral contraceptive is combined with Reyataz and Norvir, the oral contraceptive should contain at least 35 mcg of ethinyl estradiol. If Reyataz is taken without ritonavir, the oral contraceptive should contain no more than 30 mcg of ethinyl estradiol. Other hormonal contraceptives (such as the contraceptive patch, contraceptive vaginal ring, or injectable contraceptives) or oral contraceptives containing progestagens other than norethindrone or norgestimate, or less than 25 mcg of ethinyl estradiol, have not been studied with Reyataz; therefore, alternative methods of non-hormonal contraception are recommended.
     
  • Cholesterol-lowering drugs, also known as "statins," can interact with Reyataz. There are two statins that should not be used with Reyataz: Zocor (simvastatin) and Mevacor (lovastatin). Levels of these two drugs can become significantly increased in the bloodstream if they are combined with Reyataz, which increases the risk of side effects. The two statins that are considered to be the safest in combination with Reyataz are Pravachol (pravastatin) and Lescol (fluvastatin). It is also possible to take Reyataz with Lipitor (atorvastatin) or Crestor (rosuvastatin), although Reyataz can increase Lipitor and Crestor levels in the bloodstream. If Lipitor is prescribed, it's best to begin treatment with the lowest possible dose of the drug and then increase the dose if necessary.
     
  • Caution is needed when combining Reyataz with proton pump inhibitors (PPI) --used to treat heartburn and acid reflux--examples of which include include Propulsid (cisaprid), Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole) and Protonix (pantoprazole). This is because Reyataz requires stomach acid to be absorbed properly by the body. Because PPIs greatly reduce stomach acid, they can decrease the amount of Reyataz that gets absorbed into the blood stream.

    For HIV-positive people new to HIV treatment using 300mg Reyataz combined with 100mg Norvir, PPIs must be taken 12 hours before taking Reyataz, and the PPI dose must not exceed the equivalent of 20mg of Prilosec.

    HIV-positive people new to HIV treatment who are using the 400mg dose of Reyataz (without Norvir) can not take PPIs. HIV-positive people who have tried and failed other treatments in the past are also cautioned against using PPIs

    Caution is also needed with another type of stomach acid-reducing medication known as H2-receptor antagonists. Examples of H2-receptor antagonists include: Tagamet (cimetidine), Pepcid (famotidine), Axid (nizatidine), and Zantac (ranitidine). These medications must be used very carefully with Reyataz because they can decrease the amount of Reyataz absorbed into the bloodstream.

    For HIV-positive people new to HIV treatment using 300mg Reyataz combined with 100mg Norvir, H2-receptor antagonists must be taken at the same time as Reyataz and food and/or at least ten hours after, and the dose must not exceed the equivalent of 40mg, twice daily, of Pepcid.
    For patients unable to tolerate Norvir, Reyataz 400 mg once daily with food should be taken at least two hours before and at least 10 hours after the H2-receptor antagonist. For these patients, no single dose of the H2-receptor antagonist should exceed the equivalent of 20 mg of Pepcid.

    HIV-positive people who have tried and failed other treatments may take H2-antagonists at the same time as Norvir-boosted Reyataz and food and/or at least ten hours after, and the dose must not exceed the equivalence of 20mg, twice daily, of Pepcid. Also, treatment-experienced individuals taking H2 -receptor antagonists along with Viread (tenofovir) or Truvada (tenofovir plus emtricitabine) must increase the dose of Reyataz to 400mg.


    Antacids and medications with a buffered coating may reduce blood levels of Reyataz. Reyataz should be taken two hours before or one hour after such medications.
     
  • There is a class of drugs, known as PDE-5 inhibitors that are used to treat both erectile dysfunction and pulmonary arterial hypertension. Their brand names differ, depending on their use. Prezista/Norvir can significantly increase blood levels of these drugs.

    When used to treat erectile dysfunction, it is best to use a lower dose of Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil) in order to reduce the risk of side effects. When used to treat pulmonary arterial hypertension, the dose of tadalafil (Adcirca) must be reduced if combined with Prezista/Norvir. Revatio (sildenafil) and Prezista/Norvir should not be used together.

  • Reyataz can increase blood levels of a type of heart medication known as calcium channel blockers. If Reyataz is combined with diltiazem (Cardizem, Dilacor, Tiazac), the diltiazem dose should be decreased by 50 percent. Filodipine (Plendil), nifedipine (Adalat, Nifedical, and Procardia), nicardipine (Cardene), and verapamil (Veralan and Covera) should be used with caution in people taking Reyataz, and providers may wish to conduct an electrocardiogram to check on your heart rhythm.
     
  • Reyataz can increase blood levels of an asthma medication called Serevent (salmeterol), a drug that is used to open the air passages in the lungs during an asthma attack. This can result in heart rhythm problems. Use of the two drugs together is not recommended.
     
  • Reyataz can increase blood levels of immune suppressing drugs such as Cyclosporine (cyclosporin A), Rapamune (sirolimus), and Prograf (tacrolimus) that are used after a person has had transplant surgery. Blood level monitoring of the immune suppressors is recommended.
     
  • Reyataz can increase blood levels of cochicine, which is used to treat gout. Lower doses of colchicine are recommended, and the two drugs should not be used together in people with liver or kidney impairment.
     
  • Herbal products can also interact with Reyataz. St. John's wort should not be used with Reyataz, since it can greatly reduce the amount of Reyataz in the bloodstream. HIV-positive people should also be cautious about using garlic supplements or milk thistle with Reyataz—test tube studies suggest that both herbal products can interact with the same liver enzyme system (cytochrome P450 3A4) responsible for metabolizing Reyataz. This may alter the amount of Reyataz in the bloodstream. These and other herbal products should be used with caution, until further studies are conducted.
     
  • Some drugs have what is called a "narrow therapeutic window," meaning that the drug may be ineffective or cause side effects when the dose of the drug changes only a small amount. Drugs metabolized by the liver enzyme known as CY2C8 that have a narrow therapeutic window should be used with caution in people taking Reyataz. Examples of these kinds of drugs include the cancer chemotherapy Taxol (paclitaxel) and Prandin (repaglinide), which is used to control blood sugar.
     
  • A number of other negative drug interactions are possible if Reyataz is combined with Norvir. To learn more about these drug interactions, click here.

What is known about side effects?
  • Reyataz can increase levels of bilirubin, a pigment found in the liver. Increased bilirubin can cause the skin, nails, and the whites of the eyes to appear yellowish-brown. Increased bilirubin can also be a sign of liver damage. However, in people who have taken Reyataz in clinical trials, an increase in bilirubin has not been associated with any other signs of liver damage. Reyataz should not be combined with Crixivan, another protease inhibitor that can cause increased bilirubin levels.
     
  • There have been reports of patients developing painful kidney stones while on HIV drug regimens containing Reyataz. While little is known about the frequency of the kidney stones, or if certain risk factors are involved, increasing fluid intake while taking Reyataz may help decrease the risk of this possible side effect.
     
  • Changes in the way your heart beats may occur when taking Reyataz. If you get dizzy or lightheaded these could be symptoms of a heart problem.
     
  • Other possible side effects of Reyataz include headaches, pain/tingling in the arms and legs, nausea, diarrhea, abdominal discomfort, and rash.
     
  • Reyataz may not increase fat levels in the blood like other protease inhibitors. When used with Norvir, however, increased in total cholesterol, "bad" LDL cholesterol and triglycerides may be seen. Click here for our lesson called "Risks To Your Heart (Hyperlipidemia)".
     
  • It is still not known if Reyataz can cause lipodystrophy's body-shape changes, such as an increase in fat around the gut or a loss of fat in the arms, legs, or face. It is also not known if HIV-positive people who continue taking Reyataz for a long period of time (e.g., longer than one year) will be able to keep their cholesterol and triglyceride levels low.
     
  • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Who should not take Reyataz?
  • Before taking Reyataz, tell your doctor if you have diabetes, liver problems, hemophilia, or heart problems. You may not be able to take Invirase, or you may require a dosage adjustment or special monitoring during treatment, if you have any of these conditions.
     
  • Reyataz has not been studied in children younger than 6 years of age.
     
  • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
     
Can pregnant women take Reyataz?
  • Reyataz is classified by the FDA as a pregnancy category B drug. Pregnancy category B means that animal studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. HIV-positive women who become pregnant should discuss the benefits and possible side effects of HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
     
  • It is not known whether Reyataz passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

Where can I learn more about clinical trials of Reyataz?
  • If you would like to find out if you are eligible for any clinical trials that include Reyataz, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email contactus@aidsinfo.nih.gov.

Last Revised: June 30, 2010

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