Reyataz (atazanavir)

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Reyataz, also known as atazanavir, is an anti-HIV treatment in the class of drugs called Protease Inhibitors (PIs). Protease inhibitors work by blocking, or inhibiting, a part of HIV called protease. HIV needs protease to make new copies of itself. When protease is blocked, the copies that HIV makes of itself cannot infect new cells. Reyataz is one of nine approved protease inhibitors used to treat HIV.

The following considerations should be taken into account before starting any treatment combination. What anti-HIV drugs you have taken in the past, and your HIV resistance profile are important when planning your first, second or subsequent HAART regimen. The strength, or efficacy of the drug, the possible side effects, how it interacts with other drugs, how many pills and how often they must be taken, whether the drug needs to be taken with food or liquids, the overall toxicity of the drugs and how they may affect your current liver, heart or other organ functions should be considered. Whether or not the drug or combination may cause blood fats to rise, a redistribution of fat in the body (especially the face, stomach or breasts), and whether the drugs may cause or promote insulin resistance, diabetes or other abnormalities are important considerations. Being co-infected with hepatitis C (HCV) or hepatitis B (HBV) or other conditions requires special consideration.

Taking the drug:

Reyataz should not be taken as your only anti-HIV drug or the virus very quickly becomes resistant to it. Combination HIV treatment (also known as HAART) helps people live longer and develop less opportunistic infections. Drug resistance tests (genotypic or phenotypic) have been shown to be useful in choosing the optimal anti-HIV treatment regimen specific to an individual. Reyataz is taken as part of a carefully chosen combination of anti-HIV drugs. In order to get the most benefit, Reyataz should be taken with two other anti-HIV drugs known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Treatment guidelines suggest taking Reyataz with either Viread, Abacavir, Retrovir, Zerit, or Videx. In addition either Epivir or Emtriva should be taken. One pill, two drug combination pills such as Truvada (Viread and Emtriva) as well as Epzicom (Epivir and Ziagen) can be taken with Reyataz to reduce the number of pills needed. Combivir (Retrovir and Epivir), taken twice a day, is also commonly used. Some individuals prefer taking their medications twice a day, however. Discuss what feels right for you with your doctor.

Treatment Guidelines list Reyataz as an alternative for an initial HIV treatment regimen using a protease inhibitor in combination with two NRTIs. According to the guidelines panel, Reyataz's advantages over other protease inhibitors include once-daily dosing and low pill burden and fewer increases in blood levels of fats such as cholesterol and triglycerides. See Lipodystrophy Fact Sheet. Disadvantages include the probable need to take Reyataz with food, and possible side effects and interactions with other prescription drugs, recreational drugs, over the counter medications, and herbal preparations. If you are experiencing intolerable side effects that make you skip doses or not take the drugs as they are prescribed, contact your doctor or a health care provider immediately. Not being adherent to a regimen can do more harm than good. A case manager may also be able to help you resolve issues that prevent you from taking your medications as prescribed.Stopping a drug or drug combination for even a few days could pose an actual, serious health threat. Please consult with a qualified health care provider before you make any decisions.

Trial results:

Reyataz was approved based on two clinical trials involving over 1,200 people who had never taken HIV treatment before.

In one study (AI424-034), volunteers received Retrovir (AZT, zidovudine) and Epivir (3TC, lamivudine) with either Reyataz or Sustiva (efavirenz). After 48 weeks of treatment, similar numbers in each group had HIV viral loads below 400 copies: 67% for volunteers receiving Reyataz and 62% for volunteers receiving Sustiva.

In another study (AI424-008), volunteers received Zerit (d4T, stavudine) and Epivir (3TC, lamivudine) with either Reyataz or Viracept (nelfinavir). After 48 weeks of treatment, similar numbers in each group had HIV viral loads below 400 copies: 67% for volunteers receiving Reyataz and 59% for volunteers receiving Viracept.

Dosage:

Reyataz comes in 100 mg, 150 mg, and 200 mg capsules that can be stored at room temperature.

The approved dosage of Reyataz is 400 mg once a day, taken as two pills with food. Many doctors also prescribe 300 mg of Reyataz (taken as two 150 mg pills) with 100 mg of Norvir (ritonavir) once a day, taken together. Norvir boosts the blood levels of Reyataz. The Reyataz/ritonavir combination is useful for people who already have some drug resistance to protease inhibitors.

Tenofovir (Viread) and Efavirenz (Sustiva) lower the blood levels of Reyataz. If used with either of these drugs, the 300 mg dose of Reyataz in combination with 100 mg Norvir should be used. Indinavir (Crixivan) should not be used with Reyataz because both drugs can increase bilirubin levels. If you take Reyataz with Videx (ddI) or Videx EC, Reyataz should be taken with food either two hours before or one hour after you take Videx. Reyataz has not been approved for children.

Side effects:

Reyataz increases the levels of bilirubin in about one-third of people who take it. Bilirubin is a chemical made by the liver; an increased bilirubin level is called hyperbilirubinemia. Hyperbilirubinemia can lead to jaundice, where the eyes or skin turn yellow. About one in ten people taking Reyataz develop jaundice. Hyperbilirubinemia and jaundice can be signs of liver damage, but Reyataz does not seem to damage the liver. However, people with hepatitis B or C should be closely monitored for liver function when taking Reyataz.

Reyataz can cause changes in heartbeat by causing irregular blood flow in the heart. These changes usually are not serious, but Reyataz should be used with caution if you take other medications that can have this effect. Tell your doctor if you get dizzy or lightheaded, since these can be symptoms of heart problems.

Reyataz may also cause headaches, nausea and vomiting, stomach pain, diarrhea, rash, and tingling hands or feet.

Guidelines for Women:

Although the guidelines and goals for treating women for HIV disease are the same as for men, there is an ongoing debate whether lower HIV viral loads are actually more clinically relevant to women. Women who are pregnant as well as those who may become pregnant during anti-HIV therapy have a separate set of guidelines. Sustiva (efavirenz), for example should be avoided by any woman who wants to become pregnant or who may become pregnant if she does not use contraception on a regular basis. Some HIV drugs can also interact with contraceptives. Anti-HIV therapy is recommended for all pregnant women, as using these drugs and having a HIV viral load below 1,000 may have an additional effect of preventing HIV transmission to the fetus. There is not enough data to recommend the use of Reyataz in pregnant women. Guidelines for the treatment of pregnant women, preventing transmission of HIV, and treating children and adolescents are available at http://AIDSinfo.nih.gov or by asking your Network case manager.

Warnings:

Other drugs can interact with Reyataz, changing the blood levels or one or both medications. Reyataz should not be taken with simvastatin (Zocor) or lovastatin (Mevacor), rifampin or rifapentine (Priftin), pimozide (Orap), midazolam (Versed) or triazolam (Halcion), astemizole (Hismanal) or terfenadine (Seldane), St. John's wort, cisapride (Propulsid), lansoprazole (Prevacid), esomeprazole (Nexium), omeprazole (Prilosec), pantoprazole (Protonix), and all other proton-pump inhibitors. bepridil (Vascor), irinotecan (Camptosar) or dihydroergotamine (Migranal) or ergotamine.

Reyataz may also interact with drugs for the treatment of erectile dysfunction (inability to get or maintain an erection), including sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis). Reyataz increase the levels of these drugs in the blood. This can lead to high blood pressure and other effects. Tell your doctor about all of the drugs that you take, including non-prescription medicine and herbs.

Opiates, Methadone and Buproprion:

Methadone levels do not appear to be affected by Reyataz. Reyataz levels are slightly but not significantly altered by Methadone. Anyone who is taking Methadone, Buprenorphine or Opiate drugs should discuss how anti-HIV drugs could affect either the drug levels of the HAART regimen or of the opiate related drugs. Little is known about drug interactions with the newer drug Buproprion. Sudden feelings of opiate withdrawal, or toxicity due to increased concentrations of anti-HIV drugs may lead to non-adherence to prescribed HAART regimens. There are several successful models of anti-HIV treatment for active and recovering substance users, including those using prescribed opiates, although a specialty team of health care providers may be needed.

Bristol-Myers Squibb, the maker of atazanavir (Reyataz), has a patient assistance program for people having problems getting the drug. The number to call is (800) 272-4878.




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Last modified: 8/15/2006
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