Reyataz and Evotaz
atazanavir sulfate ATV Protease inhibitor and atazanavir/cobicistat ATV/COBI
Standard DoseReyataz: For most treatment-naïve (first time on HIV therapy) and treatment-experienced individuals, the dose is one 300 mg capsule plus 100 mg Norvir or 150 mg Tybost once daily with food. See package insert for dosing recommendations during pregnancy, liver or kidney impairment, and with certain drug interactions. Capsules also available in 150 mg and 200 mg. Take Norvir or Tybost at same time as Reyataz. Swallow capsules whole—do not open or mix with anything. Pediatric dose with 50 mg oral powder available based on body weight for children at least 3 months of age weighing at least 11 pounds (5 kg). Oral powder may be used by adults who cannot swallow the capsules.
Evotaz: One tablet once daily with food in adults and pediatric patients weighing at least 77 pounds (35 kg). Each tablet contains 300 mg of atazanavir boosted by 150 mg cobicistat. Use with Intelence or Sustiva is not recommended. Use in treatment-experienced people depends on protease inhibitor drug resistance. Not recommended for people with any degree of liver impairment or those who are treatment-experienced and on hemodialysis. Evotaz is not recommended during pregnancy due to substantially lower exposures of atazanavir and cobicistat during pregnancy.
Must be taken in combination with another antiretroviral(s) that does not contain this medication or medication from the same drug class(es). Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
- See package insert for more complete information on potential side effects and interactions.
Not available on formulary used
150 mg, 60 capsules: $1,517.10/month
300 mg, 30 capsules: $1,502.76/month
Potential Side Effects and Toxicity
Most common side effects may include nausea, ocular icterus (yellowing of the eyes), and jaundice. The ocular icterus and jaundice are reversible upon discontinuation. Less common side effects may include kidney stones, gallstones, abnormal heart rhythm, and elevated liver enzymes (more common in people with hepatitis B or C). Atazanavir has been associated with changes to the ECG (electrocardiogram) of some people. Because of limited experience in those with preexisting heart disease, ECG monitoring should be considered in these individuals.
Reyataz: Kidney laboratory testing should be performed on all individuals before starting Reyataz, and continued during treatment. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination. Rarely, chronic kidney disease has been observed. Reyataz capsules do not contain phenylalanine but oral powder does; thus, use with caution in individuals with phenylketonuria.
Evotaz: Cobicistat can cause a small, reversible increase in serum creatinine (SCr, which indicates the eGFR or estimated CrCl lab values) within the first few weeks of treatment without affecting actual kidney function. People experiencing a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Serum phosphorus in people with or at risk for kidney impairment should also be monitored. Kidney impairment—including cases of acute kidney failure and Fanconi syndrome—has been reported in people taking both cobicistat and tenofovir DF (TDF). When used with TDF, a baseline CrCl, urine glucose, and urine protein is needed; CrCl, urine glucose, and urine protein should be monitored regularly while taking cobicistat-containing regimens.
Potential Drug Interactions
Do not use with alfuzosin, rifampin, irinotecan, ergot derivatives, lovastatin, simvastatin triazolam, oral midazolam, St. John’s wort, Revatio, or Viramune (nevirapine). Tybost is not interchangeable with Norvir. Proton pump inhibitors and H2-receptor antagonists can prevent atazanavir from being absorbed. Treatment-experienced people should not take PPIs while on atazanavir. See package insert for antacid dosing adjustment recommendations. If taking chewable antacids, take with food two hours before or one hour after atazanavir dose. Treatment-experienced people should not take atazanavir with efavirenz. Tenofovir DF decreases levels of atazanavir, and Reyataz/Norvir increases tenofovir DF levels; monitor for adverse events. Monitoring is required when used with warfarin. Calcium channel blockers should be monitored. Reducing dose and frequency of rifabutin to 150 mg every other day or three times a week is recommended. Reyataz/Norvir as well as Evotaz increase levels of fluticasone; monitor for signs of Cushing’s syndrome. An alternative corticosteroid is recommended. Erectile dysfunction drugs should not exceed 10 mg Cialis or 2.5 mg Levitra per 72 hours, or 25 mg Viagra per 48 hours. A lower dose of trazodone is recommended. Use with caution with bosentan, salmeterol, and immunosuppressants. Do not take with Zepatier. Can be used with Harvoni if tenofovir DF is not part of the HIV regimen. Monitor for tenofovir toxicities with Epclusa if TDF is part of the HIV regimen. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are many other drug interactions not listed here.
Reyataz: Can be taken unboosted with Epzicom if absolutely necessary (Reyataz dose of 400 mg daily). Bepridil, amiodarone, quinidine, and lidocaine should be taken with caution. Use caution when taking itraconazole or ketoconazole. Voriconazole is not recommended. Reyataz can be taken with birth control pills that contain no more than 30 mcg of ethinyl estradiol if taking Reyataz without ritonavir, and at least 35 mcg if taken with it. Use caution with carbamazepine, phenobarbital, and phenytoin. Take lower dose of colchicine. Use with ritonavir when taking buprenorphine; monitor for sedation.
Evotaz: Do not take with lurasidone, pimozide, ranolazine, or dronedarone. Do not take with colchicine if there is kidney or liver impairment. Start metformin at lowest dose and titrate based on tolerability and clinical effect.
Yellowing of the eyes is a common reason for discontinuation
Dr. Melanie Thompson:
Atazanavir has more toxicities and drug interactions than INSTIs and is not recommended for initial therapy in most people. Acid blockers can’t be used with atazanavir, and the drug must be taken with food. Atazanavir-based regimens are not often used these days because of the high incidence of jaundice due to indirect hyperbilirubinemia (high bilirubin in the blood) and an increased risk of kidney and gallbladder stones, as well as kidney toxicity. On the bright side, large cohort studies have not found an association between atazanavir and cardiovascular disease. Unboosted atazanavir is FDA-approved for people who have not taken treatment before, but it is not recommended by DHHS or IAS-USA guidelines panels. Ritonavir should be used as a booster in pregnancy, with 400 mg atazanavir.
Activist Michael Broder:
Atazanavir unboosted already has a pretty bad side effect profile, and boosting makes side effects worse. Given other available options, it’s hard to imagine why any provider nowadays would recommend an atazanavir-containing regimen.