Atazanavir Cobicistat Brand Name– EVOTAZ
What is Atazanavir Cobicistat
Atazanavir cobicistat is a fixed-dose combination product containing a protease inhibitor (atazanavir) and a pharmacokinetic enhancer (cobicistat).
The drug is indicated for use in combination with other antiretroviral agents to treat HIV-1 infection in both treatment-naive and treatment-experienced adults.
Approval was based on the results of a single active-controlled study, in which 692 treatment-naive adults were randomized to receive either atazanavir; cobicistat or atazanavir plus ritonavir (both in combination with emtricitabine; tenofovir).
After 144 weeks of treatment, 72% of atazanavir; cobicistat recipients achieved HIV-1 RNA concentrations less than 50 copies/mL, compared to 74% in the atazanavir plus ritonavir group.
Studies in treatment-experienced patients are not available, and the manufacturer recommends use in this population be guided by the number of baseline primary protease inhibitor resistant substitutions.
Atazanavir cobicistat was approved by the FDA in January 2015.
Indications
- human immunodeficiency virus (HIV)
- human immunodeficiency virus (HIV) infection
Side Effects
- abdominal pain
- AV block
- bleeding
- breast enlargement
- cholelithiasis
- Cushingoid features
- depression
- diabetes mellitus
- diabetic ketoacidosis
- diarrhea
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- Fanconi syndrome
- fatigue
- folliculitis
- glycosuria
- gynecomastia
- headache
- hematoma
- hematuria
- hyperamylasemia
- hyperbilirubinemia
- hypercholesterolemia
- hyperglycemia
- hypertriglyceridemia
- insomnia
- jaundice
- lipodystrophy
- maculopapular rash
- nausea
- nephrolithiasis
- PR prolongation
- pruritus
- rash
- renal failure (unspecified)
- rhabdomyolysis
- Stevens-Johnson syndrome
- urticaria
- vomiting
Monitoring Parameters
- blood glucose
- CBC with differential
- CD4+ T cell count
- ECG
- hepatitis B serology
- LFTs
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum bilirubin (total and direct)
- serum cholesterol
- serum creatinine/BUN
- serum lipid profile
- serum phosphate
- serum triglycerides
- urinalysis
Contraindications
- autoimmune disease
- AV block
- bleeding
- breast-feeding
- cholelithiasis
- diabetes mellitus
- diabetic ketoacidosis
- dialysis
- females
- Graves’ disease
- Guillain-Barre syndrome
- hemophilia
- hepatic disease
- hepatitis
- hepatitis B and HIV coinfection
- hepatitis C and HIV coinfection
- human immunodeficiency virus (HIV) infection resistance
- hypercholesterolemia
- hyperglycemia
- hyperlipidemia
- hypertriglyceridemia
- immune reconstitution syndrome
- infants
- jaundice
- lactic acidosis
- neonates
- nephrolithiasis
- obesity
- pancreatitis
- pregnancy
- renal failure
- renal impairment
- serious rash
Interactions
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