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Sustiva

Efavirenz (brand names Sustiva® and Stocrin®) is non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of high active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. more...

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For HIV infection that has not previously been treated, efavirenz and lamivudine in combination with zidovudine, tenofovir or stavudine is the preferred NNRTI-based regimen.

Efavirenz is also used in combination with other antiretroviral agents as part of an expanded postexposure prophylaxis regimen to prevent HIV transmission for those exposed to materials associated with a high risk for HIV tranmission. The usual adult dose is 600 mgs once a day taken on an empty stomach at bedtime.

History

Efavirenz was approved by the Food and Drug Administration (FDA) on Sep 21, 1998, making it the fourteenth approved antiretroviral drug.

Drug interactions

  • Efavirenz is metabolized in the liver, and possesses both inhibitory and inducing effects on the 3A4 isoform of the cytochrome P450 system. This means efavirenz may interact with other drugs metabolized in the liver, requiring either increased or decreased dosages.
  • Efavirenz lowers blood levels of most protease inhibitors. Dosages of amprenavir, atazanavir, or indinavir may need to be increased. The blood levels of saquinavir are dramatically lowered, so that the two drugs cannot be used simultaneously.
  • St. John's Wort and garlic supplements may decrease efavirenz blood levels.

Side effects

  • Psychiatric symptoms, including insomnia, confusion, memory loss, and depression, are common.
  • rash nausea dizziness and headache may occur
  • efavirenz can cause birth defects
  • safety in children has not been established
  • use of efavirenz can cause a false positive in some urine tests for marijuana

Mechanism of action

Efavirenz is chemically described as (S)-6-chloro-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 µg/mL).


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FDA approves Sustiva®
From Drug Store News, 10/19/98 by Ellen Kim

DuPont Pharmaceuticals has received Food and Drug Administration approval for it new AIDS drug, Sustiva(r) (efavrienz), Sustiva(r) is the third non-nucleoside reverse transcriptase inhibitor. Experts says it is more potent than the other two non-nucleoside drugs, delavirdine and nevirapine, If t is as powerful as some claim Sustiva may simplify a drug regimen by lowering the number pills patients take on a daily basis to reduce their viral load. Results from clinical trials indicate Sustiva reduceplasma viral RNA to less than 400 copies/mL in antiretroviral-naive and treatment-experienced patients in two-, three-and four-drug combinations.

Meeting the FDA's fast-track criteria, Sustiva(r) was administered with AZT and 3TC, and was shown to be more effective in a larger number of patients than the standard regimen, consisting of indinavir, AZT and 3TC. In addition, more subjects from indinavir, AZT and 3TC control arm discontinued theraphy due to adverse events. Criteria for efficacy included plasma viral levels and CD4 cell counts in controlled studies in a period of 24 weeks.

Adverse events related to Sustiva(r) are generally well tolerated and transient. The most notable ones are symptoms associated with the nervous system, such as dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming. These symptoms tend to resolve within a few weeks into treatment. Sustiva(r) is contraindicated in pregnant women because of teratogenic effects seen in treated animals. Patients should also be warned of avoiding fatty meals with Sustiva(r) due to increased absorption of the durg in the presence of lipids.

COPYRIGHT 1998 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group

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