Drug Topics - March 10, 2008 - (Page 17) www.drugtopics.com MARCH 10, 2008 DRUG TOPICS 17 Rx Care New salvage HIV drug is smart choice for some Heidi Belden, Pharm.D. IV and AIDS patients harboring drug-resistant achieved in 60% and 61% in virus may find that a newly approved antiretro- patients on etravirine compared viral offers some hope when little else does. e with 39% and 41% on BR in non-nucleoside reverse transcriptase inhibitor, etravirine DUET-1 and DUET-2, respec(Intelence) from Tibotec Pharmaceuticals, is the first tively. CD4+ cell counts also inNNRTI to be granted regulatory approval in almost a creased significantly in patients decade and, according to the manufacturer, is the first on etravirine compared with BR to show activity against virus strains that are already after 48 weeks of treatment. resistant to other drugs in the same class. e most common adverse events, occurring in “Etravirine will make a difference because there is re- >10% of patients, were rash and nausea. According to sistance in this class of drugs,” said Joel Zive, Pharm.D., Tibotec, the rash is typically mild to moderate, occurred owner of Zive Pharmacy, Bronx, N.Y., and an HIV in the second week of treatment, and generally resolved specialist. Use of NNRTIs as part of combination HIV within a few weeks of therapy. Adverse events that octreatment has been limited by cross-resiscurred in 2% or more patients included diartance between drugs, where resistance to one rhea, abdominal pain, nausea, vomiting, peagent typically meant resistance to the others ripheral neuropathy, fatigue, headache, and within the class. “ ere doesn’t appear to be hypertension. Stevens-Johnson Syndrome, cross-resistance now, but that is not to say it won’t hap- hypersensitivity reactions, erythema multiforme, and pen,” Zive said of the new drug. immune reconstitution syndrome were reported, but Etravirine was granted accelerated approval for use in their incidence was rare. combination with other antiretrovirals for the treatment According to the prescribing information, etravirine of HIV-1 infection in treatment-experienced adult pa- should not be taken with ritonavir (Norvir, Abbott) tients, who have evidence of viral replication and strains in combination with tipranavir (Aptivus, Boehringer resistant to an NNRTI and other retroviral agents. e Ingelheim), fosamprenavir (Lexiva, GSK), or atazanavir approval was based on 24 weeks of pooled treatment (Reyataz, Bristol-Myers Squibb); PIs administered withdata from the DUET-1 and DUET-2 studies. Patients out ritonavir; or other NNRTIs. Co-administration of in the treatment arm received etravirine 200 mg twice etravirine with CYP3A4, CYP2C9, and/or CYP2C19 daily plus a background regimen (BR), while the other inducers or inhibitors may alter the efficacy or adverseparticipants received BR only. In order to be eligible for reaction profile of etravirine, and substrates of the same the trial, patients had to have a viral load of 5,000 cop- enzymes may also be affected when co-administered ies/ml or greater, while taking an antiretroviral regimen with etravirine. for at least eight weeks, and with evidence of at least one Tibotec Pharmaceuticals has placed the introductory NNRTI resistance-associated mutation and three or wholesale pricing for etravirine at $21.80 per day, or close more primary protease inhibitor (PI) mutations. to $8,000 per patient, per year. Prescribing information Study results showed 59.8% patients in the etravirine can be accessed at www.intelence-info.com. DT arm achieved undetectable viral load (<50 copies/ml) while only 40.2% met the goal in the TIPS TO REMEMBER Intelence BR arm. A significantly greater mean increase ♦ Intelence should be used in treatment-experienced patients in CD4+ cell count was also seen in the etrawith resistance to NNRTIs and other antiretrovirals. virine group, 81 versus 64 cells/mm3. DUET-1 ♦ The recommended dosage of Intelence is 200 mg twice daily and DUET-2 study results were published in with food. two separate articles in the July 7, 2007, issue of The Lancet. Just recently, Tibotec released ♦ The most commonly occurring adverse effects of Intelence include rash and nausea. 48-week data that also showed significant differences in etravirine-treated patients compared ♦ Intelence belongs to Pregnancy Category B. with BR only. Undetectable viral load was H http://www.drugtopics.com http://www.intelence-info.com
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