Drug Topics - November 19, 2007 - (Page 10)

10 DRUG TOPICS NOVEMBER 19, 2007 www.drugtopics.com Rx Care First-in-class HIV drug boon to patients at end of tether Heidi Belden, Pharm.D. receiving OBT plus placebo had similar reductions, respectively. Increases in CD4 cell counts from baseline after the 24 weeks were 89 and 35 cells/mm3 for patients receiving raltegravir plus OBT versus OBT plus placebo, respectively. “Raltegravir appears to be fairly well tolerated,” Conry commented. There is a low potential for drug-drug interactions at this time and, based on data shown, it is not expected to affect the pharmacokinetics of drugs that are substrates of the major CYP 450 enzymes or p-glycoprotein, he added. The prescribing information does warn, however, that caution should be exercised when co-administering raltegravir with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (i.e., rifampin) due to reduced plasma concentrations of raltegravir. Common adverse effects (incidence >10%) observed during clinical trials included nausea, headache, pyrexia, and diarrhea. In addition, creatine kinase elevations were also observed in subjects receiving raltegravir. “Myopathy and rhabdomyolysis have been reported, thus caution is warranted,” explained Conry. Particular attention should be paid to patients with concomitant use of other medications known to cause this effect, he added. During the initial phase of treatment, patients should also be monitored for Immune Reconstitution Syndrome, an inflammatory response to indolent or residual opportunistic infections, such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, Mycobacterium tuberculosis, or reactivation of varicella zoster virus, which may require further evaluation and treatment. With a low pill burden (one tablet twice daily) and no food restrictions, raltegravir may provide improved adherence compared with complicated regimens, believes Conry. “Adherence is an important factor since nonadherence is a cause of treatment failure and antiretroviral resistance,” he said. Merck has announced the wholesale acquiTIPS TO REMEMBER Isentress sition cost of raltegravir to be $9,855 a year, or Isentress 400-mg tablets are pink, oval-shaped, film-coated, $27 per day and, according to the company, and are available in bottles of 60 tablets. the price is in tune with available Isentress can be taken with or without food. ritonavir-boosted protease inhibitors. The patient-assistance program, SUPPORT, will Safety and efficacy of Isentress has not been established in treatment-naïve adult patients or pediatric patients. provide personalized support and patient advocacy regarding individual reimbursement Breast-feeding is not recommended for the patient taking issues. More information can be accessed at Isentess. www.isentress.com. DT n antiretroviral indicated for treatmentexperienced adult patients with evidence of viral replication and resistance to multiple HIV drugs was given the all-clear sign in midOctober. Raltegravir (Isentress, Merck), previously known as MK-0518, inhibits integrase, the enzyme responsible for the insertion of HIV DNA into human DNA. The drug was granted accelerated approval by the FDA. “The integrase enzyme is responsible for integrating the HIV viral DNA into the CD4 lymphocyte cell’s own DNA,” explained John M. Conry, Pharm.D., BCPS, associate clinical professor at St. John’s University School of Pharmacy. “In other words, raltegravir stops HIV from inserting its genetic code into an infected cell, thereby preventing the virus from making new copies of HIV.” The agency approval was based on a 24-week analysis of HIV RNA viral load in patients taking raltegravir in combination with optimized background therapy (OBT). “The efficacy of raltegravir was demonstrated in BENCHMRK-1 and BENCHMRK-2 with statistically significant decreases in HIV viral load and increases in CD4 cell counts,” remarked Conry. Furthermore, because raltegravir is in a new class of antiretroviral drugs, it seems to have almost no cross-resistance with the anti-retrovirals in older classes, he pointed out. “It provides a new alternative treatment for patients who are running out of options secondary to antiretroviral resistance.” According to Merck, pooled analysis from the two phase III trials of raltegravir showed that after 24 weeks of treatment, 75.5% of patients receiving the drug plus OBT achieved HIV RNA load reduction below 400 copies/ml, with 62.6% of patients below 50 copies/ml. In comparison, 39.9% and 33.3% A http://www.drugtopics.com http://www.isentress.com

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Drug Topics - November 19, 2007 Contents Latebreakers Letters Leukemia Patients Now Have More Options First-in-Class HIV Drug Boon to Patients at End of Tether 150 Years of American Pharmacy Pharmacy Schools Confront New Pressures From Pariah to Patient ACCP Releases Position Paper on Ethical Interactions New Injectable Antibiotic Welcomed with Open Arms NCCN Updates Head and Neck Cancer Guide Improved Phosphate Binder Approved for Dialysis Patients Considering Combination Concern Ensuring Seamless Care Bill Would Create Center for Comparative Effectiveness Hospital Improves Patient Safety with Automatic Drug Distribution System Infection Rates, Patient Stays Drop with New Drug Device How R.Ph.s Helped Three Hospitals Win Quality and Safety Awards A Pharmacist and Dog in Tow are Alzheimer’s Patients’ Best Friends More PBMs Agreeing to Pricing Transparency New Insulins in the Management of Diabetes New Products Advertisers Index Classified VIEWPOINT: Reflections on Pharmacy School After 30 Years

Drug Topics - November 19, 2007

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