Novel HIV Treatment Approved

August 14, 2007 – 10:56 pm | posted in HIV / AIDS

FDA and Pfizer Inc. announced the approval of Selzentry, or maraviroc, the first agent in a new class of oral HIV medications: chemokine receptor 5 (CCR5) coreceptor antagonists.

By selectively blocking the CCR5 coreceptor, which is HIV’s predominant route of entry into T cells, maraviroc prevents CCR5-tropic HIV-1 from entering the cells. All other oral HIV treatments on the market combat the virus once it has already entered T cells, according to Pfizer.

According to the product’s FDA-approved labeling (PDF), Selzentry is indicated in combination with other antiretroviral medications for the treatment of adult patients with only CCR5-tropic HIV-1 detectable disease and evidence of viral replication despite treatment with other antiretroviral agents.

Selzentry is not appropriate for the treatment of patients infected with chemokine receptor 4 (CXCR4)-tropic HIV or a mixture of CXCR4- and CCR5-tropic viruses, according to Pfizer.

The labeling for Selzentry contains a black-box warning regarding hepatotoxicity, advising physicians to immediately evaluate patients with signs or symptoms of hepatitis or an allergic reaction; this warning also appears in the medication guide.

Selzentry’s labeling also advises prescribers to use caution in administering maraviroc to patients at increased risk for cardiovascular events, patients with a history of postural hypotension or those using a medication known to lower blood pressure, patients with liver dysfunction, and patients with viral hepatitis B or C.

The most common adverse effects associated with the use of maraviroc when taken twice daily during the clinical trials were cough, pyrexia, upper-respiratory-tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.

Selzentry will be available in mid-September as 150- and 300-mg film-coated tablets, according to Pfizer.

The recommended starting dosage of maraviroc depends on the patient’s full medication regimen. If the patient is using a cytochrome P-450 isoenzyme 3A4 (CYP3A4) inhibitor, such as a protease inhibitor, delavirdine, or ketoconazole, the recommended dosage of maraviroc is 150 mg twice daily. If the patient is using a CYP3A4 inducer, such as efavirenz, but not using a strong CYP3A4 inhibitor, the recommended dosage is 600 mg twice daily. For patients using other medications, the recommended dosage is 300 mg twice daily.

In related news, Monogram Biosciences Inc. announced the launch of the company’s Trofile HIV coreceptor tropism assay, which allows clinicians to determine whether an HIV-infected patient harbors CCR5- or CXCR4-tropic virus or a mixture of the two subtypes. The Trofile test was used to select patients for entry into clinical trials of Selzentry, according to the company.

American Society of Health-System Pharmacists

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