Maraviroc Now Approved for Use in Treatment-Naive HIV-Infected Patients

The new indication maximizes the number of patients who could benefit from maraviroc, but many clinicians and patients will likely opt for agents that are simpler to use.

Two years ago, maraviroc was approved for use in treatment-experienced patients with CCR5-tropic HIV. Now, the FDA has expanded the drug's indications to include treatment-naive patients with CCR5-tropic virus.

The approval is based on 96-week results from the ongoing, manufacturer-sponsored MERIT trial, which was designed to test the hypothesis that maraviroc was not virologically inferior to efavirenz among treatment-naive patients infected with CCR5-tropic virus. The primary endpoint was the proportion of patients with viral loads <50 copies/mL at 48 weeks of follow-up.

Initial 48-week analyses indicated that maraviroc did not meet the criteria for noninferiority (JW AIDS Clin Care Sep 10 2007). However, when a new assay became available t…

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Charles B. Hicks, MD

Disclosures

Consultant / Advisory boardGilead Sciences; ViiV; Merck

RoyaltiesUpToDate, Inc.

Grant / Research supportNIH; Department of Health and Human Services

Charles B. Hicks, MD

Disclosures

Consultant / Advisory boardGilead Sciences; ViiV; Merck

RoyaltiesUpToDate, Inc.

Grant / Research supportNIH; Department of Health and Human Services

Maraviroc Now Approved for Use in Treatment-Naive HIV-Infected Patients

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