Roche Diagnostics' HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class o...( Roche HIV-1 monitoring technology u...),Health

Roche HIV-1 monitoring technology used to validate results for Isentress

INDIANAPOLIS, Oct. 29 /PRNewswire/ -- Merck's new integrase inhibitor, Isentress, approved last week by the Food and Drug Administration, used Roche Diagnostics' COBAS(R) HIV-1 AMPLICOR viral load test during its clinical trials.

The new HIV drug, generically known as Raltegravir, is an HIV integrase inhibitor. Integrase inhibitors prevent replication of the virus by blocking insertion of HIV genetic material into human DNA. There are several other HIV integrase inhibitor drugs under development.

Isentress clinical trials researchers followed patients' progress by testing their viral loads with Roche's COBAS(R)HIV-1 AMPLICOR viral load test, which targets the gag region of the HIV virus genome, a different area from the integrase region where many new drugs in the HIV pipeline are being developed. Viral load testing, which quantifies the amount of HIV RNA in a patient's blood, is critical for evaluating response to therapy and as an aid to optimize patient treatment.

"With this new drug classification, it's important to choose an assay that can accurately detect viral load," said Dr. Bill Valenti, founding medical director and staff physician for the AIDS Community Health Center in Rochester, NY. "We've seen evidence of how easily HIV can mutate. If the targeted region mutates during viral load monitoring, the virus may become difficult to detect and quantitate, which may lead to inaccurate information on patients' responses to treatment."

Twenty-one natural polymorphisms and 42 resistance mutations have been identified so far in the integrase region of the HIV genome, according to a 2007 peer reviewed study published in Antiviral Therapy.

Roche's HIV-1 viral load test has been the predominant choice in HIV anti- retroviral clinical drug trials since 1996. Roche has provided research and expertise in comprehensive diagnostic tests for developing HIV ant
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