AEGiS-GMHC: Free Introductory Offer for Viral Load Tests

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Free Introductory Offer for Viral Load Tests

GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Theo Smart

As Treatment Issues went to press, FDA marketing approval was imminent for Hoffmann-La Roche's Amplicor HIV-1 Monitor test kit. Approval will make the test, based on polymerase chain reaction (PCR), the first commercial method for measuring HIV in the blood, or viral load. The Amplicor kit will receive the FDA go-ahead for use in determining a patient's prognosis and as an aid in assessing response to anti-HIV treatment. The latter indication is very important as it will allow much more frequent use of the test. In recent weeks, AIDS activists have put considerable pressure on the FDA to support such treatment monitoring.

Roche in partnership with a number of clinical laboratories is offering to provide two free baseline tests to all comers for the first 60 days Amplicor is on the market. To enroll in what is being termed the Amplicor Access Program, call toll- free 888/AMPLICOR (888/267-5426) This program will give Amplicor a head start over Chiron's competing bDNA test, whose approval also should come soon. Persons with baseline viral load by Amplicor should stay with that brand since it is not completely interchangeable with bDNA.

The company will use the 60-day period to convince Medicaid and other third party reimbursers to pay for the test. Roche is not committed to launching an indigent patient program for those who cannot afford viral load testing after the first 60 days. The company should be able to gauge the need for such assistance since those who enroll in its baseline testing giveaway will be asked about their insurance coverage. But any support Roche could give is complicated by the fact that much of the testing fee -- expected to be $150 or more initially -- goes to the commercial laboratories that perform it, not Roche itself.

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