WASHINGTON _ Chiron Diagnostics is collecting a clinicaltoolbox of information it plans to share with managed care firms toenhance the use of two clinical assays used in the treatment of HIVand hepatitis patients.

The Emeryville, Calif.-based firm is collecting a data base ofinformation about patient treatment outcomes and devising treatmentalgorithms that will ease the adoption of these technologies bymanaged care firms.

"It is extremely important [to define] the clinical benefit of thesetechnologies so that they might be accepted by managed careorganizations," said Mike Richey, vice president of sales, ChironDiagnostics, a subsidiary of Chiron Corp.

Many drug companies now are compiling patient care data bases,treatment outcomes and clinical algorithms typically packaged indisease management programs that are sold by the drug companies oroutside firms. While some critics have referred to the diseasemanagement programs as a sophisticated form of detailing, manymanaged care firms are actively seeking disease management skills toimprove the care of chronically or seriously ill patients.

According to the Pharmaceutical Research and Manufacturers ofAmerica, in 1988 only 2 percent of drug companies were performingcost effectiveness analyses. In 1994, that figure jumped to 34 percent.(See BioWorld Today, Dec. 27, 1995, p. 1.)

To highlight the importance of these new technologies in themanaged care setting, Chiron has coined the term `therametrics' torefer to diagnostics that help define a course of clinical therapy."Therametrics is the measurement of a therapy or the effects of atherapy," explained Richey. "Our therametrics approach to managingthese critical diseases will be an important component of the way ourtechnologies are adopted in the future."

For example, measuring the level of virus at baseline prior totreatment for hepatitis patients is a technology "that might be used bya managed care organization to define which patients are most likelyto respond to therapy and to identify which ones to treat," Richeysaid.

Richey attributed the cost-effectiveness data that Chiron hadcollected on the hepatitis C virus assay as the reason the Japanesedrug ministry quickly cleared the product in 1993.

"Certainly a large factor in their decision to approve the assay wasknowledge that they could better manage hepatitis patients using thistechnology," he said.

In the case of HIV therapy, application of the highly sensitive RNAassays also permits physicians to individualize treatment. Use of theassay permits more cost-effective prescribing of anti-HIV drugs thatrange in price from $2,000 annually for AZT therapy to more than$7,000 per year for the new protease inhibitors.

Tailoring Therapy For Individuals

"Our goal is to show that the HIV RNA assays, which cost about$200 each, are a cost effective method that will permit a managedcare organization to tailor therapy to the individual. Instead oftreating the clinical population, you treat the individual," said Richey.

Chiron Diagnostics plans to submit a premarket approval applicationfor the HIV RNA assay to the FDA within the next few weeks, acompany spokeswoman said.

The HIV virus assays measure the amount of viral RNA in the plasmaof HIV patients. Results from clinical testing indicate that plasmaHIV RNA values correlate highly with the risk of progression toAIDS, according to analyses from the Multicenter AIDS CohortStudy, sponsored by the National Institutes of Health. In that study,fewer than 10,000 copies/mL were associated with a low risk ofdisease progression while more than 100,000 copies/mL wereassociated with a high risk of progression of disease.

Chiron said the RNA assays are far more sensitive than CD4 asmarkers of disease. According to Richey, the correlation betweenCD4 and viral load "is not a correlation you can draw a line through.It is actually a scatter gram over the entire disease spectrum asdefined by CD4 counts. In other words, people who had high CD4counts also had high levels of the virus. This suggests that meaningfulinformation to select patients for anti-viral therapy cannot be basedjust on their CD4 cells counts," Richey said. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.