PR Newswire; Friday September 11, 1998

The survey included responses from 937 AIDS patients undergoing treatment. Their viral loads were measured during the course of their treatment. Surveys were distributed to AIDS advocacy groups in five U.S. cities: Dallas, Los Angeles, Miami, New York and St. Louis. Most of those surveyed (61 percent) were between the ages of 35-49, with at least some college education. Eighty-five percent of the respondents were male; 56 percent were white; 24 percent Hispanic and 15 percent African-American. The vast majority (91 percent) of those surveyed were currently being treated with antiretroviral therapy.

"The results of the HIV Awareness Survey show that great strides have been made in educating patients about the importance of viral load measurement," said Jules Levin, Founder, National AIDS Treatment Advocacy Project (NATAP). "But there are gaps in the understanding of test results and their application in treatment. As tracking of viral load assumes a greater role in HIV/AIDS patients' overall healthcare, it is important for AIDS educators to continue to provide needed information about viral load testing."

Knowledge of HIV Measurement

The survey results show a patient population (67 percent) that considers themselves knowledgeable about viral load. In fact, most (75 percent) knew their viral load count, and the majority had their viral load measured every two to three months. Most of those patients understood that an "undetectable viral load" meant that the virus is present, but too low to be detected.

Although the results show a high level of viral load measurement, there appear to be several areas where more information is needed. Specifically, the data demonstrate a need for increased education on the following aspects of viral load measurement:

-- The frequency with which viral load tests need to be performed

Forty-nine (49) percent of the study group indicated that they either have no information or needed more information regarding how often the testing needed to be performed.

-- When the test should not be performed

Nearly two-thirds of the survey group needed more, or had no information, about times when viral load testing should not be performed (e.g., when a patient has the flu or after a vaccination).

-- The meaning of significant fluctuations in viral load test results

There was confusion among survey participants about what reduction or increase represents a significant change in viral load. None of the five choices offered illustrating viral load changes received a response rate of less than 7 percent or greater than 32 percent, suggesting a lack of information in this area.

-- The importance of receiving two baseline tests

Somewhat less than a majority of those surveyed had enough information regarding the importance of having two tests done when they begin viral load testing.

-- The importance of using the same type of test

Roughly one-third of survey respondents had enough information regarding the importance of using the same test for monitoring viral load.

Viral Load Testing Valued Among Survey Population

"The survey results are an example of how important viral load measurement has become in the overall care of HIV/AIDS patients," said Jules Levin. "It is promising that the educational efforts made by physicians, AIDS service organizations and manufacturers of viral load tests are having a positive impact."

Among survey responders, most said that viral load testing is very important to assess the effectiveness of drug therapy. Nearly 80 percent consider it to be important, with another 14 percent considering it somewhat important. In addition, all segments of the survey population valued the test; there was little relationship between education, where treated or who pays for the viral load test.

Overall, 95 percent of the respondents said that their doctors measure their viral load level, and 77 percent said that they have some to a great deal of influence with their doctor as far as ordering a viral load test.

Patients with HIV Disease Evaluate Current Sources of Information

A majority (89 percent) of patients surveyed said there is a need for more educational information about HIV and viral load testing. In addition, the respondents report a need for the medical community and manufacturers of HIV/AIDS products to provide increased educational information about treatment issues and viral load testing.

Physicians and AIDS service organizations were named as the major sources of information for treatment and management of HIV disease. Community-based newsletters and medical journals were also considered a reliable and important source by responders. These sources were also considered the most important and reliable. However, twenty-five (25) percent of patients surveyed said the information currently provided is too technical.

About Roche and AMPLICOR HIV-1 MONITOR(TM)

The AMPLICOR HIV-1 MONITOR(TM) Test is currently approved for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. The Test is able to quantitate viral load levels accurately and reproducibly over a dynamic range of 400 to 750,000 HIV-1 RNA copies per milliliter.

In June of 1998, Roche Molecular Systems filed with the U.S. Food and Drug Administration (FDA) for marketing approval of an optional Ultrasensitive specimen processing procedure for the AMPLICOR HIV-1 MONITOR(TM) Test. If approved by the FDA, the new procedure -- designed to measure HIV-1 RNA levels down to 50-copies per milliliter of plasma -- will be the most sensitive method commercially available to measure viral load.

In December of 1997, the Blood Products Advisory Committee to the FDA unanimously (14-0) recommended the approval of the AMPLICOR HIV-1 MONITOR(TM) Test for use as an aid in the management of patients on anti-viral therapy for HIV disease. This expanded claim, when given final approval by the FDA, will allow for use of the Test in monitoring the effects of antiretroviral therapy by measurement of plasma HIV-1 RNA levels.

The Roche Group is a world leader in research-based healthcare with principal businesses in pharmaceuticals, diagnostics, vitamins, fragrances and flavors. Through the company's Diagnostics Division, innovative testing products and services are made available to physicians, patients, hospitals and laboratories worldwide. Roche Molecular Systems, Inc., a business unit within Roche Diagnostics, develops, manufactures and oversees the commercialization of PCR-based test kits marketed under the trade name AMPLICOR(R).

SOURCE: Roche Diagnostics
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