May 12, 2005
CHAPEL HILL — Earlier diagnosis of acute infection with HIV, the virus that causes AIDS, will result if state health departments and comparable facilities across the country add nucleic acid amplification tests to standard HIV tests they now perform, a new study shows.The more sophisticated testing, already used to protect the nation’s blood supply, relies on screening specimens in groups rather than individually. As a result, it is not expensive, and the new research suggests it would be a distinct improvement over antibody tests alone, University of North Carolina at Chapel Hill researchers say. That’s because the standard tests cannot detect the virus for one to two months since it takes more than a month for patients to produce antibodies once infected with HIV.

When people are accurately diagnosed at the earliest possible time after infection, they often can avoid transmitting the virus, sparing others the so-far incurable AIDS disease. Earlier detection also potentially would save millions of dollars in health-care costs, the scientists say.

“North Carolina is leading the country with this approach to HIV testing,” said N.C. State Health Director Dr. Leah Devlin, whose department was central to the research. “This is an important innovation, not only for North Carolina public health but also for the nation and the global community.”

A report on the study evaluating the approach and documenting its benefits appears in the May 5 edition of the New England Journal of Medicine. Chief authors are Drs. Christopher D. Pilcher and Peter A. Leone, assistant professor and associate professor, respectively, of medicine at the UNC School of Medicine. Leone also is medical director of the N.C. HIV/STD Prevention and Care Branch in Raleigh and adjunct associate professor of epidemiology at the UNC School of Public Health.

The 12-month observational research was conducted to document the results of implementing new procedures for HIV testing and counseling in North Carolina. Between November 2002 and October 2003, 109,250 consenting N.C. residents at risk for HIV were tested at 110 state-funded clinics.

Technicians pooled specimens before nucleic acid testing to save time and money. If a combined group showed no HIV, that meant all 90 specimens were negative and required no further analysis. If a combined group tested positive, specimens were then screened individually.

“Of the people tested, 583 were identified as HIV-positive with the antibody tests alone, and there were an additional 23 that the more sensitive nucleic acid amplification revealed,” he said. “In other words, the former assays were only 96 percent effective at detecting HIV-infected people in North Carolina. They missed about one in every 25 cases.”

An important feature of the N.C. program was that the new testing for early infections was linked to procedures for emergency public health intervention, the researchers said.

“Acute HIV infection is a moment of critical public health opportunity,” Pilcher said. “Patients are quite infectious during this time, so being able to counsel them accurately about their HIV status during the acute period can allow them to avoid unknowingly passing HIV on to their uninfected sexual partners.

“Public health workers can also interview, test and counsel partners who may recently have transmitted the virus – something that is very difficult when a new case is reported to the health department years after infection.”

In the N.C. program’s first 12 months, emergency counseling was provided to the newly infected clients and to 48 of their sexual partners, he said. One pregnant woman identified by nucleic acid amplification was able to start taking HIV medication to protect her unborn infant.

“Routine antibody testing alone for HIV infection misses the earliest and most virulent stage of HIV infection,” Leone said. “Acute HIV may be 10 or more times more infectious than later stages. Our experience with adding HIV nucleic acid amplification screening to the North Carolina HIV Counseling and Testing Program has demonstrated that we can detect HIV in its earliest stage and intervene to possibly save lives.

“Missing infections at the earliest stage means missing an opportunity to impact transmission,” the physician said. “These individuals may go years without realizing that they are HIV infected.”

Such programs can be implemented on a large scale with patients and their partners being notified almost immediately, he said. Identification of acute HIV infection gives clinicians and public health workers the opportunity to detect the leading edge of HIV transmission in groups of people and to direct focused prevention activities to those groups specifically.

Other UNC authors are Dr. Myron S. Cohen, J. Herbert Bate professor of medicine, professor of microbiology and immunology, professor of epidemiology and chief of infectious diseases; programmer Brandt Stalzer; Drs. Lisa Hightow and William C. Miller, assistant professors of medicine; Dr. Joseph J. Eron, associate professor of medicine; Dr. Susan A. Fiscus, professor of microbiology and immunology; and project manager Trang Q. Nguyen.

Other N.C. Department of Health and Human Services authors are Evelyn Foust, head of the N.C. HIV/STD Prevention and Care Branch; Dr. Del Williams, manager of the N.C. Epidemiology and Special Studies Unit; Rhonda Ashby, assistant manager of the N.C. Field Services Unit; and Judy Owen O’Dowd of special projects in the HIV/STD branch. Many others at UNC and with the state also helped with the research.

Besides the state, support for the study came from the National Institutes of Health, the UNC Center for AIDS Research, the General Clinical Research Center and a cooperative agreement with the Association of Schools of Public Health, the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

“This important study suggests that feasible and cost-effective methods for detecting acutely HIV infected persons may create new opportunities for intervening more rapidly with social networks, enhancing partner counseling and referral, and addressing health conditions that may increase transmission risk,” said Dr. Ellen Stover, director of the Center for Mental Health Research on AIDS at the National Institute of Mental Health. “The implications for HIV prevention in clinical and other settings are considerable.”

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This release was researched and written by David Williamson of UNC News Services

News Services Contact: David Williamson, (919) 962-8596

For further information please contact Emily Smith by email at emily_smith@unc.edu

 

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