New HIV test developed in N.C.

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RALEIGH, N.C. – A new test that detects whether patients with HIV/AIDS are infected with even small amounts of drug-resistant forms of the virus has been developed by researchers at Duke University Medical Center.

The discovery, published online Sunday in the journal Nature Methods, may help doctors more accurately predict which medicines will work for patients, and which drugs will ultimately fail. Current tests only pick up drug-resistant strains if they represent a significant portion of the virus circulating in a person’s bloodstream.

Detecting resistance quicker would make it possible to keep patients healthy longer, reduce treatment costs and even help cut an infected person’s risk of spreading HIV to others. When drug treatment fails, the virus proliferates in the blood of infected people, causing them to become more contagious.

“This can be huge,” Dr. Feng Gao, a Duke HIV/AIDS researcher and co-author of the journal article, said of the new genetic test. Gao’s lab at Duke perfected the testing process and conducted the experiments to prove its accuracy and sensitivity.

To date, the new test has been used for research purposes only, but Duke is seeking patents that will enable it to develop a diagnostic screening for future commercial use. Duke does not yet have a private industry backer, and still must show through other studies that the process helps improve treatment outcome.

“A lot of questions are still unanswered, but it’s an important step forward,” said Dr. Peter Leone, an HIV/AIDS doctor at UNC-Chapel Hill and medical director of the state’s HIV prevention branch. If the test pans out, Leone said, it would “improve the odds that the first course of treatment is going to be successful.”

Unchecked by drugs, HIV reproduces in an infected person’s body at a dizzying rate. A single virus can make billions of copies of itself each day. The virus is not meticulous about making accurate copies, so tiny errors – mutations – occur as HIV replicates.

When a patient takes antiretroviral drugs, the medicines kill off the most prevalent strains of virus, allowing the mutations to survive and proliferate. Some of those mutations help HIV resist drugs.

Duke’s new test comes amid rising evidence that HIV drug-resistance is a problem, even among patients who have never been treated with antiretroviral drugs.

Studies have found that 15 percent or more of patients newly diagnosed with HIV harbor drug-resistant strains of the virus.

Such findings helped prompt the federal government, which publishes national guidelines setting standards of care for patients with HIV disease, to begin recommending routine drug-resistance testing for newly diagnosed patients. The change, which took effect last year, means most public and private insurance companies now cover resistance testing, which costs several hundred dollars per test – $1,000 or more per test for certain types.

Even the less sensitive tests available now are helpful in avoiding treatment pitfalls, said Dr. Charles Hicks, a Duke infectious disease specialist who treats patients with HIV/AIDS and is co-author on the journal article. A common mutant strain picked up by such tests resists one of the first-line treatments for HIV, he said. If patients test positive for that type of drug-resistant strain, doctors know to prescribe other medicines.

“It makes you choose a totally different treatment path,” Hicks said.

Duke’s test represents an improvement on existing laboratory tests because it is more sensitive, detecting resistant strains that make up less than 1 percent of the virus circulating in the patient’s blood. Existing tests pick up drug-resistant HIV strains only if they make up 20 percent or more of the total virus in the patient’s system.

“Even if you don’t see resistance, you can’t be sure that it’s not really there,” Hicks said. “That’s a huge problem.”

Physicians may prescribe a combination of HIV drugs to patients who test negative for resistance under the current, less sensitive screenings, only to have that patient fail to respond. Drug resistance is not the only reason patients fail on drug treatment – they may miss doses of medicine, for example – but resistance is widely acknowledged to be part of the equation.

Doctors don’t know how much drug-resistant virus is enough to derail treatment.

“Do we really need to be able to detect mutation down to 0.1 percent?” said Dr. Hawazin Faruki, an infectious disease specialist who works for the diagnostic laboratory company LabCorp. Both she and Leone reviewed an advance copy of the Duke journal article at The Raleigh News & Observer’s request. “It may turn out to be overkill.”

Leone, the UNC-CH AIDS researcher, agrees that it’s not clear the tiny levels of drug-resistant virus detected by the Duke test are significant enough to cause treatment failure. But now that the test exists, researchers can use it to find out.

“Now, those studies will get done,” Leone said.

Duke’s work in HIV resistance, which is funded by the National Institutes of Health, continues North Carolina scientists’ tradition as innovators in the area of HIV/AIDS testing.

Starting in 2002, North Carolina’s Division of Public Health began using a cutting-edge test developed in conjunction with researchers at UNC-Chapel Hill. That test diagnoses HIV infection weeks before standard tests can, allowing public health clinics to get to patients who might unwittingly spread the virus to others. Public health programs across the United States and abroad have since started testing programs based on North Carolina’s pioneering work.

Innovation has occurred outside academia, as well. LabCorp, which has its headquarters in Burlington, N.C., in 1998 became one of the first labs to offer genetic HIV-resistance tests in America, through a partnership with a Belgian company. In 2000, LabCorp introduced its own HIV resistance test, which was developed by scientists based at its research and development campus in Research Triangle Park.

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