Apr03-1-1

OraSure HIV test is centerpiece of US prevention project

By Christian Berg
Of The Morning Call

OraSure Technologies' rapid HIV test will play a critical role in a sweeping new national AIDS prevention initiative, the federal government's top public health agency said Thursday.

It was the latest in a series of high-profile government endorsements for the Bethlehem company.

The U.S. Centers for Disease Control and Prevention want to make HIV screenings part of routine doctor's visits for at-risk people such as intravenous drug users and those who have unprotected sex. The CDC is also urging all federally funded clinics, jails, shelters, substance abuse treatment centers and other locations to take advantage of OraSure's 20-minute OraQuick test.

Officials are urging the increased vigilance in response to recent statistics that indicate human immunodeficiency virus rates may be increasing. HIV is the virus that causes AIDS.

The CDC recommends OraQuick by name in its five-page outline of the initiative. That could result in increased sales of the test, which is made in Bethlehem.

The test is groundbreaking because its speed lets patients learn their HIV status before leaving a clinic or medical office. In most cases, it can replace traditional lab tests that make people wait a week or more for results. At least 8,000 people a year who test positive never return to a clinic to get the news. So they don't start life-extending treatments and don't get counseling on how to avoid transmitting the virus to others.

OraQuick, the nation's only rapid, easy-to-use HIV test, is receiving phenomenal boosts from federal officials. Since it received federal approval five months ago, it's been touted by the Food and Drug Administration, President Bush, Health and Human Services Secretary Tommy Thompson and now the CDC.

The federal support is ''off the charts'' compared with that given to most medical products, said David L. Webster, president of the Webster Consulting Group, a Bethlehem firm that advises pharmaceutical, biotech and diagnostic companies.

However, Webster cautioned that the CDC's recommendation doesn't guarantee a huge OraQuick sales surge.

''Just because the CDC waves its magic wand doesn't mean you're going to see 100 percent compliance in the health care system,'' Webster said. ''The proof will be whether the CDC is willing to back this with a serious public health effort.''

One sign that the CDC is serious is that it budgeted $35 million for the testing initiative. That money will help stage demonstration projects later this year to show OraQuick's effectiveness and encourage its use in public health settings. Officials have not yet decided how much of that money will be spent on OraQuick, when the demonstration projects will begin or how many there will be around the country, a CDC spokeswoman said.

Ron Spair, OraSure's chief financial officer, said the CDC announcement is ''a further affirmation of the power of the product.''

''The CDC and the FDA,'' Spair said, ''have been wonderful to work with, supportive of the product and supportive of the company's efforts to make the product as widely available as possible.''

CDC Director Dr. Julie Gerberding said her agency decided to modify its HIV testing recommendations because not enough progress is being made in the fight against AIDS. ''We've made enormous progress in the global epidemic, but our prevention efforts have stalled,'' she said. ''We have a very, very sad situation in the United States.''

The Centers for Disease Control and Prevention estimates that between 850,000 and 950,000 Americans are infected with HIV — including 24,000 people in Pennsylvania, and more than 800 in the Lehigh Valley. About a quarter of those infected don't know it.

One of the biggest problems is the number of people who don't learn they are infected with HIV until AIDS symptoms set in.

Gerberding believes the availability of OraQuick could dramatically improve that situation. Officials hope the testing efforts will reduce the 40,000 new HIV cases that occur every year.

''The advantage of the rapid test is that people can get their results in 20 minutes, and they don't have to make an appointment and come back for a follow-up,'' she said. ''It is a way to speed up access to the test, but more importantly, speed up access to the information.

''It's a huge technological advance that we hope has profound implications for undiagnosed people.''

As part of its new initiative, the CDC is also recommending that all pregnant women be tested to prevent the spread of AIDS to their unborn children. ''Each case of perinatal HIV transmission represents a failure of our public health system,'' Gerberding said. OraQuick will not be used to screen for HIV in most pregnant women, who typically give blood samples that are used in a variety of laboratory tests.

OraQuick is about as easy to use as a home pregnancy kit, health officials say. To use the pocket-size test, a health worker pricks a person's finger, mixes a spot of blood into a vial of developing solution and drops in the stick-like testing device.

One reddish line on the dipstick means no HIV. Two reddish lines mean the person is probably infected and needs another test to be sure.

Test kits, which cost less than $20, can be stored at room temperature, require no special equipment and can be used outside a hospital or clinic.

That stands in contrast to other rapid HIV tests, such as MedMira Inc.'s Reveal HIV test, which was approved Thursday by the FDA. The Reveal test provides results in three minutes, but the test is done using blood plasma or serum that has to be collected from whole blood in a laboratory. That will prevent Reveal from being used in public places where OraQuick is already in use, such as drug treatment centers and neighborhood health clinics.

OraSure is working to gain FDA approval for a saliva-based version of OraQuick, which would make its test even easier, said Spair, the chief financial officer.

Since OraQuick's approval in November, OraSure has sold the test to dozens of customers, including the Navy.

OraQuick is also widely used locally. Vicky Kistler, communicable disease manager at the Allentown Health Bureau, said the test is particularly useful for patients who are afraid of needles and for intravenous drug users, whose veins can be tough to locate.

OraSure has a distribution agreement with Abbott Laboratories to sell OraQuick to hospitals and doctors' offices. The deal with Abbott, one of the nation's leading marketers of medical testing products, guarantees OraSure at least $4 million in OraQuick sales this year.

The company, which makes other products such as drug testing products used to screen job candidates, had total sales of $32 million in 2002. The company expects 2003 sales to jump to $40 million, largely as a result of OraQuick sales.

OraSure, which employs about 190 people, is boosting OraQuick production at its Eaton Avenue plant in Bethlehem. The company can produce 100,000 OraQuick tests a month.

''The demand has been very encouraging. We've been cranking them out since December,'' Spair said. OraSure will provide more specific sales figures when the company announces its first-quarter financial results on April 29.

Aaron Lindberg, an analyst who covers OraSure for William Smith Special Opportunities Research in Denver, said he isn't boosting his sales forecasts as a result of the CDC's announcement. But he said it does reinforce his strong belief in the company.

''It's just one more great prospect for a company with an awesome product,'' said Lindberg, who has a ''buy'' rating on OraSure stock. ''OraSure has got a tremendous market opportunity. The main thing I am looking for is consistency and delivering results on the bottom line.''

OraSure stock closed down 3.5 percent Thursday to $6.30 a share in trading on the Nasdaq stock exchange. Shares are up 16 percent this year.

Many HIV+ May Not Take Life-Saving Drugs: Study

Thu Apr 17, 5:32 PM ET

NEW YORK (Reuters Health) - If the findings at one Texas hospital are any indication, many HIV infected patients who die of the disease are not on potentially life-saving medications at the time of death.

An analysis of patients who died at the hospital in 1999 and 2000 found that more than half of the people who died were not taking potent combinations of drug "cocktails" known as highly active antiretroviral therapy, or HAART.

"I was really startled to see that that so many patients were not on HIV therapy in an era when it's supposed to be widespread, and access is there," said the study's lead author Dr. Mamta K. Jain of the University of Texas Southwestern Medical Center in Dallas in a prepared statement.

Since 1996, when HIV drugs known as protease inhibitors were introduced, the standard of care in the U.S. has been to fight HIV infection using HAART.

In the current study, published in the journal Clinical Infectious Diseases, doctors compared HIV positive patients who died in 1995 (before HAART medications where available) to those who died in 1999 and 2000. They also assessed whether or not patients in the later group were taking HAART.

In all, Jain's team evaluated a total of 200 HIV/AIDS patients -- 112 who died in 1995 and 88 who died in either 1999 or 2000.

Despite "widespread availability" of HAART only 48 percent of patients who died in 1999 or 2000 were taking HAART at the time of death, the authors report.

The main reasons the patients weren't taking the drugs were an inability to adhere to the complex treatment regimen and an HIV diagnosis less than six months prior to death. Other reasons included an inability to tolerate the drugs due to underlying liver disease, the study indicates.

Still, the team did see a decline in the number of people dying due to HIV. However, "AIDS-defining illnesses," such as Pneumocystis carinii pneumonia were still an important cause of death in patients not taking HAART, according to the report.

"I don't want to paint a gloomy picture, said Jain. "Definitely, the number of cases of patients dying with AIDS has decreased radically. But we were expecting to see a change in the types of diseases people were dying from, and we didn't see that."

"I think the study is important because, if you look at the HIV/AIDS literature, you see these dramatic changes, and people are living longer ... but I think we kind of lose sight of the fact that there are still areas in the country that still are seeing a lot of the same problems that we did prior to HAART being available."

In the current study, many of HIV infected individuals not receiving HAART were ethnic minorities.

Nine out of 12 patients who were diagnosed with HIV shortly before death, and 12 of 18 patients who did not take HAART as prescribed were black or Hispanic, the authors write.

Last year the Centers for Disease Control and Prevention estimated that up to one-third of HIV positive people do not appear to be receiving treatment. The CDC estimates that 850,000 and 950,000 HIV-infected individuals in the U.S.

SOURCE: Clinical Infectious Diseases 2003;36.

Scientists Say Sex the Main Source of HIV in Africa

NEW YORK (Reuters Health) - Despite recent theories that the AIDS epidemic in some African countries arose from unsafe medical injections and blood transfusions, scientists said Wednesday that the pattern of the disease matches more closely with one primarily spread by unprotected sex.

The UK investigators compared the changing rate of HIV in sub-Saharan African countries -- home to the most people infected with HIV -- to that of hepatitis C, a liver-attacking virus spread mainly through contact with infected blood.

International Coalition of AIDS Groups Launch Campaign to Pressure Roche to Lower Price of New AIDS Drug Fuzeon

LOS ANGELES, April 14 /PRNewswire/ -- A coalition of AIDS groups from across California, the U.S., Italy, and other parts of the world today launched a campaign urging pharmaceutical maker, F. Hoffmann-La Roche to lower the price of its new anti-HIV drug, Fuzeon, to a level that will make it accessible to all HIV/AIDS patients. In a letter to Roche Chairman and CEO Franz B. Humer, the U.S. advocates wrote that "Fuzeon's $20,000 price tag is out of the price range for most AIDS patients," and "threatens to bankrupt already financially stressed Medicaid and AIDS drug assistance programs."

"Fuzeon must not be priced significantly above existing HIV/AIDS medications," said Michael Weinstein, AIDS Healthcare Foundation (AHF) president. "AIDS drugs are priced at the maximum the market will bear, regardless of production costs," he added. "Other drug makers will follow suit with equally high prices, and access to care will be the casualty."

"We don't want to face another situation in which patients who have failed to respond to other medications may have to fight again to access new anti-retrovirals as it was in the past for protease inhibitors" said Mauro Guarinieri, Vice Chair of The European AIDS Treatment Group, and member of The Italian Community Advisory Board, the coalition which has launched the campaign in Italy.

"People's lives should not be placed in the balance when drug companies set about determining the price of their drugs," said Doris Wahl, Executive Director of the Whittier-Rio Hondo AIDS Project. "The fact that the proposed price for Fuzeon is too high to be covered by the state AIDS Drug Assistance Program puts virtually every one of our clients at unacceptable risk."

AIDS Healthcare Foundation (AHF) officials were unimpressed by reports that Roche had made agreements to lower Fuzeon prices for U.S. AIDS Drug Assistance Programs. "AHF believes the price reduction to ADAPs are a public relations stunt," said Clint Trout, AHF Associate Director of Government Affairs. "Analysts had predicted a price range of $15,000 - $17,000 for Fuzeon. It looks like Roche priced the drug higher with the expectation to make public 'concessions.' Because the lower price is only in effect for one year, when there will not be large supply of the drug available, this is not really a large concession from the company. In addition, the price concession is not available to Medicaid programs, which serve more patients."

Trout also noted that substantial US taxpayer funds were used to invent Fuzeon. "Why should the US taxpayer be allowed only token discounts from a foreign-owned company like Roche for drugs invented with US taxpayer dollars?" Advocates have documented that the US National Institutes of Health (NIH) invested at least $3.5 million in the invention of Fuzeon, with up to 17 grants NIH grants having been involved.

AIDS Healthcare Foundation is the US' largest AIDS organization. AHF serves thousands of patients in California, New York and Florida regardless of their insurance status or ability to pay. In addition, AHF currently operates two free AIDS treatment clinics in Africa: the Ithembalabantu (Zulu for "people's hope") Clinic in KwaZulu Natal, Durban, South Africa & the Uganda Cares Healthcare Center in Masaka, Uganda. www.aidshealth.org .