A panel of advisers to the Food and Drug Administration took a historic
step last week when they recommended that the agency for the first time
approve a drug that healthy people can take once a day to prevent H.I.V.
Such a pill has long been a goal of research, something that might help
stem a global epidemic that is still causing two million new worldwide
cases each year, including 50,000 in the United States.
But the panel members worried about how to make sure doctors and patients
would use the drug correctly. Otherwise, they said, the potential harm
could be huge — not just to those taking the pill, but also to their sexual
Approval of the first H.I.V. preventive has tangled experts in complicated
scientific and psychological issues and brought sometimes furious debate.
One side says people are so unlikely to use the drug properly that it is
irresponsible and dangerous to let them have it. The other side calls that
argument paternalistic and says people who are motivated to protect
themselves should be given the tools to do so.
The drug is Truvada, which contains two antivirals and is already approved
and widely used in combination with other drugs to treat H.I.V.
infection. In the last few years, studies have shown that taking Truvada
alone every day can prevent infection.
If approved, the drug would be recommended for H.I.V.-negative people at
high risk of becoming infected, like gay men who have multiple partners and
do not use condoms consistently, prostitutes and people in relationships
with someone who is H.I.V.-positive.
Already, though, there are reports that the drug is being prescribed to men
who may not fit these criteria. Little is known about how consistently they
are taking it. And that raises a big worry: viral resistance.
Although Truvada alone can prevent an H.I.V. infection, it cannot control
one that has already taken hold. If an H.I.V.-positive patient were to take
Truvada alone, or if a user were to become infected while taking it, the
H.I.V. strains they carry could become drug-resistant.
The infection would be hard to treat, and it could spread to other people.
To prevent drug resistance, people who want to use Truvada for prevention
first would have to make sure they were H.I.V.-negative and then be
retested regularly, every few months, because it is possible, though
unlikely, to become infected while taking the drug. But experts testifying
before the panel on Thursday acknowledged that there is no way to ensure
that people taking the drug receive frequent H.I.V. tests.
Then there is the question of adherence. Skipping doses or using Truvada on
occasion, as if it were a party drug, would invite both infection and the
emergence of drug-resistant strains. But research shows that people are not
good at sticking to the required daily regimen. In one major study, only 10
percent of the participants took Truvada as directed.
Side effects may be one reason: The drug can cause stomach upset in the
first weeks it is taken. Patients must also be monitored for kidney
problems and bone thinning, rare but potentially serious complications.
Perhaps the most serious concern is that some who take the drug will assume
they no longer need condoms. But condoms are still necessary, because
Truvada is not 100 percent effective. If people take the drug
inconsistently and also skip condoms, they may wind up at even greater risk
than they were before Truvada came along.
At the committee meeting on Thursday, one young man said he and his friends
would not abandon condoms, because they still had concerns about syphilis,
gonorrhea and other sexually transmitted infections.
But people slip up once in a while, he added, and for those lapses, Truvada
might be a safety net.
The F.D.A. has yet to decide whether to approve Truvada for prevention, but
the agency usually follows its experts’ advice. On Thursday, one of the
panel members who voted for approval also said it would be important to
watch what happens once Truvada gains greater use, especially in terms of
drug resistance, and to make changes if something goes wrong. It was a
WASHINGTON (AP) -- The Food and Drug Administration is considering approval
of the first over-the-counter HIV test that would allow consumers to
quickly test themselves for the virus at home, without medical supervision.
FDA reviewers said Friday the OraQuick In-Home HIV test could play a
significant role in slowing the spread of HIV, according to briefing
documents posted online. But they also raised concerns about the accuracy
of the test, a mouth swab that returns results in about 20 minutes.
The review comes one day after an FDA advisory panel endorsed the HIV pill
Truvada for preventive use. If FDA follows the group's advice, the daily
medication would become the first drug approved to prevent healthy people
from becoming infected with the virus that causes AIDS.
Public health experts estimate one-fifth, or about 240,000 people, of the
1.2 million HIV carriers in the U.S. are not aware they are infected.
Testing is one of the chief means of slowing new infections, which have
held steady at about 50,000 per year for two decades.
In a trial conducted by the company OraSure Technologies Inc., the test
correctly detected HIV in those carrying the virus 93 percent of the time.
That rate is below the FDA-recommended 95 percent threshold for accuracy.
The FDA estimates the test would miss about 3,800 HIV-positive people per
year, if approved for U.S. consumers.
The test was more accurate at correctly clearing patients who do not have
the disease. In company studies, OraQuick correctly identified HIV-negative
users 99 percent of the time.
In their briefing documents, FDA scientists noted both the benefits and
risks of expanding HIV testing with the take-home diagnostic kit.
"There is considerable personal and public health value in informing
infected, but otherwise untested, persons of their true positive HIV
status," the reviewers state. "However, this benefit is offset in some
measure by HIV-positive individuals who receive an incorrect message that
they are not infected."
The lukewarm endorsement apparently spooked investors. OraSure's stock
tumbled $1.32, or 11.8 percent, to close at $9.85 in trading Friday.
On Tuesday, the FDA will ask a panel of outside experts whether the test
should be approved for over-the-counter sales in U.S. The agency is not
required to follow the group's advice, though it usually does.
Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to
doctors, nurses and other health care practitioners since 2004. The test
sells for $17.50, though OraSure declined to discuss how it would price the
consumer version. When used by professionals, the test is shown to
accurately identify both carriers and non-carriers 99 percent of the time.
While it's not clear why the test was less accurate in consumer trials, CEO
Doug Michels said company researchers anticipated that its "performance in
the hands of a consumer would be different from that observed in hands of a
OraSure tried the new version of the test in a study of 5,800 people of
various sexual orientation, race and income levels. The trial identified
about 100 HIV carriers who were previously undiagnosed.
The FDA has already approved HIV test kits that people take home.
However, those kits, which require a blood sample, must be sent to a
laboratory for development. But OraSure argues that a test that can be done
at home will appeal to a much broader group of people.
According to the company's study, 41 percent of people who discovered they
were HIV-positive using OraQuick had never been tested previously.
In its own briefing documents, the company estimates that 9,000 new HIV
carriers would be identified for every 1 million people who use the test.
http://www.bloomberg.com/news/2012-05-11/orasure-hiv-test-has-risks-o... * OraSure HIV Test Has Risks of False Results, FDA Says By Anna Edney - May
11, 2012 9:30 PM GMT+0200
People who use what could be the first completely at-home HIV test under
development by OraSure Technologies Inc. (OSUR) risk receiving false
results, U.S. regulators said in a report.
Outside advisers to the Food and Drug Administration should weigh whether
the benefits of the kit are greater than the potential risk of false
negative and false positive results, agency staff said in the report today
ahead of a May 15 advisory panel meeting. Regulators are considering
approval of the OraQuick In-Home HIV Test, which would be sold without a
prescription and provide users with their HIV status at home in a similar
fashion to pregnancy tests.
“There is considerable personal and public health value in informing
infected, but otherwise untested, persons of their true positive HIV
status,” FDA staff wrote. “However, this benefit is offset in some measure
by HIV-positive individuals who receive an incorrect message that they are
OraSure fell 14 percent to $9.65 at 3:15 p.m. New York time, the largest
intraday decline in two years.
About 1.2 million people in the U.S. have HIV, the virus that causes AIDS,
and 20 percent of those people are unaware they are infected, according to
the Centers for Disease Control and Prevention. The test made by Bethlehem,
Pennsylvania-based OraSure would be the first of its kind. Other kits, such
as Home Access Health Corp.’s Express HIV Test System, require users to
anonymously send blood samples to a laboratory for testing.
Clinical Trial Findings
A clinical trial of OraSure’s test identified 100 previously undiagnosed
people infected with HIV of 5,800 patients who used the product, according
to the company. OraSure markets the only FDA-approved rapid HIV test that
detects HIV antibodies in oral fluid and provides results in a clinic or
doctor’s office within 20 minutes.
OraQuick would produce one false negative result for every 13 true positive
tests, FDA staff said. That would total an estimated 3,800 people with HIV
who falsely test negative each year, according to the report. In addition,
the test would produce one false positive result for every 3,750 true
negative tests resulting in 1,100 people a year who aren’t infected
believing they are, the report said.
The false negatives reported were higher than what the FDA considers a
“minimum acceptable performance” while the false positives were lower.
‘Confident’ in Test
“We are very confident in the efficacy, safety and performance of the
OraQuick In-Home HIV Test, which has been proven to have a calculated
accuracy of 99 percent in extensive self-test clinical studies,” Ron Ticho,
a spokesman, said in an e-mail.
OraQuick would identify 9,087 previously undiagnosed HIV- positive
individuals for each 1 million who use the test, Ticho said.
OraSure doesn’t have an estimate for when the FDA may decide on the
home-results test, said Susan Brophy, of Golin Harris, who is a spokeswoman
for the company.
The FDA cleared the Home Access test in 1996. Results can be obtained the
day a sample arrives at a laboratory and retrieved anonymously using a pin
number, according to the Hoffman Estates, Illinois-based company.
The FDA stresses the benefit of having medical professionals help users
interpret the results and understand treatment options on its website.
The FDA staff expressed concern that people who may have gotten tested
professionally would turn to the “less sensitive, but more private,”
alternative. No studies have been done to test the potential impact,
according to the report.
“Counseling, which uses both printed material and telephone interaction,
provides the user with an interpretation of the test result,” the FDA said
on its website about the Home Access test system.
Counseling also can provide information on preventing transmission of the
disease for people who are infected and on treatment options and doctor
referrals, the FDA said.
More than 16,000 people with AIDS were estimated to have died in 2008, the
To contact the reporter on this story: Anna Edney in Washington at
To contact the editor responsible for this story: Reg Gale at
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Division of Pharmacology
Discipline of Pharmaceutical Sciences
School of Health Sciences
* Consultant Pharmacist
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
University of KwaZulu-Natal PBag 7 Congella 4013 South Africa
email: gra...@ukzn.ac.za or a...@gray.za.net