News (Updated December 17, 2005)
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Patients with blood levels above 2.74 micrograms/milliliter were at more than five-fold greater risk of central nervous system side effects than other patients, Dr. Felix Gutierrez of the Hospital General Universitario de Elche in Alicante and colleagues report.
New research suggests as many as half of patients on long-term efavirenz may develop mental disorders, but there is little information on which patients are at risk, Gutierrez and his team note in Clinical Infectious Diseases.
To investigate whether monitoring blood levels of the drug could predict central nervous system side effects, the researchers followed 17 patients taking drug combinations containing efavirenz. None had a history of mental illness.
Participants were evaluated at the beginning of the study and every three months for a total of 18 months, while efavirenz levels were measured five times.
Ten of the patients reported mental issues during the study, with sleep problems being the most common. Moderate or severe side effects occurred in four of the patients -- two had depression, one had changes in mood and concentration and attention problems, and one developed obsessive disorder. All four discontinued the drug.
Patients' blood levels ranged from 0.62 to 12.59 micrograms/mL. The cutoff point of 2.74 micrograms/mL was highly accurate in predicting mental disturbances, the researchers found.
Past research has shown a blood level of efavirenz greater than 1 microgram/milliliter may be enough to suppress HIV, suggesting "there may be room for dose reduction to avoid (side effects) in selected cases," Gutierrez and his colleagues write. However, they add, blood levels above 3 micrograms/milliliter may be necessary in patients who have failed treatment with other drugs.
"Future studies are needed to assess whether therapeutic drug monitoring will result in a decrease in the percentage of patients developing (mental problems) while receiving efavirenz-containing regimens with no loss of efficacy," the authors state.
SOURCE: Clinical Infectious Diseases, December 1, 2005.
Sat Dec 17, 2005 1:29 AM GMT
By Debra Sherman
CHICAGO (Reuters) - A California clinic halted use of OraSure Technologies Inc.'s rapid oral HIV test because of growing concerns about its reliability, sending the company's shares down 26 percent on Friday.
The Gay and Lesbian Center in Los Angeles said that 13 people who took the OraQuick oral test there in November falsely registered as HIV-positive.
Clinics in San Francisco and New York have also reported large numbers of false-positives with the popular test, according to the group.
The Los Angeles center is now offering people the option of a finger prick blood test -- again made by OraSure -- that also delivers an answer in 20 minutes and continues to be reliable.
"The biggest desire people have is to take a rapid test. We haven't had anyone walk away now that we are offering the finger prick test," said Jim Key, a spokesman for the center.
In a telephone interview, OraSure President and Chief Executive Douglas Michels characterized the problems as "isolated," and said it was his top priority to find out why those clinics were reporting so many false positives.
"We just received the data (from the Gay and Lesbian Center in Los Angeles). We're still collecting data," he said. "We're following up with the other sites aggressively."
Michels said the LA clinic, which performs about 600 rapid oral tests per month, was the only clinic that stopped using the oral application.
He said OraSure's OraQuick test can detect the HIV antibody using blood samples instead of oral fluid and added he does not expect the company's sales to suffer as a result of these problems.
The OraQuick oral test screens for the HIV antibody using saliva and provides a result in about 20 minutes, compared with a seven-day waiting period for traditional HIV tests.
Michels said he stands by the financial forecast he provided on November 9. At that time, the Bethlehem, Pennsylvania company forecast 2006 sales would increase 25 percent over 2005, which are expected to top $69 million. The company forecast 2006 earnings per share to be 18 cents to 20 cents, excluding the negative impact of expensing stock options.
He said there are many possible explanations for the false positives, including errors administering the test and the existence of other medical conditions that might influence the outcome.
The LA clinic's decision to stop using the OraQuick oral test, announced late on Thursday, caused brokerage firm Jefferies & Co. on Friday to cut its investment rating on OraSure to "underperform" from "hold" and it forecast more clinics would stop using the test.
OraSure's shares fell $2.91 to close at $8.46 on the Nasdaq, after touching a 6 month low earlier. The stock was the biggest percentage loser on the Nasdaq and among the most actively traded.
(Additional reporting by Deena Beasley in Los Angeles)
Thu Dec 15, 2005 8:27 PM GMT
NEW YORK (Reuters Health) - The results of a large European study suggest that
mother-to-child transmission of hepatitis C virus (HCV) occurs significantly
more often among girls than among boys.
The study findings, based on 1,787 HCV-infected pregnant women and their infants seen at 33 centers, also "strongly suggest" that women should not be encouraged to undergo elective cesarean section or discouraged from breast feeding solely in the hopes of preventing mother-to-child HCV transmission, the researchers add.
The overall mother-to-child HCV transmission rate for the study group was low (6.2 percent), Dr. Pier-Angelo Tovo from the University of Turin in Italy and colleagues report in The Journal of Infectious Diseases.
According to the team, elective cesarean section did not protect against HCV transmission. Maternal history of injection drug use, prematurity, and breast-feeding were also not significantly associated with mother-to-child HCV transmission. HCV transmission occurred more often in women with detectable levels of virus in their blood, but it also occurred in a few women without detectable virus.
As mentioned, Tovo and colleagues found that girls were twice as likely to be infected with HCV as were boys. To their knowledge, this is the first report of a significant association between sex and HCV vertical transmission.
The sex association is "an intriguing finding" that probably reflects hormonal or genetic differences in susceptibility or response to infection between males and females, they suggest.
In a related editorial, Dr. R. Palmer Beasley from the University of Texas in Houston says the higher HCV infection rates in female infants of HCV-infected mothers is "interesting, provocative, and worth further investigation."
This finding, the author further notes, is in accord with recent observations of similar excesses of HIV infections in infant girls of HIV-infected mothers.
SOURCE: The Journal of Infectious Disease, December 1, 2005.
Mon Dec 12, 2:30 AM ET
China's human trials of an AIDS vaccine were proceeding "smoothly," state press reported, nine months after the program was launched.
The last batch of 15 Chinese volunteers received the vaccine over the weekend and reported no side-effects in the crucial first 24 hours, Xinhua news agency quoted medical officials involved in the trial as saying.
"The first 24 hours are a vital period for observation," the deputy director of the Guangxi regional disease prevention and control centre in the nation's south, Chen Jie, said, according to Xinhua.
"So far, no volunteers have reported ill reactions. They have entered a relatively stable period for observation."
The latest inoculations bring to 49 the number of Chinese volunteers to have received the potential AIDS vaccine since the centre began trials on March 12 in Nanning, the capital of Guangxi province.
"So far the tests have been going on smoothly," Chen said.
With all the 49 volunteers inoculated, the first phase of the three-phase trials has come to an end.
The initial gathering of clinical data from the volunteers will be completed in June next year, after which a decision will be made on whether the centre can go ahead with phase two, Chen said.
The second phase of the trials will test the immune nature and safety of the vaccine, according to Chen.
There have been about 35 AIDS vaccine trials on humans throughout the world, most of which are still in the first phase, according to Xinhua.
In the 24-year history of AIDS, only one vaccine has completed the full three-phase trial process -- AIDSVAX, which was found to be a disappointing failure.
In the latest trial to make headlines, Swedish researchers announced on December 1 that their trial for a so-called DNA vaccine against the AIDS virus was going better than expected.
The vaccine had successfully completed the first phase of tests among 40 Swedish HIV-negative volunteers, the Karolinska Institute in Stockholm said.
"It has been more effective than we thought it would be," the professor and head of clinical testing at the institute, Eric Sandstroem, told AFP.
"We have also failed to find any vaccine-related side effects at all."
Karolinska professor Britta Wahren, who developed the vaccine, also expressed optimism.
"There is every reason to be hopeful, even though the study is not finished," Wahren said.