News (Updated January,
2004)
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Monday, December 29, 2003 · Last updated 10:33 a.m. PT
WASHINGTON -- The Food and Drug Administration has approved a 10-minute HIV test, the Irish company that makes the test said Monday.
Trinity Biotech PLC plans to market the test to government programs, physicians and hospitals for quick testing of health workers who accidentally prick their fingers with bloody needles. Traditional laboratory tests can take days or weeks to return results.
"It is a very significant market not being met at the moment," said Brendan Farrell, president of the Dublin-based company.
"There are over 800,000 needlestick injuries per year in U.S. hospitals. They need to know urgently if that patient was infected with HIV," Farrell said.
If a health care worker accidentally exposed to a patient's HIV-positive blood is treated with a combination of anti-HIV drugs within a few hours of exposure, the chance that the worker will become infected can be reduced.
The Uni-Gold Recombigen HIV test will cost doctors and hospitals $10 per test.
Trinity expects to sell 400,000 to 500,000 tests in the United States in 2004. The test is already sold in Africa and Asia.
Trinity also plans to target the roughly 200,000 pregnant women considered at high risk for passing infection to their unborn child. If the mother's HIV status is learned quickly, drugs can be administered to prevent her from passing the disease to the child during birth.
The test requires one drop of whole blood, serum or plasma. In the company's trials of more than 9,000 patient samples, the Trinity test detected 100 percent of the HIV positive specimens and was 99.7 percent accurate on the negative samples.
"It is every bit as accurate as lab-based tests," Farrell said.
The Trinity product will compete directly with OraSure Technologies Inc.'s OraQuick Rapid HIV-1 test approved in November 2002. OraSure's 20-minute test can be used only on whole blood, Farrell said, which will give his product an advantage in marketing to hospitals because they frequently test plasma and serum.
In June, the CDC said it would buy 250,000 OraQuick tests and training materials for 50 U.S. locations. The CDC's $2 million purchase was part of a larger HIV-prevention plan.
In Monday afternoon trading, shares of Trinity had soared $1.25, or 38 percent, to $4.53 on the Nasdaq Stock Market.
Also on the Nasdaq, shares of OraSure, of Bethlehem, Pa., had fallen 62 cents, or 7.2 percent, to $8.02.
Thursday January 1, 4:31 AM
By Paul Simao
ATLANTA (Reuters) - Women now account for more than a third of new HIV diagnoses in New York City, according to a study released on Wednesday that appears to confirm a slight gender-based shift in the U.S. AIDS epidemic.
Since first being diagnosed in 1981, AIDS has killed nearly half a million Americans, most of them believed to be homosexuals and intravenous drug users. But in recent years an increasing number of people outside these high-risk groups have been testing positive for HIV, the virus that causes AIDS.
Data collected by the New York City Department of Health and Mental Hygiene and published by the Centers for Disease Control and Prevention showed that 35 percent of the 6,662 new HIV cases reported in the nation's most populous city in 2001 occurred in women.
In comparison, 28 percent of AIDS sufferers diagnosed with HIV in the city before 2001 were female, according to the study, which was the first analysis of annual HIV diagnosis data collected as a result of a 2000 state law requiring health-care workers to report the names of newly diagnosed HIV or AIDS patients.
Dr. Susan Manning, a CDC epidemiologist and a co-author of the study, said the findings provided an opportunity to improve HIV prevention programs so that they target everyone at the highest risk of getting infected.
"Although we should continue to focus on the groups that have the highest rates of diagnoses -- males and non-Hispanic blacks -- we also should focus our prevention efforts more toward women and younger people," Manning said.
She noted that New York City's HIV epidemic remained centered among men, non-Hispanic blacks and people between the ages of 25 and 44. Blacks accounted for about 54 percent of new HIV diagnoses in New York City in 2001.
The new study comes amid fears of a resurgence of HIV in the United States. In the past year, health officials have warned of a rise in HIV infections among blacks and intravenous drug users.
There have also been a number of syphilis outbreaks among gay and bisexual men. Studies have shown that sexually transmitted diseases increase the likelihood of HIV infection.
The trends prompted the CDC earlier this year to recommend that routine HIV testing be expanded to include pregnant women, intravenous drug users and anyone who engaged in unsafe sex.
An estimated 16,000 Americans die each year from AIDS and another 40,000 become infected with HIV.
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Wed Dec 31, 5:32 PM ET
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NEW YORK (Reuters Health) - People with genital herpes can reduce their risk of spreading the disease to sexual partners if they take the drug Valtrex (valacyclovir) on a daily basis, new research shows. Nevertheless, since prevention is incomplete, other safe-sex practices are still necessary.
Genital herpes is usually caused by herpes simplex virus type 2 (HSV-2). Previous reports have shown that treatment with certain drugs, like Valtrex, can suppress shedding of HSV-2 in genital secretions. However, it was unclear if this translated into a reduced risk of transmission.
To investigate, Dr. Lawrence Corey, from the Fred Hutchinson Cancer Research Center in Seattle, and colleagues studied 1,484 sexually active couples in which one partner was infected with HSV-2. The infected partner was treated with either Valtrex or an inactive "placebo" once daily for 8 months. All of the subjects had intact immune systems and all couples were heterosexual and monogamous.
The new findings are reported in The New England Journal of Medicine.
Overall, 27 partners in the placebo group became infected with HSV-2 compared with just 14 in the Valtrex group. Consistent with previous reports, Valtrex use was associated with a drop in the percent of days in which evidence of HSV-2 was detected in genital secretions.
"Because the observed reduction in the rate of transmission of genital herpes with (Valtrex) is clinically relevant but not complete, it is important that disclosure of genital herpes to the susceptible partner and the practice of safe sex continue, since both may reduce the risk of transmission of genital herpes," the authors emphasize.
"The current report provides the scientific basis for a future intervention study with daily acyclovir to determine whether suppressing HSV-2...will diminish the risk of HIV transmission," Dr. Clyde S. Crumpacker notes in a related editorial.
"Millions could benefit if the use of acyclovir is proven to decrease the transmission of HIV by preventing HSV-2 genital ulcers," Crumpacker, from Beth Israel Deaconess Medical Center in Boston, adds.
SOURCE: The New England Journal of Medicine, January 1, 2004.
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Fri Jan 2, 6:40 PM ET
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By Will Boggs, MD
NEW YORK (Reuters Health) - Herpes simplex virus
(HSV) infections are common among women who report sex with other women, though
most are unaware of their infection, according to a new study.
Nearly half the women (46 percent) who participated in the study were
positive for HSV-1, which is the usual cause of "cold sores," the
report indicates, and 7.9 percent were positive for HSV-2, which causes genital
infections. The study is the first to report on HSV prevalence in this group
specifically, Dr. Jeanne M. Marrazzo from Harborview Medical Center, Seattle,
Washington told Reuters Health.
Marrazzo and colleagues obtained medical and sexual histories from 392 women
(including both members of 71 couples) who reported sex with another woman
within the preceding year, and tested their blood for HSV-1 and HSV-2
antibodies.
Most of the women (80 percent) reported having had sex with a man at some
time, and 28 percent had sex with a man in the previous year. Among 257 women
who self-identified as lesbian, the corresponding figures were 73 percent and
8.6 percent.
"This means that routine acquisition of chronic viral sexually
transmitted diseases, like herpes, human papillomavirus (HPV), HIV, and
hepatitis B, can occur at the same rate as in strictly heterosexual women,"
Marrazzo said.
She says health care providers should keep this in mind. "Providers
should really assume nothing when a woman says 'I'm a lesbian' -- at least in
terms of prior viral sexually transmitted disease acquisition -- until a more
complete sexual history is taken."
Virtually all women reported giving and receiving oral-vaginal and
digital-vaginal sex with female partners during the past year, the authors
report in the medical journal Sexually Transmitted Diseases, while 34 percent
reported oral-anal and 63 percent reported digital-anal sex.
Most women did not experience herpes symptoms. Only 9 of 31 HSV-2-positive
subjects reported a history of genital herpes, and only 30 percent of
HSV-1-positive women reported a history of cold sores.
The likelihood of having HSV-2 seropositivity was linked to having a male sex
partner with genital herpes. On the other hand, "Our data indicated that
risk of HSV-1 seropositivity was directly related to number of prior female sex
partners," Marrazzo explained.
"This suggests, but does not prove, that lesbians might be at increased
risk for sexual acquisition of HSV-1 from their female partners, likely through
oral sex," she said.
SOURCE: Sexually Transmitted Diseases, December 2003. NEW YORK (Reuters Health) - While rates of mother-to-infant HIV spread have
dropped dramatically in industrialized countries like the US, when it does occur
a lack of prenatal care is largely to blame, findings from a new study suggest. In an effort to reduce such HIV spread, the US Public Health Service released
guidelines in the mid-1990s recommending universal prenatal HIV counseling,
voluntary testing, and anti-HIV drug use for pregnant women found to be
infected. Several reports have shown that the risk of mother-to-child HIV spread
can be reduced if the mother takes AIDS drugs during pregnancy and if the baby
receives such drugs for a few days after birth. In the current study, reported in this week's Morbidity and Mortality Weekly
Report, researchers from the Centers for Disease Control and Prevention assessed
compliance with these recommendations at Grady Memorial Hospital in Atlanta
between 1997 and 2000.
Of the 253 infants born to HIV-infected mothers during the study period, 17
were infected, lead author Dr. S. Nesheim and colleagues report. The
transmission rates ranged from a low of 3 percent in 1999 to a high of 10
percent in 2000.
Throughout the four-year period, the percentage of HIV-infected women who
received one or more AIDS drugs held steady at around 75 percent. Moreover,
rates of infant AIDS drug use never fell below 92 percent.
No cases of HIV spread occurred among women who received complete prenatal
care, prenatal HIV testing, and AIDS drugs, the authors note. Of the nine cases
that occurred in 1999 and 2000, six involved mothers who received no prenatal
care. In the remaining three cases, some prenatal care was provided but the
timing or compliance with the AIDS drugs was suboptimal.
"For pregnant women who receive prenatal care and know their HIV status,
prevention programs should focus on promoting adherence to recommended treatment
regimens and administering (AIDS drugs) during pregnancy," the CDC notes.
"Efforts to reduce (mother-to-infant) HIV transmission should continue
to focus on increasing prenatal care rates and prenatal HIV testing,
particularly in areas where missed opportunities for prevention of perinatal HIV
transmission persist," the group adds.
SOURCE: Morbidity and Mortality Weekly Report, January 2, 2004.
By Merritt McKinney
NEW YORK (Reuters Health) - Shyness may be harmful to the health of people
with HIV, the virus that causes AIDS, suggests the results of a new study.
In the study, HIV levels tended to be higher in people who were socially
inhibited, and they responded less well to anti-HIV drugs. "A shy, socially sensitive temperament has long been associated with
increased vulnerability to infectious disease," lead author Dr. Steve W.
Cole at the University of California at Los Angeles told Reuters Health.
"This study identifies the biological processes involved," he said.
Cole explained that in shy people, the autonomic nervous system -- which
regulates automatic functions such as heart rat and is hyperactive. In response
to stress, the autonomic nervous system releases a hormone called norepinephrine
that "seems to increase HIV replication," he said.
In previous research, Cole and his colleagues found that stress may allow HIV
to reproduce more quickly and reduce the effectiveness of drugs used to treat
HIV.
To investigate further, the team evaluated 54 gay men who had HIV, but who
had not developed full-blown AIDS. At the start of the study, the researchers
assessed the autonomic nervous system of the men by measuring several markers,
including blood pressure, skin moisture, heart rate and resting pulse rate.
Measures of autonomic nervous system activity tend to be higher in people who
are prone to stress. Other measures used to calculate a stress profile for each
man included testing their responses to beeping sounds and their reactions
during a fast-paced series of math exercises.
The participants were also assessed for an inhibited temperament using scales
to rate them for introversion, social avoidance, and emotional inexpressiveness.
For the next 12 to 18 months, the researchers measured blood levels of HIV,
or viral load, as well as levels of immune system T-cells called CD4 cells that
decline as HIV disease progresses.
Viral load was eight times higher in men who were judged to be socially
inhibited than in more outgoing men, the researchers report in the December 15th
issue of the journal Biological Psychiatry. Also, among men who started taking
combination therapy during the study, suppression of HIV levels was eight times
worse in socially inhibited men, according to the report.
The effect of personality was independent of other factors that can influence
HIV progression, including age, ethnicity, socioeconomic status, recreational
drug use and high-risk sexual activity.
However, socially inhibited individuals had higher activity of the autonomic
nervous system, and this accounted for at least 64 percent of the link between
social inhibition and poor viral control, the researchers found.
With the new findings, Cole said, "We have a biological target for
interventions aimed at protecting especially vulnerable people from accelerated
HIV disease progression."
The next step, according to the UCLA researcher, is to see whether drugs that
block interactions between norepinephrine and HIV-infected T-cells can protect
these vulnerable people.
Biological Psychiatry, December 15, 2003.