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Tue Apr 22,11:47 PM ET
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TUESDAY, April 22 (HealthScoutNews) -- A three-minute test to detect the AIDS-causing HIV virus in a person's blood has been approved by the U.S. Food and Drug Administration, its Canadian manufacturer says.
Halifax-based MedMira Inc.'s Reveal Rapid HIV-1 Antibody Test kit is similar to a home pregnancy test. If it detects HIV antibodies in a person's blood, it will show two red lines.
The company says the three-minute results could prevent people who are unsure of their HIV status from infecting others. Typical HIV detection tests take days or even weeks to yield results, MedMira says.
The test is designed to be administered only in clinics or hospitals. It has a one-year shelf life at room temperature.
Earlier this month, the same test was approved for use in China. Cardinal Health, an international health-products firm, will market the test in the United States, MedMira says.
| Press Release | Source: ViroLogic, Inc. |
Wednesday April 23, 8:04 am ET
By analyzing phenotypic and genotypic assay results from more than 1,000 HIV samples in ViroLogic's proprietary database, Company researchers developed an improved, comprehensive scoring system for interpreting genotypic results. ViroLogic identified known and new mutations responsible for resistance to lopinavir and demonstrated that cross-resistance between lopinavir and amprenavir may be more common than previously believed. The study also found that HIV viruses containing a low number of protease mutations may retain susceptibility to lopinavir.
"These study findings indicate that for recently-approved drugs, genotypic interpretations of drug resistance may be incomplete or immature especially for drugs like Kaletra that require multiple mutations for clinically significant resistance to arise," said Andrew Zolopa, M.D., Assistant Professor of Medicine, Department of Infectious Diseases, Stanford University Medical Center. "Therefore, use of these drugs may be more appropriately guided by phenotypic testing, such as PhenoSense(TM) HIV."
Study Details
In the study, 1,418 unique HIV samples with reduced susceptibility to PIs and/or resistance-associated mutations from ViroLogic's database of phenotypic and genotypic test results were used to develop improved rules for interpreting genotypes for lopinavir.
"Previous rules for interpreting HIV genotype for lopinavir were based on studies involving small numbers of patients participating in clinical trials, and few of the patients had been pre-treated with amprenavir," said Neil Parkin, Ph.D., Scientific Director of Research and Development at ViroLogic and first author of the clinical research article. "In our study, we expanded the genotypic analysis to patient samples from our large database, and we used the phenotypic clinical cut-off value in the analysis. By these methods, we were able to significantly improve the ability to predict whether a sample was resistant to lopinavir."
Commenting in an accompanying editorial that appeared in the same issue of AIDS, Dr. Zolopa emphasized that, "Testing for HIV resistance to anti-retroviral drugs is accepted as part of standard of care for HIV/AIDS patients in developed countries and the selection of therapeutic regimens depends on thorough monitoring of viral and patient parameters, including measurements of viral load, phenotypic and genotypic resistance to anti-retroviral agents, and CD4+ cells."
| Press Release | Source: AIDS Research Consortium of Atlanta, Inc. |
Wednesday April 23, 9:03 am ET
- Drug Offers Hope to Patients With Few Treatment Options -
"Currently available anti-HIV drugs have enabled people with HIV to live longer, but with long-term treatment, HIV frequently develops resistance to these drugs. Therefore, building effective treatment regimens can often hinge on new anti-HIV drugs coming to market," said Melanie Thompson, MD, founder and principal investigator of ARCA and investigator in the RESIST trial. "We feel that it is important to participate in the RESIST trial in order to help bring new options to patients in Atlanta."
A recent large-scale study in the U.S. estimated that 78% of people with HIV have drug-resistant virus.1 Drug resistance develops most commonly when patients do not consistently take their anti-HIV medications. Resistance is a problem because it renders drugs less effective, or even ineffective, and therefore significantly limits treatment options for people with HIV.
RESIST Clinical Trial
The tipranavir Phase III studies are part of the RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir) clinical trial program, the largest study program ever undertaken for HIV-positive patients previously treated with three classes of anti-HIV drugs. RESIST investigators will evaluate the efficacy and safety of tipranavir in more than 280 clinical trial sites worldwide, approximately 100 of which are in the U.S.
Tipranavir
Tipranavir is the first of a new generation of anti-HIV drugs called "non-peptidic protease inhibitors" (NPPIs) and is being developed by Boehringer Ingelheim for the treatment of HIV-1 infection in combination therapy. Based on available clinical and in vitro data, tipranavir is active against strains of HIV-1 that are resistant to currently available peptidic protease inhibitors.
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Wed Apr 23,11:42 AM ET
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CHICAGO (Reuters) - A new nonhormonal, low-cost birth control device which can also protect women against HIV and other sexually transmitted diseases is now on the market, its manufacturer said on Wednesday.
FemCap Inc., a private company based in San Diego, California, said the silicone rubber device called FemCap completely covers the cervix, preventing sperm from entering the uterus.
To protect against HIV, the FemCap must be used in conjunction with a microbicide, a type of spermicide that kills germs which is now under development by several firms. The new device incorporates a delivery system for microbicides or spermicides.
"The FemCap has the potential to protect against sexually transmitted disease and HIV only when used with a microbicide," said Dr. Deborah Anderson, an associate professor at Harvard University Medical School.
In order for the HIV virus to enter and cause an infection, there must be certain receptors present. The cervix has been found to be the main portal of entry for HIV, Anderson said.
The FemCap can be worn for up to 48 hours at a time, unlike similar birth control devices which can be worn for just 24 hours.
Its silicone rubber is less irritating than the latex used in diaphragms, which the FemCap resembles. FemCap can be reused for two years, costing users as little as $2 per month, and comes in three sizes.
Clinical studies for the device were funded by the United States Agency for International Development.
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Wed Apr 23, 5:54 PM ET
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NEW YORK (Reuters Health) - A survey of Ohio doctors found that less than half offered HIV tests to pregnant women as part of routine screening, and roughly a third say they offer the test to 25 percent or fewer of their pregnant patients.
The U.S. Public Health Service currently recommends HIV counseling and voluntary testing for all women during pregnancy. Typically, 44 to 80 percent of pregnant women who are offered the test agree to it, according to the report in the journal AIDS Patient Care and STDs.
Treating HIV-infected pregnant women with antiretroviral drugs can dramatically reduce the chances that the baby will get HIV before, during or after birth.
"We can largely prevent perinatal HIV transmission," said Dr. Joan Duggan, "but we have to know the HIV status of the mother to do this."
"Physicians ought to discuss HIV testing with any pregnant woman they see and make sure they get tested," Duggan told Reuters Health.
Prompted by the recent diagnosis of two young children in their region with HIV, Duggan and colleagues from Medical College of Ohio in Toledo, Ohio surveyed 431 physicians in obstetrics/gynecology and primary care regarding their HIV screening practices.
The results are based largely on the responses of 261 physicians who routinely saw pregnant women.
Less than half (42%) of physicians offered HIV testing as part of the standard prenatal battery of tests in their practice, the results indicate, and 36% of physicians offered testing to less than a quarter of their pregnant patients and/or tested only those pregnant women with a risk factor for HIV infection.
Obstetricians did better than family physicians, and more than 90 percent routinely offered HIV tests to patients. However, many women in rural Ohio rely on general practitioners or family physicians for their treatment, according to the report.
Fifty-four percent of respondents felt HIV testing during pregnancy should be a routine part of care, the researchers note, but 7% of doctors felt it was not necessary for most pregnant women. All 20 physicians who had diagnosed HIV during pregnancy through routine testing felt that HIV testing should be part of the prenatal battery of tests.
Only a quarter of physicians felt that the majority of their patients accepted HIV testing when it was offered, the report indicates.
Only 41% of physicians included all the elements of HIV pretest counseling required by Ohio State law, the researchers note.
"A more streamlined procedure may help," Duggan said, "such as an 'opt-out' testing strategy. Performing HIV testing without adequate pretest counseling is a controversial question, and I know the CDC is actively looking at this issue right now. Receiving a positive test result is a life-altering event and not to be taken lightly."
SOURCE: AIDS Patient Care STD 2003;17:121-127.
| Press Release | Source: MedMira Inc. |
Thursday April 24, 12:18 pm ET
"Receiving this additional order for 150,000 units in such a short time following SDA approval (announced April 9, 2003) reaffirms our anticipation of the market demand for our rapid HIV test in China," said Stephen Sham, Chairman and CEO of MedMira. "We are extremely pleased to take such an active role in the Chinese point-of-care diagnostic industry. Chinese authorities and agencies are making extraordinary efforts to curb the spread of HIV, and we are very pleased to know that our technology can make a contribution to such a significant public health campaign."
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Fri Apr 25,12:37 PM ET
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Christopher Lisotta, Gay.com / PlanetOut.com Network
SUMMARY: Researchers report in the May 2 edition of the medical journal AIDS that a California man has been infected with two different strains of HIV.
Researchers report in the May 2 edition of the medical journal AIDS that a California man has been infected with two different strains of HIV, picking up a wild-type (otherwise known as drug-sensitive) strain of HIV after first contracting a drug-resistant strain of the virus.
Initially enrolled in a study that was looking at people with drug-resistant HIV, the man was discovered -- four months after enrolling in the program -- to be infected with more than one strain of HIV. The infection was confirmed after the researchers performed a series of genetic tests to show that the second strain wasn't resistant to reverse transcriptase inhibitors.
The man was infected with HIV strains common in North America. His superinfection apparently had an adverse effect on his health, driving up his viral load in two months from 2,400 to over 200,000, while over the course of 11 months his T-cell count went from a high of over 800 to a low of 282.
HIV superinfection, or the presence of two strains of HIV in the same person, has been a controversial issue in AIDS health and social service circles. It raises issues about HIV-positive people having unprotected sex even with each other, and raises significant stumbling blocks to researchers trying to develop an AIDS vaccine. Activists and health officials also raise concerns about overtalking superinfection, since it could encourage more HIV-infected people to seek out negative partners, which could increase overall infection rates.
Scientists believe current HIV tests used to show if a patient is infected with drug-resistant HIV wouldn't work if the patient also is infected with the wild-type strain. But if the person began drug therapy, evidence of the drug-resistant strain would emerge.
At least two other HIV superinfections have been reported. In September 2002 a Swiss research team reported they had discovered a 38-year-old man with dual strain infections, while in July 2002 at the international AIDS conference in Barcelona, Spain, a researcher reported a similar infected patient in Boston.