News (Updated February 26,
2006)
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Wed Feb 22, 2006 09:21 PM ET
NEW YORK (Reuters Health) - Tenofovir gel is safe and well tolerated when used
vaginally to prevent HIV transmission, according to a report in the medical
journal AIDS.
Tenofovir administered as an intravaginal gel has been proven effective in blocking the transmission of simian immunodeficiency virus (SIV) in animal models, the authors explain. Dr. Kenneth H. Mayer from Brown University, Providence, Rhode Island and colleagues evaluated the safety and tolerability of tenofovir gel in HIV-negative and HIV-positive women and their male sexual partners.
Most participants of the 84 women reported at least one mild adverse event, the authors report, but specific adverse event patterns were not associated with gel concentration, sexual activity, or HIV status.
Just over half the women tested had low, but detectable blood levels of tenofovir at one or more points following dosing, the results indicate. Oral administration of tenofovir results in systemic exposure that is 10-times greater than the levels seen in this study, the investigators explain.
Among 12 women who had detectable blood levels of HIV, there were no new resistance mutations detected after gel exposure.
The vast majority of the women (94 percent) said they would definitely or probably use the gel if it were available and they wanted protection from HIV transmission, the report indicates. Similarly, 81 percent of their male partners agreed that they would use the gel under similar circumstances.
The higher dose used twice daily was just as well tolerated as the lower dose used only once a day, the investigators note.
Because tenofovir gel was well tolerated and acceptable in this study, a new trial of tenofovir gel in at-risk women "is now underway in New York and Pune, India, which may further support the rationale for efficacy trials of this promising new topical microbicide."
SOURCE: AIDS February 28, 2006.
Thu Feb 23, 12:29 PM ET
Human trials for a new drug to fight HIV and hepatitis B have begun in China, raising hope for a cheaper alternative treatment for AIDS sufferers, state media reported.
A research team at the Academy of Military Medical Sciences recently began a six-month clinical trial on 200 healthy volunteers, the China Daily reported.
If the trials are successful, the medicine might be available on the market within two years, the report said, quoting Dong Junxing, a scientist at the institution.
"If clinical experiments back up initial findings, the compound will be an irreversible HIV and hepatitis B virus integrase inhibitor, which provides a new alternative for AIDS and hepatitis B treatment," Dong said.
Extracted from a Chinese herb called Inula britannic, the drug has proven to be able to work on both viruses in a way different from other HIV medicines currently on the market, he said.
The price of the new drug may be "much lower" than other medicines currently available, Dong said, since scientists are able to synthesise the drug chemically instead of having to extract it from herbs.
Mon Feb 20, 10:31 AM ET
The number of infectious diseases threatening human life have risen in the past quarter century and most are believed to have originated from animals, according to researchers.
A total of 38 new pathogen species linked to infectious diseases have been uncovered in the past 25 years.
Such pathogens and the diseases they trigger, especially those transmitted by animals, are coming under heightened scrutiny amid the global spread of bird flu, or the H5N1 virus, by wild and migratory birds.
Scientists are concerned bird flu could mutate to humans and spark a worldwide pandemic.
A better understanding of pathogens and how they jump between species could help stave off future infectious diseases, according to Mark Woolhouse, a researcher at the University of Edinburgh, Scotland.
Woolhouse issued his latest insights Sunday at the annual meeting of the AAAS (The American Association for the Advancement of Science) here.
"A total of 38 apparently new pathogen species associated with infectious diseases of humans have been reported in the past 25 years," Woolhouse explained.
He indicated that almost two-thirds of the new pathogen species come from a particular group of pathogens which have small genomes and high mutation rates.
"The great majority of the new human pathogens are thought to have originated from animals," according to Woolhouse.
"Examples include HIV from primates, vCJD from cattle and SARS perhaps from civets," he noted.
"Although we are developping a better understanding of the biology, epidemiology and evolution of species jumps, we are not yet able to predict future infectious disease threats," Woolhouse said.
"Effective surveillance must cross national boundaries and less obviously, traditional species boundaries too," he added.
Wednesday February 22, 6:45 am ET
The designation streamlines the regulatory review process.
Progenics said PRO 140, now being tested in early-stage trials, belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. The product is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
PRO 140 also may be considered for priority six-month review (versus the standard 10-month review) and accelerated approval.