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Tue Mar 11, 4:05 PM ET
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CHICAGO (Reuters) - China is suffering an
unpublicized chlamydia epidemic, raising concerns that sexual practices in the
world's most populous country may lead to a rapid spread of AIDS and other
sexually transmitted diseases, U.S. researchers said on Tuesday.
An estimated 2.1 percent of Chinese men and 2.6 percent of women are infected
with chlamydia -- similar to rates in developed Western countries -- but China's
government does not track the disease because of a lack of visible symptoms. "The silent chlamydia epidemic may cause many women to be infertile, to
have ectopic pregnancies and be at greater risk of HIV infection," said
study author William Parish, a professor of Chinese Studies at the University of
Chicago.
Genital chlamydia, which is usually treatable with antibiotics, is a fairly
common sexually transmitted disease that can lead to infertility. Anywhere from
5 percent to 13 percent of U.S. women have been infected by the disease, which
is caused by several strains of microorganisms.
Though often symptomless, in men it can cause discharge from the penis and
swelling of the testes. In women, it can cause vaginal discharge or pain while
urinating and may lead to inflammation of the cervix or the fallopian tubes.
A surprising finding of the study, which surveyed more than 3,000 Chinese
adults, was that the disease was being spread most rapidly by upper-income
businessmen having unprotected sex with prostitutes and then infecting their
wives and lovers.
The study, published in this week's issue of the Journal of the American
Medical Association, found 15 percent of the high-income men who had sex with
prostitutes have chlamydia, and 6 percent of the partners of those men were also
infected.
Chlamydia was spreading fastest along China's rapidly developing southern
coastal regions, where 16 percent of the men and 10 percent of the women have
the disease, according to the study.
Chlamydia's spread could also blaze a path for AIDS in China, where the
number of AIDS cases is expected to surpass the United States within two years
and global leader South Africa within a decade, the report said.
"China is only now beginning to suffer the ravages of HIV, and the
unexpected prevalence of chlamydia and attendant high-risk sexual behavior are
critical and instructive warning signs," said researcher Dr. Myron Cohen of
the University of North Carolina, Chapel Hill.
China could combat the epidemics by educating the public about sexually
transmitted diseases and by persuading prostitutes to require their clients to
use condoms, it said.
Prostitution was relatively rare in Communist China before the economy was
liberalized beginning in the 1980s. About 9 percent of Chinese men, many of them
affluent, report that they frequent prostitutes, much of it unprotected sex.
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Tue Mar 11, 8:21 PM ET
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LOS ANGELES (Reuters) - A clinical trial of GlaxoSmithKline Plc's AIDS drug Trizivir was halted after the drug was shown to be inferior to other combinations of medication, according to the National Institutes of Health unit conducting the study.
The AIDS division of the National Institute of Allergy and Infectious Diseasessaid in a letter on Monday to AIDS doctors that Trizivir, which combines three different types of HIV drugs, was shown to be less effective than two other treatment regimens being evaluated in the study.
Officials at Glaxo could not be immediately reached for comment. The company's 2002 sales of Trizivir totaled $473 million.
The study -- involving 1,147 previously-untreated HIV patients -- compared Trizivir alone to a combination of Trizivir and Bristol-Myers Squibb Co.'s Sustiva and to a combination of Sustiva and another Glaxo drug called Combivir.
The institute said the data met pre-specified guidelines for stopping the trial arm based on a key measure of the disease called viral load, but there were no concerns about toxicity.
After 32 weeks of treatment, 21 percent of study volunteers in the group receiving Trizivir had levels of HIV that exceeded the preset threshold levels, compared with 10 percent in each of the other two groups, according to the letter.
The researchers also said this occurred sooner and more often in patients on Trizivir, regardless of their initial viral load.
The institute said volunteers originally given one of the other two drug combinations will continue the trial as planned.
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Fri Mar 14, 7:18 PM ET
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By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - The newest HIV drug, just approved by the U.S. Food and Drug Administration , buys time for even the most desperately ill AIDS patients, researchers said on Friday.
Fuzeon, also known as T-20, won FDA approval on Thursday. It is designed for patients who have developed resistance to other anti-HIV drugs, meaning the drugs no longer fully control the virus.
The approval caused a stir, both because it is the first in a new class of drugs and because its makers, Swiss drug giant Roche and Trimeris Inc., are pricing it at $20,000 or more per year.
The researchers who tested the drug say it is worthwhile to those who will be able to take it -- HIV patients who already can pay for the expensive cocktails of drugs that can give them back their lives.
The FDA approved the drug based on studies that showed it was safe and could help patients who had run out of options. After the approval, the New England Journal of Medicine released another study, to be published in May, showing how well the drug works.
"The people who enrolled in this study, by and large, had used up all their treatment options. Many of them not only had bad numbers, but many of them were sick," Dr. Jacob Lalezari of Quest Clinical research and the University of California San Francisco, who led the study, said in a telephone interview.
By numbers, Lalezari means measures of disease such as how much HIV is in their blood and counts of immune system cells.
STUDY OF 500 PATIENTS
For the study, Lalezari and colleagues tested 491 HIV patients who had used most of the 16 drugs available for using in the drug cocktail known as highly active antiretroviral therapy. The drugs had stopped working, and the virus was building up, destroying their immunity.
Two-thirds of the patients started out getting T-20, which is injected twice a day, and one-third got a placebo shot. They also all got reformulated drug cocktails.
After two months, 33 percent of the patients who got a placebo had "virologic failure" -- meaning the amounts of virus had grown to a certain level -- compared to 16 percent of the patients who got T-20.
Six months later, 64 percent of patients given the placebo had virologic failure compared to 41 percent of the T-20 group.
Lalezari said he thinks T-20 will work better for patients who have not become as desperately ill as those in the study. What will be difficult is deciding when to start T-20, which cannot be used alone.
"Physicians and patients are going to have to sit down and re-evaluate which drugs from the remaining elements of the cocktail can be used with T-20," he said.
"The more drugs patients have to combine with T-20 to which the virus is sensitive, the more sustained and durable the response would be."
Activists say not all HIV patients will be able to take the drug if Roche persists in pricing it so high.
"There's no guarantee, perhaps not even a likelihood, that most of the people who truly need this drug will be in a position to get it," Martin Delaney of AIDS information group Project Inform, said in a statement.
| Press Release | Source: amfAR |
Monday March 10, 11:25 am ET
Grantees and Fellows Seek Treatments that Might Eradicate HIVNEW YORK, March 10 /PRNewswire/ -- The American Foundation for AIDS Research (amfAR) announced today more than $1.2 million dollars in research grants and fellowships to combat HIV/AIDS.
"amfAR pursues a research strategy that can be described as entrepreneurial," said Jerome J. Radwin, amfAR's Chief Executive Officer. "Much of this funding supports the study of viral reservoirs, where HIV may lie dormant despite years of antiretroviral therapy. These grantees and fellows will help describe viral latency, which may be the major factor preventing the eradication of HIV. Their work stands at the vanguard of current HIV research."
HIV can sequester itself in reservoirs in the body and in some cases remains latent in long-lived immune cells, out of the reach of anti-HIV drugs, only to re-emerge later and repopulate the body with high levels of virus. The existence of viral reservoirs effectively ensures that current drug cocktails, even when they lower the virus to undetectable levels, will never cure HIV/AIDS.
"Antiretroviral therapy has changed the lives of many patients," said Dr. Jeffrey Laurence, amfAR's Senior Scientific Consultant for Programs and Director of AIDS Virus Research at Cornell University's Weill College of Medicine. "But even the best drug combinations cannot eradicate HIV from the body because of viral reservoirs. Several awardees will be looking at how HIV hides in cellular reservoirs and how we might flush the virus out of the body."
amfAR also named four fellows in basic research who will share $396,000 for guided research projects on HIV reservoirs and viral latency, microbicides, disrupted immune function, and new anti-HIV drugs.
Both amfAR grantees and fellow are selected through a rigorous process of peer review conducted by members of amfAR's Scientific Advisory Committee, a large group of highly qualified professionals who volunteer their time and expertise to evaluate proposals on the basis of scientific merit, relevance, and promise. A list of grantees, grant amounts, and brief descriptions of the research proposals are available on amfAR's website at www.amfar.org.
amfAR is the nation's leading nonprofit organization dedicated tot he support of AIDS research, AIDS prevention, treatment education, and the advocacy of sound AIDS-related public policy.
| Press Release | Source: GlaxoSmithKline |
Monday March 10, 3:09 pm ET
GSK had moved to dismiss the lawsuit on the basis that AHF's claims were without merit, offered no new information and attempted to reopen issues that have already been thoroughly reviewed and decided by the courts.
After considering the arguments of both sides, Judge Terry J. Hatter Jr. ruled in favor of GSK on March 5 and dismissed the lawsuit.
"We are pleased that the court agreed with our position and dismissed what was a frivolous and wasteful lawsuit," said Peter Hare, vice president of GSK's HIV business. "The needs of patients demand that our energies remain focused not on litigation, but on research to find new treatments and on developing positive relationships to help more patients access existing treatments."
GSK is a leader in the research and development of HIV/AIDS medicines. The company brought the first HIV/AIDS treatment - Retrovir (AZT) - to patients and has worked for years with government and advocacy groups to meet the needs of patients in the U.S. and around the world. GSK was the first company to reduce the price of its anti-retrovirals in developing countries, and since May 2000 has offered Combivir - two HIV/AIDS medicines in one pill - at a 90 percent savings over the price in the developed world. The company has provided $55 million to help implement a wide variety of projects to assist people living with AIDS, their families and their communities through a program called Positive Action that was initiated in 1992. GSK will have enrolled 16,000 patients in its clinical trials in developing countries by the end of 2003.
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
| Press Release | Source: Chiron Corporation |
Thursday March 13, 8:30 am ET
Patent Expands Company's Intellectual Property Position
"This patent reflects the value of Chiron's pioneering work in HIV dating back to 1984," said Robert Blackburn, vice president and chief patent counsel. "Chiron scientists were the first to clone, sequence and correctly characterize the domains of the HIV-1 genome. As a result of this and further innovations resulting from Chiron's research and development investments, the safety of the world's blood supply has increased dramatically. Chiron has a history of consistently contributing to the improvement of health worldwide through its ground-breaking research and product development."
In 2002, Chiron and its collaborator, Gen-Probe Incorporated, received FDA approval for the Procleix® HIV-1/HCV Assay, an NAT test designed to detect the presence of all known HIV-1 subtypes and hepatitis C virus (HCV) genotypes during the very early stages of infection, when those agents cannot be detected by immunodiagnostic screening technologies. The Procleix HIV-1/HCV Assay is currently available commercially in 16 countries.
Chiron has made its HIV technology available to others. Chiron's intellectual property for its HIV-1 probe-based technology has been licensed to Bayer A.G. and Organon Teknika B.V. Chiron will also now receive royalties on NAT products of F. Hoffmann-LaRoche (Roche) used in the U.S. Chiron already receives royalties for its HIV technology from Roche and other licensees under Chiron's European patent. In October 2000, Chiron and Roche reached a broad patent license agreement for nucleic acid probe-based clinical diagnostics for HIV-1. Under the terms of that agreement, Chiron will now receive from Roche a milestone payment of $10 million. The U.S. patent will expire in 2020.