News (Updated April 29, 2007)
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Sat Apr 28, 2007 1:24 AM BST
NEW YORK (Reuters Health) - Sexually active teenage girls infected around the
time of birth with HIV, the virus that causes AIDS, are more likely to have
cervical infections and abnormal Pap test results, new research shows.
Extensive research has examined the reproductive health outcomes among teenagers who acquire HIV infection through sex, senior investigator Dr. Susan B. Brogly of Harvard School of Public Health in Boston told Reuters.
In contrast, this is the largest cohort study, and the first to publish on rates of genital infections, cervical lesions, and pregnancy among girls who had been living with HIV since birth, she said.
Their results will be published in the June issue of the American Journal of Public Health.
The study involved a total of 638 girls infected with HIV during birth, and who were 13 to 21 years old when they entered a pediatric AIDS study between 2000 and 2005. Brogly and her co-investigators estimate that 174 of the girls were sexually active. More than three-quarters were receiving HIV medication.
Pelvic examinations revealed multiple cases of genital warts. Many of the HIV-infected teenage girls were found to have sexually transmitted diseases, including trichomoniasis, chlamydia, gonorrhea and syphilis.
Of the 101 sexually active girls who had Pap tests, 30 (29.7 percent) had abnormal results at the first examination including lesions that have the potential to become cancerous called squamous intraepithelial lesions or SIL.
"We were surprised at the high rates of SIL that were observed," Brogly said. "It is concerning to find such high rates in young adolescent girls."
She and her colleagues were also taken aback by the finding that "pap smears were so infrequent among these girls identified as sexually active."
Thirty-eight girls became pregnant for the first time while in the study. Seven were pregnant more than once, resulting in 32 pregnancies that ended with live births. Of these, only one newborn was known to be HIV-infected.
The rate of pregnancy is much lower in this cohort than among HIV-uninfected girls of similar ages in the US, the team reports. Brogly attributes the low pregnancy rates to the fact that "some of these girls have severely compromised health and serious illness, making it difficult to become pregnant."
SOURCE: American Journal of Public Health, June 2007.
Tue Apr 24, 2007 9:56 PM BST
By Lisa Richwine
SILVER SPRING, Maryland (Reuters) - A novel AIDS drug by Pfizer Inc. should be approved to give a new option to patients who are not responding to current medicines, U.S. advisers unanimously said on Tuesday.
The Food and Drug Administration is expected to make a final decision on the drug, called maraviroc, within weeks.
The twice-a-day pill is the first designed to keep the HIV virus from entering healthy immune cells. Older AIDS medicines attack the virus itself.
Maraviroc may benefit some patients who are running out of alternatives, panel members said.
"There's a clear indication it is helpful for patients who don't have other options," said Dr. Barbara Alexander, a panel member from Duke University Medical Center in Durham, North Carolina.
Pfizer should continue studying the drug after approval to learn more about potential risks, panel members said.
The FDA usually approves drugs that win endorsements from advisory panels. Industry analysts have projected maraviroc sales of about $500 million in 2011 if the drug goes to market.
An estimated 25,000 to 40,000 U.S. AIDS patients resist treatment with current drugs meant to keep the virus at bay.
About 45 percent of patients who took maraviroc in Pfizer studies had their HIV suppressed to undetectable levels. The same was true for 23 percent who got a placebo. All patients also were treated with a cocktail of the best available drugs and had tried other regimens.
Maraviroc blocks the CCR5 co-receptor that serves as a main doorway for the HIV virus into immune cells. HIV needs to get into the cells to replicate.
Researchers found years ago that the fraction of people without a working CCR5 receptor seemed resistant to HIV infection or slow to develop full-blown AIDS. That sparked drugmaker interest in blocking CCR5.
But drugs that target CCR5 ran into safety problems. Earlier medicines were associated with risks such as lymphoma and liver damage.
FDA reviewers said they saw no higher rate of cancers with maraviroc, but they noted a possible increase in certain heart problems. Any new cases will be analyzed to "try to understand whether or not this is a pattern," FDA medical officer Scott Proestel told the panel.
No clear evidence of liver toxicity was seen, but herpes and some other infections may occur more frequently with maraviroc, he said.
Panel members said the drug's risks were not fully known and should be studied closely after approval.
The safety issues "raise a red flag for me, but they are not a deal breaker" that should keep the drug off the market, said Lynda Dee, the panel's patient representative.
Pfizer said the drug was well-tolerated and the company would follow some patients in its studies for five years.
The drugmaker is seeking FDA approval to sell maraviroc for patients who have tried other treatments and have a form of HIV that uses the CCR5 receptor.
Monogram Biosciences Inc. makes a blood test to determine if a patient falls into that category.
In Pfizer's screening, 56 percent of previously treated patients had a virus that used CCR5.
Pfizer's proposed brand name for maraviroc is Celsentri.
Doctors hope maraviroc will be the first in a wave of new AIDS medicines to reach the market in the coming months. Merck & Co Inc., Johnson & Johnson and other companies are developing new HIV-fighting drugs.
Pfizer shares fell 20 cents to close at $26.15 on the New York Stock Exchange.
Wed Apr 25, 2:20 PM ET
Two studies have thrown up conflicting evidence as to whether circumcision could harm a man's sex life, New Scientist reports in its next issue.
The question is especially important, given the World Health Organisation's (WHO's) recent endorsement of circumcision in the panoply of weapons to tackle the spread of AIDS.
In a study led by Kimberley Payne of the Riverside Professional Center in Ottawa, 20 circumcised and 20 uncircumcised men watched erotic movies while their penises were measured for sensitivity at two points, using filaments that pressed down with predetermined amounts of pressure.
There was no difference in penile sensation between the two groups, according to their research.
However, a team led by Robert Van Howe of Michigan State University used a similar method, but measuring penile sensitivity at 19 points among 163 circumcised and uncircumcised men.
The five most sensitive points are all in portions of the penis removed by circumcision, especially those in folds exposed as the penis becomes erect, Van Howe believes.
"The glans of the circumcised penis is less sensitive to fine touch than the glans of the uncircumcised penis," his paper says. "(...) Circumcision ablates the most sensitive parts of the penis."
The report appears in next Saturday's issue of the British weekly. Payne's research appears in The Journal of Sexual Medicine, while Van Howe's is published by the British Journal of Urology (BJU) International.
On March 28, the WHO and other agencies in the fight against AIDS gave the stamp of approval to promoting circumcision to help prevent the spread of the human immunodeficiency virus (HIV).
Three studies carried out in southern and eastern Africa found that circumcised men were more than half less likely to be infected by HIV compared to uncircumcised counterparts.
BANGKOK (Reuters) - Thailand is weighing an offer from Abbott Laboratories Inc. to sell a newer form of its AIDS drug Kaletra at a discounted price, Health Minister Mongkol na Songkhla said on Monday.
He gave no details of the offer for Aluvia weeks after Abbott refused to launch the drug in Thailand in protest against the government's decision in January to override an international patent on Kaletra.
"They have proposed some price cuts for Aluvia tablets, but nothing has been concluded," Mongkol told Reuters.
The Wall Street Journal reported that Abbott offered to resubmit Aluvia at a new price, which is lower than any generic, provided Bangkok did not issue a compulsory licence allowing for the purchase or production of generic versions on Kaletra.
Mongkol declined to say whether Thailand would give such an assurance to the U.S. drug maker. "You have to wait until the negotiation is complete," he said.
Abbott announced earlier this month it would cut the price of Kaletra by more than half to $1,000 per patient per year in low and middle-income countries.
AIDS activists had criticized the blocking of Aluvia because it is a heat-stable form of Kaletra, eliminating the need for costly cold storage in poor countries.
But now they fear Thailand will bargain away its rights under World Trade Organisation rules to issue a licence allowing the manufacture of a patented drug without the consent of a foreign patent owner.
"Basically, Abbott is still holding patients hostage in an attempt to force the government to backtrack on the compulsory licence," Paul Cawthorne of Medicins Sans Frontieres said.
Abbott officials were not available to comment on the Journal report, which said the company would continue to withhold six other drugs from Thailand.
The post-coup government shocked pharmaceutical giants last November when it decided to override the patent on Efavirenz, an HIV-AIDS treatment made by Merck & Co.
Since then, the drug firms have tried to persuade Bangkok to back down in return for cheaper prices.
In February, Merck cut the price of Efavirenz by 46 percent for countries hard hit by HIV-AIDS, including Thailand where 580,000 people are living with the disease.
French drugmaker Sanofi-Aventis has also offered better access to its heart disease medicine Plavix after Thailand announced a compulsory licence, the first by a developing country for such a drug.
The details of these offers have not been disclosed, but Cawthorne said Thai negotiators should be careful.
"Brazil has taken these kinds of offers and they found themselves paying prices way above other countries because they are locked into these contracts with the companies," he said.
The research, published in PLoS ONE (11 April), showed that the oral test OraQuick HIV1/2 was 100 per cent accurate in a clinical trial conducted on 450 patients in a rural hospital in Maharashtra, India. Standard blood tests had an accuracy of 99.7 per cent.
The US Food and Drug Administration approved Oraquick in 2004 but there were doubts over its accuracy after tests showed false positive results in the United States and on pregnant women in India.
According to lead author Nitika Pai, of the McGill University Health Centre, Canada, the test is simple and quick.
Swabs of oral fluid are taken and tested for the presence of antibodies against HIV. "The test kit is all inclusive. It contains the swab, a stand and test solution. You get the test result in less than 20 minutes,'' Pai told SciDev.Net.
The study also found that 66 per cent of those who received the blood test complained of discomfort while only eight per cent of those receiving the oral test did the same.
The authors say the test could be used in rural, resource-limited areas in Africa, China, India and Russia, and could greatly enhance the control of the HIV epidemic in these areas.
But at present, OraQuick can only give tentative positive results because it has to be confirmed by analysis, which is not yet available in villages.
Pai also concedes that there are problems with testing for HIV in remote areas without providing adequate counselling on managing the disease. "But it's good to know that it is possible to get good results in a rural setting," she adds.
The test is likely to cost around US$10 in Asia. It was developed by OraSure Technologies and has been approved for use in Korea and Singapore.