News (Updated June 25, 2006)
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WASHINGTON (Reuters) - U.S. health officials on Friday approved the use of a new HIV drug, made by Johnson & Johnson, in combination with related therapies to help treat patients who do not first improve with other treatment.
The drug, Prezista, is a protease inhibitor designed to treat resistant strains of HIV, the virus that causes AIDS.
The approval marks the New Jersey-based drugmaker's first entry into the $1.5 billion U.S. market for protease inhibitors, a class of drugs designed to suppress the virus and prevent it from replicating.
Also known as TMC114, the drug is given with a low dose of an older protease inhibitor called ritonavir, which slows the breakdown of Prezista in the body, increasing its concentration in a patient's system, the Food and Drug Administration said.
The human immunodeficiency virus that causes AIDS infects close to 40 million people worldwide, with more than 1 million in the United States. The U.S. Centers for Disease Control and Prevention estimates that 40,000 Americans become infected with HIV each year.
While many HIV therapies are now available, AIDS specialists and activists have said resistance to them is becoming a problem because the virus can quickly mutate and current drugs can become ineffective.
TRIAL RESULTS
JP Morgan analyst Michael Weinstein, in a note to clients on Wednesday, forecast Prezista sales of $65 million in the second half of 2006 and peak sales of $800 million to $900 million.
"I really expect it to be used quite widely even with the indication that it has," Dr. Tim Wilkin of Weil-Cornell Medical College, New York, who helped conduct one of the Prezista clinical trials, said in an interview before the approval.
J&J said the drug, which will be taken in combination with other HIV drugs, will have a wholesale cost of $25 a day.
Still, other doctors sounded a more cautious note.
Dr. Steven Deeks, an associate professor of medicine at the University of California, San Francisco, said he plans to delay prescribing the J&J drug for patients who are highly resistant to existing HIV drugs until he can combine it with a second compound that would work for these patients.
He said these drugs need to be partnered with another effective drug. "For many patients with truly highly resistant HIV, there is no drug yet to partner with it," Deeks said in an interview on Friday.
The FDA said it approved Prezista based on two six-month trials that found 70 percent of patients who had tried other therapies improved when they added Prezista and ritonavir to their drug cocktails compared with 21 percent of those who took ritonavir with other protease inhibitors.
In a separate release, Roche Holding AG said the trial showed that its anti-HIV drug Fuzeon, in combination with Prezista and ritonavir, resulted in undetectable virus levels in up to two-thirds of patients who had become resistant to other drugs.
Side effects of Prezista can include diarrhea, nausea and headache as well as mild to serious skin rashes. The risks for patients who have not undergone other treatments first is unknown, the agency said.
J&J must also conduct post-marketing studies, it said.
Prezista is the first of three advanced compounds in J&J's HIV franchise, which aims to combat HIV drug resistance.
Prezista will be followed by TMC125, a non-nucleoside reverse transcriptase inhibitor typically used in combination with other drugs expected to be launched in late 2008.
That will be followed by TMC278, a second non-nucleoside reverse transcriptase inhibitor.
J&J also is studying Prezista in comparison to currently approved protease inhibitors.
Shares in the company were up 66 cents, or 1 percent, at $61.98 in after-hours trade on the Inet exchange after earlier closing up 14 cents at $61.32 on the New York Stock Exchange.
Thu Jun 22, 2006 10:51 PM ET
WASHINGTON (Reuters) - A quick saliva test for the AIDS virus has helped many
more people discover whether they are infected, the U.S. Centers for Disease
Control and Prevention reported on Thursday.
A program in which the CDC distributed nearly 800,000 OraSure Technologies Inc. tests to community groups and prisons brought in many more people to be tested than otherwise would have come in, the agency said.
The findings validate a widely held assumption -- that people are more likely to get tested if there is a quick and easy diagnostic such as the OraSure test, which uses saliva, the CDC said.
If the results are available in half an hour, people are more likely to await the results than they are to return a week or two later, as other testing can require.
The CDC said at the end of 2003 an estimated 1 million people in the United States had the human immunodeficiency virus (HIV) infection, including those who had developed acquired immune deficiency syndrome (AIDS). About one-fourth of those people had not had their infections diagnosed.
Starting in 2003, the CDC distributed tests to 230 organisations in 21 states and Washington, D.C. Of the 372,960 tests administered, 4,650 or 1.2 percent of them were positive for the AIDS virus.
"The results suggest that (the program) helped scale up rapid HIV-testing programs in the United States and enabled diagnosis of HIV in persons who might not have had their infections diagnosed otherwise," the CDC researchers said.
Studies have shown that when conventional blood tests are used, which typically require clients to return in two weeks for results, nearly one-third of people tested never come back.
"Although follow-up client data were not collected on the 4,650 confirmed HIV-positive test results, previous research has indicated that the majority of persons who learn they are infected with HIV take steps to prevent transmission to others and obtain health care that can prolong the quality and duration of their lives," the report said.
There is no cure for HIV infection but drug cocktails can keep patients healthy. Since the first cases of AIDS were detected 25 years ago, 65 million people around the world have become infected with the HIV virus and 25 million have died.
By LINDA A. JOHNSON, Associated Press WriterThu Jun 22, 9:15 PM ET
For the first time, scientists have proof that condoms offer women impressive protection against the virus that causes cervical cancer.
A three-year study of female college students — all virgins at the start — found that women whose partners always wore a condom during sex were 70 percent less likely to become infected with the human papilloma virus, or HPV, than those whose partners used protection less than 5 percent of the time.
"That's pretty awesome. There aren't too many times when you can have an intervention that would offer so much protection," said Dr. Patricia Kloser, an infectious-disease specialist at University of Medicine and Dentistry of New Jersey who was not part of the study.
Condoms have been shown convincingly to prevent pregnancy and AIDS. But conservatives who want to see abstinence taught in schools have long argued that condoms do not protect well against diseases such as HPV, because men can spread the virus to women from sores on their genitals outside the area covered by a condom.
However, the researchers at the University of Washington found that the chances of HPV being spread that way appear to be small.
Human papilloma virus — which can cause cervical cancer, genital warts and vaginal, vulvar, anal and penile cancers — is the most common sexually transmitted disease, infecting about 80 percent of young women within five years of becoming sexually active. An estimated 630 million people worldwide are infected.
The virus is spread during sex from contact with the sores, or lesions, that develop around infected cells.
Often, the virus is killed by the immune system, but in some people HPV can take hold and cause lesions that can turn cancerous years later. Cervical cancer strikes about 10,520 American women and kills about 3,500 each year. Worldwide, about 500,000 women develop cervical cancer and nearly 300,000 die from it every year.
In the HPV study, published in Thursday's New England Journal of Medicine, none of the women who reported that their partners always used condoms developed lesions during the three-year period. Fourteen women whose partners used condoms less regularly got lesions.
Twelve of the 42 women who said their partners always used condoms became infected. Rachel Winer, a researcher in the university's epidemiology department, said it could be that the couples did not use the condoms correctly or had some sexual contact before putting on a condom.
Recent medical advances might someday render the condom debate moot: Earlier this month, the government approved the first vaccine against HPV, and public health officials are urging that girls be routinely vaccinated before they become sexually active.
The study comes as the Food and Drug Administration is revising rules for the claims that manufacturers can make on how well condoms prevent sexually transmitted diseases.
Packages now must state: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." But revisions were ordered by Congress in 2000 amid pressure from conservative groups demanding "medically accurate" claims as to condoms' effectiveness.
Safe-sex advocates warn that changing the wording would undermine public confidence in, and use of, condoms.
At the time, there was solid evidence only on how well condoms prevent pregnancy, HIV and, in men, gonorrhea. Recent research has produced strong evidence condoms protect well against gonorrhea, chlamydia and herpes in both men and women, said Dr. Ward Cates Jr., president of the Institute for Family Health at Family Health International. This study adds HPV to that list, he said.
"This will help clinicians to counsel their patients about the effectiveness of condoms to reduce another of the sexually transmitted infections — if condoms are used consistently and correctly," Cates said.
The researchers invited 24,000 female students ages 18 to 22 at the Seattle university to be in the study. Starting in 2001, they followed 82 from before their first vaginal intercourse, testing the women for HPV with swabs of the cervix and other genital areas every four months. The women kept online diaries detailing each act of intercourse, including condom use and whether there was any genital contact without a condom.
Winer said previous HPV studies either showed no protection from condoms or were inconclusive. This one included only virgins and collected more details, and the computer diaries helped women be more honest about condom use than those in studies where people are interviewed about their sexual behavior, she said.
"This is about as ideal a study as you can get," said Dr. Tom Fitch, a San Antonio pediatrician and board chairman at the Medical Institute for Sexual Health, which stresses abstinence and monogamy as the only sure ways to prevent sexually transmitted infections.
Nevertheless, Fitch noted that some consistent condom users still were infected with HPV. Fitch and Kloser also suggested that the results in the real world — say, among poor, inner-city women — might be different from those with college women.
Fitch said several studies have shown that at most, 50 percent of people reported using a condom every time they had sex.
Monday June 19, 3:44 PM
The excitement over a novel class of drugs being developed to fight HIV has been dampened by fears they could pose serious safety risks, including the possibility they might actually speed the progression of AIDS.
The new class of drugs,
called CCR5 receptor antagonists, blocks a secondary but crucial doorway
typically used by the human immunodeficiency virus to enter cells in the body.
Researchers have known for more than a decade that people who lack a working
version of that doorway, called a receptor, are, at best, highly resistant to
infection by HIV and, at worst, slow to develop AIDS once infected.
From a treatment standpoint, drugs that provide the same benefit would be a welcome addition to the mix of medicines now used to fight HIV. More dramatically, the drugs would represent a shift in the fight against HIV, since they don't target the virus itself, as do the 27 other treatments already approved by the Food and Drug Administration.
That difference is at the root of much of the concern surrounding the drugs. The drugs attack a target on human white blood cells that play an important role in the immune system.
"HIV profoundly affects the immune system. We are adding another layer of complexity by using a drug that also affects the immune system," said Veronica Miller, director of the Forum for Collaborative HIV Research based at George Washington University.
Even as development continues, there is a growing wariness about the future of the drugs.
"It's a very exciting class and at the same time, people are approaching it with some trepidation," said Tom Gegeny, executive director of The Center for AIDS Information & Advocacy in Houston.
Most worrisome is that the drugs could accelerate a shift from one variant of HIV to a second, which is most often seen in the sickest AIDS patients. It also is unclear whether the drug would provide the same protection as occurs naturally in some people.
Nor do researchers know the long-term health effects of the drugs, since they tinker with cells that are the sentinels of the body's defenses against infection and disease.
Some of the drugs have been linked to liver problems and cancer.
"It is targeting a novel pathway with which we don't have a great deal of experience," said Dr. Scott Proestel, an FDA medical officer. Indeed, a recent study found that the West Nile virus can be more lethal to people who naturally lack a working CCR5 doorway. Researchers warned the same could be true in patients treated with drugs that block that doorway.
That and other concerns reflect the sea change that the world of HIV has undergone since 1987, when AZT, the first effective treatment for the virus, gained FDA approval.
A year later, demonstrators mobbed the FDA to demand the agency speed access to new therapies to treat HIV, even as the safety of those drugs remained under study. At the time, HIV infection could be a death sentence; efficacy trumped safety when it came to drugs capable of fighting the virus.
Now, AIDS can be a manageable condition. Existing drugs aren't perfect, but they work. That has raised the barrier for drugs under development, even as preliminary research suggests they work, the Forum's Miller said. Pharmaceutical companies must show their drugs are both safe and effective to gain FDA approval.
"It becomes more and more difficult to do something different," said John Moore, a Cornell University AIDS researcher. "The pendulum has gone toward safety at all costs."
A year ago, there was hope the CCR5 antagonists would debut as a class. Now, it appears more likely they will dribble out one by one _ if at all. A headline on a study published in April in the journal Infection summed up the doubt: "CCR5 Antagonists Teeter on a Knife-Edge."
GlaxoSmithKline, one of the three major pharmaceutical companies that are developing the drugs, said in October that it halted trials of aplaviroc after patients showed signs of liver damage. Schering-Plough Corp. scrapped a portion of trials of its drug in January after smaller doses of its drug didn't work as well as had been anticipated. And in March, the company reported that a small number of its patients had developed lymphomas, sparking worries that the drugs could make patients vulnerable to cancer and infection because of their effect on the immune system.
Pfizer Inc. reported a single case of liver problems in its trials, but said it appeared unrelated to its drug, maraviroc. The company may file with the FDA later this year for approval, putting it at the head of the CCR5 drug competition.
"There is probably more of a dose of reality than a year ago, because all three drugs were moving forward," said Rob Camp, the antiretroviral project director at the Treatment Action Group, a New York advocacy group. "All this stuff has come out in the past six months. Things have been a little less exciting _ and a little less excited, I guess."
Meanwhile, as a condition of approval, the FDA has suggested pharmaceutical companies follow for five years the health of patients enrolled in clinical trials. Drug companies, researchers and others said that's not feasible, given the mobility of U.S. society and the likelihood those patients will start taking other HIV drugs. That will probably confound attempts to gauge the long-term effects.
"The clinical development of this class has, in a word, been challenging," said Dr. Roy Gulick, another Cornell University AIDS researcher.
Wednesday June 21, 10:24 am ET
The test, called the EHIV, or Human Immunodeficiency Virus-Enhanced, was approved for use on Bayer's ADVIA Centaur Immunoassay System. EHIV is an in vitro diagnostic test that looks for antibodies in human serum and plasma to HIV 1, HIV 2 and a subtype of HIV 1. The test is automated, allowing laboratories to increase testing with more accurate results, Bayer said in a statement.
The system is made and sold by Bayer Diagnostics for Ortho Clinical Diagnostics, a subsidiary of Johnson & Johnson.