Tuesday, July 31, 2007

Facts about the HPV Vaccine Gardasil

Facts about the HPV vaccine Gardasil
(Knoxville News Sentinel)

HPV is the name of a group of viruses that includes more than 100 different types. More than 30 of these viruses can be passed from one person to another through sexual contact. For most women, the body’s defense system will clear the virus; however, some types of HPV can cause cervical cancer or abnormal cells in the lining of the cervix that can sometimes progress to cancer. Other types of HPV are a major cause of genital warts.

The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

According to the CDC, if females are vaccinated before their first sexual experience, Gardasil prevents about 70 percent of cervical cancers.

Gardasil is given as three injections over a six-month period. The second dose is given two months after the first, and the third dose is given six months after the first. The injection is administered in the upper arm or thigh.

The vaccine can be given to girls as young as 9 and can be given to women up to age 26.

Gardasil is not approved for use in males to prevent HPV, but the manufacturer has a study under way to determine if it is safe and effective for them.

The clinical trials found no increased number of serious side effects in girls/women who received vaccine, compared with those who received placebo. Like all vaccines, Gardasil has some side effects, but the CDC’s Advisory Committee on Immunization Practice has determined that the benefits outweigh the risks.

It is not yet known if boosters will be needed. Studies show persistent high protection from the vaccine through five years and suggest protection will last much longer.

Sources: www.cdc.gov; www.fda.gov


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HPV Vaccine and Pap Test Both Essential in the Fight Against Cervical Cancer

HPV Vaccine and Pap Test Both Essential in the Fight Against Cervical Cancer
By: IOS Press

The development of the first vaccine for the prevention of cancer came 30 years after Harald zur Hausen first hypothesized that human papilloma virus (HPV) might be associated with cervical cancer. In those 30 years, much progress has been made in the diagnosis, treatment and now prevention of cervical cancer. In a special issue of Disease Markers, published this month, twelve articles explore the epidemiology of HPV, testing strategies for HPV infections, new HPV detection methods, and other potential biomarkers that might prove useful in cervical cancer diagnosis.

Guest Editors of this special issue, Magnus von Knebel Doeberitz, and Nicolas Wentzensen, both of the University of Heidelberg, have gathered a series of insightful articles that present both historical background and recent research into HPV and cervical cancer. They stress that, "Despite all this success a word of caution: we have not yet reached all the goals. Cervical cancer still is an important public health issue and the prevention approach will only work if at least most women in the world will have access to these vaccines. To achieve this, we will certainly need a lot of efforts and resources. The worst thing to do now would be to neglect the very successful screening programs for cervical cancer that made cervical cancer the prime paradigm for successful cancer prevention strategies."

Jenkins summarizes the various histo- and cyto-pathological features associated with acute and persistent HPV-infections and provides the reader with the essential knowledge to understand how HPV gene products alter shape and function of normal epithelial cells.

Bosch and de Sanjose present a current and extensive survey of HPV and cervical cancer epidemiology. Moscicki gives an overview of HPV infections, screening, triage, and treatment in adolescents that is highly relevant for vaccination programs, since adolescents represent the primary target population and HPV infection in ever younger girls emerges as a new arising problem. Shah and Westra provide an up-to-date review of HPV associated disease in the aerodigestive tract, including the benign recurrent respiratory papillomatosis as well as head and neck cancers. Nindl and colleagues have summarized biological and clinical data on the role of human papilloma viruses in non-melanoma skin cancer. Palefsky contributes a comprehensive overview of HPV infections in men with respect to disease patterns observed in men, transmission of the virus to women and the related issues concerning the possible vaccination of women and men. Moving towards new approaches in screening, Meijer and colleagues present an extensive survey of different HPV detection methods including genotyping and mRNA detection together with different possible scenarios of their application. Pagliusi contributes an important article on the international standardization of HPV testing.

Further articles address the emerging research on new biomarkers for cervical cancer screening that appear to help to overcome several of the important limitations of the current cancer early detection strategies. Doorbar extensively reviews molecular processes in transition from viral infection to the development of high grade disease and cervical cancer. A special focus is put on the changes of the viral life cycle with effects on cellular genes and proteins. Wentzensen and von Knebel Doeberitz summarize the current state of the most promising biomarkers that have been identified so far for revised cervical cancer screening, triage programs and potential clinical applications. The last two articles deal with the important topic of prophylactic and therapeutic vaccines. Müller and Gissmann contribute an exciting historical essay of the discovery of HPV and the development of therapeutic and prophylactic vaccines. Kast and colleagues present an excellent and very timely survey on therapeutic vaccines against HPV and associated disease with a detailed description of the lessons learned from the limitations of previous vaccination trials and of novel promising approaches.


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Saturday, July 21, 2007

HPV Test or Pap: Understanding the Choices

This article, published in the L.A. Times on July 2, 2007.


Advertisements can be very persuasive — whether they're promoting a snack food, a toy or even a medical test. If you've watched much television lately, you may have seen a commercial touting the benefits of a relatively new screening test for cervical cancer. Its message is unambiguous: "A Pap test isn't enough."

The advertisement encourages women to get tested for human papillomavirus (HPV), the virus known to cause cervical cancer. The test looks for the presence of 13 types of "high-risk" viruses that cause more than 99% of cervical cancers.

But the test isn't necessary or even appropriate for everyone.

For starters, women who have had three consecutive Pap smears showing no abnormalities face an extremely slim chance of developing cervical cancer, less than one in 1,000. So, for women who get regular pap smears, the test adds little beyond expense and additional lab work.

Further, the HPV test, when combined with the Pap smear, can sometimes create more problems than it solves.

"In the vast majority of patients, the results of the combined testing will be very straightforward," says Alan Waxman, a professor of obstetrics and gynecology at the University of New Mexico's School of Medicine. "But about 5% of patients are left in something of a dilemma."

A Pap smear with mild abnormalities along with a negative test for HPV can leave a woman guessing if she has a problem; a normal Pap smear and a positive HPV test can cause her to wonder if problems are imminent.

For some, simply testing positive for HPV causes unnecessary worry. About 90% of women who become infected with HPV clear the virus before it causes problems. Even among those who develop a persistent infection, only a small fraction will develop cancer, and the HPV test does not differentiate those who will get it from those who won't.

And even though the infection is common, learning that they have a sexually transmitted infection is emotionally upsetting for many people. In an article published last year in the journal Sexually Transmitted Infections, British researchers found that women who tested positive for HPV described feeling stigmatized, anxious and stressed; they also expressed concern about their sexual relationships and worried about disclosing the results to others.

For women who don't get Pap smears regularly, combined testing with the Pap smear and HPV test does appear to offer a clear advantage. "A single Pap smear is not a very good test," says Waxman. An isolated smear will identify only half to three-quarters of all women with precancerous or cancerous changes. The remaining women will receive false-negative Pap results, and their problems will go undetected.

Screening with both the Pap smear and the HPV test is more likely to identify a problem if one exists. A normal Pap smear and negative HPV test tells a woman that her risk of developing cancer over the next several years is exceptionally low; an abnormal Pap smear and positive HPV test, on the other hand, suggests that she is clearly at risk and that close follow-up is necessary.

"When I see a woman who hasn't gotten regular Pap tests, I want the biggest bang for the buck and am more inclined to do both tests," Waxman says.

In 2003, the American College of Obstetrics and Gynecology issued new cervical cancer screening recommendations that took HPV testing into consideration for the first time. For women younger than 30, the group now recommends annual screening with Pap smears alone and discourages the use of combined testing. While younger women are more likely to test positive for high-risk HPV types, these infections are highly likely to clear up relatively quickly.

For women older than 30, the recommendations are less clear-cut and endorse two approaches. Annual screening with the Pap smear alone remains a viable option. If three consecutive annual smears are normal, testing only needs to be performed once every two to three years.

Alternatively, HPV testing can be performed along with a Pap smear. Women with a normal Pap smear and a negative HPV test should then be re-screened with both tests every three years. If only one of the tests is negative, however, more frequent screening or follow-up testing will be necessary.

The 30-second television ad sponsored by the manufacturer of the HPV test, Digene, is a good one — from a sales perspective at least. It makes a compelling argument for HPV testing. What it doesn't tell you is just who should be persuaded.



Letters: HPV Test Could Have Been a Lifesaver


HPV test could have been a lifesaver
July 9, 2007

My wife had a Pap smear every year of her adult life ["HPV Test or Pap: Understanding the Choices," July 2]. I know, because I was with her since the 11th grade.

When doctors found cervical cancer it was stage IVB, no treatment, no cure. She was the "one in a thousand," and died a year later at a too-young 57 years old. If HPV tests had been in use she might have had a chance.

Take the test. Even if the results are confusing, as Dr. Valerie Ulene writes, it may generate greater attention, which in turn may save your life.

Neil Reichline

Tarzana


While Dr. Valerie Ulene mentioned that the HPV test can be beneficial for women who don't get regular Pap smears, I want to point out that it is also important for those who do. My own personal experience has taught me that the Pap smear alone — no matter how many times you have it — is not always enough.

Earlier this year at my gynecological exam, my doctor gave me both the Pap and HPV tests. My Pap test came back normal (as it had for the last 19 years!), but we were surprised by my positive HPV test results. After being retested a few months later, my Pap came back abnormal and my HPV test was still positive. Based on these results, my doctor took a closer look and discovered that I had pre-cancerous cervical cells.

Luckily, I was able to have these bad cells removed without going through any major surgeries or drastic treatments. If I hadn't had the HPV test, I would have waited a full year before having another Pap, and I could have easily gotten full-blown cancer.

As a busy mother of five, I feel extremely thankful for the HPV test. Women should take advantage of the new technology that's available to help keep them safe, especially when it doesn't require an additional appointment or any effort beyond simply asking to get the test done.

Jodi McKinney

Bethlehem Township, N.J.


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EU Panel Backs Glaxo's Cervical Cancer Vaccine

LONDON, July 18 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) won a green light for its cervical cancer vaccine, Cervarix, from European medical experts on Wednesday, paving the way for the launch of one of its biggest new product hopes.

Europe's largest drugmaker said an expert committee at the European Medicines Agency had given a positive opinion on Cervarix based on data from clinical trials involving the vaccination of girls and women aged between 10 and 25.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months.

The positive opinion is in line with guidance from UK-based Glaxo, which had said previously it expected to launch Cervarix in Europe in the second half of 2007. The European decision marks an important step forward for Cervarix, which won approval its first major market -- Australia -- in May.

Glaxo's vaccine will compete with U.S.-based Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) Gardasil, which is already available in both in the United States and Europe, where it sold via a vaccines joint venture with France's Sanofi-Aventis SA (SASY.PA: Quote, Profile, Research). Cervarix is not likely to go on sale in the key U.S. market before 2008.

Both vaccines protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV). They are expected to create a multibillion-dollar market, although most analysts think Merck's first-mover advantage will win it the lion's share.


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Monday, July 16, 2007

Stirrups-Free Pap Smear May Be a Welcome Cervical Cancer Screening Option

Women who know they should get regular Pap smears but dread the stirrups that go along with the test may finally get a reprieve.

New research shows that Pap results are just as accurate when the screen is performed with the patient keeping her feet on the examining table.

There was a real bonus in terms of comfort, too.

"There's about a 50 percent reduction in physical discomfort if women did not use the stirrups," said lead researcher Dr. Dean Seehusen, a family physician at the Eisenhower Army Medical Center at Fort Gordon, in Augusta, Ga. Women also said they felt psychologically less vulnerable, he said.

Seehusen, who published his findings recently in the British Medical Journal, remains hopeful that the practice of giving women a choice -- stirrups or no stirrups -- will catch on.

It could even boost women's health by inspiring them to have the exam more regularly, he added.

Seehusen said he had long suspected that one reason some women avoid potentially lifesaving Pap smears, and the accompanying pelvic exam, is due to the anxiety and discomfort of the stirrups position.

It can raise real anxiety in some women, he said, because "when your feet are in the stirrups you cannot easily get out." Women with mobility problems can also have an especially difficult time, he said. On top of those issues, many stirrups are cold to the touch, as well.

The study involved 197 women, ages 18 and up, who had come to the medical clinic for their annual pelvic exams. They were assigned to undergo the Pap test either in the stirrups or not.

After the tests, the women answered questions about their physical comfort, as well as their psychological sense of vulnerability and loss of control.

The result: The quality and accuracy of the Pap smears were similar, regardless of whether stirrups were used or not.

Seehusen's advice: "If a woman thinks she wants to try this method, she should ask her provider," he said.

Another women's health expert agreed.

"If a doctor can do without using the stirrups and you are more comfortable, by all means ask," said Dr. Celeste Robb-Nicholson, editor-in-chief of the Harvard Women's Health Watch and assistant professor of medicine at Harvard Medical School, Boston.

"If this alternative is offered," she said, "it could result in higher screening rates" for pap smears.

But your doctor may still prefer to do some exams with the stirrups, for better stability, she cautioned. While a simple Pap test may be no problem to perform when a woman's legs are not in the stirrups, more complicated procedures -- such as getting an endometrial biopsy -- might be better conducted with a woman's legs stabilized by the stirrups, Robb-Nicholson explained.

And some doctors may still prefer to do the Pap smear while a woman's feet are in stirrups.

But for those women who are uncomfortable in the stirrups, "It is reasonable to ask" to skip them, Robb-Nicholson said.


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Uninsured Women Are Not Getting Regular Pap Smears / Cervical Cancer Screening

One-fourth of uninsured U.S. women between the ages of 18-64 reported not having had a Pap smear within the last three years. This was double the 11 percent rate for women with private insurance and more than the 15 percent rate for women covered by Medicaid or any other public insurance.

One-fourth of uninsured U.S. women between the ages of 18-64 reported not having had a Pap smear within the last three years when surveyed in 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. This was double the 11 percent rate for women with private insurance and more than the 15 percent rate for women covered by Medicaid or any other public insurance.

The U.S. Preventive Services Task Force, which is sponsored by AHRQ, recommends that women from ages 21-64 receive a Pap smear screening every three years to detect cervical cancer and abnormal cells that can develop into cancer.

AHRQ data also shows that:

• Overall, 14 percent of U.S. women age 18 to 64 – with or without insurance – did not receive a Pap smear within the last three years.

• Asian women are more than twice as likely (21.5 percent ) to have not received a Pap smear in last three years than African American women (10 percent). White and Hispanic women fall in between (13.5 percent and 16 percent, respectively)

• Women age 50-64 are nearly twice as likely (17 percent) to have not received a Pap smear compared to women ages 30-39 (9 percent). For women age 40-49 the rate is about 12 percent.

AHRQ, which is part of the U.S. Department of Health and Human Services, works to enhance the quality, safety, efficiency, and effectiveness of health care in the United States. The data in this AHRQ News and Numbers summary are taken from the Medical Expenditure Panel Survey, a highly detailed source of information on the health services used by Americans, how frequently they use them, the cost of those services, and how they are paid. For more information, go to: Use of the Pap Test as a Cancer Screening Tool Among Women Age 18-64, U.S. Civilian Noninstitutionalized Population, 2005.



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Wednesday, July 11, 2007

HPV Vaccine Helps Protect against Cervical Cancer

What does the new cervical cancer vaccine do and who should get it? How should you take calcium? Should it be spread out during the day?


If you are referring to the new Human Papillomavirus (HPV) vaccine (Gardasil), it is used to prevent infection with HPV virus types 6, 11, 16, 18. The first two types are usually associated with genital warts and the second two types have been linked to cervical cancer. If a certain type of HPV virus infects a female and the virus does not clear up on its own, then abnormal cells may develop along the lining of the cervix, which could lead to pre-cancerous or even cancerous cells.

It has been estimated that HPV types 16 and 18 cause 70 percent of cervical cancer cases, and HPV Types 6 and 11 cause 90 percent of genital warts cases. Other HPV types can cause cervical cancer, but the ones mentioned above are the most common. Unfortunately, people may carry an HPV virus without experiencing any symptoms, and unknowingly infect others.

The Gardasil vaccine can be given to females, ages 9 through 26, to protect against an HPV infection. The vaccine is most effective when given before the patient comes into contact with any HPV virus. It is administered via injection to the patient three times over a period of six months.

Because Gardasil may not fully protect all girls and women and does not prevent all types of cervical cancer, it is important to continue regular cervical cancer screenings. It is vital to note, therefore, that the vaccine does not replace your yearly pap smear. And, you should always check with your doctor to determine if the vaccine is right for you.

The recommended dose of calcium for pre-menopausal women is 1,000 mg per day. The calcium should be taken in divided doses, 2-4 times per day. Post-menopausal women who do not take estrogen should take 1,500 mg per day.

Calcium citrate, which is easy to digest, is a commonly recommended calcium supplement; it is better when not taken with a meal. An over-the-counter alternative is calcium carbonate, which should be taken with a meal, preferably at breakfast. Side effects may include dyspepsia and constipation.



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Wednesday, July 4, 2007

Cervarix: Second Cervical Cancer Vaccine Ready for Market


Second Cervical Cancer Vaccine Ready for Market
By Carol Pearson
Washington
03 July 2007

jkkA second cervical cancer vaccine has passed a key clinical trial and its maker is seeking to use the vaccine in countries around the world. As VOA's Carol Pearson reports, more women may be able to use this new vaccine by drug giant GlaxoSmithKline than use the first cervical cancer vaccine, Gardisil.


Gardisil

When drug maker Merck made Gardisil available in 2006, it was the first vaccine designed to prevent cancer in humans, specifically cervical cancer. Gardisil is recommended for girls and women ages nine to 25 before they become sexually active.


Cervarix

But now a second vaccine, Cervarix, has proven effective in clinical trials for women up to the age of 45, including those who are sexually active.

Dr. Gary Dubin oversaw clinical trials of Cervarix that involved more than 18,000 women from 14 countries across Europe, Asia, Latin and North America.

Dr. Gary Dubin

He says the results show Cervarix provides 100 percent protection against two major strains of the human papillomavirus, or HPV, which cause cervical cancer.
"The reason this is important is that these two HPV types are responsible for about 70 percent of cervical cancers globally."
Dr. Levi Downs is an investigator in the Cervarix study at the University of Minnesota. He adds, "Secondly, and very important, they show us the vaccine is also effective against other HPV types that can cause cervix cancer.

Dr. Levi Downs

Virtually 100 percent of women have the potential of receiving some benefit from this vaccine."
The studies also show Cervarix is effective even for women who previously had cancerous lesions, provided those lesions have been cleared.

More than half a million women around the world will be diagnosed with cervical cancer this year. The disease will claim the lives of nearly 300,000 women.

GlaxoSmithKline has initiated a study comparing Cervarix with Gardisil to see if one vaccine is more effective than the other. So far, no data is available.

But with the expected approval of Cervarix in many countries, women can add another weapon in their arsenal against the cancer-causing human papillomavirus.



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Sunday, July 1, 2007

Cervarix, New Cernival Cancer Vaccine May Provide Broader Protection Against Cervical Cancer

A new cervical cancer vaccine, Cervarix, may provide even broader protection against cervical cancer to women from 15-45.

Science Daily — Just under 150 women in Perth, Australia, have contributed to major international research that has proved that the new Cervarix vaccine provides broader protection against cervical cancer.

The results, published today in the prestigious international journal Lancet, show that while the vaccine provides effective protection against high grade cervical pre-cancerous lesions caused by human papillomavirus (HPV) types 16 and 18, it also demonstrated additional protection against infectious from other strains of HPV that account for another 10 percent of cervical cancers.

The Perth component of the international study was conducted by the Vaccine Trials Group at the Telethon Institute for Child Health Research in collaboration with Princess Margaret Hospital and King Edward Memorial Hospital.

Report co-author Dr Rachel Skinner, who headed the Perth trial, said the results were very encouraging.

"We have found through this study that this vaccine is extremely effective in the prevention of pre-cancerous disease of the cervix due to infection with HPV types 16 and 18," Dr Rachel Skinner said.

"However we now have evidence that Cervarix offers women broader protection by providing some protection against infections caused by HPV types 45 and 31. These types together with HPV types 16 and 18 account for 80 per cent of cases of cervical cancer worldwide.

"Not only will vaccinated women potentially benefit from a high level of protection against cervical cancer, they will also benefit from a reduction in abnormal Pap smears. However it is crucial that women who choose vaccination continue with regular Paps as the vaccine does not provide complete protection against cervical cancer."

The international study is the single largest cervical cancer vaccine efficacy study with over 18,000 women aged 15-25 years involved from all corners of the globe, including Europe, Asia Pacific, Latin and North America and women from six centres throughout Australia.

The Therapeutic Goods Adminstration has now approved Cervarix for women aged 10-45 years, making it the first vaccine in Australia available for women over the age of 26 years.

The research is reported in the journal Lancet.


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