Cervical Cancer Vaccines May Start Soon
A cervical cancer vaccine programme is likely to be introduced in the Republic in the near future, on foot of today’s publication of a Health Information and Quality Authority (Hiqa) report.
The HIQA value-for-money report should pave the way for the early announcement of a formal immunisation programme aimed at 12-year-old girls. The report also recommends a once-off vaccination programme for 13 to 15 year-olds.
Cervical cancer is caused by certain types of the human papillomavirus (HPV), with evidence of infection found in 99 per cent of women with cervical cancer.
The Minister for Health, Mary Harney has said she would introduce a HPV/cervical cancer vaccine programme if advised to do so.
Although there are in excess of 200 HPV strains, just a small number are associated with the development of cancer of the cervix. HPV types 16 and 18 are found in almost 70 per cent of cervical cancers, while another five sub types are responsible of a further 20 per cent of cases. Some HPV types are non cancerous but are linked to the presence of warts in the genital area.
Cancer of the neck of the womb (cervix) is diagnosed in almost 200 women here every year; some 70 women die from the disease annually.
Cervical cancer usually develops quite slowly, passing through a number of pre invasive stages (carcinoma in situ - CIN) before progressing to full blown disease. If caught in the early stages, it has a five-year survival rate of 80 per cent or greater.
HPV is a sexually transmitted infection; it is estimated that almost 80 per cent of sexually active people have been infected with at least one virus type by the age of 50. It is usually symptomless and in 90 per cent of cases, the body clears itself of the virus within two years of infection. But it is when the virus persists that the risk of cervical cancer increases.
Gardasil and Cervarix are the approved vaccines against HPV. Both aim to prevent cervical cancer; in addition Gardasil is active against those HPV subtypes known to cause genital warts. Both products involve a three-vaccine course, given over a six-month period. And clinical trials involving a five-year follow-up, have shown that vaccination is 100 per cent effective in preventing HPV infection and non-invasive cancer .
HPV vaccines must be given before infection with the virus occurs. This means administering the course prior to the person becoming sexually active so that a comprehensive vaccination program would need to be administered to girls in the 11- to 13-year age bracket.
Vaccination Against Human Papillomavirus Decreases Related Tests and Treatment for Cervical Cancer
Researchers affiliated with the Quadrivalent HPV Vaccine Merck Study Group have reported that vaccination against human papillomavirus (HPV) is associated with a reduction in Pap tests, colposcopy, cervical biopsy, and definitive treatment among women who were uninfected at the time of vaccination. The details of this study were presented at the 39th annual meeting of the Society of Gynecologic Oncologists (SGO) in Tampa, Florida, from March 9 to 12, 2008.
Pap smears have decreased the incidence and death rate of cervical cancer among women in developed countries such as the United States. Cervical cancer is caused by specific high-risk strains of HPV, which can be detected by a special test called Hybrid Capture II (made by Digene).
Now that an HPV vaccine (Gardasil®, manufactured by Merck) has been approved by the U.S. FDA, further reductions in cervical cancer incidence and death may be anticipated. Gardasil is a quadrivalent vaccine because it confers protection against four subtypes of HPV (HPV 6 and HPV 11, which cause 90 percent of genital warts, and HPV 16 and HPV 18, which cause 70 percent of cervical cancers).
Despite the success of Pap smear programs and the ability to detect HPV, over 2 billion dollars in healthcare expenditure occurs annually as a result of abnormal Pap tests and their subsequent evaluation, which often requires cervical biopsies and other surgical procedures on the cervix. This is because, although Pap smears and HPV detection allow a pre-cancerous or dysplastic state of the cervix to be detected and treated before it can turn into cancer, neither of these two methods eliminate the original problem, which is infection with HPV.
The end-of-study data from three pivotal Phase II/III clinical trials of the quadrivalent HPV vaccine were reported at the SGO meeting. A total of 18,150 16 to 26-year-old women were enrolled in one of three randomized, placebo-controlled trials. Vaccine or placebo was given at Day 1, Month 2, and Month 6. Subjects underwent Pap testing on Day 1 and every six to 12 months for up to 48 months. Patients with specific abnormalities on the Pap smear were referred for colposcopy and, depending on the findings, definitive treatment was carried out.
After an average follow-up period of four years, the investigators noted a reduction in Pap tests, colposcopy, cervical biopsy, and definitive treatment among women who were uninfected with HPV at the time of vaccination. Interestingly, these reductions were seen irrespective of the specific type of HPV involved.
Comments: Vaccination with the quadrivalent vaccine appears to be able to decrease the number of Pap tests, colposcopies, cervical biopsies, and treatment women require. This occurs presumably because the vaccine protects against infection with HPV, which is the inciting event in the development of pre-cancerous cervical disease. Long-term studies are required to determine the duration of protection that is achieved by the three-dose vaccination series.
Gen-Probe HPV assay launched in Europe
Gen-Probe has launched its new Aptima HPV Assay in Europe. The diagnostic test, for detecting high-risk strains of the human papillomavirus (HPV), has been CE-marked and is now available for sale in 13 European countries.
The assay is an amplified nucleic acid test that detects 14 high-risk HPV types associated with cervical cancer. Specifically, it detects two messenger RNAs (mRNAs), E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer. Gen-Probe believes that targeting these mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women who are infected, but HPV infections are common and many resolve without causing cervical cancer.
“Increased specificity – meaning fewer false positive results – is important so women are not subjected to the anxiety and expense of unnecessary medical procedures,” said Jack Cuzick, professor of epidemiology at the Cancer Research UK Centre for Epidemiology, Mathematics and Statistics in London, who is leading the 953-woman ‘Predictors’ study – a head-to-head comparison of various HPV assays.
The assay has been designed to run on Gen-Probe’s fully-automated Tigris instrument system and on the company’s semi-automated DTS instrument platform.
It is being manufactured in Cardiff by Molecular Light Technology, a subsidiary of Gen-Probe.
The assay is still in clinical studies in the US, and has not yet been approved for marketing in that country by the US Food and Drug Administration.
HPV is a group of viruses with more than 100 types, 14 of which are considered to be high-risk for the development of cervical cancer. Most women will be infected with HPV at some point in their lives, but most of these infections resolve without any clinical symptoms or consequences. A small number of HPV infections progress and result in disease, which can range from genital warts to cervical cancer.
1 in 4 teen girls have STD
A virus that causes cervical cancer is by far the most common sexually transmitted infection in teen girls ages 14 to 19, while the highest overall prevalence is among black girls — nearly half the blacks studied had at least one STD. That rate compared with 20% among both whites and Mexican-American teens, the study from the federal Centers for Disease Control and Prevention found.
About half of the girls acknowledged ever having sex; among them, the rate was 40%. While some teens define sex as only intercourse, other types of intimate behavior including oral sex can spread some infections.
For many, the numbers likely seem “overwhelming because you’re talking about nearly half of the sexually experienced teens at any one time having evidence of an STD,” said Dr. Margaret Blythe, an adolescent medicine specialist at Indiana University School of Medicine and head of the American Academy of Pediatrics’ committee on adolescence.
But the study highlights what many doctors who treat teens see every day, Blythe said.
Dr. John Douglas, director of the CDC’s division of STD prevention, said the results are the first to examine the combined national prevalence of common sexually transmitted diseases among adolescent girls. He said the data, from 2003-04, likely reflect current rates of infection.
“High STD rates among young women, particularly African-American young women, are clear signs that we must continue developing ways to reach those most at risk,” Douglas said.
The CDC’s Dr. Kevin Fenton said given that STDs can cause infertility and cervical cancer in women, “screening, vaccination and other prevention strategies for sexually active women are among our highest public health priorities.”
The study by CDC researcher Dr. Sara Forhan is an analysis of nationally representative data on 838 girls who participated in a 2003-04 government health survey. Teens were tested for four infections: human papillomavirus, or HPV, which can cause cervical cancer and affected 18% of girls studied; chlamydia, which affected 4%; trichomoniasis, 2.5%; and herpes simplex virus, 2%.
Blythe said the results are similar to previous studies examining rates of those diseases individually.
The results were prepared for release Tuesday at a CDC conference in Chicago on preventing sexually transmitted diseases.
HPV can cause genital warts but often has no symptoms. A vaccine targeting several HPV strains recently became available, but Douglas said it likely has not yet had much impact on HPV prevalence rates in teen girls.
Chlamydia and trichomoniasis can be treated with antibiotics. The CDC recommends annual chlamydia screening for all sexually active women under age 25. It also recommends the three-dose HPV vaccine for girls aged 11-12 years, and catch-up shots for females aged 13 to 26.
The American Academy of Pediatrics has similar recommendations.
Douglas said screening tests are underused in part because many teens don’t think they’re at risk, but also, some doctors mistakenly think, ‘”Sexually transmitted diseases don’t happen to the kinds of patients I see.”‘
Blythe said some doctors also are reluctant to discuss STDs with teen patients or offer screening because of confidentiality concerns, knowing parents would have to be told of the results.
The American Academy of Pediatrics supports confidential teen screening, she said.
HPV Vaccine & Fainting
by Amy Fleming
Allentown, PA - Recently the Centers for Disease Control & Prevention reported that in the last two years, more than 450 youngsters fainted after getting a vaccination.
That may explain why some teenagers are taking a new position on the HPV vaccine.
Gardasil protects against a virus that cervical cancer and genital warts.
Researchers aren’t sure why, but about 10% of girls in studies for the HPV vaccine got dizzy or passed out after the shot.
The Gardasil website lists fainting as a possible side effect.
To be safe rather than sorry, doctors are proposing an easy solution.
“The recommendation as a result of this, is pretty simple. Just that you give them a vaccine either sitting sown or lying down and you watch them for 15 to 20 minutes just to make sure that they don’t have any significant reaction,” said Dr. Larry Glazerman.
The vaccine is given in a series of three shots.
For more information on the vaccine go to www.gardasil.com.
More links found between cancer in men and HPV, but men aren’t approved for vaccination
by Brian Boyer
Men are neither vaccinated nor screened for human papillomavirus, but two university studies suggested last week that it may be the cause of cancer for many men, and that those cancers could have been prevented.
The virus, better known as HPV, is the primary cause of cervical cancer in women. Recent research, at the University of Michigan and University of Louisville, suggests that it is also the cause of a disease that disproportionately affects men, cancers of the head and neck.
“You should be testing everybody,” said Payal Desai, leader of a pilot study at the Louisville’s James Graham Brown Cancer Center. Both men and women carry HPV, the virus that will affect at least 50 percent of sexually active people, according to the Food and Drug Administration, though only a fraction of those will develop cancer.
More than 35,000 new cases of head and neck cancer are expected to be diagnosed in the United States in 2008, according to the American Cancer Society. Twice as many men as women will develop the disease, which the society estimates will kill 7,590 Americans this year.
Currently a screening test only exists for women. Similarly, a vaccine for HPV exists, but is only approved for use in women ages 9 to 26. Studies are under way to test the efficacy of the HPV vaccine in men, according to the FDA.
If the vaccine were successful in preventing HPV infections in men, the studies suggest it is possible that a significant number of cancer cases in men could be avoided.
In one study, tissue samples from 43 head and neck cancer patients were tested by the Louisville team. They found that almost one-third of the samples tested positive for HPV, specifically the strain of the virus known as HPV 16.
In the other study, at Michigan’s Comprehensive Cancer Center, had similar findings. More than one-third of the 66 head and neck cancer cases they examined tested positive for HPV 16. This study’s primary finding was encouraging: The HPV-associated tumors responded significantly better to treatment than those not associated with HPV.
In women, HPV types 16 and 18 are responsible for 70 percent of cervical cancer cases. The American Cancer Society estimates that 11,070 cases will be diagnosed, and that the disease will kill 3,870 women in the United States in 2008.
Infection by strains 16 and 18 can be prevented through vaccination, with almost 100 percent effectiveness. The drug Gardasil, first made available to young women in 2006, also vaccinates against types 6 and 11, which are responsible for 90 percent genital warts cases.
Desai presented the findings of their study May 15 at the American College of Physicians Internal Medicine Conference. The results have not yet been published. The University of Michigan study was published online May 12 in the Journal of Clinical Oncology. In February, another study, at the National Cancer Institute and Johns Hopkins Medical Insitutions, suggested a link in men between HPV and oral cancer.
Recent
- Genital Warts — How to Cope With Psychological and Emotional Pain?
- Genital Rash Can Transmit HIV
- Teen Sexual Behavior Does Not Predict HPV Risk
- Merck's Gardasil not cleared for older women
- Cervical Cancer Vaccines May Start Soon
- Vaccination Against Human Papillomavirus Decreases Related Tests and Treatment for Cervical Cancer
- Gen-Probe HPV assay launched in Europe
- 1 in 4 teen girls have STD
- HPV Vaccine & Fainting
- More links found between cancer in men and HPV, but men aren't approved for vaccination
- Boys should also get HPV protection
- Government promises free cervical cancer vaccination campaign
- Officials urge caution after local STD increase
- University Health Services nears 1,000th course of HPV vaccine
- Treating and Preventing HPV
- Consequences of HPV
- Understanding HPV
- Genital Warts Health Project
- Home Remedies to Remove Common Warts
- Genital Warts Medicine And It's Uses
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