Cervarix

Vaccines Do Not Cover Most Common HPV Types in Black Women.

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The HPV subtypes that are most common in black women in the United States are not targeted by the currently available vaccinesGardasil and Cervarix, according to new research.

The findings suggest that current HPV vaccination will be less beneficial for black women in the US than for their white counterparts, said study coauthor Catherine Hoyo, PhD, MPH, of Duke University, in Durham, North Carolina.

She spoke at a press briefing today at the annual International Conference on Frontiers in Cancer Prevention Research, in National Harbor, Maryland. The meeting is sponsored by the American Association for Cancer Research.

“The approved cervical cancer vaccines are effective but may not be effective for everyone,” said Paul Limburg, MD, from the Mayo Clinic, in Rochester, Minnesota, who moderated the press briefing. He was not involved with the study.

Persistent infection with HPV 16 and/or HPV 18 accounts for about 70% of all cervical cancers, said Dr. Hoyo. These are the subtypes targeted by Gardasil and Cervarix. Gardasil also targets HPV 6 and HPV 11.

Some black women in the new study did, in fact, have infections with HPV 16 and/or HPV 18. But much less often — their rate was about half of that of white women.

“Since African-American women don’t seem to be getting the same subtypes of HPV with the same frequency, the vaccines aren’t helping all women equally,” said study coauthor Adriana Vidal, PhD, in a press statement. She is also from Duke University.

The investigators prospectively looked at 572 women at 10 Duke-affiliated clinics with abnormal Pap tests who then underwent colposcopy; the group was about evenly divided among blacks (n = 280) and whites (n = 292). And just about even numbers of the respective racial groups subsequently had evidence of cervical intraepithelial neoplasia 1 (CIN1; 112 vs 118).

For whites with CIN1, the most frequent HPV subtypes were 16, 18, 56, 39, and 66.

But for blacks with CIN1, the most frequent HPV subtypes were 33, 35, 58, and 68.

Thus, in blacks, the most common genotypes were not HPV 16 and 18, which defies conventional wisdom about HPV infection.

There were no data on Hispanics in the new presentation because their numbers were too small at this point to be included, said Dr. Hoyo.

Without HPV 16/18, Are Some Black Women “Getting Dropped”?

The study findings may help explain why black women in the US are harder hit by cervical cancer than white women, said Dr. Hoyo.

She pointed out that both the incidence of invasive cervical cancer and related mortality rates are higher in blacks than in whites.

“We don’t know what is causing the disparity,” Dr. Hoyo told Medscape Medical News in a phone interview after the press conference.

“The problem is not likely detection,” she said, explaining that screening rates for precancerous lesions are comparable for black and white women.

The new data, however, suggest that, if clinicians are strongly focusing on HPV 16 and 18 for more careful follow-up in their black patients, then they may be missing some eventual cervical cancers, Dr. Hoyo said.

“Somewhere along the line, some black women may be getting dropped because they don’t have the HPV subtypes that are considered to be most aggressive,” she summarized.

Her advice to clinicians with black females who HPV infection and CIN is: “Broaden the subtypes that you look at.”

Currently, there is a vaccine in phase 3 clinical trials that targets 9 HPV subtypes (6, 11, 16, 18, 31, 45, 52, and 58). That means that 2 of the 4 most common subtypes in blacks are targeted by the experimental vaccine. “We need more African American women to enroll in trials like this to see how beneficial this new vaccine will be for them,” Dr. Hoyo said.

The new study is not the first to indicate that black women have lower rates of HPV 16 and 18.

A recent report found that black race was a predictor of lower HPV 16 and 18 positivity among women with high-grade cervical lesions (Cancer. 2013;119(16):3052-3058).

However, the new study from the Duke team is the first to indicate that this race-influenced distribution of HPV subtypes also occurs in lower-grade cervical lesions.

The Duke investigators also looked at high-grade lesions (CIN2/3).

In CIN2/3, HPV 16, 18, 33, 39, and 59 were the most common genotypes detected in white women, whereas HPV 31, 35, 45, 56, 58, 66, and 68 were the most prevalent in African American women.

Gardasil and Cervarix don’t work, are dangerous, and weren’t tested.

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Dr. Diane Harper was the lead researcher in the development of the human papilloma virus vaccines, Gardasil and Cervarix. She is the latest to come forward and question the safety and effectiveness of these vaccines. She made the surprising announcement at the 4th International Public Conference on Vaccination, which took place in Reston, Virginia on Oct. 2nd through 4th, 2009. Her speech was supposed to promote the Gardasil and Cervarix vaccines, but she instead turned on her corporate bosses in a very public way. When questioned about the presentation, audience members remarked that they came away feeling that the vaccines should not be used.

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all.”  – Joan Robinson

Dr. Harper explained in her presentation that the cervical cancer risk in the U.S. is already extremely low, and that vaccinations are unlikely to have any effect upon the rate of cervical cancer in the United States. In fact, 70% of all H.P.V. infections resolve themselves without treatment in a year, and the number rises to well over 90% in two years. Harper also mentioned the safety angle. All trials of the vaccines were done on children aged 15 and above, despite them currently being marketed for 9-year-olds. So far, 15,037 girls have reported adverse side effects from Gardasil alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions. At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillian Barré Syndrome (paralysis lasting for years, or permanently — sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. Parents are usually not made aware of these risks. Dr. Harper, the vaccine developer, claimed that she was speaking out, so that she might finally be able to sleep at night.

“About eight in every ten women who have been sexually active will have H.P.V. at some stage of their life. Normally there are no symptoms, and in 98 per cent of cases it clears itself. But in those cases where it doesn’t, and isn’t treated, it can lead to pre-cancerous cells which may develop into cervical cancer.”  – Dr. Diane Harper

One must understand how the establishment’s word games are played to truly understand the meaning of the above quote, and one needs to understand its unique version of “science”. When they report that untreated cases “can” lead to something that “may” lead to cervical cancer, it really means that the relationship is merely a hypothetical conjecture that is profitable if people actually believe it. In other words, there is no demonstrated relationship between the condition being vaccinated for and the rare cancers that the vaccine might prevent, but it is marketed to do that nonetheless. In fact, there is no actual evidence that the vaccine can prevent any cancer. From the manufacturers own admissions, the vaccine only works on 4 strains out of 40 for a specific venereal disease that dies on its own in a relatively short period, so the chance of it actually helping an individual is about about the same as the chance of him being struck by a meteorite. Why do nine-year-old girls need vaccinations for extremely rare and symptom-less venereal diseases that the immune system usually kills anyway?

Sources: RealFarmacy.com

 

A vaccine that prevents cervical cancer becomes more widely available to millions of women around the world.

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When a major global vaccine alliance announced today that it had struck an agreement with two pharmaceutical companies to drastically reduce the price of human papillomavirus (HPV) vaccines in poor countries, there was plenty to celebrate at Fred Hutch.

Fred Hutch, via Dr. Denise Galloway and colleagues, made major breakthrough contributions to the vaccine that prevents HPV.

Their work showed that HPV is associated with nearly all genital-tract cancers and with many head and neck cancers. Her team also played a pivotal role in identifying how HPV causes cancer.

Cervical cancer used to be one of the most common causes of cancer death among American women, but thanks to widespread use of the Pap test, early detection and the introduction of the HPV vaccine, it’s no longer one of the biggest cancer threats.

“In just 25 years, we went from not having any idea what viruses were involved in these cancers to having a vaccine,” Galloway said in a previous interview about her work. “That’s amazingly fast.”

 

However, Galloway has often said it is imperative to take the vaccine into low-income countries, where HPV is a major killer of women, and where a vaccine would do the most good.

The price of the vaccine, which is about $300 for the three needed doses in the U.S. and other developed nations, is out of reach for poor women in Africa, Asia, Latin America and other parts of the world.

And yet, according to the World Health Organization, cervical cancer remains the second most common cancer in the world, with more than 500,000 new cases and 275,000 deaths each year—virtually all linked to HPV. More than 85 percent of cervical cancer deaths occur in developing countries.

This is why the agreement reached by the Global Alliance for Vaccines and Immunization with Merck, the maker of Gardasil vaccine, and GlaxoSmithKline, the maker of Cervarix, is so important.

Both companies have agreed to sell their vaccines in poor countries for under $5 per dose.

It’s certainly a transformational moment—a cause for celebration here and around the globe as research continues to move forward against cancer.

Source: questmagazine

 

 

 

 

 

 

ASCO Expert Corner: HPV Vaccination for Cervical Cancer.

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Most cervical cancers are caused by infection with the human papillomavirus (HPV). HPV is the most common sexually transmitted infection in the United States. Although many women infected with the virus eventually clear the infection, some women develop a persistent (lasting) infection, which is a risk factor for cervical cancer. Approval of two HPV vaccines has prompted questions about the use and effectiveness of these vaccines. To help answer common questions, Cancer.Net discussed the HPV vaccine with Maurie Markman, MD. If you have specific questions, talk with your doctor about whether one of these vaccines is appropriate for you.

Q. What is the purpose of the HPV vaccine, and who needs to be vaccinated?

A. The goal of this vaccination is to prevent the establishment of a persistent HPV infection after a person has been exposed to the virus through sexual contact. Strong scientific evidence demonstrates that a persistent HPV infection is required for cervical cancer to begin developing.

In 2006, the U.S. Food and Drug Administration (FDA) approved the first HPV vaccine, called Gardasil, for use in girls and women between the ages of 9 and 26. The vaccine helps prevent infection from the two HPVs known to cause most cervical cancers and precancerous lesions in the cervix. The vaccine also prevents against the two low-risk HPVs known to cause 90% of genital warts. In 2009, FDA approved a second HPV vaccine, called Cervarix, for the prevention of cervical cancer in girls and women ages 10 to 25; it also approved the use of Gardasil in boys and men ages 9 through 26 to prevent genital warts.

Q. How effective is the vaccine?

A. Several large clinical trials have revealed that the vaccine is highly effective in preventing precancerous cervical lesions, assuming a woman does not have a preexisting (before vaccination) persistent HPV infection. Because it takes many years before a precancerous lesion develops into an invasive cancer, it will likely take at least a decade before there will be evidence that the number of new cases of cervical cancer in vaccinated individuals has been reduced. However, in view of the known very strong association between persistent HPV infection, the development of precancerous cervical lesions, and cancer of the cervix, it is essentially certain a substantial reduction in the risk of cervical cancer will be clearly seen with sufficient time for follow-up.

Q. Does the vaccine work right away? How long does it last?

A. The vaccine appears to be very effective in preventing persistent HPV infection, as long as there is no preexisting infection with the virus. It is important to note that the vaccine will not eliminate an existing persistent HPV infection.

It is currently unknown how long a single series of vaccinations with the HPV vaccine will last, and if revaccination will be required, and how often. Existing data suggest that immunity against the development of an infection upon exposure to the virus will last a minimum of three to five years, and perhaps much longer. Further follow-up of people who received the vaccine in clinical trials will provide important information regarding if, and when, the necessary degree of immunity decreases to a point where re-immunization is required.

Q. How does this vaccine affect a woman’s need for a regular Pap test?

A. There have been no specific recommendations for how HPV vaccination should influence existing, well-established guidelines for regular Pap tests. For now, it is strongly recommended that current guidelines should be followed. This important issue will be directly addressed in the future by experts in this area.

Q. What are the most important things a patient should know about the HPV vaccine?

A. Existing data indicate HPV vaccination is both safe and highly effective in preventing persistent infection by a virus known to be the cause of cervical cancer. It is extremely important that patients understand this vaccine works to prevent a persistent HPV infection, but it is not an effective treatment to eliminate such an infection once it is established.

Dr. Markman is Vice President for Clinical Research, Professor of Cancer Medicine, and Chair, Department of Gynecologic Medical Oncology at The University of Texas M. D. Anderson Cancer Center in Houston. He serves as the Cancer.Net Associate Editor for gynecologic cancers.

Source: cancer.net

 

HPV and Cancer.

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Human papillomavirus (HPV) is a virus that is most commonly transmitted during sex and direct skin-to-skin contact. There are more than 100 different types or strains of HPV. Most men and women aren’t aware they have an HPV infection because they don’t develop any symptoms or health problems. But in some cases, certain types of HPV can cause warts (noncancerous, abnormal growths on the skin) in various parts of the body. In other cases, specific HPV types can cause precancerous lesions (areas of abnormal tissue) or cancer.

How HPV Spreads

Approximately 60 types of HPV have the potential to cause common warts, which grow on areas such as the hands and feet. Approximately 40 of the viruses are called “genital type” HPVs. These viruses are spread from person to person when genitals come into contact, usually during vaginal or anal sex. The virus can also be transmitted through oral sex. HPV is the most common sexually transmitted disease in the United States.

Genital HPV types can infect the genital area of women, including the vulva (outer portion of the vagina), the lining of the vagina, and the cervix (the lower, narrow part of a woman’s uterus), as well as the genital area of men, including the penis. In both men and women, genital HPV can infect the anus and some areas of the head and neck. Sometimes “low-risk” strains of genital HPVs, most commonly HPV-6 or HPV-11, can cause genital warts or lesions to form on or around these locations. The growths can vary in size, shape, and number, and rarely lead to cancer.

HPV-Related Cancers

Genital HPV types that are more likely to cause cancer are referred to as “high-risk” HPVs. Usually the immune system of a man or woman infected with low-risk or high-risk HPV gets rid of the infection and the virus does no harm. However, some people develop a persistent (lasting) infection that slowly, often over many years, causes changes to normal cells that lead to precancerous lesions or cancer.

Cancers associated with HPV include:

Cervical cancer. Essentially all cancers of the cervix are caused by HPV infection. Whether a woman who is infected with HPV will develop cervical cancer depends on a number of factors, including the type of HPV. Of the cervical cancers related to HPV, about 70% are caused by two strains, HPV-16 or HPV-18. In women who have HPV, smoking may increase the risk of cervical cancer. Although almost all cervical cancers are caused by HPV, it is important to remember that most genital HPV infections won’t cause cancer.

Oral cancer. HPV can cause oral cancer (cancer of the mouth and tongue) and oropharyngeal cancer (cancer of the oropharynx, the middle part of the throat located from the tonsils to the tip of the voice box) in men and women. These HPV-related cancers are increasing steadily in men. In fact, the HPV virus now causes as many cancers of the upper throat in men as tobacco and alcohol use, according to a recent study. Changes in sexual behavior, including an increase in oral sex, may be one reason for the rise.

Other cancers. HPV is also associated with less common cancers. Almost one-half of cancers of the vulva are associated with HPV. The types of HPV that cause cervical cancer are also related to anal cancer. High-risk HPV types are also associated with vaginal cancer and penile cancer.

Treatment

There is no cure for HPV. However, most HPV infections simply go away over time or are weakened to the point where they do not affect the body. An infection that is not active may become active when a person’s immune system is weakened by treatment for other diseases, such as cancer.

Health problems caused by HPV can be treated. Warts and precancerous lesions can be removed through cryotherapy (freezing); loop electrosurgical excision procedure (LEEP), which uses electric current to remove abnormal tissue, or surgery. Topical medications (such as creams that are applied directly to the skin) can also be prescribed for genital warts. However, removing genital warts does not mean a person no longer has HPV. Warts may return later because the virus may still be living in cells. A person with HPV who does not have any visible warts can still infect a sexual partner with the virus.

Prevention Strategies

There are ways to reduce your risk of HPV infection, including receiving an HPV vaccine. Limiting your number of sex partners is another way to reduce your risk because having many partners increases the risk of HPV infection. Using a condom cannot fully protect you from HPV during sex.

The U.S. Food and Drug Administration (FDA) has approved two vaccines that help prevent infection with HPV: Gardasil and Cervarix. Gardasil helps prevent infection from the two HPVs known to cause most cervical cancers and precancerous lesions in the cervix. The vaccine also prevents against the two low-risk HPVs known to cause 90% of genital warts. Gardasil is approved for the prevention of cervical, vaginal, vulvar in girls and women ages nine to 26. It is also approved to prevent anal cancer in women and men and genital warts in men and boys in the same age range. Meanwhile, Cervarix is approved for the prevention of cervical cancer in girls and women ages 10 to 25.

Because a vaccine can only prevent infection, not cure an existing one, it is important that it be given to people before they become sexually active. People who are already sexually active and who may already be infected with HPV should talk with their doctor. The vaccine may protect them from strains of HPV that they don’t have.

In addition to the vaccine, women should protect themselves by having Pap tests, the most common test to help detect cervical cancer. Pap tests can find precancerous cells that can be removed before they turn into cancer. Researchers have found that combining a Pap test with a test designed to detect HPV in women provides the most accurate results. A woman should talk with her doctor about having a Pap test and possibly an HPV test.

Questions to Ask Your Doctor

Learn more about HPV, including your risk of infection and ways to help prevent it, by asking your doctor the following questions:

  • What is my risk of getting HPV?
  • How can I reduce my risk of getting HPV?
  • Can I get genital HPV without having sex?
  • What are some of the signs and symptoms of HPV?
  • How soon after sex do HPV symptoms appear?
  • Should I be tested to see if I have HPV?
  • Should I receive the HPV vaccine? Why or why not?
  • Is the HPV vaccine safe? What are the side effects?
  • How is the vaccine given? Is more than one shot needed?
  • How long does the HPV vaccine last?
  • Does my health insurance cover the cost of the HPV vaccine?
  • I’m pregnant and have HPV. Can it harm my baby?

More Information

ASCO Expert Corner: HPV Vaccination for Cervical Cancer

Cervical Cancer

Head and Neck Cancer

Additional Resources

Centers for Disease Control and Prevention: Human Papillomavirus Infection

National Cancer Institute: Human Papillomaviruses and Cancer

Food and Drug Administration: Human Papillomavirus Infection Vaccines

Source: cancer.net