HPV screening may be better than Pap test

NEW YORK (CBS) ― Cervical cancer claims the lives of an estimated 4,000 Americans each year, with many of those deaths preventable with earlier detection.

But new research says the most popular screening test may not be the most effective.

HPV stands for human papilloma virus, and it’s the most common sexually transmitted infection.

Early detection of the virus is crucial, since HPV leads to cervical cancer in women.

Until now the pap smear has been the gold standard of screening, but a landmark new study says it may no longer be the best.

Jodi McKinney is back on her feet after a simple test helped her beat cervical cancer.

“When they first told me that I had cancer cells, I was devastated,“ McKinney says.

The 43-year-old got the news when her doctor ran a test for the HPV virus along with her pap smear.

The pap smear was negative, but the HPV test came up positive, allowing doctors to diagnose the cancer at an earlier stage.

“I was about to avoid having the hysterectomy, the chemo, the radiation,“ McKinney says.

The HPV virus causes nearly 90 percent of cervical cancers, and a new study says that routine HPV testing for women over 30 could save millions of lives.

“The pap smear is not as sensitive as the HPV,“ general practitioner Dr. Steven Lamm says. “So there are a lot of women who might be negative on the pap smear, and then turn out to actually have cervical cancer.“

The study of 130,000 women was done in India, and was partly funded by the maker of the HPV test.

The results are so clear that the National Cancer Institute says HPV testing should eventually replace pap smears as the best early detection method.

“This will be the new standard,“ Dr. Lamm says.

Gynecologists are now being urged to make HPV testing part of the annual exam, along with the pap test.

“If your doctor doesn’t offer it to you, please ask for it,“ McKinney says. “Insist on it.“

McKinney, a mother of five, is now cancer-free – and looking forward to watching her family grow.

It should be relatively simple for doctors to add the HPV test to the annual gynecological exam – it uses the same tissue sample taken during the regular pap test, so it does not require any additional procedures or cause any additional discomfort for the patient.

HPV Test Better than Pap Smear for Detecting Cervical Cancer, Study Finds - Health News |

HPV Test Better than Pap Smear for Detecting Cervical Cancer, Study Finds

A relatively new screening test for cervical cancer may be twice as accurate as the traditional pap smear in detecting the disease, according to a new study.

The new test could replace the 50-year-old Pap in a matter of years, experts say. And there's a bonus for women: They won't need a screening test as often.

The HPV test, which looks for the virus that causes cervical cancer, correctly spotted 95 percent of the cancers. The Pap test, which checks for abnormal cells under a microscope, only found 55 percent, according to researchers at McGill University in Montreal, who published their findings in Thursday's New England Journal of Medicine.

"We've had the Pap test for over 50 years and it's high time it be replaced by technology that's more robust," said Eduardo Franco, director of McGill's division of cancer epidemiology, who led the study.

Franco said some feared the HPV test would result in more false alarms, causing anxiety and requiring more follow-up testing. In the study, there were only slightly more false positives for the HPV tests (6 percent) than the Pap smears (3 percent).

HPV, or human papilloma virus, is a common sexually transmitted disease. Infections are mostly in young women and most go away on their own. The HPV test looks for the high-risk viruses that can cause cervical cancer if the infection persists. Like the Pap, it uses cells scraped from the cervix, the lower part of the uterus.

Because the Pap test misses about half of the cases, doctors use frequent testing to catch the slow developing cancer at its earliest, most treatable stages.

The HPV test has been available in the U.S. since 2000 and was first used for inconclusive Pap tests. Now women over 30 can get a HPV test - but only along with a Pap - and wait three years to be tested again if both tests are negative.

More recently, scientists have been studying whether the HPV test can be used alone and whether it can prolong the intervals between exams. Debbie Saslow, director of breast and gynecologic cancer for the American Cancer Society, said evidence from a number of studies supports using the HPV test in place of a Pap.

"Overall, I don't think there's any doubt that HPV testing has a lot of advantages over the Pap test," she said.

Saslow said there are still issues to be resolved, and federal approval needed, but "it's definitely coming." She said experts expect that to happen sometime in the next decade.

A Swedish study also in the journal compared Pap with HPV testing to Pap alone in 12,527 women in their 30s. They found the combo test detected precancerous lesions or cancer earlier than the Pap test alone.

The Canadian study, which was government-funded, included 10,154 women ages 30 to 69 in Montreal and St. John's, Newfoundland. The women got both tests. Still to be determined is the best way to start using the HPV test by itself and what follow-up action to take after positive results, the researchers said.

The HPV test is more expensive: In the U.S., Medicare pays about $50 for the HPV test and $15 to $28 for a Pap test.

Some of the researchers have received fees or grants from drug makers including Merck Frosst Canada Ltd., a subsidiary of Merck & Co., which makes a cervical cancer vaccine. One has stock in Digene Corp., which developed the only approved HPV test.

Franco emphasized that girls who have been vaccinated against HPV will still need to be screened because the vaccine only protects against some of the cancer-causing strains.

Dr. Carolyn D. Runowicz, who wrote a journal editorial, noted that the two studies used a different kind of Pap test, not the liquid-based technology used in the U.S, which may be more sensitive The results of a British study that used liquid Pap are due to be presented in November.

"We're not ready for prime time. We're moving in that direction. But we're not there yet," said Runowicz, a former president of the American Cancer Society.

Human Papillomavirus (HPV) Test - Test Overview - Health.com

Human Papillomavirus (HPV) Test

A human papillomavirus (HPV) test is done to find a high-risk HPV infection in women. HPV is a sexually transmitted disease (STD). An HPV test checks for the genetic material (DNA) of the human papillomavirus. Like a Pap test, an HPV test is done on a sample of cells collected from the cervix Click here to see an illustration.

There are many types of HPV. Some types cause warts that you can see or feel. Other types do not cause any symptoms. Most people do not know they have an HPV infection.

This test will identify whether a high-risk type of HPV is present. In women, high-risk types of HPV (such as types 16, 18, 31, and 45) cause changes in the cells of the cervix that can be seen as abnormal changes on a Pap test. Abnormal cervical cell changes may resolve on their own without treatment. But some untreated cervical cell changes can progress to serious abnormalities and may lead to cervical cancer over time if it is not treated.

For information about treatment of abnormal cervical cell changes seen on a Pap smear, see the topic Abnormal Pap Test.

Although HPV is found in both men and women, this test is not used on men. Also, your doctor can usually diagnose visible genital warts with a physical exam, so this test is not used to diagnose genital warts caused by low-risk types of HPV.

Seminar held on Cervical Cancer Management Strategies

Over 75 doctors from the UAE attended a Continuous Medical Education Seminar (CME) proudly organised by Eastern Biotech & Life Sciences on Management Strategies of Cervical Cancer & Sexually Transmitted Disease.

Cervical cancer is the second most common cancer and cause of death in women worldwide. In the UAE it is on the rise with reported cases tripling in 2005. Worldwide there are an estimated 650 deaths, which is the equivalent of 10 women in the Middle East dying every day. HPV (Human Papilloma Virus) is the cause of 99.7% of cervical cancer cases and HPV Genotypes 16 and 18 causes approximately 70% of cervical cancers worldwide. Thus it is important to clearly identify those women at increased risk of developing cervical cancer at an early stage.

The seminar & workshop was held at Rotana Towers Hotel, Dubai on 1^st July 2009. It was organised by Eastern Biotech & Life Sciences, supported and sponsored by Dubiotech, Glaxo smithcline & Life Cell International. It was supported by the Ministry of Health, United Arab Emirates and has been formally granted 4.0 CME credit points. Seminar was Chaired by Dr. Marco Baccanti, Executive Director of DuBiotech, Dubai.

The primary objective of the seminar & workshop is to raise awareness of cervical cancer among the clinicians and how it can be prevented. In seminar also discussed by eminent speaker about combination of liquid based cytology using the Digene Hybrid capture 2 techniques and the latest DNA based HPV detection technologies utilised for the prevention of cervical cancer.

“HPV infection is very common in sexually active men and women. It is usually transient and results only in mild cytological abnormalities. About 80 % of women between 19 and 30 years clear this infection within months or years, but in some cases persistent infection of high risk HPV can lead to the development of cervical cancer said Dr. Rihab from Mitera Clinic, Duai.” She discussed on The Need of Clinical Education to Raise an Awareness of HPV Screening and Cervical Cancer Prevention.

Dr. Sanjida from Research Director for Eastern Biotech & Life Sciences raised the issue of Sexually Transmitted Infections (STI) screening program and enlightens the available high end techniques for other STI such as HIV, HCV, HBV, Chlamydia, HSV1/2, Syphilis, Gonorrhoea etc along with HPV.

The need for additional efforts for detection of cervical cancer and with FDA approved technique was also highlighted by Dr. Dinesh Gupta from National Clinical Reference Laboratory, New Delhi India. Dr. Gupta discussed on Opportunistic Screening for Cervical Precancer Lesions. According to him relevant diagnostic tools for prevention and diagnosis of cervical cancer are already available:
- The traditional PAP smear and its variant, the Liquid Based Cytology for the detection of cervical abnormalities.

- The HPV DNA and which together with cytology tests increases the sensitivity and/or specificity of the cytology exam improving management and follow-up of high risk women.

Vaccination against HPV of young women is now available and also consists in a new powerful weapon against cervical cancer. Dr. Rima AbuOmar from Al Zahra Hospital, Sharjah said Vaccine is the Primary Protection Against Cervical Cancer.

About Eastern Biotech & Life Sciences:
Eastern Biotech & Life Sciences is a UAE based Biotechnology Company under the Dubai Biotechnology and Research Park, DUBIOTECH, Dubai. The company has a vision to prevent morbidity and mortality among individuals and families with or at risk of genetic, congenital, and/or familial disorders. Eastern Biotech provides quality screening, education and family-centered comprehensive services for the Middle Eastern people. The company is also offering HC2 Hybrid capture technique for detection of HPV in combination with Liquid based cytology and other STI on same sample.

For more information, please visit Eastern Biotech & Life Sciences website or contact:
Pankaj Sohaney, Manager Marketing & Business Development (Tel. +00971 4 3692061)

www.easternbiotech.ae

info@easternbiotech.com

HPV Vaccine Information For Young Women

There is now a vaccine that prevents the types of genital human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts. The vaccine, Gardasil®, is given in three shots over six-months. The vaccine is routinely recommended for 11 and 12 year old girls. It is also recommended for girls and women age 13 through 26 who have not yet been vaccinated or completed the vaccine series.

Why the HPV vaccine is important

Genital HPV is a common virus that is passed on through genital contact, most often during sex. Most sexually active people will get HPV at some time in their lives, though most will never even know it. It is most common in people in their late teens and early 20s.

There are about 40 types of HPV that can infect the genital areas of men and women. Most HPV types cause no symptoms and go away on their own. But some types can cause cervical cancer in women and other less common genital cancers— like cancers of the anus, vagina, and vulva (area around the opening of the vagina). Other types of HPV can cause warts in the genital areas of men and women, called genital warts. Genital warts are not a life-threatening disease. But they can cause emotional stress and their treatment can be very uncomfortable.

Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 women die from this disease in the U.S.

About 1% of sexually active adults in the U.S. (or 1 million people) have visible genital warts at any point in time.
Who should get the HPV vaccine

The HPV vaccine is recommended for 11 and 12 year-old girls.1 It is also recommended for girls and women age 13 through 26 years of age who have not yet been vaccinated or completed the vaccine series.

1 Note: The vaccine can also be given to girls 9 or 10 years of age.

Will sexually active females benefit from the vaccine?

Ideally females should get the vaccine before they become sexually active, when they may be exposed to HPV. Females who are sexually active may also benefit from the vaccine, but they may get less benefit from it. This is because they may have already gotten an HPV type targeted by the vaccine. Few sexually active young women are infected with all HPV types covered by the vaccine so they would still get protection from those types they have not yet gotten. Currently, there is no test available to tell if a girl/woman has had HPV in the past, or which types.

Can pregnant women get the vaccine?

The vaccine is not recommended for pregnant women. There has been limited research looking at vaccine safety for pregnant women and their unborn babies. So far, studies suggest that the vaccine does not cause health problems for pregnant women or their developing child. But more research is still needed. For now, pregnant women should wait until their pregnancy is over before getting the vaccine. If a woman finds out she is pregnant after she has started getting the vaccine series, she should wait until her pregnancy is over before finishing the three-dose series.

Should girls/women be screened for cervical cancer before getting vaccinated?

No. Girls/women do not need to get an HPV test or Pap test to find out if they should get the vaccine. Neither of these tests can tell the specific HPV type(s) that a woman has (or has had in the past), so there’s no way to know if she has already had the HPV types covered by the vaccine.

Why is the HPV vaccine only recommended for girls/women through age 26?

The vaccine has been widely tested in girls/women 9 through 26 years of age. New research is being done on the vaccine’s safety and efficacy in women older than 26 years of age. The FDA will consider licensing the vaccine for these women when there is enough research to show that it is safe and effective for them.
What about vaccinating boys and men?

We do not yet know if the vaccine is effective in boys or men. It is possible that vaccinating males will have health benefits for them by preventing genital warts and rare cancers, such as penile and anal cancer. It is also possible that vaccinating boys/men will have indirect health benefits for girls/women. Studies are now being done to find out if the vaccine works to prevent HPV infection and disease in males. When more information is available, this vaccine may be licensed and recommended for boys/men as well.
Effectiveness of the HPV Vaccine

This vaccine targets the types of HPV that most commonly cause cervical cancer and genital warts. The vaccine is highly effective in preventing those types of HPV and related diseases in young women.

The vaccine is less effective in preventing HPV-related disease in young women who have already been exposed to one or more HPV types. That is because the vaccine does not treat existing HPV infections or the diseases they may cause. It can only prevent HPV before a person gets it.
How long does vaccine protection last? Will a booster shot be needed?

Research suggests that vaccine protection will last a long time. More research is being done to find out if women will need a booster vaccine many years after getting vaccinated to boost protection.

What does the vaccine not protect against?

The vaccine does not protect against all types of HPV— so it will not prevent all cases of cervical cancer. About 30% of cervical cancers will not be prevented by the vaccine, so it will be important for women to continue getting screened for cervical cancer (regular Pap tests). Also, the vaccine does not prevent other sexually transmitted infections (STIs). So it will still be important for sexually active persons to lower their risk for other STIs.

Will girls/women be protected against HPV and related diseases, even if they don’t get all three doses?

It is not yet known how much protection girls/women would get from receiving only one or two doses of the vaccine. For this reason, it is very important that girls/women get all three doses of the vaccine.
Safety of the HPV vaccine

This vaccine has been licensed by the FDA and approved by CDC as safe and effective. It was studied in thousands of females (ages 9 through 26 years) around the world and its safety continues to be monitored by CDC and the FDA. Studies have found no serious side effects. The most common side effect is soreness in the arm (where the shot is given). There have recently been some reports of fainting in teens after they got the vaccine. For this reason, it is recommended that patients wait in their doctor’s office for 15 minutes after getting the vaccine.
Cost and Paying for the HPV vaccine

The retail price of the vaccine is about $125 per dose ($375 for full series).

Is the HPV vaccine covered by insurance plans?

While some insurance companies may cover the vaccine, others may not. Most large insurance plans usually cover the costs of recommended vaccines.

How can I get help paying for the vaccine?

Children age 18 and younger may be eligible to get vaccines, including the HPV vaccine, for free through the Vaccines for Children (VFC) program if they are: Medicaid eligible; uninsured; or American Indian or Alaska Native. Doctors may charge a small fee to give each shot. However VFC vaccines cannot be denied to an eligible child if the family cannot afford the fee.

Some states also provide free or low-cost vaccines at public health department clinics to people without health insurance coverage for vaccines. Contact your State Health Department to see if your state has such a program.
What vaccinated girls/women need to know
Will girls/women who have been vaccinated still need cervical cancer screening?

Yes, women will still need regular cervical cancer screening (Pap tests) because the vaccine will NOT protect against all HPV types that cause cervical cancer. Also, women who got the vaccine after becoming sexually active may not get the full benefit of the vaccine if they had already acquired HPV.
Other ways to prevent HPV and Cervical Cancer

Another HPV vaccine is now being considered for licensure by the FDA. This vaccine would protect against the types of HPV that cause most cervical cancers, but it would not protect against genital warts.
Are there other ways to prevent cervical cancer?

Regular cervical cancer screening and follow-up can prevent most cases of cervical cancer. The Pap test can detect cell changes in the cervix before they turn into cancer. Pap tests can also detect most, but not all, cervical cancers at an early, treatable stage. Most women diagnosed with cervical cancer in the U.S. have either never had a Pap test, or have not had a Pap test in the last 5 years. The HPV test can tell if a woman has HPV on her cervix. This test can be used with the Pap test to help your doctor determine next steps in cervical cancer screening.
Are there other ways to prevent HPV?

The only sure way to prevent HPV is to abstain from all sexual activity. For those who are sexually active, condoms may lower the chances of getting HPV, if used all the time and the right way. Condoms may also lower the risk of developing HPV-related diseases (genital warts and cervical cancer). But HPV can infect areas that are not covered by a condom—so condoms may not fully protect against HPV.

Sexually active adults can also lower their risk of HPV by being in a mutually faithful relationship with someone who has had no or few sex partners, or by limiting their number of sex partners. The fewer partners a person has had – the less likely he or she is to have HPV. But even persons with only one lifetime sex partner can get HPV, if their partner has had previous partners.
Sources

Food and Drug Administration (FDA). FDA News: FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus.

The FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007; 196:1438-1446.

FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007; 356(19):1915-27.

Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007; 356(19):1928-43.

Harper DM, Franco EL, Wheeler C, et al; HPV Vaccine Study Group. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised controlled trial. Lancet. 2006; 367(9518): 1247-1255.

Ho GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginal papillomavirus infection as measured by repeated DNA testing in adolescent and young women. N Engl J Med. 1998; 338(7):423-428.

Koutsky LA. Epidemiology of genital human papillomavirus infection. Am J Med. 1997; 102(5A):3-8.

National Institutes of Health (NIH). NIH Consensus Statement: Cervical Cancer. 1996; 14:1-38.

Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 2007;370(9596):1414.

United States Cancer Statistics, National Program of Cancer Registries (NPCR). U.S. Cancers by Type.

Weinstock H, Berman S, Cates W, Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004; 36(1):6-10.

Winer R, Hughes JP, Feng Q, et al. Consistent condom use from time of first vaginal intercourse and the risk of genital human papillomavirus infection in young women. N Engl J Med. 2006;354:2645–2654.

How to Get the HPV Test

Women Under Age 30 Women Over Age 30

I was persistent and kept repeating that I wanted
the HPV test for "extra peace of mind."

Read Frances Masterman's story
So, you've decided that you want to take every step possible to make sure you do not get cervical cancer.

Most doctors will honor your wishes on issues such as this. If not, remember that you are the one who is ultimately responsible for your health. You need to decide how important it is to have a healthcare provider who partners with you.

Here are some tips to ensure you get the HPV test:

* Arm yourself with the facts about cervical cancer, HPV and the HPV test. Read the information in this Web site thoroughly. Doctors' offices are very tight on time these days, and they will be more receptive to your requests if they can tell you have "done your homework."
* Call your doctor's or nurse's office before your next exam to find out if the HPV test is offered as part of routine screening for cervical cancer, along with the Pap. Remember: Make sure the office understands that you want the HPV test no matter what the Pap shows. Some doctors and nurses only order an HPV test when your Pap results are inconclusive (called an "ASC-US" Pap).
* If your doctor or nurse says the office does not order HPV testing for all of its female patients who are 30 and older, indicate you'd like them to make an exception for you.
* If your doctor or nurse (or the office staff) responds by saying he/she doesn't think routine HPV testing is necessary, the simplest way to respond is to say that you would still like to have the test "for my extra peace of mind."
* Follow up on test results. Keep calling until you receive an answer regarding your test results.


Do you need to ask your doctor or nurse for the HPV test?

It's a good idea to ask your doctor or nurse for the HPV test. That's because some healthcare providers do not yet order the HPV test as part of routine cervical cancer screening, or offer it only if you ask for it. However, most laboratories can do the HPV test if your doctor or nurse requests it.
Why your doctor or nurse might not automatically order the HPV test for you – and what you should do about it …

*

Unaware of approval of HPV test for routine screening.
*

Thinks the Pap is good enough.
*

Concerned the test will unnecessarily alarm you.
*

Afraid you won't return for your annual visit if HPV testing shows you don't need yearly cervical cancer screening.
*

Believes HPV testing might result in the need for unnecessary further procedures.

Some doctors and nurses are not aware that the U.S. Food and Drug Administration (FDA) has approved the HPV test for use along with the Pap for routine screening of women age 30 years and older. Some still believe that the HPV test should only be given to women if their Pap test results are unclear (called an "ASC-US" Pap). Still others simply aren't familiar with the data supporting the value of the HPV test for routine screening. Medical practice takes a while to change.

Share with your doctor or nurse the recent publication on HPV and HPV testing issued by the American Association of Reproductive Health Professionals.

Other healthcare professionals may actually recommend against routine HPV testing because they believe that although the Pap may not be perfect, it is good enough.

Respond that you know the Pap test catches many women with pre-cancerous cells, but that you would feel even more confident if you took an additional step and got the HPV test. You may want to refer your doctor or nurse to the April 2006 issue of the International Journal of Cancer ("Overview of the European and North American studies on HPV testing in primary cervical cancer screening"). This analysis of 11 studies involving more than 60,000 women documented that the HPV test is a more sensitive tool for cervical cancer screening than the Pap alone.

Your healthcare provider may worry that you will be unnecessarily anxious or alarmed if you find out you have a high-risk (potentially cancer–causing) type of the virus. After all, most women fight off the infection before it causes any problems.

Assure your doctor or nurse that you have researched the subject, and that you see the HPV test as a way to increase your peace of mind. Your healthcare provider will be more likely to feel comfortable ordering the test for you if he or she knows you already are educated on the virus and HPV testing. Show him or her the brochure (PDF) on HPV testing, available on this Web site, as evidence that you have educated yourself and know what to expect.

Some doctors and nurses fear that once women learn they do not have HPV, and thus only need another HPV and Pap test every three years, they will not come back for an annual office visit.

Communicate to your doctor or nurse that you understand the need for regular health checks – such as a breast exam – regardless of your HPV status. You can demonstrate this commitment by scheduling your next visit well in advance.

Some healthcare providers may believe the HPV test could result in the need for other, unnecessary procedures (such as a biopsy to remove cervical tissue for analysis).

Respond that you'd rather take the chance of having an extra exam that turns out to be normal, than to risk doing nothing until cervical cancer develops. You also might want to refer your doctor or nurse to an article in the October 2007 issue of the American Journal of Obstetrics & Gynecology titled "Consensus Guidelines for the Management of Women with Abnormal Cervical Cancer Screening Tests." One of the topics covered is how to manage the care of women who have HPV, but whose Pap results are normal or inconclusive. A short summary of these and other guidelines can be found in this brochure (PDF) on HPV testing. Following these guidelines should help assure that women with HPV do not have any more follow-up tests than when the Pap alone is used. Tell your doctor or nurse that you would like to get the HPV test for "extra peace of mind."

HPV testing in combination with liquid-based cytology in primary cervical screening

Prof Henry C Kitchener MD a Corresponding AuthorEmail Address, Maribel Almonte PhD c, Claire Thomson BSc a, Paula Wheeler MRes a, Alexandra Sargent PhD a, Boyka Stoykova MD d, Clare Gilham MSc e f, Helene Baysson PhD e, Christopher Roberts PhD b, Robin Dowie PhD d, Mina Desai MBchB g, Jean Mather MIBMS g, Andrew Bailey FIBMS h, Andrew Turner MB ChB h, Sue Moss PhD f, Prof Julian Peto DSc e f


Background
Testing for human papillomavirus (HPV) DNA is reportedly more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial, which was done over two screening rounds approximately 3 years apart (2001—03 and 2004—07) by comparing liquid-based cytology (LBC) combined with HPV testing against LBC alone.

Methods
Women aged 20—64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were randomly assigned (between July, 2001, and September, 2003) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on, or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator. The primary outcome was the detection rate of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) in the second screening round, analysed by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number ISRCTN25417821.

Findings
There were 24 510 eligible women at entry (18 386 in the revealed group, 6124 in the concealed group). In the first round of screening 233 women (1·27%) in the revealed group had CIN3+, compared with 80 (1·31%) women in the concealed group (odds ratio [OR] 0·97, 95% CI 0·75—1·25; p>0·2). There was an unexpectedly large drop in the proportion of women with CIN3+ between the first and second rounds of screening in both groups, at 0·25% (29 of 11 676) in the revealed group and 0·47% (18 of 3866 women) in the concealed group (OR 0·53, 95% CI 0·30—0·96; p=0·042). For both rounds combined, the proportion of women with CIN3+ were 1·51% (revealed) and 1·77% (concealed) (OR 0·85, 95% CI 0·67—1·08; p>0·2).

Interpretation
LBC combined with HPV testing resulted in a significantly lower detection rate of CIN3+ in the second round of screening compared with LBC screening alone, but the effect was small. Over the two screening rounds combined, co-testing did not detect a higher rate of CIN3+ or CIN2+ than LBC alone. Potential changes in screening methodology should be assessed over at least two screening rounds.

Funding
National Institute of Health Research Health Technology Assessment Programme.