The HPV vaccine is important for preteens and teenagers. What about older women? - Washington Post

The HPV vaccine is important for preteens and teenagers. What about older women? - Washington Post


The HPV vaccine is important for preteens and teenagers. What about older women? - Washington Post

Posted: 13 Apr 2019 09:01 AM PDT

'Is Gardasil 9 right for me?" my patient asked during a recent office visit.

She is 45, recently divorced from her husband of 20 years and crafting her online dating profile. She's also wondering whether she is a candidate for the vaccine that protects against nine strains of the human papilloma virus (HPV) — a virus that causes most cervical, oral and anal cancer.

Ten years ago, L — I'm referring to her by her first initial to protect her privacy — brought her then preteen daughter to a pediatrician to get her immunized against HPV.

"I asked the pediatrician whether I should also get the shot because it did not exist when I was a kid," L said. "She told me I was too old."

But recently some of L's 40-something friends have had their first-ever abnormal Papanicolaou (PAP) smear and tested positive for "high-risk" HPV. They've needed regular visits to the gynecologist for colposcopy (an examination of the cervix using a microscope) with uncomfortable cervical biopsies, an ordeal L wants to avoid.

Querying Dr. Google, she learned that condoms are not an effective prevention against HPV but noticed that the Food and Drug Administration had expanded the use of Gardasil 9 to include women up to age 45. While insurance won't cover the three-shot series for her age group, she is ready to pay the steep $600-plus vaccine cost — but only if I, her physician, think the investment is worthwhile.

I didn't know what to tell her but I decided to do some digging.

Before having sex

At this point, it's pretty clear that if you get the HPV vaccine series before ever having sex, it works really well. A review of 26 randomized controlled trials shows that giving the vaccine to preteen and teenage girls before they become sexually active will protect them from genital warts and HPV-related precancers that show up on PAP screening.

These studies also show that the vaccine reduces the total number of colposcopies, biopsies and other procedures. And while it's still too early to say for sure, it looks like the HPV vaccine may protect this group of girls from developing cervical, oral and anal cancers, diseases that can appear several decades after initial HPV infection.

(There is a consensus that giving the HPV vaccine to boys will also prevent HPV-related cancers, although males are not the focus of this report.)

I also know the vaccine is safe; in the review of the HPV studies, severe adverse events were rare and were not significantly higher in vaccine recipients than in those who received a placebo injection.

But L had a number of partners in her early 20s followed by many years of monogamy. Does the vaccine make sense for her and the roughly 30 million other women under 46 who missed the opportunity to get the HPV shots as kids? After all, studies show that most women get exposed to at least one strain of HPV within a couple of years after first having sex and that the likelihood of exposure increases with each sexual partner. While most women clear their infections within 12 to 24 months, a small percentage go on to develop cervical precancers or cancers — which is why cervical cancer screening is important.

To answer L's question, I looked up the guidelines for HPV vaccination put out by the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), a group of medical experts that determines which vaccines we should use in the United States. Despite the FDA's recent approval of the vaccine for women up to age 45, I saw no mention of women over age 26 in the ACIP guidelines.

Then I moved to the American College of Obstetrics and Gynecology website to see what it said about HPV vaccination for older women. ACOG's Practice Advisory encourages me to "welcome conversations" with women up to age 45 and that "any decision to be vaccinated should be individually based using shared decision making and clinical judgment based on those patients' circumstances, preferences, and concerns."

I'm all for collaborating with my patients to come up with a game plan but to do this I need data. How was I to know what "circumstances" might make the vaccine more or less effective? And what "preferences" or "concerns" was the vaccine likely to address?

Plenty of confusion

To get some clarity on ACOG's recommendations, I called Lois Ramondetta, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center. She is on the ACOG HPV immunization expert working group. She said that the ACIP was doing a cost-benefit analysis and would soon decide whether to recommend the HPV vaccine up to age 45. But she agreed that, at the moment, there is plenty of confusion about which older women would benefit.

"Perhaps it would be very useful for someone who hasn't been exposed, and who's intimacy situation has changed," she told me.

Measuring exposure to HPV is tricky. The only option in my lab is to do a cervical swab to test for high-risk HPV genotypes including HPV 16 and 18 — the two strains that cause over 70 percent of HPV-related cancers. This is a great test for diagnosing active infection with HPV but doesn't measure past exposure or latent HPV infections. (To measure these, I would need an antigen test, which is only available in research labs.)

But combing through the data from VIVIANE, one of two big drug industry funded studies to measure the effectiveness of HPV vaccine in older women, I realized that the vaccine was about 80 percent effective at preventing infection with HPV 16 and 18 in women whose cervical swabs were negative for these strains, regardless of past exposure. That sounded pretty good to me. As long as L was HPV genotype 16 and 18 negative, maybe she should get the vaccine.

Not so fast, cautioned Karen Smith-McCune, professor emeritus of obstetrics and gynecology at the University of California at San Francisco. She is an HPV researcher and works in the cervical dysplasia clinic taking care of women infected with HPV.

"When you look at these studies, you have to ask: 'Effective for what?' If your goal is to prevent cancer, we have no proof the vaccine does that in the older age group," she said.

It was true that older women who received the HPV vaccine became infected with HPV 16 and 18 at a lower rate than the women who were unvaccinated. But the advanced precancers, the ones most likely to go on to become cancer, were rare in both the vaccinated and unvaccinated groups, and the difference was not statistically significant.

How is it that the vaccine can prevent infection in older women but does not seem to protect against cervical cancer?

Smith-McCune has a variety of explanations for this, including that new HPV infection in older women may simply be a reactivation of latent infection and less likely to progress to cancer.

"The take-home message is that cervical cancer is really rare in older women who get regular screenings and [the HPV] vaccine adds little in terms of prevention," Smith-McCune said.

Screening older women

Indeed, because we have good screening in the United States, cervical cancer incidence and death rates were low even before the introduction of the HPV vaccine in 2006. In 2017, about 4,000 women died of the disease. (For reference, 41,000 die of breast cancer and 66,000 of lung cancer). Compare that with some low-income countries, such as Malawi or Bolivia, where screening is practically unobtainable and the mortality rate from cervical cancer is three to four times higher.

And what about avoiding costly and uncomfortable colposcopies and biopsies, something that the vaccine did accomplish in younger women — especially those who had never had sex.

Well there were slightly fewer of these procedures in the older women who received the vaccine, but not an amount that was statistically significant.

So what is the best choice for L?

"If she is a 40-something-year-old virgin who decides to start dating, the vaccine will be 100 percent effective," Smith-McCune said. "But beyond that, let's vaccinate adolescents, that is where you have the public health impact."

Smith-McCune added that L should get the recommended cervical cancer screening up to age 65, which means getting a PAP plus HPV test every five years, or a PAP every three years.

At this point, I was pretty sure what I would say to L and other women her age: "The HPV vaccine is unlikely to help but, aside from cost, there is no big downside to getting it."

But then I learned that there is a global shortage of HPV vaccine. According to the World Health Organization, the two manufacturers, Merck and GlaxoSmithKline, are not producing enough. And while there are plans for other pharmaceutical companies in China and India to pick up the slack, right now only 20 percent of countries with the highest rates of cervical cancer are able to immunize girls who are 9 to 14 years old, the age group where the vaccine is known to be most effective.

Given the limited supply and the lack of evidence that the vaccine protects older women from colposcopies or cervical cancer, I agree with Smith-McCune: Let's leave the vaccine for the teens and preteens. And if you are a woman in your mid-40s who is suddenly thrown back on the dating scene, the best strategy is use condoms (because they do protect against other sexually transmitted infections) and get regular cervical cancer screening.

I called L to share what I had learned. She had done some of her own research and came to pretty much the same conclusion.

She was also considering a donation to Gavi, an international organization which gets vaccines to places they are most needed. To me, that sounded like a great way to spend $600.

Daphne Miller is a family physician and author of "Farmacology" and "The Jungle Effect."

HPV vaccination study finds cervical pre-cancer rates down 88% - The Independent

Posted: 14 Apr 2019 03:00 PM PDT

Cervical cancer is the third most common cancer among women in the UK under the age of 35 after breast and skin cancer. In the majority of cases, the cancer only develops if the patient is infected with human papillomavirus (HPV) types 16 or 18. This virus is mainly transmitted between people having vaginal, anal or oral sex. At some point in their lives, four in five people will be infected by HPV strains – as many as 14 can cause cancer. According to recent studies, other cancers heavily linked to HPV infections include head-and-neck, vulvo-vaginal and anal.

In an effort to reduce rates of cervical cancer, a number of countries launched immunisation programmes in the late 2000s, starting with Austria in 2006. The UK and its devolved governments launched a school immunisation programme in 2008 to vaccinate all girls aged 12-13. To speed up the time lag associated with achieving the benefits of vaccination, they also kicked off a three-year catch-up programme for girls aged up to 18 years.

A decade on, we are finally able to publish the first results. The data relates to Scotland, since it was cervically screening women from the age of 20 until 2016 – before falling into line with the minimum age of 25 used in the rest of the UK. This meant that Scotland obtained screening data for the 2008-09 cohort before the change in screening age. Scotland also has very detailed information about uptake rates, which have been very high: running to approximately 90 per cent in Scotland for the routinely vaccinated girls and 65 per cent for the older girls vaccinated as part of the catch-up programme.

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For the first time, we can now confirm that the vaccination programme has begun to profoundly alter the prevalence of HPV 16 and 18 among Scottish women – and presumably elsewhere as well.

The study

My team performed an eight-year study of the women eligible for the Scottish national vaccination and cervical screening programmes. We looked at their vaccination status, year of birth, indicators of deprivation and whether they lived in urban or rural areas. Using complex statistical modelling, we were able to calculate the effect of vaccination on cervical pre-cancer. Though not all pre-cancer becomes cancer, all cancer requires pre-cancer. Cervical pre-cancer occurs quicker than cancer and therefore this focus has allowed us to see the impact of the vaccine earlier.

Among women born in 1995-96 – the first group to go through the regular vaccination programme in 2008-09 – there has been an 88 per cent reduction in rates of cervical pre-cancer. This is a fall in incidence from 1.44 per cent to 0.17 per cent.

Administration of HPV vaccine prevents multiple cancers (iStockphoto)

Not only that; women born in these years who had not received the vaccine were also less likely to develop cervical pre-cancer. This was because the high vaccine uptake meant that HPV incidence was much lower in their age group, thanks to a phenomenon known as "herd protection". This is particularly good news, since this group is also less likely to attend cervical screenings.

The findings clearly show that the routine HPV vaccination programme for girls aged 12-13 has been a resounding success. This is consistent with the fact that we have also seen a big fall in high-risk HPV infection in Scotland in recent years. The obvious conclusion is that we are going to see far fewer cases of cervical cancer in years to come.

From September, the UK is going to extend the vaccination programme to boys – becoming one of numerous countries to do so. This is in response to the fact that rates of head-and-neck cancer are rising in men: approximately 60 per cent of head-and-neck cancer is associated with HPV16 infection, and should therefore be mostly preventable through vaccination. This programme should also mean that high-risk HPV infections among the population should be eliminated more quickly, which should have knock-on benefits for rates of HPV-driven cancers.

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Meanwhile, in parts of Canada, HPV vaccinations are now being offered to uninfected women as part of the cervical screening process. This may protect older women from developing cervical cancer. This process may be adopted internationally, including the UK. When we look at the picture as a whole, eliminating the HPV virus, and making huge inroads into the various cancers that it can catalyse, is now becoming a realistic possibility.

Kevin Pollock is a senior research fellow at Glasgow Caldonian University. This article originally appeared on The Conversation

Childhood HPV vaccination 'profoundly' cuts cervical disease in young women - KFGO News

Posted: 10 Apr 2019 09:39 AM PDT

By Ankur Banerjee

(Reuters Health) - - Young women who received human papillomavirus (HPV) vaccines as adolescents had significantly lower rates of a condition that's a precursor to cervical cancer, in a nationwide study in Scotland.

"The magnitude of the effect is greater than expected," study author Dr. Tim Palmer from the University of Edinburgh told Reuters Health by email.

Receiving three doses of the vaccine at the recommended ages of 12 to 13 was associated with "a profound reduction of cervical disease seven years later," he and his colleagues report in The BMJ.

One of the most common sexually transmitted diseases, HPV doesn't cause symptoms and usually goes away on its own. But the virus can cause cancer of the cervix, the fourth most common cancer in women, as well as cancers of the throat and penis.

Palmer's team studied 138,692 women, about half of whom had been fully vaccinated against HPV either at ages 12-13, or later in their teens. At age 20, the women all had tests to look for abnormal cells on the cervix - called cervical intraepithelial neoplasia, or CIN - that can lead to cancer.

Rates of CIN were low overall. But compared with unvaccinated women, vaccinated women had an 89 percent lower rate of CIN grade 3 or worse (0.59 percent in unvaccinated women versus 0.06 percent in the vaccinated group), an 88 percent lower rate of CIN grade 2 or worse (1.44 percent versus 0.17 percent), and a 79 percent lower rate of CIN grade 1 (0.69 percent versus 0.15 percent).

Grades 2 and 3 are usually treated with surgery.

Girls who were vaccinated at ages 12-13 got a greater benefit: the vaccine was 86 percent effective for them, and 51 percent effective when given at age 17.

"The findings are dramatic and document a considerable reduction in high-grade cervical disease over time," Julia Brotherton, medical director at VCS Foundation in East Melbourne, Australia, writes in an editorial published with the study.

In the U.S., many girls and boys don't receive the vaccine at least in part because their parents may question whether it's necessary to protect them against a sexually transmitted disease at an age when they think children shouldn't be having sex, previous studies have found.

Scotland, which has an organized national cervical screening program, introduced a national immunization program against HPV in 2008, targeting girls aged 12 and 13, followed by a three-year catch-up program up to age 18.

The study also revealed a decreasing rate of disease in unvaccinated women. "This is called herd protection and is a function of the high uptake of vaccine in Scotland," Palmer explained. Unvaccinated women are being protected because the spread of HPV between men and women has been interrupted because there are not enough susceptible women, he said.

There were an estimated 570,000 new cervical cancer cases globally in 2018, representing 6.6 percent of all female cancers, according to the World Health Organization, with about 90 percent of deaths from cervical cancer occurring in low- and middle-income countries.

These countries, however, do not have the resources to support organized screening, the authors write, highlighting the importance of developing vaccines against the most important cancer-causing HPV strains.

In February, the WHO and cancer experts called the HPV vaccine a "critical" health tool and said access to it should be scaled up as swiftly as possible, especially in poorer countries.

SOURCE: https://bit.ly/2WWlBLQ and http://bit.ly/2KEmDuH The BMJ, online April 3, 2019.

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