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A Primer on HPV Vaccination for Primary Care Practitioners: NACI Recommendations Should Prevail

This report is based on medical evidence presented at sanctioned medical congress, from peer reviewed literature or opinion provided by a qualified healthcare practitioner. The consumption of the information contained within this report is intended for qualified Canadian healthcare practitioners only.

PRIORITY PRESS - 11th Canadian Immunization Conference

Ottawa, Ontario / December 2-4, 2014

Ottawa - Primary care providers are required to answer three questions for patients when they come asking about the human papilloma virus (HPV) vaccine: Is it safe? Does it work? And what do you think about it? Providing good, evidence-based answers to these questions is key in helping young patients take ownership of their health but physicians also need to keep in mind that HPV vaccination is now standard-of-care and is recommended for females between the ages of 9 and 45 and males between the ages of 9 and 26 across Canada regardless of whether a province funds it or not. Reducing the burden of HPV-related disease also goes far beyond current school-based HPV vaccination programs and physicians are in an excellent position to counsel female and male patients who could clearly benefit from its protection.

Chief Medical Editor: Dr. Léna Coïc, Montréal, Quebec                        

“There are three questions patients want to have answered when they come to you for a vaccine,” Dr. Vivien Brown, Assistant Clinical Professor of Medicine, University of Toronto told delegates here. First: Is the vaccine safe? When it comes to the quadrivalent human papilloma virus (qHPV) vaccine, the answer is an unequivocal yes. Meticulous post-licensure scrutiny of the qHPV vaccine by the World Health Organization, the Food and Drug Administration (FDA) and European regulatory officials among others continue to report that no safety concerns have yet emerged over the qHPV vaccine and surveillance is on-going.

Indeed, the FDA has stated that 94% of any reports related to the qHPV vaccine were not serious. Yes, patients might develop a headache following vaccination, reports of syncope have occurred and injection site reactions are common. “But,” said Dr. Brown, “I haven’t had anyone not come back for their second or third shot based on a local reaction or any reaction to their first shot. If you tell patients that their arm might be sore or that they might feel a bit light-headed or get a headache, they are less worried that it is a serious side effect if it happens.”

Does The Vaccine Work?

Second: Does the vaccine work? The best efficacy data are coming out of Australia where uptake of the qHPV vaccine has been almost universal following the introduction of a national immunization program for young girls in 2007. Currently, among females between 21 and 30 years of age, the incidence of genital warts (GWs) – which the qHPV vaccine uniquely prevents – has dropped by over 72%; among females <21 years, the incidence has dropped by over 92%.

In contrast, the incidence of GWs has not declined nearly as dramatically in heterosexual men over the same interval and it has not declined at all in men who have sex with men (MSM). (There has been a decline in GWs in females under the age of 20 in Quebec but only by about 45%, again, only about half that decline has been seen in males under the age of 20 and there has been no change in GW incidence in males in other age groups). In British Columbia, rates of cervical dysplasia of grade 2 and higher (CIN 2+) in young females between 15 and 18 years of age have dropped by at least 75% following the introduction of the qHPV vaccine and this in a setting where vaccine uptake rates hover around 70%, as Dr. Brown pointed out.

US investigators are also observing a greater impact than predicted on the prevalence of HPV-related lesions following the introduction of the vaccine – likely because of herd immunity – and this in a country that does not have a school-based HPV vaccination program. It is also worth repeating that the pivotal trials in which the qHPV vaccine was initially evaluated demonstrated the vaccine to be virtually 100% effective against all cervical, vulvar and vaginal lesions related to the vaccine types, speakers here emphasized.

Third and most importantly: What do you think about the vaccine? “We have to be very clear about how we feel about a preventative vaccine,” Dr. Brown said. “We are doing a great job with our PAP tests, we are picking lesions up very early but we don’t prevent cancer with a PAP test, it’s only with a vaccine that we can prevent cancer so what I say to my patients is: ‘After more than 30 years in practice, I’m really excited as a physician to be able to prevent a cancer and that is what we are doing with this vaccine’.”

Total Burden of HPV Disease

Prevention of cervical cancer is an important attribute of the qHPV vaccine but it pales in light of the total burden of preventable HPV-related disease if vaccine use was promoted outside the realm of school-aged females. “The burden of cervical cancer in terms of dollars spent on cancer is minimal compared to the management of low-grade [cervical dysplasias] and GWs alone,” Dr. Marc Steben, Medical Director, STI Unit, Public Health Institute of Quebec, Montreal, said.

Moreover, the cost and morbidity associated with the detection and treatment of HPV-related lesions is substantial, speakers agreed. The pivotal qHPV clinical trials also demonstrated that protection against CIN from the qHPV vaccine was greater in females who had been previously exposed to the virus than those who had not.  It has been shown that the qHPV vaccine reduces the risk of new disease related to HPV types 6, 11, 16 or 18 by 79% in women who have already been treated for cervical disease.

“Not to have a conversation with women who have already been treated for HPV-related lesions is bizarre,” Dr. Steben said. “The vaccine has a strong benefit for these women and we have to make a point that these women are receiving the vaccine.” Then there is the whole issue of a female-only HPV vaccination policy.

Currently, Alberta and Prince Edward Island are the only two provinces offering a school-based HPV vaccination program for boys.  Yet, similar to high-grade cervical disease in women, several studies in MSM with high-grade disease of the anus have shown that men who received the qHPV vaccine had good protection against further HPV-related disease lasting up to four years, the study endpoint.

"There was also a strong tendency for protection against anal warts [in these studies]," Dr. Steben added. Turning to other cancers in which HPV has been strongly implicated, speakers reminded delegates that not all head and neck cancers are HPV-related.

 On the other hand, the phenomenal increase in cancers of the oropharynx being reported in the US among other countries is largely related to HPV infection: HPV-related oropharyngeal cancers disproportionately affect men.

Expanding Protection against HPV Disease

If greater uptake of the qHPV vaccine could eradicate a substantially greater proportion of the burden of HPV-related disease in women and in men, a 9-valent HPV vaccine might be expected to expand this protection quite considerably. For example, HPV types 6, 11, 16 and 18 are implicated in about 70% of cervical cancer but 20% of cervical cancer is associated with HPV types 31, 33, 45, 52 and 58. By adding these 5 additional HPV types to the qHPV vaccine, a single vaccine could be expected to prevent 90% of all cervical cancer if optimally used prior to a female’s sexual debut.

To date, results indicate that the 9-valent HPV vaccine is 97% effective against any grade of cervical, vulvar or vaginal disease related to these five additional HPV types and it is non-inferior to the qHPV vaccine on all other endpoints. Increasing the number of antigens in the new vaccine has led to a few more injection site reactions, Dr. Steben said, but they have been comparable to injection-site reactions seen with the qHPV vaccine.

Finally, there is the issue of who pays for the vaccine outside the female-only school-based HPV vaccination program. Speakers agreed that physicians must now consider the HPV vaccine as “standard-of-care” and offer it to not only females between the ages of 9 and 45 but to males between the ages of 9 and 26 as the National Advisory Committee on Immunization (NACI) recommends they do—regardless of whether or not the vaccine is provincially funded.

“We have a lot of things in Canada that are recommended but unfunded,” Dr. Brown reminded delegates. “To make it very practical, I talk to patients about the fact that baby car seats are recommended—they are the law in fact—but no one hands you a car seat when you leave the hospital. We’ve got vaccines that are recommended but not funded and while we need to advocate for funding, our primary role is still around education and we have to let patients know what is recommended.” 

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