Study In Nordic Countries Shows Increasing Burden Of Genital Warts Reflecting Recent HPA Data For The UK

Main Category: Women's Health / Gynecology
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 12 Dec 2007 - 2:00 PDT

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A study of nearly 70,000 women aged 18-45 years from four Nordic countries, reveals at least one in ten women* reported having had at least one episode of clinically diagnosed genital warts. The proportions were 9.5%** in Norway, 10.1%*** in Denmark, 11.3%**** in Sweden and 12.0%***** in Iceland. The results published in the Journal of Infectious Diseases 1 also indicate an increasing occurrence of genital warts in young women.

This is the largest study to assess the occurrence of genital warts. In contrast to the majority of previous studies that focused on selected populations2,3,4,5, this study was conducted on a nationwide basis investigating random samples from the general population with the results providing insights into genital warts occurrence in the general population in Europe.

"Genital warts are very frequent among women and strike at young ages in Nordic countries, and there is no reason to believe that this is different in the rest of Europe", comments Professor Susanne Krüger-Kjaer from the Danish Institute of Cancer Epidemiology in Copenhagen. "These results will help policymakers better understand the tremendous burden of genital warts."

In the United Kingdom (UK) recent reports show the diagnosis of genital warts has increased by more than five times between 1972 and 2006 and reached ~60,000 cases****** in women alone in 2006.6

Over the last 10 years, reports of newly diagnosed genital warts in the UK have increased by 22%. Recurrent cases accounted for almost a third of cases presenting to GUM clinics and a further 12% were for episodes requiring treatment for more than three months. Diagnoses have been consistently most frequent in young adults, with rates six times higher******* among women aged 16-24 years than in women in total.6,7

In their last report, the UK Health Protection Agency (HPA) said: "If the prevention of warts is included in the vaccine programme's objectives, a fairly rapid reduction in genital warts in young age groups should be seen."7

"Exposure to human papillomavirus is sufficiently common that it is an inevitable part of adolescent and adult life through normal loving relationships," says Professor Charles Lacey from the UK's Hull York Medical School. "Genital warts are a huge economic and psychological burden; I believe we need to implement population-based cervical cancer vaccination with a vaccine that can also help prevent other human papillomavirus-related genital diseases, including genital warts."

* 7,351 out of 69,147 women in the study (10.6%)
** 95% CI [9.0-9.9]
*** 95% CI [9.7-10.5]
**** 95% CI [10.8-11.8]
***** 95% CI [11.5-12.6]
****** First, recurrent and re-registered diagnoses
******* Around 750-800/100,000 population compared to 58/100,000 population

Benefits of preventing genital warts already recognised by several countries

Denmark, France and Belgium identified the additional benefit of also preventing other human papillomavirus-related genital diseases, including genital warts, in their cervical cancer vaccination recommendations.8,9,10 The recent recommendation in the UK was supported by an analysis presented by the HPA showing that a four-type (6,11,16,18) vaccine could prevent up to 70% of cervical cancer and 95% of genital warts.11 Australia currently only funds vaccination with a four-type (6,11,16,18) vaccine because of the additional benefit of preventing genital warts.12

Although the virus types 6 and 11 that cause 90% of genital warts episodes13,14,15,16,17 have not been shown to cause cervical cancer, women with a history of genital warts have an increased risk of cervical lesions (Cervical Intraepithelial Neoplasia, CIN) and cancer18,19 which is most likely explained by a higher risk of having other cancer-causing human papillomavirus types.

Preventing genital warts accelerates and widens the benefits of vaccination programmes

Modelling studies recently showed that early reductions in disease and associated costs were primarily attributable to the prevention of infection with HPV types 6/11. For example, by including a catch up campaign from age 12-17, 98% of the costs of HPV disease and 99% of the cases avoided during the first 5 years after vaccination were attributable to preventing HPV 6/11.20

"Targeting types 6 and 11 in addition to types 16 and 18 greatly increases the early benefits for women and the early return on investment for cervical cancer vaccination programmes," underlines Richard Stubbins, Managing Director, Sanofi Pasteur MSD.

In large clinical phase III studies, including more than 15,000 women, the four-type (6,11,16,18) cervical cancer vaccine Gardasil® α prevented 99%******** of genital warts due to human papillomavirus virus types 6 and 11 through a mean follow up of three years.21,22,*********

More about the individual and societal burden of genital warts

Even though genital warts are not life threatening, these lesions can cause clinical symptoms, such as burning, itching, bleeding, and pain, and can also cause psychosocial stress, resulting in decreased self-esteem, negative self-perception, embarrassment, and anxiety.23,24 Even if effective in the short term, physically ablative therapies are painful, and recurrence rates can be high as only the visible lesion is excised while the infection persists.25,26,27

Genital warts also represent an economic burden on society. One study of genital warts among privately insured individuals estimated an annual cost of $140 million for US private health plans in relation to the diagnosis and treatment of genital warts.2 Results from a recent study estimated a cost of £10.1 million for managing incident cases of genital warts in 2003 in the United Kingdom.28

About the study

Information on clinically diagnosed genital warts and lifestyle habits was collected using a questionnaire. By use of computerised population registries, which cover the entire population in the respective country, a random sample of women (18-45 years) was drawn from the general female population in each country, using the unique personal identification number as the key identifier. Informed consent was obtained from each study participant. The study was approved in each country by the data protection board and the scientific ethics committee.

From November 2004 to June 2005, the authors recruited for the study 22,199 Danish women (participation rate: 81.4%), 15,051 Icelandic women (54.6%), 16,604 Norwegian women (68.0%), and 15,713 Swedish women (63.6%), for a total of 69,567 women. They excluded 81 women who had incomplete questionnaires or a discrepancy between their personal identification number and the year of birth reported, such that the population in this study consisted of 69,486 women (22,173 from Denmark, 15,025 from Iceland, 16,575 from Norway and 15,713 from Sweden). For this article, they excluded 339 women who did not answer the question about genital warts; consequently, a total of 69,147 women were available for the analysis.

******** 95% CI [95,4,99,9], n (vaccine group/placebo group) = 7899/7900; women not infected with types 6/11/16/18
********* After the start of vaccination
α Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed))

Current indication of Gardasil®

Gardasil®, (Human Papillomavirus Vaccine [Types 6,11,16,18] (Recombinant, adsorbed)), can be given to children and adolescents 9 to 15 years and adult females 16 to 26 years and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia CIN2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by human papillomavirus types 6, 11, 16 and 18.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

References

1. Kjaer SK et al. The Burden of Genital Warts: A Study of Nearly 70,000 Women from the General Female Population in the 4 Nordic Countries. J Infect Dis 2007;196:1447-1454.

2. Insinga RP et al. The health and economic burden of genital warts in a set of private health plans in the United States. Clin Infect Dis 2003; 36:1397- 403.

3. Koutsky LA et al. Epidemiology of genital human papillomavirus infection. Epidemiol Rev 1988; 10:122- 63.

4. Burkett BJ,et al. The relationship between contraceptives, sexual practices, and cervical human papillomavirus infection among a college population. J Clin Epidemiol 1992; 45:1295-302..

5. Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis 2004; 31:748-52.

6. www.hpa.org.uk/hpr/archives/2007/hpr3507.pdf (PDF).

7. http://www.hpa.org.uk/publications/2007/hiv_sti/hiv_sti_ar_2007.pdf (PDF).

8. www.sst.dk/upload/nyheder/indstillling_hpvvaccine_4okt07.pdf (PDF).

9. http://www.sante.gouv.fr.

10. https://portal.health.fgov.be/portal/page....

11. http://www.hpa.org.uk/hpa... 2007/070919_hpv_cost.htm.

12. http://www.health.gov.au...20July%202007.pdf (PDF).

13. Gardasil, Summary of Product Characteristics.

14. Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.

15. Wieland U and Pfister H. papillomaviruses in human pathology: Epidemiology, pathogenesis and oncologic role. In: Gross, Barasso Eds.Human Papilloma Virus Infection: A clinical atlas. Ullstein Mosby 1997;1-18.

16. von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.

17. UK Health Protection Agency. CDR Weekly 2003;3(44).

18. Friis S et al. Cervical intraepithelial neoplasia, anogenital cancer, and other cancer types in women after hospitalization for condylomata acuminata. J Infect Dis 1997; 175:743--8.

19. Kjær SK et al. Case control study of risk factors for cervical neoplasia in Denmark. II. Role of sexual activity, reproductive factors, and venereal infections. Cancer Causes Control 1992; 3:339-48.

20. Assessment of the health and economic impact of a quadrivalent vaccine in the United Kingdom using a transmission dynamic model, Dasbach Eet al., Oral presentation, EUROGIN, 5th October 2007, Monaco, Monte Carlo

21. Barr E and Tamms G. Quadrivalent human papillomavirus vaccine. Clin Infect Dis 2007:45: 609-617.

22. Olsson S. et al., quadrivalent HPV types 6/11/16/18 L1 virus-like particle vaccine in preventing cervical intraepithelial neoplasia (CIN): 3- year efficacy results, abstract presented at the 2007 EUROGIN conference, Monte-Carlo, 4-6 oct. 2007.

23. Maw RD, Reitano M, Roy M. An international survey of patients with genital warts: perceptions regarding treatment and impact on lifestyle. Int J STD AIDS 1998; 9:571- 8.

24. Clarke P et al. The psychosocial impact of human papillomavirus infection: implications for health care providers. Int J STD AIDS 1996; 7:197-200.

25. Beutner KR and Wiley DR. Recurrent external genital warts: A literature review. Papillomavirus Rep 1997;8:69-74.

26. Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases. National guideline for the management of anogenital warts. (last visit 18.08.06).

27. McMillan A. The management of difficult anogenital warts. Sex Transm Dis 1999;75:192-194.

28. Brown RE et al. Costs of detection and treatment of cervical cancer, cervical dysplasia and genital warts in the UK. Curr Med Res Opin 2006; 22:663-70.

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