Human Papillomavirus (HPV) Vaccination for Men who have sex with men (MSM)

Transcription

1 Human Papillomavirus (HPV) Vaccination for Men who have sex with men (MSM) An update for Practitioners including vaccination details for Registered Healthcare Practitioners May 2017

2 Key Messages Men who have sex with men (MSM) have a significantly increased burden of HPV related disease and adverse outcomes compared to heterosexual men A targeted HPV-MSM vaccination programme is being introduced in Scotland from the 1 st of July 2017 The aim of the programme is to provide direct protection against HPV infection, HPV associated cancers and genital warts to the MSM population up to, and including the age of 45 years The vaccine will be offered opportunistically through existing appointments at local sexual health and HIV services

3 Aims of the Resource To support Practitioners involved in discussing HPV vaccination with men who have sex with men (MSM) by providing evidence based information To raise awareness of the current epidemiology of HPV and the important role of vaccination in the MSM population To provide Registered Healthcare Practitioners with guidance on the administration of the vaccine including recommended dosage and schedule, contraindications, precautions and potential adverse reactions

4 Learning Outcomes After completing this resource Practitioners will be able to: Describe the aetiology of HPV Understand the rationale and evidence base for a targeted HPV-MSM vaccination programme to those aged up to and including 45 years and their role in delivering it Discuss the benefits of vaccination against HPV with their eligible MSM clinic attending population Safely administer the vaccine (Registered Healthcare Practitioners only) Identify sources of additional information

5 Contents 1. What is HPV? 2. Why vaccinate MSM? 3. The HPV-MSM Vaccination programme 4. Vaccination against HPV - use of Gardasil 5. The role of the Practitioner and Registered Healthcare Practitioner 6. Resources

6 Human Papillomavirus (HPV) DNA virus Infects skin and mucosal sites (squamous epithelium) through skin-to-skin contact HPVs are a large group of related viruses. Each virus in the group is given a number, which is called an HPV type HPV infections are often asymptomatic Can resolve spontaneously: - 70% new high-risk infections will clear within a year - 90% new infections clear within 2 years Persistent infection can cause cell changes leading to lesions including warts, ano-genital and some oropharyngeal cancers

7 Human Papillomavirus (HPV) (contd.) Main oncogenic HPV types that affect genital areas 16,18,26,31,33,35,39,45,51,52,53,56,58,59, 66,68,73,and 82 Main HPV types that cause genital warts 6 and 11 Those above shown in red are vaccine-specific Those above shown in green are genetically related to HPV 16 and 18 and reduced through crossprotection (Cervarix )

8 Human Papillomavirus (HPV) Of the 200 different types of HPVs - Over 40 types affect genital area - High risk types (16,18) cause cancer - Low risk types (6,11) cause genital warts HPV16: HPV18: HPV :6 HPV :11 Together account for 80% all cervical cancers remaining 20% due to 13 other HPVs. Also cancer of the anus, penis, mouth & throat, vagina & vulva 90-95% of cases of genital warts are due to HPV 6 and 11

9 Transmission HPV is one of the most common sexually transmitted infections in the UK Nearly all sexually active people get infected with HPV at some point in their lives The risk of acquiring infection increases with: The number of previous sexual partners; The introduction of a new sexual partner HPV can still be present many years after an individual has been sexually active

10 Why vaccinate MSM?

11 HPV Vaccination The National HPV Immunisation Programme began in September 2008 (throughout the UK) Targeting year old girls and catch up programme up to age 18 Cervarix : HPV types 16/18 Evidence of some cross-protection Gardasil since September 2012 HPV types 6/11/16/18 Direct protection against warts and cervical cancer caused by HPV16/18.

12 HPV vaccine uptake in Scotland routine cohorts Uptake (%) Dose 1 Dose 2 Dose /9 2009/ / / / / /15 S2 in School year Two-dose regime

13 Impact of vaccine on HPV prevalence among 20 year old screened females in Scotland

14 Percentage (%) Results from Australia (Note: Quadrivalent HPV vaccination programme started in 2007 for girls and 2013 for boys) Proportion diagnosed with genital warts at Melbourne Sexual Health Centre (<21 year olds) Australian born women Australian born heterosexual men 5 0

15 Indirect herd protection through reduced transmission N=NOT VACCINATED N HPV N HPV N Y= VACCINATED Y Much reduced N Much reduced N Vaccinating females at high coverage pre-sexual debut protects females through direct and indirect herd protection males through indirect herd protection

16 Indirect herd protection through reduced transmission N=NOT VACCINATED N HPV N HPV N Y= VACCINATED Y Much reduced N Much reduced N Some reduction N Some reduction HPV N

17 Herd protection in males Proportion of Australian-born women, heterosexual men, and men who have sex with men (MSM) diagnosed as having genital warts at Melbourne Sexual Health Centre, from July 2004 to June 2014: stratified by (A) all age groups, (B) <21 years, (C) years and (D) >32 years. The vertical line represents the implementation of the national HPV vaccination programme for girls in In 2013 the national HPV vaccination programme for boys was introduced.

18 Why vaccinate MSM against HPV? HPV infection in all men is linked to: o o o Also: 80-85% of anal cancers; 30-70% a subset of oro-pharyngeal cancer; 50% of penile cancer. MSM who attend sexual health and HIV treatment services experience higher rates of HPV infection and related cancers; HPV 16-associated anal cancer is far more common in MSM compared to heterosexual men; The incidence of anal cancer is also highest in HIV positive MSM; Some MSM have high risk sexual behaviour; Would benefit from direct effect of vaccine

19 JCVI, November 2015 A HPV-MSM immunisation programme should be introduced for MSM up to and including the age of 45 years who attend Sexual Health and HIV clinics, subject to procurement of the vaccine and delivery of the programme at a cost-effective price.

20 Why deliver the service through sexual health clinics? MSM accessing sexual health and HIV services are known to be at higher risk of HPV infection and disease More is known about MSM using these services, which allowed the evidence of the benefit from HPV vaccination to be assessed for this group Sexual healthcare and HIV services are also the services where MSM are most likely to present their sexual orientation Efficiencies in delivery, cost and clinic capacity are likely to be added advantages of this approach May have an additional benefit of increased adherence and acceptability

21 HPV MSM Vaccination programme

22 Aims of HPV-MSM immunisation To provide the HPV vaccine to MSM up to and including the age of 45 attending participating Sexual Health and HIV clinics To reduce the number of HPV infections and their onward transmission To reduce morbidity and mortality from HPV-related disease, including anal, penile and oropharyngeal cancers and genital warts

23 Vaccination against HPV Information for Registered Healthcare Practitioners: The use of Gardasil

24 Programme Eligibility A full course of vaccination should be offered to all MSM up to and including 45 years of age attending Sexual Health or HIV clinics systematically, regardless of risk, sexual behaviour or disease status Any eligible vaccinee up to and including 45 years of age who started, but did not complete, the schedule should complete the vaccination course

25 The recommended vaccine: Gardasil Brand name: Gardasil Generic Name: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant, adsorbed Marketed by: Merck Sharp & Dohme Limited Approved for use: in females and males aged from 9 years of age

26 HPV Vaccines Made from the proteins of the outer coat of the HPV Virus types Inactivated vaccine cannot cause the diseases against which it protects Highly immunogenic Clinical trials show very high efficacy and well tolerated: Over 99% effective at preventing pre-cancerous lesions associated with HPV types 16 and 18; 99% effective at preventing genital warts associated with vaccine types in young women A clinical trial of Gardasil in men indicated that it can prevent anal cell changes caused by persistent infection, and genital warts May boost immunity and prevent re-infection or reduce reoccurrences in people with established diseases

27 HPV Vaccines (Contd.) A course of 3 injections is needed for individuals aged 15 years of age and over Recent studies indicate that for individuals under 15 years of age, a two dose course given a minimum of 6 months apart induces the same protection Prior infection with one HPV type does not diminish the efficacy of the vaccine against other HPV types included in the vaccine To get the best protection, it is important the full course of vaccination is received Currently protection is maintained for at least 10 years although protection is expected to last longer

28 Safety of Gardasil vaccine The safety of Gardasil vaccine has been established through rigorous testing in clinical trials, followed by use of many millions of doses across the world In the UK, since autumn 2012 more than three quarters of a million schoolgirls have received at least one dose of the vaccine Some people may experience a side effect, but these are generally of short duration and are far outweighed by the expected benefits of the vaccine The UK Medicines and Healthcare products Regulatory Agency (MHRA) have published extensive reviews of HPV vaccine safety ( The US health authorities have also posted very clear advice on their website supporting the safety of HPV vaccine (

29 Postural Orthostatic Tachycardia Syndrome (POTS) Recently in the UK and other European countries parents and pressure groups have raised safety concerns linking the HPV vaccine to a condition called Postural Orthostatic Tachycardia Syndrome (POTS). In June 2015, the JCVI concluded that it had no concerns about the safety of the HPV vaccine. The European Medicines Agency independent review concluded evidence does not support a causal link between the vaccine and the condition. and_events/news/2015/11/news_detail_ jsp&mid=w C0b01ac058004d5c1

30 Ordering & Storage of Gardasil Gardasil should be ordered from NHS Board vaccine holding centres. Store between +2 and +8 C Store in original packaging Protect from light Effectiveness cannot be guaranteed for vaccines unless the cold chain has been maintained and vaccine has been monitored as per national recommendations Refer to local NHS board policy on vaccine storage and handling

31 Vaccine Stock Management All Sexual Health and HIV clinics offering the vaccine should: Review available fridge space to ensure adequate storage capacity before ordering new vaccine. Do not over-order 2 weeks of stock is usually adequate Have local protocols in place to reduce vaccine wastage to a minimum and protect vaccines in the event of a cold chain incident. Report any cold chain failures in line with local NHS board arrangements. Small percentage reductions in vaccine wastage will have a major impact on the financing of vaccine supplies.

32 Administration of Gardasil The vaccine comes as pre-filled suspension that must be shaken before use to form a white suspension Two separate needles are available with the pre-filled syringe. Given by intramuscular injection into the deltoid region of the upper arm For individuals with a bleeding disorder, Gardasil should be given by deep subcutaneous injection to reduce the risk of bleeding Can be given at the same time as Hepatitis B or other national schedule vaccines

33 Gardasil dosage and schedule Individuals 15 years of age and older Gardasil should be administered as a 3 dose schedule of 0.5 ml Second dose should be administered at least 1 month after the first dose Third dose should be administered at least 3 months after the second dose All three doses should ideally be given within12 months 24 month period is clinically acceptable. Individuals under 15 years of age Gardasil can be administered as a 2 dose schedule of 0.5ml Second dose should be administered at least 6 month after the first dose 6-24 months is clinically acceptable As long as the first dose was received before the age of 15 years the two dose schedule can be followed

34 Administration of Gardasil Gardasil should only be administered using a: Prescription written manually or electronically by a registered medical practitioner or other authorised prescriber; Patient Specific Direction; Patient Group Direction

35 Administration of Gardasil with other vaccines HPV vaccines can be given at the same time as other vaccines such as Td/ IPV, MMR, Influenza, MenC and hepatitis A and B The combined hepatitis A and B vaccine (Twinrix ) should be offered to MSMs in conjunction with the HPV vaccine if they have not had this vaccine(s) already due to the higher likelihood of infection from these viruses and the ongoing outbreak of hepatitis A in MSMs in the UK, as per JCVI recommendations The vaccines should be given at a separate site, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart

36 Contraindications and Precautions Contraindications Gardasil should not be administered to those who have had: A confirmed anaphylaxis to a previous dose of the vaccine; OR A confirmed anaphylaxis to any component or excipient of the vaccine. Please note : Yeast allergy is not a contraindication to the HPV vaccine. Even though Gardasil is grown in yeast cells, the final vaccine product does not contain any yeast

37 Immunosuppression and HIV Infection Individuals with human immunodeficiency virus (HIV) infection in the eligible cohort should be given HPV vaccine regardless of CD4 count, antiretroviral therapy use or viral load HPV vaccines are known to be safe and immunogenic when given to individuals infected with HIV The immune response to this vaccination and its effectiveness may be less than that observed among those who are non-hiv infected

38 Most Common Possible Adverse Reactions Erythema (redness), pain, swelling at the injection site Headache, myalgia, fatigue and low grade fever These adverse reactions are usually mild or moderate in intensity

39 Reporting Suspected Adverse Reactions Yellow card scheme Voluntary reporting system for suspected adverse reaction to medicines/vaccines Success depends on early, complete and accurate reporting Report even if uncertain about whether vaccine caused condition See chapter 8 of Green Book for details

40 The key role of Registered Healthcare Practitioners is to: To provide clear and concise information regarding vaccination against HPV To emphasise the importance of completing the full course of vaccines to ensure full protection and encourage timely uptake of doses To safely administer the vaccine to MSM in the eligible cohort Every effort should be made by registered healthcare practitioners to maximise the success of the HPV-MSM programme and promote the uptake of the HPV vaccine in the Sexual Health and HIV clinic setting

41 Resources 1. Gardasil Summary of Product Characteristics. Available at the electronic Medicines Compendium (emc) 2. NHS Education for Scotland and Health Protection Scotland Q&As for healthcare practitioners 3. Public Health England. Immunisation against infectious diseases: Human papillomavirus (HPV) 18a NHS Health Scotland- public information leaflet, The HPV Vaccine for men who have sex with men (MSM), to support the programme. This can be accessed at: 5. CMO letter

42 References 1. Ho GY, Bierman R, Beardsley L et al. (1998) Natural history of cervicovaginal papillomavirus infection in young women. N Engl J Med 338(7): Franco EL, Villa LL, Sobrinho JP et al. (1999) Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a highrisk area for cervical cancer. J Infect Dis 180(5): McCance DJ (2004) Papillomaviruses. In: Zuckerman AJ, Banatvala JE, Pattison JR, Griffiths P and Schoub B (eds) Principles and practice of clinical virology. 5th edition. Wiley & Sons Ltd. 4. Li N, Franceschi S, Howell-Jones R, et al. (2011) Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: variation by geographical region, histological type and year of publication. Int J Cancer 28: Mesher D, Cuschieri K, Hibbitts S, et al. (2015) Type-specific HPV prevalence in invasive cervical cancer in the UK prior to national HPV immunisation programme: baseline for monitoring the effects of immunisation. J Clin Pathol 68: Munoz N, Castellsague X, de Gonzalez AB et al. (2006) Chapter 1:HPV in the etiology of human cancer. Vaccine 24 S3/1-10

43 References Cont. 7. Lacey CJ, Lowndes CM, Shah KV. (2006) Chapter 4: Burden and management of noncancerous HPV-related conditions: HPV-6/11 disease. Vaccine 24(Suppl 3):S3/ (Malagón T, Drolet M, Boily MC, Franco EL, Jit M, Brisson J, Brisson M. Cross-protective efficacy of two human papillomavirus vaccines: a systematic review and metaanalysis. Lancet Infect Dis Oct;12(10): doi: /S (12) Epub 2012 Aug Chow EP et al (2015) Ongoing decline in genital warts among young heterosexuals seven years after the Australian human papillomavirus (HPV) vaccination programme. Sexually Transmitted Infections 91 (3): Giuliano AR, Nyitray AG, Kreimer AR, Pierce Campbell CM et al. (2014) EUROGIN 2014 roadmap: Differences in human papillomavirus infection natural history, transmission and human papillomavirus-related cancer incidence by gender and anatomic site of infection. Int J Cancer Jul 17. doi: /ijc Kreimer AR, Clifford GM, Boyle P, Franceschi S. (2005) Human Papillomavirus Types in Head and Neck Squamous Cell Carcinomas Worldwide: A Systematic Review. Cancer Epidemiol Biomarkers Prev; 14: Chin-Hong PV, Vittinghoff E, Cranston RD, Buchbinder S et al. (2004) Age-Specific prevalence of anal human papillomavirus infection in HIV-negative sexually active men who have sex with men: the EXPLORE study. J Infect Dis 190: Daling JR, Weiss NS, Hislop TG, Maden C et al. (1987) Sexual practices, sexually transmitted diseases, and the incidence of anal cancer. N Engl J Med 317:973-7

44 References cont. 14. Ault KA and FUTURE II Study Group (2007) Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet 369(9576): Lu B et al. (2011) Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis. BMC Infectious Diseases 11: Harper DM et al. (2006) Sustained efficacy up to 4.5 years of a bivalent L1 viruslike particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 367(9518): Barr E and Tamms G (2007) Quadrivalent human papillomavirus vaccine. Clin Infect Dis 45(5): Giuliano AR et al. (2011) Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. New England Journal of Medicine, 364(5): Swedish KA et al (2012) Prevention of recurrent high-grade anal neoplasia with quadrivalent human papillomavirus vaccination of men who have sex with men: a nonconcurrent cohort study. Clin Infect Dis.54:891-8

45 References cont. 20. Miltz A, Price H, Shahmanesh M, Copas A, Gilson R. (2014) Systematic review and meta-analysis of L1-VLP-based human papillomavirus vaccine efficacy against anogenital pre-cancer in women with evidence of prior HPV exposure. PLoS One 9:e BHIVA guidelines on the use of vaccines in HIV-positive adults (2015) chapter 9 HUMANPAPILLOMAVIRUS. ation/2015- Vaccination-Guidelines.pdf 21. Outbreak of hepatitis A associated with men who have sex with men (MSM), England, July 2016 to January 2017www.eurosurveillance.org/images/dynamic/EE/V22N05/art22706.pdf