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NASPAG, the “Go To” Society
J Pediatr Adolesc Gynecol (2006) 19:321–323
The Editor’s Workshop NASPAG, the ‘‘Go To’’ Society If you are interested in reaching a key population of health care providers that see patients who today or in the future will be at risk for Human Papilloma Virus (HPV), who do you turn to? Indeed NASPAG is high on the list of candidates. Or as one reference focuses on the problem: Human Papilloma Virus infection: An old disease, a new vaccine1 Strategies have been aimed at the development of vaccination against the rotavirus, HPV. Safety, reactogenicity, immunogenicity, and efficacy of the recently developed vaccines have entered a new dimension and the vaccines are now available. Historically, Jennerian approaches as well as the new human-derived rotavirus vaccine have been guided through clinical studies by pharmaceutical manufacturers. As we speak, two rotavirus vaccines are identified as efficacious and with appropriate safety profiles for clinical use. The currently available vaccines are related to: a pentavalent human-bovine reassorbant formulation, or attenuated rotavirus of human origin The latter vaccine has been evaluated in more than 70,000 infants worldwide. Prophylactic vaccines focused on HPV have been tested in over 25,000 young patients.2 The phase I and II studies provided the initial efficacy for prevention of genital condyloma as well as cervical carcinomas.2 The bottom line is that an extensive immunization program involving 60–80% of infants worldwide will reduce by 50% the number of rotavirus associated hospitalizations and deaths if HPV prophylactic vaccination occurs. The entire subject of sexually transmitted disease (STD) in adolescents remains an area of discussion. When 18.9 million new cases of STD occur annually, of which 9 million are in adolescents, we who provide healthcare to this age group must stop and notice.3 A number of interesting statistics are worth mentioning:
One in ten female adolescents have chlamydia The highest rate of gonorrhea is in 15–24 year olds Prevalence of HPV infection in sexually active young women is O30% Hepatitis B virus infection is 78,000 cases per year, down from 260,000 in the 1980s Of new HIV infections in the USA, 50% are among young individuals
Focusing on HPV, it is the most common STD infection in the states, affecting upwards of 75% of the population.4 Unfortunately it is quite prevalent among sexually active adolescents and young adults. If one were to test sexually active teens, 64% to 82% would be positive for HPV.4 The majority of HPV disease is associated with four (HPV) types: Low grade genital lesions: O90% of genital warts: HPV 6 and 11 High-grade CIN or dysplasia and cervical carcinoma: HPV 16 and 18 Even with our best efforts 4000 women in the USA die annually from this disease.4 Ó 2006 North American Society for Pediatric and Adolescent Gynecology Published by Elsevier Inc.
1083-3188/06/$22.00 doi:10.1016/j.jpag.2006.07.002
322
Sanfilippo: The Editor’s Workshop Management of Women with Low-grade Squamous Intraepithelial Lesions In Special Circumstances Adolescents
or
Repeat Cytology 6 months after index Pap
Negative
≥ ASC
HPV DNA testing 12 months after index Pap
HPV Positive
HPV Negative
(for high-risk types)
(for high-risk types)
Repeat Cytology 6 months later
Negative ≥ ASC
Colposcopy
Repeat Cytology @ 12 mos
Routine Screening
Fig. 1. Management of LSIL in special circumstances. Cancer Society for Cervical Colposcopy and Cervical Pathology Bethesda Guidelines.
Enter the world of HPV vaccines! The problem is that papilloma viruses cannot be grown in large quantities in vitro. The generation of HPV virus particles by synthesis and self-assembly in vitro of the major virus capsid protein L1 provides a potentially effective sub-unit vaccine.5 The safety profiles of the HPV L1 virus like particles is excellent. Phase III trials continue to note protection against the virus ill effects. The name of the game is to have immunization on board prior to contact with the virus. The quadrivalent HPV vaccine, which is effective against HPV 6, 11, 16, and 18 has continued efficacy at the 361 month following immunization. HPV is associated with the following cancers: Cervix Anus Vagina Vulva Penile Oropharynx To embellish this concept, allow me to ask the next logical question: how long will the immunizations last? Effectiveness against HPV 16 and 18 L1 virus-like particle AS04 vaccine has been noted to provide protection for up to 4.5 years. This data is based on a multi-center, randomized, double-blind, placebo-controlled study conducted by the manufacturer of the vaccine.6 Of note, cervical cancer is the second most common cancer among women, affecting 400,000 annually. We have received new guidelines for management of abnormal Pap smears in adolescents from coordination by The American Cancer Society (ACS), American Society for Colposcopy and Cervical Cytology (ASCCP) and the National Institutes of Health (NIH) (Fig. 1). I draw your attention to the Management Quandary in this issue of The Journal of Pediatric & Adolescent Gynecology, entitled: ‘‘Teen pregnancy and sexually transmitted diseases: Rethinking the bedfellow question means that condoms will never be a substitute for seatbelts’’, by Dr. Catherine Stevens-Simon. The time has come for NASPAG to stand up and be the primary vehicle for distribution of the vaccine for HPV, an old disease with a new vaccine. Joseph S. Sanfilippo, MD, MBA Editor References 1. Giles M, Garland S: Human papillomavirus infection: An old disease, a new vaccine. Aust NZ J Obstet Gynaecol 2006; 46:180
Sanfilippo: The Editor’s Workshop 2. Linhares A, Villa L: Vaccines against rotavirus and human papillomavirus (HPV). J Pediatr 2006; 82(suppl):1 3. Weinstock H, Berman S, Cates W Jr: Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health 2004; 36:6 4. Wiley D, Masongsong E: Human papillomavirus: the burden of infection. Obstet Gynecol Surv 2006; 61(6 suppl):S3 5. Stanley M: Human papillomavirus vaccines. Rev Med Virol 2006; 16:139 6. Harper D, Franco E, Wheeler C, et al: 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 randomized control trial. Lancet 2006; 367:1247
323
The Editor’s Workshop NASPAG, the ‘‘Go To’’ Society If you are interested in reaching a key population of health care providers that see patients who today or in the future will be at risk for Human Papilloma Virus (HPV), who do you turn to? Indeed NASPAG is high on the list of candidates. Or as one reference focuses on the problem: Human Papilloma Virus infection: An old disease, a new vaccine1 Strategies have been aimed at the development of vaccination against the rotavirus, HPV. Safety, reactogenicity, immunogenicity, and efficacy of the recently developed vaccines have entered a new dimension and the vaccines are now available. Historically, Jennerian approaches as well as the new human-derived rotavirus vaccine have been guided through clinical studies by pharmaceutical manufacturers. As we speak, two rotavirus vaccines are identified as efficacious and with appropriate safety profiles for clinical use. The currently available vaccines are related to: a pentavalent human-bovine reassorbant formulation, or attenuated rotavirus of human origin The latter vaccine has been evaluated in more than 70,000 infants worldwide. Prophylactic vaccines focused on HPV have been tested in over 25,000 young patients.2 The phase I and II studies provided the initial efficacy for prevention of genital condyloma as well as cervical carcinomas.2 The bottom line is that an extensive immunization program involving 60–80% of infants worldwide will reduce by 50% the number of rotavirus associated hospitalizations and deaths if HPV prophylactic vaccination occurs. The entire subject of sexually transmitted disease (STD) in adolescents remains an area of discussion. When 18.9 million new cases of STD occur annually, of which 9 million are in adolescents, we who provide healthcare to this age group must stop and notice.3 A number of interesting statistics are worth mentioning:
One in ten female adolescents have chlamydia The highest rate of gonorrhea is in 15–24 year olds Prevalence of HPV infection in sexually active young women is O30% Hepatitis B virus infection is 78,000 cases per year, down from 260,000 in the 1980s Of new HIV infections in the USA, 50% are among young individuals
Focusing on HPV, it is the most common STD infection in the states, affecting upwards of 75% of the population.4 Unfortunately it is quite prevalent among sexually active adolescents and young adults. If one were to test sexually active teens, 64% to 82% would be positive for HPV.4 The majority of HPV disease is associated with four (HPV) types: Low grade genital lesions: O90% of genital warts: HPV 6 and 11 High-grade CIN or dysplasia and cervical carcinoma: HPV 16 and 18 Even with our best efforts 4000 women in the USA die annually from this disease.4 Ó 2006 North American Society for Pediatric and Adolescent Gynecology Published by Elsevier Inc.
1083-3188/06/$22.00 doi:10.1016/j.jpag.2006.07.002
322
Sanfilippo: The Editor’s Workshop Management of Women with Low-grade Squamous Intraepithelial Lesions In Special Circumstances Adolescents
or
Repeat Cytology 6 months after index Pap
Negative
≥ ASC
HPV DNA testing 12 months after index Pap
HPV Positive
HPV Negative
(for high-risk types)
(for high-risk types)
Repeat Cytology 6 months later
Negative ≥ ASC
Colposcopy
Repeat Cytology @ 12 mos
Routine Screening
Fig. 1. Management of LSIL in special circumstances. Cancer Society for Cervical Colposcopy and Cervical Pathology Bethesda Guidelines.
Enter the world of HPV vaccines! The problem is that papilloma viruses cannot be grown in large quantities in vitro. The generation of HPV virus particles by synthesis and self-assembly in vitro of the major virus capsid protein L1 provides a potentially effective sub-unit vaccine.5 The safety profiles of the HPV L1 virus like particles is excellent. Phase III trials continue to note protection against the virus ill effects. The name of the game is to have immunization on board prior to contact with the virus. The quadrivalent HPV vaccine, which is effective against HPV 6, 11, 16, and 18 has continued efficacy at the 361 month following immunization. HPV is associated with the following cancers: Cervix Anus Vagina Vulva Penile Oropharynx To embellish this concept, allow me to ask the next logical question: how long will the immunizations last? Effectiveness against HPV 16 and 18 L1 virus-like particle AS04 vaccine has been noted to provide protection for up to 4.5 years. This data is based on a multi-center, randomized, double-blind, placebo-controlled study conducted by the manufacturer of the vaccine.6 Of note, cervical cancer is the second most common cancer among women, affecting 400,000 annually. We have received new guidelines for management of abnormal Pap smears in adolescents from coordination by The American Cancer Society (ACS), American Society for Colposcopy and Cervical Cytology (ASCCP) and the National Institutes of Health (NIH) (Fig. 1). I draw your attention to the Management Quandary in this issue of The Journal of Pediatric & Adolescent Gynecology, entitled: ‘‘Teen pregnancy and sexually transmitted diseases: Rethinking the bedfellow question means that condoms will never be a substitute for seatbelts’’, by Dr. Catherine Stevens-Simon. The time has come for NASPAG to stand up and be the primary vehicle for distribution of the vaccine for HPV, an old disease with a new vaccine. Joseph S. Sanfilippo, MD, MBA Editor References 1. Giles M, Garland S: Human papillomavirus infection: An old disease, a new vaccine. Aust NZ J Obstet Gynaecol 2006; 46:180
Sanfilippo: The Editor’s Workshop 2. Linhares A, Villa L: Vaccines against rotavirus and human papillomavirus (HPV). J Pediatr 2006; 82(suppl):1 3. Weinstock H, Berman S, Cates W Jr: Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health 2004; 36:6 4. Wiley D, Masongsong E: Human papillomavirus: the burden of infection. Obstet Gynecol Surv 2006; 61(6 suppl):S3 5. Stanley M: Human papillomavirus vaccines. Rev Med Virol 2006; 16:139 6. Harper D, Franco E, Wheeler C, et al: 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 randomized control trial. Lancet 2006; 367:1247
323