Estudio piloto comparativo del test VPH con genotipado parcial en primera línea frente a otras estrategias de cribado poblacional del cáncer de cérvix. Estudio CRYGEN 16/18 / Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study

Introducción: La detección precoz del cáncer de cérvix requiere la implementación de programas de cribado del virus del papiloma humano (VPH). Sin embargo, existen discrepancias en la optimización de esas estrategias. Se evalúa el rendimiento de 10 protocolos basados en técnicas moleculares, citológicas o combinadas en cribado primario. Material y métodos: Se diseña un estudio ciego, prospectivo e intervencionista en 1.977 mujeres de 35 años. La determinación molecular se realizó por la plataforma Cobas 4800HPV. Los análisis citológicos se realizaron en las mismas muestras sin conocimiento del resultado molecular. Todas las mujeres en las que se detectaba VPH-16/VPH-18 o presentaban alteración citológica y detección de otros genotipos de alto riesgo (VPHar) eran derivadas a colposcopia. Resultados: El ensayo molecular detectó presencia de VPHar en el 12,5% de las mujeres, mientras solo el 8,1% de las citologías fueron patológicas. El 19,5% de las pacientes derivadas a colposcopia revelaron lesiones de alto grado, estando VPH-16 presente en el 65,3% de ellas. En 6 de esas ocasiones (VPH-16 siempre presente) la citología había sido informada como normal. El seguimiento al año de las mujeres con citología normal y detección de VPHar identificó una lesión HSIL/CIN2+(asociada a VPH-33). En el estudio comparativo con otras estrategias el protocolo denominado CRYGEN 16/18 rindió el mejor equilibrio de sensibilidad y especificidad con la menor derivación a colposcopia. Conclusiones. La realización de detección molecular de VPH con genotipado parcial en primera línea, al menos VPH-16, con derivación directa a colposcopia, aumenta la tasa de detección de lesiones HSIL/CIN2+.(AU)

Introduction: The early detection of cervical cancer requires the implementation of molecular screening programs for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. Material and methods: A blind, prospective, and interventional study was designed in 1977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis was performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy. Results: The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy. Conclusions: Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.(AU)

Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study.

INTRODUCTION: The early detection of cervical cancer requires the implementation of molecular screening programmes for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. MATERIAL AND METHODS: A blind, prospective, and interventional study was designed in 1.977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis were performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy. RESULTS: The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy. CONCLUSIONS: Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.

Quadrivalent Human Papillomavirus Vaccine Effectiveness after 12 Years in Madrid (Spain).

A fully government-funded human papillomavirus (HPV) vaccination program started in 2007 in Spain (only 11-14-year-old girls). The first of those vaccinated cohorts, with the quadrivalent vaccine (Gardasil), turned 25 years old in 2018, the age at which cervical cancer screening begins in Spain. The current study could provide the first evidence about the effectiveness of the quadrivalent vaccine against HPV in Spain and the influence of age of vaccination. The present ambispective cohort study, which was conducted on 790 women aged 25 and 26 years old, compares the rate of HPV prevalence and cytologic anomaly according to the vaccination status. The overall infection rate was 40.09% (vaccinated group) vs. 40.6% (non-vaccinated group). There was a significant reduction in the prevalence of HPV 6 (0% vs. 1.3%) and 16 (2.4% vs. 6.1%), and in the prevalence of cytological abnormalities linked to HPV16: Atypical Squamous Cells of Undetermined Significance (ASCUS) (2.04% vs. 14%), Low-grade Squamous Intraepithelial Lesions (LSIL) (2.94% vs. 18.7%) and High-grade Squamous Intraepithelial Lesion (HSIL) (0% vs. 40%), in the vaccinated group vs. the non-vaccinated group. Only one case of HPV11 and two cases of HPV18 were detected. The vaccine effectively reduces the prevalence of vaccine genotypes and cytological anomalies linked to these genotypes.

Effectiveness of Prophylactic Human Papillomavirus Vaccine in the Prevention of Recurrence in Women Conized for HSIL/CIN 2-3: The VENUS Study.

Background: Recent data have shown that the human papillomavirus (HPV) vaccine could impact on a decrease in high-grade cervical intraepithelial lesions (HSIL) in women who have undergone surgical treatment. This study aimed to evaluate the efficacy of human papilloma virus (HPV) vaccination against persistent/recurrent disease in patients undergoing conization for high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia-grade 2-3 (HSIL/CIN 2-3). Methods: From January 2009 to March 2019, 563 patients with HSIL/CIN 2-3 underwent conization. The population was divided into two groups according to vaccination status: vaccinated-group (V-Group) and non-vaccinated-group (NV-Group). Bivalent or quadrivalent vaccines were administered indiscriminately. A follow-up was scheduled every 6-12 months according to clinical guidelines. The mean follow-up was 29.6 vs. 36.5 months in the V-group and NV-group, respectively. Results: 277 (49.2%) women were vaccinated, while 286 (50.8%) were not. Overall, persistent/recurrent HSIL/CIN 2-3 was presented by 12/277 (4.3%) women in the V-Group and 28/286 (9.8%) in the NV-Group (HR: 0.43, 95% Confidence interval 0.22-0.84, p = 0.014). Vaccination was associated with a 57% reduction in HSIL persistence/recurrence after treatment. When no disease was present in the first 6-month follow-up visit, persistence/recurrence rates were very low in both groups: 1.1% in the V-Group vs. 1.5% in the NV-Group (p > 0.05). The factor associated with a high-risk of HSIL persistence/recurrence was the presentation of a positive co-test in the first control after treatment (p < 0.001). Conclusions: Our results corroborate the benefit of HPV vaccination in woman treated for HSIL/CIN 2-3, showing a reduction of persistent/recurrent HSIL/CIN 2-3.

Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study. / Estudio piloto comparativo del test VPH con genotipado parcial en primera línea frente a otras estrategias de cribado poblacional del cáncer de cérvix. Estudio CRYGEN 16/18.

INTRODUCTION: The early detection of cervical cancer requires the implementation of molecular screening programs for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. MATERIAL AND METHODS: A blind, prospective, and interventional study was designed in 1977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis was performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy. RESULTS: The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy. CONCLUSIONS: Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.

Prevención primaria del virus del papiloma humano / Primary prevention of human papillomavirus

La patología relacionada con la infección por el virus del papiloma humano constituye en la actualidad un ver-dadero problema de salud pública. Si bien la primera relación causal entre el virus del papiloma humano y un cáncer fue con el cáncer de cérvix, a lo largo de los últimos años se ha podido demostrar cómo es también el agente causal de cánceres en otras localizaciones, siendo el responsable de una fracción nada despreciable de los casos de cáncer de ano, vagina, vulva, pene y orofaringe, algunos de ellos con un incremento considerable en su incidencia en los últimos años. El descubrimiento de la asociación del virus del papiloma humano con estos cánceres ha permitido el desarrollo de vacunas frente al virus del papiloma humano que sirven para la prevención primaria. Si bien en el caso del cáncer de cérvix disponemos de estrategias de prevención secundaria basadas en el cribado, no ocurre lo mis-mo con el resto de cánceres VPH-dependientes, donde la prevención solo es posible a través de estrategias de prevención primaria basadas en la vacunación. Es crucial por tanto que los profesionales sanitarios tengan un conocimiento actualizado sobre la infección por el virus del papiloma humano, la carga de enfermedad asociada y las estrategias de que disponemos para su prevención

The pathology related to human papillomavirus infection is currently a real public health problem. Although the first causal relationship between human papillomavirus and a cancer was with cervical cancer, over the last few years it has been possible to show how it is also the causative agent of cancers in other locations, being responsible for a not inconsiderable fraction of cases of cancer of the anus, vagina, vulva, penis and oropharynx, some of them with a considerable increase in their incidence in recent years. The discovery of the association of human papillomavirus with these cancers has allowed the development of vaccines against human papillomavirus that serve for primary prevention. Although in the case of cervical cancer we have secondary prevention strategies based on screening, the same is not possible for the other HPV-dependent cancers, in which prevention is only possible through primary prevention strategies based on vaccination. It is therefore essential that health professionals have up-to-date knowledge about human papillomavirus infection, the burden of associated disease and the strategies available to prevent it

[Definitive contraception with Essure device: Single institutional experience on 517 procedures]. / Anticoncepción definitiva con Essure: experiencia unicéntrica de 517 procedimientos.

OBJECTIVES: To analyse the outcomes of patients undergoing Essure sterilization in a single institution, interns of complications and technique failure. PATIENTS AND METHODS: Retrospective descriptive study of 517 patients underwent definitive contraception with Essure device in outpatient hysteroscopy office without anesthesia and controlled at 3 months with abdominal radiography, ultrasonography and hysterosalpingography in selected cases. RESULTS: The success rates of the insertion of Essure was 96.8%, similar to data reported in the literature with 3.7% of vagal reactions, as most prevalent complication. 7 (1.35%) unintended pregnancies were observed. CONCLUSIONS: Essure is a permanent birth control device, with high rate of successful insertion and a low rate of complications. Unintended pregnancies in our study are high and we must change the protocols of placement and monitoring, considering hysterosalpingography as a routine control test.