Abstract: Objective: To review evidence on the efficacy of HPV vaccines in the prevention of non-cancer lesions (anogenital warts [AGW], recurrent laryngeal papillomatosis and oral papillomatosis). Materials and methods: We conducted a systematic review of randomized trials. We performed random effect models and effects were reported as relative risks (RR) and their confidence intervals (95%CI) following both intention to treat (ITT) and per protocol (PP) analyses. Results: We included six studies (n=27 078). One study was rated as high risk of bias. One study could not be included in the meta-analysis because it provided combined results. We found that quadrivalent vaccine reduced the risk of AGW by 62% (RR: 0.38, 95%CI:0.32-0.45, I2:0%) in the ITT analysis and by 95% (RR: 0.05, 95%CI:0.01-0.25, I2:66%) in the PP analysis. Subgroup analyses of studies in women or with low-risk of bias provided similar results. Conclusion: HPV quadrivalent vaccine is efficacious in preventing AGW in men and women.

Resumen: Objetivo: Revisar la evidencia sobre la eficacia de las vacunas contra el virus del papiloma humano en la prevención de lesiones no oncológicas (verrugas anogenitales [VAG], papilomatosis recurrente respiratoria y papilomatosis oral). Material y métodos: Realizamos una revisión sistemática de ensayos clínicos aleatorizados. Empleamos modelos de efectos aleatorios, calculando riesgos relativos (RR) y sus intervalos de confianza al 95% (IC95%), utilizando el análisis por intención a tratar (ITT) y por protocolo (PP). Resultados: Seleccionamos seis estudios (n=27 078). Un estudio tuvo alto riesgo de sesgo y otro no fue incluido en el metanálisis. La vacuna cuadrivalente reduce el riesgo de VAG en 62% (RR: 0,38; IC95%:0,32-0,45; I2:0%) en el análisis ITT y en 95% (RR: 0,05; IC95%:0,01-0,25; I2:66%) en el análisis PP. Los análisis de subgrupos (mujeres y estudios con bajo riesgo de sesgo) proporcionaron resultados similares. Conclusión. La vacuna cuadrivalente es eficaz en la prevención de VAG en hombres y mujeres.

Abstract: Objective: To review evidence on the efficacy of HPV vaccines in the prevention of non-cancer lesions (anogenital warts [AGW], recurrent laryngeal papillomatosis and oral papillomatosis). Materials and methods: We conducted a systematic review of randomized trials. We performed random effect models and effects were reported as relative risks (RR) and their confidence intervals (95%CI) following both intention to treat (ITT) and per protocol (PP) analyses. Results: We included six studies (n=27 078). One study was rated as high risk of bias. One study could not be included in the meta-analysis because it provided combined results. We found that quadrivalent vaccine reduced the risk of AGW by 62% (RR: 0.38, 95%CI:0.32-0.45, I2:0%) in the ITT analysis and by 95% (RR: 0.05, 95%CI:0.01-0.25, I2:66%) in the PP analysis. Subgroup analyses of studies in women or with low-risk of bias provided similar results. Conclusion: HPV quadrivalent vaccine is efficacious in preventing AGW in men and women.

Resumen: Objetivo: Revisar la evidencia sobre la eficacia de las vacunas contra el virus del papiloma humano en la prevención de lesiones no oncológicas (verrugas anogenitales [VAG], papilomatosis recurrente respiratoria y papilomatosis oral). Material y métodos: Realizamos una revisión sistemática de ensayos clínicos aleatorizados. Empleamos modelos de efectos aleatorios, calculando riesgos relativos (RR) y sus intervalos de confianza al 95% (IC95%), utilizando el análisis por intención a tratar (ITT) y por protocolo (PP). Resultados: Seleccionamos seis estudios (n=27 078). Un estudio tuvo alto riesgo de sesgo y otro no fue incluido en el metanálisis. La vacuna cuadrivalente reduce el riesgo de VAG en 62% (RR: 0,38; IC95%:0,32-0,45; I2:0%) en el análisis ITT y en 95% (RR: 0,05; IC95%:0,01-0,25; I2:66%) en el análisis PP. Los análisis de subgrupos (mujeres y estudios con bajo riesgo de sesgo) proporcionaron resultados similares. Conclusión. La vacuna cuadrivalente es eficaz en la prevención de VAG en hombres y mujeres.

Information about resistance profile of darunavir (DRV) is scarce in Brazil. Our objectives were to estimate the prevalence of DRV resistance mutations in patients failing protease inhibitors (PI) and to identify factors associated with having more DRV resistance mutations. All HIV-infected patients failing PI-based regimens with genotyping performed between 2007 and 2008 in a referral teaching center in São Paulo, Brazil, were included. DRV-specific resistance mutations listed by December 2008 IAS-USA panel update were considered. Two Poisson regression models were constructed to assess factors related to the presence of more DRV resistance mutations. A total of 171 HIV-infected patients with available genotyping were included. The number of patients with lopinavir, saquinavir, and amprenavir used in previous regimen were 130 (76%), 83 (49%), and 35 (20%), respectively. The prevalence of major DRV resistance mutations was 50V: 5%; 54M: 1%; 76V: 4%; 84V: 15%. For minor mutations, the rates were 11I: 3%; 32I: 7%; 33F: 23%; 47V: 6%; 54L: 6%; 74P: 3%; 89V: 6%. Only 11 (6%) of the genotypes had > 3 DRV resistance mutations. In the clinical model, time of HIV infection of > 10 years and use of amprenavir were independently associated with having more DRV resistance mutations. In the genotyping-based model, only total number of PI resistance mutations was associated with our outcome. In conclusion, the prevalence of DRV mutations was low. Time of HIV infection, use of amprenavir and total number of PI resistance mutations were associated with having more DRV mutations.