Produção Nacional
Revisado por pares
Risk estimates for persistent high-risk human papillomavirus infections as surrogate endpoints of progressive cervical disease critically depend on reference category: analysis of the combined prospective cohort of the New Independent States of the Former Soviet Union and Latin American Screening Studies
2011; SAGE Publishing; Volume: 22; Issue: 6 Linguagem: Inglês
10.1258/ijsa.2009.009365
ISSN1758-1052
AutoresKarí Syrjänen, I. P. Shabalova, Paulo Naud, В. П. Козаченко, Sophie Derchain, S Zakharchenko, Cecília Roteli-Martins, Raisa Nerovjna, Adhemar Longatto‐Filho, Ludmila Kljukina, Sílvio Tatti, Marina Branovskaja, L S Hammes, M Branca, V Grunjberga, Mojca Eržen, Anna Juschenko, S Costa, Luı́s Otávio Sarian, J Podistov, S Syrjäen, Karí Syrjänen, Stina Syrjänen, I. P. Shabalova, Nicolaj Petrovichev, В. П. Козаченко, T. Zakharova, Julia Pajanidi, J Podistov, G. Yu. Chemeris, Larisa G. Sozaeva, Elena Lipova, Irena Tsidaeva, Olga Ivanchenko, Alla Pshepurko, Sergej Zakharenko, Raisa Nerovjna, Ludmila Kljukina, Oksana Erokhina, Marina Branovskaja, Maritta Ņikitina, V Grunjberga, A Grunjberg, Anna Juschenko, Rosa Santopietro, Marcella Cintorino, P Tosi, Karí Syrjänen, Paulo Naud, Sophie Derchain, Cecília Roteli-Martins, Adhemar Longatto‐Filho, Sílvio Tatti, M Branca, Mojca Eržen, L S Hammes, João Paulo Abdallah Matos, Rodrigo Modesto Gadelha Gontijo, Luı́s Otávio Sarian, Joana Fróes Bragança, F C Arlindo, MYS Maeda, A Lörincz, G B Dores, S Costa, Stina Syrjänen,
Tópico(s)Hepatitis B Virus Studies
ResumoSummary To make feasible future clinical trials with new-generation human papillomavirus (HPV) vaccines, novel virological surrogate endpoints of progressive disease have been proposed, including high-risk HPV (HR-HPV) persistence for six months (6M+) or 12 months (12M+). The risk estimates (relative risks [RRs]) of these ‘virological endpoints’ are influenced by several variables, not yet validated adequately. We compared the impact of three referent groups: (i) HPV-negative, (ii) HPV-transient, (iii) HPV-mixed outcome on the risk estimates for 6M+ or 12M+ HR-HPV persistence as predictors of progressive disease. Generalized estimating equation models were used to estimate the strength of 6M+ and 12M+ HR-HPV persistence with disease progression to squamous intraepithelial lesions (SILs), cervical intraepithelial neoplasia (CIN) grade 1 +, CIN2+, CIN/SIL endpoints, comparing three optional reference categories (i)-(iii) in a prospective sub-cohort of 1865 women from the combined New Independent States of the Former Soviet Union (NIS) and Latin American Screening (LAMS) studies cohort ( n = 15,301). The RRs of these viral endpoints as predictors of progressive disease are affected by the length of viral persistence (6M+ or 12M+) and the surrogate endpoint (SIL, CIN1, CIN2, CIN/SIL). Most dramatic is the effect of the referent group used in risk estimates, with the HPV-negative referent group giving the highest and most consistent RRs for both 6M+ and 12M+ viral persistence, irrespective of which surrogate is used. In addition to deciding on whether to use 6M+ or 12M+ persistence criteria, and cytological, histological or combined surrogate endpoints, one should adopt the HPV-negative referent group as the gold standard in all future studies using viral persistence as the surrogate endpoint of progressive disease.
Referência(s)