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\begin{document}

\title{Usefulness of E7 mRNA in HPV16-positive women to predict the risk of
progression to HSIL/CIN2+}



\author[1]{Cristina Marti}%
\author[2]{Lorena Marimon}%
\author[1]{Ariel Glickman}%
\author[1]{Carla Henere}%
\author[2]{Adela Saco}%
\author[2]{Natalia Rakislova}%
\author[3]{Aureli Torné}%
\author[2]{Jaume Ordi}%
\author[4]{Marta del Pino}%
\affil[1]{Institute Clinic of Gynaecology, Obstetrics, and Neonatology, Hospital Clinic }%
\affil[2]{Hospital Clínic de Barcelona}%
\affil[3]{Hospital Clinic de Barcelona Institut Clinic de Ginecologia Obstetricia i Neonatologia}%
\affil[4]{Institute Clinic of Gynaecology, Obstetrics, and Neonatology, Hospital Clinic - Institut dInvestigacions Biomediques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona,}%


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  \date{June 13, 2024}


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\begin{abstract}
Objective: To evaluate whether E7 mRNA can predict the risk of
progression in women with HPV16 infection. Design: prospective
observational study Setting: Tertiary university hospital Population: A
cohort of 139 women referred to colposcopy for an abnormal screening
result fulfilling the following inclusion criteria: 1) a positive test
result confirming HPV16 infection; 2) a biopsy sample with a
histological diagnosis of absence of lesion or low-grade SIL/CIN grade1
(LSIL/CIN1); 3) no previous HPV vaccination; 4) no pregnancy; and 5) no
previous cervical treatments; and 6) no immunosuppression. Methods: At
the first visit all women underwent a cervical sample for liquid-based
cytology, HPV testing and genotyping, and HPV16 E7 mRNA analysis and a
colposcopy with at least one colposcopy-guided biopsy. Follow-up visits
were scheduled every six months. In each control a liquid-based Pap
smear, HPV testing, as well as a colposcopy examination with biopsy if
necessary were performed. Main outocome measures: Histological diagnosis
of HSIL/CIN2+ at any time during follow-up Results: E7 mRNA expression
was positive in 55/127 (43.3\%) women included in the study and seven
(12.7\%) progressed to HSIL/CIN2+. In contrast, only 1/72 (1.4\%) women
with no HPV16 E7 mRNA expression progressed (p=0.027). HPV16 E7 mRNA
expression was associated with a 10-fold increased risk of progression
(HR 10.0; 95\%CI 1.2-81.4). Conclusions: HPV16 E7 mRNA could be useful
for risk stratification of women with HPV16 infection in whom a
HSIL/CIN2+ has been ruled out.%
\end{abstract}%



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