Estudo sobre a Vacina quadrivalente contra HPV (Gardasil) publicada no NEJM

À cerca de três semanas atrás, foi chumbada na A.R. pelo PS a inclusão da vacina para prevenção do cancro do colo do útero no PNV.

A justificação dada foi a de que ainda existem poucos estudos publicados sobre a eficácia da vacina.

Mas já começam a surgir estudos publicados, como o desta semana no NEJM com resultados bastante satisfatórios no endpoint primário estabelecido.

"Results Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31).
Conclusions In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov] .) " NEJM
Volume 356:1915-1927
May 10, 2007

Os estados que se cuidem pois vão provavelmente começar a ser pressionados para a inclusão nos PNV ou para a comparticipação de uma vacina que nas 3 doses custa cerca de 480€