Original Title: Vacuna contra virus del papiloma humano (VPH) en pacientes con lesiones o infección por VPH

Authors' recommendations: The human papilloma virus vaccine has been approved by ANMAT (Argentina’s Administration of Drugs, Food and Medical Technology) for its indication in children as from 9 years old and is part of the National Immunization Calendar in children 11 years old. This document assesses the use of the vaccine in patients with virus infection or lesions prior to vaccination (population not specifically included in the package insert, an “off-label” use). No studies assessing the efficacy of the human papilloma virus vaccine in reducing the mortality or incidence of cancer in patients with lesions or infections due to the virus prior to immunization have been found (off-label indication). Moderate-quality evidence suggests that human papilloma virus immunization is superior to placebo in preventing relapse of Grade 2 or higher intraepithelial cervical neoplasms in patients with a history of these lesions diagnosed and treated prior to vaccination. Low-quality evidence suggests that the technology might reduce the recurrence of anal, vulvar and vaginal intraepithelial lesions. Very low-quality evidence does not allow to conclude about the benefits of administering the vaccine in patients with recurrent respiratory papillomatosis. Moderate-quality evidence suggests that vaccination in patients with no history of pre-malignant lesions but with DNA positive and/or serology positive for human papilloma virus does not show clear benefits in preventing cervical, anal and oral lesions while it might have some benefit in reducing the incidence of new infections due to some virus genotypes. However, none of the international recommendations support viral infection screening prior to vaccination. The clinical practice guidelines and recommendations on immunization surveyed recommend vaccination in all individuals between 11 (it could be started at the age of 9) and 26 years old; mainly at 11 years old, prior to contact with the virus. Most of them recommend shared medical decision making, assessing each case individually, in subjects 27 to 45 years old; especially in patients who have risk factors for acquiring a new infection. Public funders from the United States, United Kingdom and Latin America do not mention the indication for vaccination in patients with previous lesions or infections due to the virus. Private funders from the United States consider the vaccine as experimental for these indications; although some of them consider their coverage in selected cases. No local economic studies on the cost-effectiveness of this technology in the assessed indications have been found.

Project Status: Completed

Year Published: 2020

URL for published report: https://www.iecs.org.ar/home-ets/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)