HPV vaccination to prevent recurrence of anal intraepithelial neoplasia in HIV+ MSM.

Autor:	Gosens KCM; Department of Dermatology.; Division of Infectious Diseases, Department of Internal Medicine, Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam., van der Zee RP; Department of Dermatology.; Division of Infectious Diseases, Department of Internal Medicine, Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam.; Department of Pathology, Cancer Center Amsterdam (CCA), Amsterdam UMC, Vrije Universiteit Amsterdam., van Heukelom MLS; Department of Dermatology., Jongen VW; Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam)., Cairo I; Department of Dermatology, OLVG., van Eeden A; DC Klinieken Lairesse., van Noesel CJM; Department of Pathology, Cancer Center Amsterdam (CCA), Amsterdam UMC, University of Amsterdam, Amsterdam., Quint WGV; DDL Diagnostic Laboratory, Rijswijk., Pasmans H; Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven., Dijkgraaf MGW; Department of Epidemiology and Data Science, Amsterdam Public Health Institute, Amsterdam UMC, University of Amsterdam., de Vries HJC; Department of Dermatology.; STI Outpatient Clinic, Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands., Prins JM; Division of Infectious Diseases, Department of Internal Medicine, Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam.
Jazyk:	angličtina
Zdroj:	AIDS (London, England) [AIDS] 2021 Sep 01; Vol. 35 (11), pp. 1753-1764.
DOI:	10.1097/QAD.0000000000002928
Abstrakt:	Objective: Anal cancer precursor lesions high-grade anal intraepithelial neoplasia (HGAIN) are highly prevalent among HIV+ MSM. Treatment of HGAIN is frustrated by high recurrence rates. We investigated the efficacy of the quadrivalent human papillomavirus (qHPV) vaccine as posttreatment adjuvant in preventing HGAIN recurrence in HIV+ MSM. Design: Randomized, double-blind, placebo-controlled, multicentre trial. Setting: Three HIV outpatient clinics in Amsterdam, the Netherlands. Subjects: HIV+ MSM with CD4+ cell count more than 350 cells/μl, biopsy-proven intra-anal HGAIN successfully treated in the past year, and lesions still in remission at enrolment, as assessed by high-resolution anoscopy (HRA). Intervention: Participants were randomized to three doses of qHPV (Gardasil-4, MSD) or placebo with vaccinations at 0, 2, and 6 months. HRA was repeated at 6, 12, and 18 months. Main Outcome Measure: The primary outcome was cumulative, biopsy-proven HGAIN recurrence rate at 18 months, evaluated in an intention-to-treat (ITT) (received all vaccinations) and per-protocol analysis (all vaccinations and complete follow-up). Results: We randomized 126 participants of which 64 (50.8%) received qHPV and 62 (49.2%) placebo. All participants received three vaccinations, and in both groups for two participants follow-up was incomplete. We found no difference (P = 0.38) in cumulative HGAIN recurrence rates between the qHPV (44/64, 68.8%) and placebo group (38/62, 61.3%) in the ITT analysis [absolute risk reduction -7.5 (95% confidence interval (CI) -24.1 to 9.2)]. This was similar in the per-protocol analysis. Conclusion: Despite adequate serological responses to qHPV vaccination, short-term recurrence of HGAIN was not prevented. These findings do not support qHPV vaccination as a treatment adjuvant to prevent HGAIN recurrence in HIV+ MSM. (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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