HPV vaccination to prevent recurrence of anal intraepithelial neoplasia in HIV+ MSM.
AIDS
; 35(11): 1753-1764, 2021 09 01.
Article
en En
| MEDLINE
| ID: mdl-33966029
ABSTRACT
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 350âcells/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 6âmonths. HRA was repeated at 6, 12, and 18âmonths. MAIN OUTCOMEMEASURE:
The primary outcome was cumulative, biopsy-proven HGAIN recurrence rate at 18âmonths, 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 (Pâ=â0.38) 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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias del Ano
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Infecciones por VIH
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Infecciones por Papillomavirus
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Minorías Sexuales y de Género
Tipo de estudio:
Clinical_trials
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Guideline
Límite:
Humans
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Male
Idioma:
En
Revista:
AIDS
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
2021
Tipo del documento:
Article