HPV vaccine does not prevent short-term recurrence of high grade lesions in HIV positive gay men
Simon Collins, HIV i-Base
The hope that the HPV vaccine might protect against recurrence of high-grade anal intraepithelial neoplasia (HGAIN) in HIV positive gay men was unfortunately not seen in a randomised clinical study from the Netherlands, published ahead of print in the journal AIDS.
HGAIN are precursors to anal cancer and rates of recurrence after treatment in this population are high, often >50% within 12 months.
This double-blind placebo controlled study randomised 126 HIV positive gay men with CD4 counts >350 cells/mm3 and recent successful treatment of HGAIN to quadrivalent HPV (qHPV) vaccine or placebo at 0, 2 and 6 months. Participants were enrolled between March 2014 and June 2017. Median age was 49 (+/–9) years old.
The primary endpoint was return of biopsy-proven lesions by high resolution anoscopy (HRA) at 18 months.
The study reported no differences in cumulative recurrence between the groups: 68% (44/64) vs 61% (38/62) in the active vs placebo groups respectively, p = 0.38. This was despite adequate serological responses to the vaccine.
Of the 78 participants with a recurrent HGAIN, 47%, 24% and 28% recurred at 6, 12 and 18 months respectively. There were no progressions to anal cancer.
In both groups, approximately 40% vs 60% of recurrent HGAIN were with HPV types covered by the vaccine vs other HPV strains.
In multivariate analysis, higher baseline CD4 count was associated with recurrence (aOR=1.30 per 100 cell increase (95%CI: 1.05 to 1.61), p=0.02.
Earlier preliminary results from this study had been presented at specialist medical meetings in 2019 and 2020.
Although this vaccine is highly effective in preventing anal HPV infections and related complications in young men it is disappointing that this study did not find a short-term treatment effect.
The lack of effect was seen in all analyses and in all sub groups.
This doesn’t mean that the vaccine might not have other benefits, including in reducing the risk of anal cancer linked to HPV strains covered by the vaccines.
Some advocates also think that there might be a longer-term benefit that was not shown in this study and that if available to individuals the vaccine is unlikely to cause harm.
Karien G et al. HPV vaccination to prevent recurrence of Anal Intraepithelial Neoplasia in HIV+ MSM: a randomised placebo-controlled multicentre trial. AIDS, doi: 10.1097/QAD.0000000000002928OPENSDCPAP. (5 May 2021).
This reports was first published on 10 May 2021.