(P466) Prediction of Bacterial Vaginosis Recurrence by Clinical and Molecular Testing

Background

Antibiotic suppression is recommended for women with recurrent bacterial vaginosis (BV), yet treatment failure is common. The BD MAX^TM Vaginal Panel (MAX BV) uses an algorithm to define relative quantities of key vaginal bacteria, and is approved for diagnosis of BV in symptomatic women. We compared the performance of the MAX BV and Amsel’s clinical criteria obtained at test-of-cure (TOC) in a prospective clinical trial in predicting clinical and microbiologic recurrence in women with a history of recurrent BV (RBV).


Methods

Cis-women with current BV and history of RBV were eligible. All were treated with a standard 1-week course of oral metronidazole at enrollment. Participants with clinical cure (< 2 Amsel criteria day 1; TOC) were eligible for follow-up and were assessed for BV monthly for 3 months. A total of 62 participants with available MAX BV results at day 1 visit were analyzed. Kaplan-Meier analyses were performed to compare incidence of both clinical and molecular (MAX BV) BV recurrence between participants stratified by baseline MAX BV results.

Results

Sixty-two participants were clinically negative (< 2 Amsel’s criteria) following initial treatment at day 1, and proceeded into the prospective trial. Of those, 18 (29%) were MAX BV positive. Twenty-two women (35%) had clinical BV recurrence during follow-up. Recurrence was significantly less frequent (p=0.024) in the 44 participants with baseline negative MAX BV compared to the 18 participants with baseline positive MAX BV results (Figure).

Conclusion

A substantial proportion (29%) of women with a history of RBV who were clinically cured after initial treatment were BV positive by molecular testing, and those women were more likely to experience a clinical BV recurrence in the subsequent 3 months. Prospective BV studies that require a negative assessment at enrollment should consider molecular testing as inclusion criteria. Positive BD MAX despite clinical response following metronidazole treatment may predict RBV and help prioritize use of suppressive antimicrobial therapy.