The following is a summary of “Response to antibiotic treatment of bacterial vaginosis predicts the effectiveness of LACTIN-v (lactobacillus crispatus CTV-05) in the prevention of recurrent disease,” published in the FEBRUARY 2023 issue of Obstetrics and Gynecology by Hemmerling A, et al.
Living biotherapeutic products (LBPs) with vaginal Lactobacillus are promising adjuvant therapies for preventing recurrent bacterial vaginosis (BV). For a study, researchers sought to investigate the effectiveness of an 11-week LACTIN-V dosing regimen in preventing BV recurrence, specifically concerning the success of initial antibiotic treatment.
They conducted a post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial. In addition, the study explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 FDA guidance) two days after treatment with vaginal metronidazole gel was completed on the effectiveness of LACTIN-V dosing regimen in preventing BV recurrence by 12 and 24 weeks.
At the beginning of the study, 88% of participants had achieved a clinical BV cure. The effeActiveness of LACTIN-V in preventing BV recurrence compared to placebo was influenced by initial clinical BV cure status (P=0.02 by 12 weeks, and P=0.08 by 24 weeks). The LACTIN-V effect was only observed after the clinical BV cure. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (CI: 0.35, 0.77) among participants with initial clinical BV cure but 1.34 (CI: 0.47, 2.23) participants without clinical BV cure. Similar outcomes were observed by 24 weeks. Successful colonization levels of L. crispatus CTV-05 were also associated with initial clinical BV cure. Additionally, the number of previous lifetime episodes of BV did not impact the risk of BV recurrence among women receiving LACTIN-V.
LACTIN-V effectively decreased BV recurrence in women with a clinical cure of BV following antibiotic treatment. Therefore, future trials of LBPs should consider limiting enrollment to these women