Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease
05/2024
Journal Article
Authors:
Hemmerling, A.;
Wierzbicki, M. R.;
Armstrong, E.;
Cohen, C. R.
Volume:
51
Pagination:
437-440
Issue:
6
Journal:
Sex Transm Dis
PMID:
38733973
URL:
https://www.ncbi.nlm.nih.gov/pubmed/38733973
DOI:
10.1097/OLQ.0000000000001962
Keywords:
Humans Female *Vaginosis, Bacterial/drug therapy/prevention & control/microbiology *Metronidazole/administration & dosage *Anti-Bacterial Agents/administration & dosage/therapeutic use Adult *Lactobacillus crispatus/physiology
*Probiotics/administration & dosage Treatment Outcome Recurrence Secondary Prevention Administration, Intravaginal Young Adult Vagina/microbiology Double-Blind Method
Abstract:
OBJECTIVES: Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. METHODS: A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. RESULTS: At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure. CONCLUSIONS: LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.
