Astodrimer sodium and bacterial vaginosis: a mini review

Abstract

Bacterial vaginosis (BV) is the most common vaginal infection affecting women of childbearing age, and is associated with a substantial burden on women’s physical, emotional, sexual and social lives, as well as being linked to a number of gynaecological and obstetrical complications and adverse pregnancy outcomes. Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium gel is a novel, non-antibiotic treatment for BV that is not systemically absorbed. It prevents pathogenic bacteria from adhering to the vaginal wall, and disrupts and inhibits the formation of pathogenic bacterial biofilms. Clinical cure rates of 50–57% were observed in patients with BV treated with astodrimer sodium compared with 17–21% treated with placebo (p < 0.001) in Phase 3 trials. In a separate Phase 3 trial, recurrence of BV occurred in 44% of patients treated with astodrimer sodium compared with 54% of patients who received placebo (p = 0.015). Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition.

Dendrimers, an Emerging Opportunity in Personalized Medicine?

“…Another phase 3 study (NCT02237950, 12 September 2014, and 2014-000694-39, 21 October 2014) demonstrated that the gel administered every second day for 16 weeks was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV [ 39 ]. A recent review emphasized that such formulation inhibits growth of bacteria associated with BV via a novel mechanism of action, compared with conventional antibiotics, by blocking the attachment of bacteria to cells and inhibiting the formation of and disrupting biofilms [ 40 ]. Table 1 displays the different types of clinical trials carried out with VivaGel ® .…”