Women with human immunodeficiency virus (HIV) and bacterial vaginosis (BV) may not experience a reduced BV recurrence risk after treatment with lactobacilli-containing vaginal tablets (VT) following standard oral metronidazole treatment, according to a study published in the International Journal of Infectious Diseases.
Researchers included 80 women (mean age, 34 years) with HIV and BV in the 12-month, double-blind investigation between 2018 and 2021 and randomized them to treatment with a lactobacilli-containing VT (n=40) or placebo VT (n=40) for 4 months following a 7-day course of treatment with metronidazole (400 mg). The team obtained sociodemographic information, performed clinical examinations, and compared recurrence rates between the 2 treatment arms.
Investigators found that 85% of participants in the treatment group and 93.5% of control group participants experienced BV resolution. Researchers observed equal rates of clinical recurrence in both groups, with 13/29 (44.8%; 95% CI, 26.4-64.3%) from each arm presenting clinical symptoms of BV. The rates for confirmatory recurrence were nearly identical, with 12/29 (41.4%; 95% CI, 23.5-61.1%) in the treatment group and 13/29 (44.8%; 95% CI, 26.4-64.3%) in the placebo arm presenting with confirmed BV. No major adverse events were reported, and 7 participants in the treatment arm reported only minor self-limiting events including vaginal irritation, discomfort, and vaginal redness.
The study authors stress the need for treatments that limit BV recurrence. “Currently, internationally recommended antibiotic treatments are provided as monotherapies, however, the recurrence is high, and sustained cure rates are less,” according to the researchers. “There is a need for more effective combination therapies that can restore the vaginal flora and sustain it for the BV recurrence prevention among HIV-infected women.”
Study limitations included a loss to follow-up due to COVID-19-related restrictions and the use of Nugent score for endpoint assessment, which limited the definition of recurrence and may have undercounted true recurrence rates.
Bangar S, Sonar P, Mane A, et al. Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial. Int J Infect Dis. Published online February 10, 2023. doi:10.1016/j.ijid.2023.02.003