By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The FDA has approved a one-course treatment for bacterial vaginosis. The product received qualified infectious disease product, fast track, and priority review designations. Clindamycin gel is distributed as Xaciato.
INDICATIONS
Clindamycin gel can be prescribed to treat bacterial vaginosis in women age 12 years and older.1
DOSAGE
The recommended dose is 100 mg of clindamycin administered once intravaginally at any time of day.1 Clindamycin is available as a 25 g tube, with one applicator delivering 5 g of gel containing 100 mg of clindamycin.
POTENTIAL ADVANTAGES
Clindamycin gel is formulated with a proprietary thermosetting hydrogel vehicle, which uses body temperature to convert a solution into a gel, improving retention of the drug in the vagina.2 This permits a one-dose regimen, which may improve patient adherence. Other single-dose clindamycin products are oil based and may weaken condoms and diaphragms.3 The gel does not contain mineral oil.
POTENTIAL DISADVANTAGES
Recurrent disease is a common problem.3,4 There are no data on efficacy or recurrence rates after treatment with a single-dose clindamycin gel vs. a seven-day regimen.
COMMENTS
The efficacy of clindamycin gel was demonstrated in a randomized, double-blind, placebo-controlled trial that included women age 12 years and older with bacterial vaginosis.1 This was defined as vaginal discharge, clue cells > 20% of total epithelial cells on saline set mount, positive whiff test (i.e., fishy odor of vaginal discharge with a drop of 10% potassium hydroxide [KOH]). Subjects were randomized in a 2:1 ratio to clindamycin (n = 204) or placebo vaginal gel (n = 103). Test of cure was assessed on visit day 21 to day 30 after screening/randomization visit. Clinical cure was defined as resolution of the abnormal discharge associated with bacterial vaginosis, a negative 10% KOH whiff test, and clue cells < 20% of the total epithelial cells in the saline wet mount. Bacterial cure was defined as a Nugent score < 4. This is based on the relative concentrations of Lactobacilli, G. vaginalis or Bacteroides, and Mobiluncus organisms based on microscopic examination of a gram-stained smear of vaginal discharge.3 Therapeutic cure was defined as the presence of both a clinical cure and bacteriological cure.
Proportions with clinical cure were 70.5% for clindamycin gel and 35.6% for placebo. Bacteriological cures rates were 43.4% vs. 5.1% and therapeutic cure rates were 36.9% vs. 5.1%. Clinical cure rates were similar between the subset of subjects with ≤ 3 episodes and more than three episodes in the previous 12 months.
CLINICAL IMPLICATIONS
Bacterial vaginosis is a highly prevalent condition among women of reproductive age.3 It is believed to be a vaginal dysbiosis when Lactobacillus species are replaced by anaerobic bacteria.3 CDC recommendations for treatments of bacterial vaginosis are metronidazole tablets (500 mg twice daily for seven days), metronidazole gel (0.75% intravaginally once daily for five days), or clindamycin cream (intravaginally at bedtime for seven days).3 Other options include clindamycin 2% vaginal cream (Clindesse) in a single dose.
A comparison between a single dose of clindamycin vaginal cream and clindamycin cream for seven days suggested similar efficacy in terms of clinical cure and therapeutic cure.5 Clindamycin gel provides another single-dose regimen. The cost was unavailable at the time of this review.
REFERENCES
- Daré Bioscience, Inc. Xaciato prescribing information. December 2021.
- Daré Bioscience, Inc. Daré announces FDA approval of Xaciato™ (clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis. Dec. 7, 2021.
- Centers for Disease Control and Prevention. Sexually transmitted infections treatment guidelines, 2021. Bacterial vaginosis. Page last reviewed July 22, 2021.
- Coudray MS, Madhivanan P. Bacterial vaginosis - A brief synopsis of the literature. Eur J Obstet Gynecol Reprod Biol 2020;245:143-148.
- Faro S, Skokos CK; Clindesse Investigators Group. The efficacy and safety of a single dose of Clindesse vaginal cream versus a seven-dose regimen of Cleocin vaginal cream in patients with bacterial vaginosis. Infect Dis Obstet Gynecol 2005;13:155-160.
Clindamycin gel can be prescribed to treat bacterial vaginosis in women age 12 years and older.
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