Abstract
Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21–30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.
Highlights
Every year, upwards of 21 million females between the ages of 14 and 19 years are affected by bacterial vaginosis (BV), making it the most common gynecologic infection in women in this age group [1, 2]
Secnidazole treatment was self-administered on day 1 in both studies and patients were to return for a “test of cure” (TOC) visit between days 21 and 30 or an “end of study” (EOS) visit if the final visit occurred before day 21 or after day 30
Of patients treated with 2-g secnidazole who had reported three or fewer episodes of BV in the previous year, 64.5% were found to be clinical outcome responder (COR), as were 42.2% of those who had reported four or more cases of BV in the previous year
Summary
Upwards of 21 million females between the ages of 14 and 19 years are affected by bacterial vaginosis (BV), making it the most common gynecologic infection in women in this age group [1, 2]. Poor adherence, which increases with longer durations of treatment and more complex care paradigms, is common. Studies of compliance rates have found that nearly 50% of patients do not adhere to a 5- to 7-day treatment regimen [6, 7]. Low patient compliance leads to failure of treatment, recurring infections, and, possibly, accelerated growth of drug-resistant microorganisms [8]. Poor adherence to the current BV SOC drug regimens may be a contributing factor to the increasing incidence of chronic BV and the need for multiple antibiotic treatments in an individual patient [4, 9]
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