Xpert Xpress MVP Improves Vaginitis Treatment; Male-Partner BV Therapy Cost-Saving

Use of Cepheid's Xpert Xpress MVP multiplex vaginal panel at the point of care led to significantly more women with vaginitis symptoms receiving appropriate treatment within 24 hours of their clinic visit compared with standard diagnostic methods, according to a randomized clinical trial published in Sexually Transmitted Diseases. The study found that 89.6% of women tested with Xpert Xpress MVP received appropriate treatment within 24 hours versus 51.9% with usual care (p < 0.001).

The trial, led by investigators at Magee-Womens Research Institute and the University of Pittsburgh and supported by an investigator-initiated grant from Cepheid, is the first randomized clinical trial to evaluate the utility of a multiplex molecular test for vaginitis at the point of care. Among symptomatic women confirmed with no infection, 50% in the usual care arm received unnecessary antimicrobial treatments compared to 27.1% in the Xpert Xpress MVP arm (p = 0.031). Most providers whose patients were randomized to Xpert Xpress MVP were satisfied with the turnaround time and workflow, and 87% indicated they would like to incorporate this type of testing into routine clinical practice. Investigators reported that 25% of providers relied solely on symptoms to guide treatment decisions, and standard approaches correctly identified infections only about 50–63% of the time.

The study authors noted that overuse of antimicrobials when no pathogens are detected should be avoided since it can contribute to antimicrobial resistance, may disrupt the vaginal microbiome, may cause side effects and adds costs to women and their insurers. The chief medical officer at Cepheid said the study demonstrates how molecular point-of-care tests, such as Xpert Xpress MVP, can help clinicians make more informed treatment decisions in a single visit, improving care while reducing unnecessary treatment.

A separate cost-effectiveness analysis found that adding male-partner treatment to standard female care for bacterial vaginosis (BV) reduces recurrence and is cost-saving in both Australia and South Africa. Using decision-analytic models informed by randomized controlled trial data, simulated cohorts of 10,000 women with symptomatic BV were followed over 12 months. Threshold analyses showed male-partner treatment became cost-saving at uptake of at least 28.0% in Australia and at least 2.0% in South Africa. At a base-case uptake of 73%, concurrent treatment reduced pregnancy complications from 4,454 to 3,910, increased quality-adjusted life-years (QALYs) from 0.89 to 0.92, and yielded cost-savings with incremental cost-effectiveness ratios of -USD 24.6 million per QALY in Australia and -USD 43.0 million per QALY in South Africa. Main cost drivers were consultation, medication, and recurrent BV treatment in Australia, and preterm birth, low birthweight, and syndromic STI care in South Africa. The authors said the findings support updates to clinical guidelines.

Vaginitis accounts for millions of clinical visits in the US every year, and evaluation is often complicated by overlapping symptoms. One study found that one in five women presenting with vaginitis symptoms had at least one concurrent sexually transmitted infection, and chlamydia and Mycoplasma genitalium are two to three times more likely when BV is present. The CDC recommends STI testing for every patient diagnosed with BV. As many as 30% of women with symptoms remain without a diagnosis after clinical evaluation. Microscopy-based evaluation can miss up to 45% of Trichomonas vaginalis infections, and Amsel's criteria has a reported sensitivity as low as 37% to 40% for BV. Conventional methods cannot distinguish specific species of Candida, such as C glabrata, which can be drug resistant and may require targeted therapy. Recent guidance from the American College of Obstetricians and Gynecologists recommends that physicians consider concurrent treatment of sexual partners in cases of recurrent BV. Xpert Xpress MVP is an FDA-cleared, CLIA-waived PCR test that detects the causative agents of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, including co-infections, in women 14 years old and over, and provides results in approximately 1 hour.