Table 3.
Change in Vaginal Microbiota Prevalence and Concentration Following Ring Use in Postmenopausal Women a
| Organism | Dapivirine Vaginal Ring-004 (n = 64) |
P Value DPV vs Baseline |
Placebo Ring (n = 22) |
P Value PL vs Baseline |
P Value PL vs DPV |
|---|---|---|---|---|---|
| BV prevalenceb | 1.11 (.73–1.67) | .64 | 1.01 (.68–1.50) | .95 | .74 |
| Nugent scorec | –0.23 (–.80 to .34) | .42 | –0.48 (–1.18 to .23) | .18 | .58 |
| Lactobacillus crispatus | |||||
| Prevalenceb | 1.19 (.94–1.49) | .15 | 1.02 (.70–1.49) | .92 | .49 |
| Quantityc | 0.15 (–.19 to .48) | .38 | 0.02 (–.37 to .40) | .93 | .61 |
| Lactobacillus iners | |||||
| Prevalenceb | 1.10 (.96–1.26) | .18 | 1.22 (1.03–1.45) | .02 | .29 |
| Quantityc | 0.10 (–.21 to .42) | .51 | 0.39 (–.16 to .93) | .16 | .36 |
| Lactobacillus jensenii | |||||
| Prevalenceb | 1.19 (.96–1.47) | .12 | 0.80 (.48–1.32) | .38 | .15 |
| Quantityc | 0.20 (–.14 to .55) | .25 | –0.02 (–.42 to .38) | .92 | .42 |
| Lactobacillus gasseri | |||||
| Prevalenceb | 1.39 (1.06–1.82) | .02 | 1.11 (.92–1.35) | .28 | .16 |
| Quantityc | 0.34 (–.04 to .73) | .08 | 0.18 (–.11 to .48) | .23 | .51 |
| Limosilactobacillus vaginalis | |||||
| Prevalenceb | 1.03 (.72–1.48) | .87 | 1.40 (.91–2.15) | .12 | .25 |
| Quantityc | 0.02 (–.32 to .37) | .89 | 0.36 (–.18 to .90) | .19 | .30 |
| Gardnerella vaginalis | |||||
| Prevalenceb | 1.11 (.92–1.34) | .27 | 1.01 (.78–1.30) | .96 | .50 |
| Quantityc | 0.13 (–.36 to .63) | .59 | –0.35 (–1.15 to .45) | .39 | .28 |
| Atopobium vaginae | |||||
| Prevalenceb | 1.02 (.82–1.27) | .88 | 1.03 (.60–1.78) | .92 | .97 |
| Quantityc | –0.01 (–.39 to .37) | .95 | –0.08 (–1.08 to .91) | .87 | .90 |
| Megasphaera lornae | |||||
| Prevalenceb | 1.20 (.90–1.60) | .21 | 0.83 (.56–1.22) | .34 | .13 |
| Quantityc | 0.12 (–.07 to .30) | .22 | –0.16 (–.39 to .08) | .19 | .06 |
| Prevotella bivia | |||||
| Prevalenceb | 0.99 (.70–1.40) | .96 | 0.43 (.14–1.38) | .16 | .16 |
| Quantityc | 0.02 (–.38 to .43) | .90 | –0.55 (–1.23 to .14) | .12 | .11 |
| Prevotella amnii | |||||
| Prevalenceb | 1.15 (.64–2.07) | .64 | 0.72 (.17–2.99) | .65 | .55 |
| Quantityc | 0.06 (–.22 to .35) | .67 | –0.26 (–.73 to .21) | .29 | .18 |
| Prevotella timonensis | |||||
| Prevalenceb | 1.42 (1.13–1.79) | .003 | 0.91 (.61–1.35) | .64 | .03 |
| Quantityc | 0.94 (.38–1.50) | .001 | –0.39 (–1.04 to .27) | .25 | .001 |
| Enterococcus | |||||
| Prevalenceb | 1.01 (.68–1.50) | .95 | 1.19 (.76–1.87) | .45 | .55 |
| Quantityc | 0 (–.38 to .37) | .99 | 0.01 (–.40 to .42) | .96 | .96 |
| Group B Streptococcus | |||||
| Prevalenceb | 1.72 (.94–3.18) | .08 | 1.05 (.53–2.10) | .88 | .24 |
| Quantityc | 0.47 (.12–.82) | .009 | 0.14 (–.21 to .50) | .44 | .22 |
| Staphylococcus aureus | |||||
| Prevalenceb | 2.09 (.22–20.20) | .52 | 4.05 (.37–44.33) | .25 | .46 |
| Quantityc | 0.06 (–.09 to .20) | .44 | 0.20 (–.16 to .55) | .28 | .45 |
| Escherichia coli | |||||
| Prevalenceb | 1.23 (.82–1.83) | .31 | 0.81 (.44–1.50) | .51 | .26 |
| Quantityc | 0.34 (–.16 to .83) | .18 | –0.28 (–.72 to .15) | .21 | .05 |
| Candida albicans | |||||
| Prevalenceb | 4.41 (1.26–15.44) | .02 | 1.34 (.22–8.01) | .75 | .14 |
| Quantityc | 0.33 (.06–.60) | .02 | 0.09 (–.22 to .41) | .56 | .26 |
| Other yeasts | |||||
| Prevalenceb | 2.06 (1.09–6.22) | .03 | 3.88 (1.14–13.22) | .03 | .43 |
| Quantityc | 0.39 (.07–.70) | .02 | 0.59 (–.04 to 1.21) | .07 | .59 |
Sample sizes are 64 and 22 for DPV and placebo rings for qPCR samples, respectively. Bold values indicate statistical significance in either prevalence and/or quantity from baseline through ring use.
Abbreviations: BV, bacterial vaginosis; DPV, dapivirine vaginal ring-004; PL, placebo ring.
Microbiota prevalence and concentration evaluated at baseline and at 4 and 12 weeks following ring use.
Change in prevalence expressed as relative risk (95% confidence interval [CI]); values <1.0 reflect a decrease, whereas values >1.0 reflect an increase; P value from modified Poisson regression model.
Change in Nugent score and log10 quantity expressed as mean (95% CI); values <0 reflect a decrease, whereas values >0 reflect an increase; P value from mixed-effects linear regression model.