Table 4.
Change in Vaginal Microbiota Prevalence and Concentration Following Ring Use in Lactating Women a
| Organism | Dapivirine Vaginal Ring-004 (n = 16) |
P Value DPV vs Baseline |
|---|---|---|
| BV prevalenceb | 0.55 (.22–1.41) | .22 |
| Nugent scorec | 0.03 (–1.07 to 1.13) | .95 |
| Lactobacillus crispatus | ||
| Prevalenceb | d | |
| Quantityc | 0 (0–.01) | .31 |
| Lactobacillus iners | ||
| Prevalenceb | 1.07 (.92–1.24) | .36 |
| Quantityc | 0.08 (–.20 to .35) | .59 |
| Lactobacillus jensenii | ||
| Prevalenceb | 1.52 (.79–2.91) | .21 |
| Quantityc | 0.64 (–.43 to 1.70) | .24 |
| Lactobacillus gasseri | ||
| Prevalenceb | 0.80 (.50–1.28) | .35 |
| Quantityc | –0.18 (–.62 to .26) | .43 |
| Limosilactobacillus vaginalis | ||
| Prevalenceb | 1.01 (.23–4.40) | .98 |
| Quantityc | 0.18 (–.80 to 1.16) | .72 |
| Gardnerella vaginalis | ||
| Prevalenceb | d | |
| Quantityc | 0.11 (–.39 to .62) | .66 |
| Atopobium vaginae | ||
| Prevalenceb | 1.02 (.52–2.00) | .94 |
| Quantityc | –0.10 (–1.55 to 1.35) | .89 |
| Megasphaera lornae | ||
| Prevalenceb | d | |
| Quantityc | 0.01 (–.01 to –.04) | .32 |
| Prevotella bivia | ||
| Prevalenceb | 2.27 (.98–5.27) | .06 |
| Quantityc | 0.85 (.26–1.44) | .005 |
| Prevotella amnii | ||
| Prevalenceb | d | |
| Quantityc | 0 (0–.01) | .32 |
| Prevotella timonensis | ||
| Prevalenceb | 1.26 (.60–2.66) | .54 |
| Quantityc | 0.63 (–.66 to 1.92) | .34 |
| Enterococcus | ||
| Prevalenceb | 1.82 (.47–7.06) | .39 |
| Quantityc | 0.35 (–.32 to 1.02) | .31 |
| Group B Streptococcus | ||
| Prevalenceb | 1.52 (.57–4.03) | .40 |
| Quantityc | 0.26 (–.10 to .62) | .16 |
| Staphylococcus aureus | ||
| Prevalenceb | e | |
| Quantityc | e | |
| Escherichia coli | ||
| Prevalenceb | 0.52 (.03–9.24) | .66 |
| Quantityc | –0.03 (–.36 to .30) | .87 |
| Candida albicans | ||
| Prevalenceb | 1.79 (.54–5.92) | .34 |
| Quantityc | 0.55 (–.29 to 1.38) | .20 |
| Other yeasts | ||
| Prevalenceb | e | |
| Quantityc | e | |
Abbreviations: BV, bacterial vaginosis, DPV, dapivirine vaginal ring-004. Bold values indicate statistical significance in either prevalence and/or quantity from baseline through ring use.
Microbiota prevalence and concentration evaluated at baseline and 14 and 16 days of 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.
Unable to provide estimates as model did not achieve convergence; 2 participants remained colonized by L. crispatus at each follow-up visit; 11 participants remained colonized by G. vaginalis at each follow-up visit; 1 participant remained colonized by M. lornae and 1 by P. amnii.
S. aureus and other yeasts were not detected at any visit in this cohort.