There is increased evidence of higher diversity of the vaginal microbiota of HPV-positive Vs HPV-negative women. Bacterial species among HPV infected patients are possible cytokine profile modifying agents (Th1 to Th2), causing local immunosuppression resulting in HPV persistency. Thus, re-balance or normalization of the microbiota, may help to produce a more hostile microenvironment for HPV, thereby making easier its clearance
Review of 3 prospective studies:
- Exploratory, non-comparative, prospective, real life study conducted on healthy women aged 18 - 45 years, once daily application of Papilocare® for 12 consecutive days to measure changes in vaginal microbiota
- Prospective, non-controlled observational study including 21 sexually active positive-HPV women aged > 25y with negative pap and no colposcopy cervical lesions. PapilocareR once daily for 21 consecutive days to evaluate changes in vaginal microbiota by pyrosequencing
- Randomized, open, parallel group, controlled clinical trial to evaluate the efficacy of Papilocare® to both normalize cytology and clear HPV, in HPV-positive women with ASCUS or LSIL alterations and consistent colposcopy image
-First study showed a trend of improvement (21.2% final vs baseline) of vaginal microbiota
-Second study showed a significant improvement in the cervix mucosa epithelialization vs baseline. Evaluation of changes in vaginal microbiota by pyrosequencing are under analysis and will be disclosed during Congress
Third study interim analysis:
-At 3 months, 69.2% of patients using Papilocare® (n=26) negativized pap and colposcopy vs. 33.3% in control group (n=15) (p=0.048; Fisher test). This difference is even more evident in high risk genotype population: 67% vs 20% for PapilocareR (n=18) and control group (n=10), respectively (p=0.046; Fisher test)
-At 6 months, a positive trend of Papilocare® vs control in normalizing Pap and colposcopy in high risk genotype population: 73% vs 40% in PapilocareR (n=11) and control groups (n=5), respectively (p=ns)
-At 6 months, a positive trend to clear HPV in Papilocare® vs control group: 56% vs 30% of patients cleared HPV , respectively (p=ns). This positive trend was even more evident in high risk genotype population: 50% of patients in PapilocareR group (n=12) showed HPV cleared vs 17% (n=6) in control group (p=ns)
Papilocare® shows a postive outcome on vaginal microbiota which may enhance local immunity and might explain that Papilocare® shows a significant normalization Pap at 3 months vs control and a positive trend in both HPV clearance at 6 months with higher differences in high risk HPV patients. These findings need to be confirmed upon study completion