A retrospective study on two cohorts of immunocompetent women treated with nonavalent HPV vaccine vs. Ellagic acid complex: outcome of the evolution of persistent cervical HPV infection.

OBJECTIVE: The nonavalent HPV vaccine has demonstrated its efficacy in women and men who already suffer from HPV genital lesions, with little chances to clear the infection. The efficacy of new therapeutic or complementary alternatives as Ellagic acid plus Annona Muricata (Ellagic acid complex) has emerged recently. Our retrospective study compares the evolution of persistent cervical HPV infection in two cohorts of immunocompetent women after the administration of nonavalent vaccine or Ellagic acid complex. PATIENTS AND METHODS: At Tor Vergata University Hospital, Rome, forty women in childbearing age, suffering from persistent cervical HPV infection, were enrolled in two study's groups: nonavalent HPV vaccine (20 women) vs. Ellagic acid complex tablets (20 who refused the vaccine). Cytological features, HPV DNA genotypes and mRNA oncogenic genes E6/E7 presence and clearance were analyzed and confronted between the groups. RESULTS: Demographics and clinical features of the cohorts were comparable. Evaluation of Pap smear, HPV DNA test and mRNA genes E6/E7, were performed at baseline (T0) and after 6 months (T1) and 12 months (T2) from the last dose of vaccine/tablet. At T1 and T2, Ellagic acid complex group showed a statistical reduction of abnormalities in Pap smears (p = 0.018 and 0.006, respectively), probably due to its direct anti-inflammatory, antioxidative and antiviral activities. At T1, vaccinated group showed a higher rate of HPV clearance (p = 0.001), instead Ellagic acid complex group didn't report significative differences. At T2, respect to T0, both groups showed an increase in percentage of negative HPV DNA detection, although more marked for vaccinated group respect to Ellagic acid complex group (p = 0.039 and 0.062 respectively). Regarding mRNA E6/E7 clearance, at T1 and T2, the group of vaccinated women showed a higher negativization respect to the other group (p= 0.077 and 0.042, respectively). CONCLUSIONS: Despite the limited sample of women enrolled for the present study, the results confirmed the clinical usefulness of HPV vaccination as adjuvant agent for the immune system of women affected by persistent HPV infection. Moreover, in women who refused to be vaccinated, the administration of a biocompound like Ellagic acid plus Annona Muricata, represented an interesting clinical strategy in terms of increasing chance of HPV viral clearance.

Prevalence of human papillomavirus infection in Italian and immigrant women.

Human papillomavirus (HPV) is the most common sexually transmitted agent worldwide. Prevalence varies according to the geographic regions, and is highest in developing countries. Geographic differences exist also in the detection rate of oncogenic types in malignant cervical lesions. In this study, the prevalence of HPV infection as well as the spectrum of HPV types was evaluated in Italian and immigrant women of the urban area of Rome. Several risk factors (age at first intercourse, number of partners, smoking, pregnancy, age at first pregnancy, contraception, education, and menarche) were taken into consideration. Overall, there was a high prevalence of HPV infection in the two groups studied. No significant differences were observed in the spectrum of HPV types detected. HPV 16 and 18 were the types detected more frequently in both groups. Interestingly, HPV 54 and 70 were found only in the immigrants. Whether this finding reflects a recent introduction of these HPV types in the population studied remains to be established. Monitoring of HPV types in the population is advisable, especially in countries like Italy which is a destination and a gateway for immigrants directed towards north and central Europe. The introduction of high risk HPV variants may have a clinical impact and affect the diagnostic procedures.