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 wom-en and men who already suffer from HPV geni-tal lesions, with little chances to clear the infec-tion. The efficacy of new therapeutic or comple-mentary alternatives as Ellagic acid plus Anno-na 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 El-lagic acid complex.PATIENTS AND METHODS: At Tor Verga-ta University Hospital, Rome, forty women in childbearing age, suffering from persistent cer-vical 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 geno-types and mRNA oncogenic genes E6/E7 pres-ence and clearance were analyzed and confront-ed 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-in-flammatory, 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 differ-ences. 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 vac-cinated 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 vacci-nation as adjuvant agent for the immune system of women affected by persistent HPV infection. Moreover, in women who refused to be vaccinat-ed, the administration of a biocompound like El-lagic acid plus Annona Muricata, represented an interesting clinical strategy in terms of increas-ing chance of HPV viral clearance.