O10.4 Efficacy and Safety of Intralesional (IL) Injection of Mycobacterium W Vaccine Vs. Imiquimod Cream in the Treatment of Anogenital Warts: A Double Blind Randomised Trial

Abstract

Introduction External Anogenital warts (EGW) are associated with poor response to treatment and high recurrence rates. There is a need for development of immunotherapeutic agents for treatment of AGW. Objectives To compare efficiency and safety of IL injection of killed Mycobacterium w (Mw) Vaccine and Imiquimod cream in complete resolution of EGWs, recurrence rates, and reduction in HPV viral load. Method 89 patients (71 male and 18 female) with EGW were recruited over a period of 3 years. Patients were randomised in to two Group: Group A Patients (Male 34, Female 10) received Imiquimod cream and IL placebo injection; Group B patients (Male 37 and female 8) received Placebo cream and IL Mw injections. HPV Genotyping was done by reverse line blot hybridization by the Linear Array (Roche) and viral load was done by Real Time quantitative PCR. Results: Mean percentage reduction in Imiquimod and Mw groups were 84.7% and 83.2%, respectively (P > 0.05). Overall, 59% and 66.7% of patients in Imiquimod and Mw groups respectively showed complete clearance. There was no significant difference in adverse events and recurrence rates. HPV DNA was detected in anogenital warts samples in 84 (94.38%) of 89 patients. The predominant types were HPV‐6(55%), 11(41.5%) followed by HPV 16(5.6%), 18(4.4%), and others(27.5%). 22(24.7%) showed infection by multiple HPV types. Baseline HPV 6 and 11 DNA load ranges were 1.4 × 102‐2.1 × 108 and 2.6 × 102‐2.1 × 108 copies/mg, respectively (P value < 0.001). After treatment, there was a significant decline in viral load of HPV 6 in both the groups, but of HPV 11 only in Mw group. Conclusions There was no significant difference in efficacy and adverse events in both the treatments. HPV viral load declined significantly and correlated with clinical resolution. Further studies are needed to explore whether injection Mw works for patients who do not respond to topical imiquimod.