PMO-168 Effects of lidocaine 3% gel delivered rectally in anorectal dysfunction (ARD) induced by Telapravir therapy in chronic hepatitis C (CHC-C) a randomised placebo control study

Abstract

Objective: Telaprevir is a potent protease inhibitor, which causes anorectal dysfunction (ARD) comprising proctalgia, rectal ulcers, hemorrhoids, and rectal bleeding. Conventional therapy is suboptimal causing treatment failure. This study evaluates 3% topical lidocaine gel rectal delivery to abate the drug-related ARD to avoid treatment failure. Method(s): Fifty-two patients (mean age 51) were recruited undergoing therapy with telaprevir, peg interferon, and ribavirin for CHC-C: 45/52 (86%), with rectalgia, 8/52 (15%) rectal ulcers, hemorrhoids 19/52 (36%) with bleeding 6/19 (31%) without bleeding 13/19 (68%). Group A (n=17) placebo, Group B (n=17) hydrocortisone 2.5% cream, and Group C (n=18) lidocaine 3% gel foam per rectally twice daily. All underwent pre and post proctoscopic evaluation and ano-rectal manometry. (Table presented) Results: Rectalgia resolved in 3/17 (17%), 8/17 (47%), and 7/18 (94%) for Group A, B, and C respectively. Rectal ulcers healed in 0/2 (0%), 1/3 (33%), and 2/3 (66%) for all the above groups. Hemorrhoids resolved in 1/6 (16%), 2/6 (33%), and 5/7 (71%) in all groups. Pre/Post-proctoscopy revealed normal mucosal integrity 4/17 (23%), 7/17 (41%), and 17/18 (94%) above groups. Results of Pre/Post-Rx mean scores for pain, itching, and burning shown on Table 3. AR manometry results showed Pre/post-treatment high sphincter tone >4 mm in Group A 2/ 15(8%) and no differences in pre- and post-treatment, Group B 7/15 (41%), 4/15 (22%), and Group C 5/15 (20%), 2/15 (10%) respectively (Table 4). Side events: numbness, 4/17(23%) in lidocaine. Conclusion(s): Rectally delivered lidocaine 3% gel is efficacious, tolerable compared with the SOC and placebo for ARD causing treatment failure, retention, and SVR. Larger trial needs to validate this finding. (Table presented).