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Viral hepatitis
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
  1. P Basu1,2,
  2. T Nair3,
  3. S Farhat3,
  4. M Jafri4,
  5. K Mittimani3,
  6. N James Shah3,
  7. L Ang3,
  8. S foustin3,
  9. A Anwarullah3
  1. 1Department of Gastroenterology and Hepatology, Columbia University, College of Physicians and Surgeons, New York, New York, USA
  2. 2Gastroenterology, North Shore University, New York, USA
  3. 3Internal Medicine, North Shore University, New York, USA
  4. 4Internal Medicine, NYMC Richmond, New York, USA

Abstract

Introduction Telapravir 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.

Methods 52 Patients (mean age 51) were recruited undergoing therapy with Telapravir, Peg Interferon and Ribaviran 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.

Group AGroup BGroup C
Rectalgia3/17 (17%)8/17 (47%)17/18 (94%)
Rectal ulcers0/2 (0%)1/3 (33%)2/3 (66%)
Hemorrhoids resolved w/o bleed1/6 (16%)2/6 (33%)5/7 (71%)
Proctocopic examination showing normalisation of mucosa post therapy4/17 (23%)7/17 (41%)17/18 (94%)

Conclusion 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 (Abstract PMO-168 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 (Abstract PMO-168 table 4). Side events; Numbness, 4/17 (23%) in lidocaine. Conclusion: Rectally delivered Lidocaine 3% gel is efficacious, tolerable compared to the SOC and placebo for ARD causing treatment failure, retention and SVR. Larger trial needs to validate this finding.

Competing interests None declared.

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