Real World Response To Direct Acting Antivirals DAA In African Americans Treated In A Non-Gastroenterology Setting

Abstract

Introduction: The approval of highly effective direct acting antiviral agents such as sofosbuvir/ledipasvir (Harvoni) for the treatment of hepatitis C, provided an oral, tolerable and effective regimen with fixed dosing and treatment period. Given the large numbers of patients to be treated, it is anticipated that non-GI physicians will be treating more patients than in previous years. The goal of this study was to compare the response to Harvoni of patients treated in a Gastroenterology (GI) clinic to that of an Infectious Disease (ID) clinic.

Methods: The study collected and analyzed data for HCV patients treated with Harvoni between June 2015 and December 2016 using a university physicians’ practice EMR. There were 389 patients with 294 treated by GI and 95 treated by ID.

Results: The protocol viral clearance responses were similar for hepatitis C virus infection (HCV) patients treated in GI (93%) and ID (94%) as well as for HIV co-infected patients treated in ID (100%).  The responses were similar for naïve (92%) and experienced (95%) and for both AA (93%) and  non-AA (96%).  Significant numbers of patients did not complete therapy (8%) or did not show up for their SVR visit (13%), thus lowering the intent to treat response compared to the protocol adherence response (97% vs 79%). The primary factor for not achieving an SVR was cirrhosis (99% vs 92%).

Conclusions: ID treated significant numbers of both HIV and non-HIV HCV patients and response to treatment with Harvoni was similar to the SVR rate in the GI clinics.  Our data also reflects the real-world results of Harvoni treatment where, intent to treat and per protocol are significantly different.   We conclude from our study that treatment of hepatitis C with Harvoni has a high SVR   without regard to physician specialty, race, HIV co-infection or previous treatment status.