OMV/PTV/RTV +/- RBV in Genotype 4, Hard-To-Treat cohorts: real Life Data From Qatar
AASLD LiverLearning®. Derbala M. Nov 14, 2016; 144880
Topic: Clinical Trials and Therapeutic Developments
Prof. Moutaz Derbala
Prof. Moutaz Derbala
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TITLE: OMV/PTV/RTV +/- RBV in Genotype 4, Hard-To-Treat cohorts: real Life Data From Qatar


In PEARL-I,the12 week course of oral interferon-free regimen of ombitasvir (OMV), paritaprevir (PTV), dosed with ritonavir(RTV), has delivered high virologic cure rates among non cirrhotic, Hepatitis C virus (HCV), Genotype(GT) 4. This encourages the treatment of 'difficult to treat'-cohorts, however, trial inclusion/exclusion
criteria may make outcomes less reproducible in routine clinical care. In addition, GT4, is genetically diverse, with 17 confirmed subtypes, and comprises approximately 13% of infections worldwide and more than 90% in our area. Aim: to study the safety and efficacy of OMV/PTV/RTV +/- RBV,in difficult-to-treat genotype 4 patients, including prior null responders,cirrhosis, renal impairment and post transplant.

An ongoing open-label, non-Interventional, retrospective, parallel-arm, single-center cohort is being conducted in HCV Genotype 4patients, conducted in Hamad hospital, Qatar. Data of 54 Patients treated with 12weeks OMV/PTV/RTV +/- RBV, were enrolled. The inclusion criteria included, Child A & B cirrhosis, renal impairment, liver transplant, thalassemia minor and null responders with poor baseline predictors
Fifty four patients were included, 80% were cirrhotic, 9% were child B, 20% post liver transplant, 11% were renal impairment. About 10% of the patients were ribavirin-free, because of renal impairment, anemia or thalassemia. Patients were evaluated at Weeks 2, 4, 8, 12, and 24. Negative PCR test seen in, 80.27%, 95%,100% and 95.54%, at weeks 2,4,12 and 24,respectively. SVR achieved in 100% of patients with renal impairment,liver transplant and child B.There was no significant difference between Naïve GT4 and experienced, where SVR was 96.4% Vs. 94.4% (P = 0.747),pre-treatment IL28B polymorphism did not affect response to treatment, where IL28B C/C was 100% compared to 92.9% in non C/C. Increased in transaminases >5 times the pre-treatment were seen in 5% of cases, severe drug interaction seen with tacrolimus, but not with cyclosporine and one patients developed aggressive HCC in the follow up period
The low relapse rate, shorter duration, and favorable tolerability and safety profile make 12 weeks of OBV/PTV/r regimens recommended in genotype 4, including experienced patients with prior null response, cirrhotic,renal impairment, and post transplant.The risk of aggressive HCC in the course DAAs therapy, needs further study
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