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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ABSTRACT FINAL ID: 1988

TITLE: OMV/PTV/RTV +/- RBV in Genotype 4, Hard-To-Treat cohorts: real Life Data From Qatar

SPONSORSHIP - THIS STUDY WAS SPONSORED BY: (IF THIS ABSTRACT WAS NOT SPONSORED PLEASE INDICATE):
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ABSTRACT BODY:
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.


Method:
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
Results:
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
Conclusion:
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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