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Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis

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Liana Gheorghe1,2, Speranta Iacob1,2, Manuela Curescu3, Ciprian Brisc4, Cristina Cijevschi5, Florin Caruntu2,6, Carol Stanciu5, Iulia Simionov1, Ioan Sporea7, Cristian Gheorghe1,2, Razvan Iacob1,2, Victoria Arama2,6, Roxana Sirli7, Anca Trifan5

1) Digestive Diseases and Liver Transplantation Center, Fundeni Clinical Institute, Bucharest;
2) Carol Davila University of Medicine and Pharmacy, Bucharest;
3) Department of Infectious Diseases, Victor Babeș University of Medicine and Pharmacy, Timisoara;
4) Department of Gastroenterology, University of Medicine, Oradea;
5) Institute of Gastroenterology and Hepatology, Gr.T. Popa University of Medicine and Pharmacy Iasi;
6) Matei Bals National Institute of Infectious Diseases, Bucharest;
7) Department of Gastroenterology and Hepatology, Victor Babeș University of Medicine and Pharmacy, Timisoara, Romania

DOI: http://dx.doi.org/10.15403/jgld.2014.1121.263.iac

Background & Aims: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir (OBV/PTV/r+DSV) is one of the elective direct-acting antivirals (DAAs) recommended by international guidelines and the only one covered by the National Insurance System in Romania until November 2016. Our aim was to present the first prospective Romanian cohort evaluating the effectiveness and safety in clinical practice of this 3DAA combination in patients with HCV genotype-1b Child A liver cirrhosis.
Methods: 681 patients received OBV/PTV/r+DSV+RBV for 12 weeks and were assessed clinically and biologically at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained viral response, SVR).
Results: Per protocol, EOT virological response was 99.8% and SVR12 rate was 99.4%. Adverse events were present in 36.4% of patients. Permanent discontinuation of 3DAA regimen due to side effects was reported in 11 patients (1.6%). In 47.6% (185/389) of patients, Transient Elastography values were >20kPa (defined as clinically significant portal hypertension, CSPH) at baseline. Independent variables associated with CSPH were: baseline cholesterol level (p=0.003), platelet count <120,000/mm³ (p=0.02), MELD score (p=0.01).
Liver stiffness measurement has significantly improved between baseline (26.6±12.7kPa) and SVR12 (21.6±11.8kPa) (p<0.0001). The same was true for APRI score (2.66±0.15 at baseline vs 0.85±0.02 at SVR12, p<0.0001) and FIB4 score (5.53±0.28 vs 3.24±0.08, p<0.0001), but not for Lok score (0.57±0.01 vs 0.63±0.01, p<0.0001).
Conclusions: We report a high efficacy of the 3DAA regimen in a homogeneous compensated HCV genotype-1b liver cirrhosis population, in a real-life setting. Noninvasive fibrosis scores significantly improved at SVR12.
Key words: hepatitis C – cirrhosis – portal hypertension – therapy.
Abbreviations: AE: adverse effect; AFP: alpha feto-protein; CSPH: clinically significant portal hypertension; DAA: direct-acting antiviral; EOT: end of treatment; GT: genotype; HCV: hepatitis C virus; HCC: hepatocellular carcinoma; LSM: liver stiffness measurement; MELD: Model of end stage liver disease; NHIA: National Health Insurance Agency; OBV/PTV/r+DSV: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir; RBV: ribavirin; SAE: serious adverse effect; SVR: sustained viral response; TE: transient elastography.