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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.
- Source :
-
Journal of gastrointestinal and liver diseases : JGLD [J Gastrointestin Liver Dis] 2017 Sep; Vol. 26 (3), pp. 275-281. - Publication Year :
- 2017
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Abstract
- Background and 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.<br />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).<br />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).<br />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.
- Subjects :
- 2-Naphthylamine
Aged
Anilides adverse effects
Antiviral Agents adverse effects
Carbamates adverse effects
Cyclopropanes
Drug Therapy, Combination
Elasticity Imaging Techniques
Female
Genotype
Hepacivirus genetics
Hepacivirus pathogenicity
Hepatitis C diagnosis
Hepatitis C virology
Humans
Lactams, Macrocyclic
Liver Cirrhosis diagnosis
Liver Cirrhosis virology
Macrocyclic Compounds adverse effects
Male
Middle Aged
Proline analogs & derivatives
Prospective Studies
Ritonavir adverse effects
Romania
Sulfonamides adverse effects
Sustained Virologic Response
Time Factors
Treatment Outcome
Uracil adverse effects
Uracil therapeutic use
Valine
Anilides therapeutic use
Antiviral Agents therapeutic use
Carbamates therapeutic use
Hepacivirus drug effects
Hepatitis C drug therapy
Liver Cirrhosis drug therapy
Macrocyclic Compounds therapeutic use
Ritonavir therapeutic use
Sulfonamides therapeutic use
Uracil analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1842-1121
- Volume :
- 26
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of gastrointestinal and liver diseases : JGLD
- Publication Type :
- Academic Journal
- Accession number :
- 28922440
- Full Text :
- https://doi.org/10.15403/jgld.2014.1121.263.iac