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

Abstract

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.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.

Impact of successful treatment with direct-acting antiviral agents on health-related quality of life in chronic hepatitis C patients

“…The use of RBV was not associated with significant disutility, a fact that suggests a lower impact of side effects such as anaemia and pruritus, when administered in combination with DAA compared to when administered with interferon. This aspect reinforces the idea of the good tolerability of DAA in real life conditions [ 45 , 46 ].…”

Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

“…Beyond clinical trials, numerous studies have evaluated the PTV/r/OBV + DSV combination administered for 12 weeks in clinical practice, all of them including a great proportion of patients with cirrhosis . As a whole, these studies have consistently shown SVR12 rates higher than 95% in all subgroups of patients, confirming data obtained from pivotal clinical trials.…”

Liver Remodeling on CT Examination in Patients with HCV Compensated Cirrhosis Who Achieved Sustained Virological Response after Direct-Acting Antivirals Treatment

“…Worldwide, one of the main causes of cirrhosis is the infection with hepatitis C virus (HCV) [2]. Direct acting antivirals (DAAs) introduced in 2014 have represented a revolution for the treatment of patients with HCV due to high sustained virologic response (SVR) rate (95-100% in genotype 1) and excellent tolerability [3,4]. Despite the proven SVR, there is still a risk of developing HCC that justifies careful monitoring of these patients [5].…”