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. 2017 May 6;8(2):137-146.
doi: 10.4292/wjgpt.v8.i2.137.

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Huascar Ramos  1 , Pedro Linares  1 , Ester Badia  1 , Isabel Martín  1 , Judith Gómez  1 , Carolina Almohalla  1 , Francisco Jorquera  1 , Sara Calvo  1 , Isidro García  1 , Pilar Conde  1 , Begoña Álvarez  1 , Guillermo Karpman  1 , Sara Lorenzo  1 , Visitación Gozalo  1 , Mónica Vásquez  1 , Diana Joao  1 , Marina de Benito  1 , Lourdes Ruiz  1 , Felipe Jiménez  1 , Federico Sáez-Royuela  1 , Asociación Castellano Y Leonesa de Hepatología ACyLHE  1
Affiliations

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Huascar Ramos et al. World J Gastrointest Pharmacol Ther. .

Abstract

Aim: To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).

Methods: We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).

Results: The most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).

Conclusion: A high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.

Keywords: Direct-acting antiviral agents; Genotype 1-4; Hepatitis C virus infection; Real world treatment.

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Conflict of interest statement

Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.

Figures

Figure 1
Figure 1
Rates of virological response. Patients with undetectable viral loads during and post treatment. A: At treatment week 4 and post-treatment week 12 (sustained virological response) by genotype; B: At treatment week 4 and post-treatment week 12 (sustained virological response) by fibrosis stage; C: At treatment week 4 and post-treatment week 12 (sustained virological response) by CT-met and CT-unmet. Data for 5 patients were lost: genotype 1, data from three patients were lost; genotype 3 and 4, a patient data in each genotype were lost. Data for 4 patients were lost. Data for 1 patient were lost. GT: Genotype; RVR: Undetectable HCV RNA at week 4; SVR: Sustained virological response; CT: Clinical trial.
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