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J Hepatol. 2017 Jun;66(6):1138-1148. doi: 10.1016/j.jhep.2017.01.028. Epub 2017 Feb 9.

Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.

Author information

1
Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid and CIBERehd, Madrid, Spain. Electronic address: joseluis.calleja@uam.es.
2
Hospital Universitario Marques de Valdecilla, IDIVAL, Santander and Facultad de Medicina, Universidad de Cantabria, Spain.
3
Hospital General Universitario Gregorio Marañón, Facultad de Medicina de la Universidad Complutense and CIBERehd, Madrid, Spain.
4
Hospital Universitario Puerta de Hierro, Madrid, Spain.
5
Hospital Universitario 12 de Octubre, Madrid, Spain.
6
Hospital Universitario Ramon y Cajal, Madrid, Spain.
7
Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
8
Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
9
Hospital San Pedro, Logroño, Spain.
10
Hospital Universitario La Fe and CIBERehd, Valencia, Spain.
11
Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Cantabria, Spain.
12
Hospital Universitario Virgen del Rocío and CIBERehd, Seville, Spain.
13
Complejo Hospitalario Universitario de Pontevedra and IISGS, Spain.
14
Hospital Santa Creu i Sant Pau and CIBERehd, Barcelona, Spain.
15
Hospital Germans Trias I Pujol and CIBERehd, Badalona, Spain.
16
Hospital Universitario Vall D'Hebrón, Barcelona, Spain.
17
Hospital Clínico de Valencia, Valencia, Spain.
18
Hospital Universitario General de Valencia, Valencia, Spain.
19
Hospital Universitario Fundación Alcorcón, Madrid, Spain.
20
Hospital Universitario Virgen del Rocío, IBIS and CIBERehd, Spain.
21
Complejo Asistencial Universitario León, León, IBIOMED and CIBERehd, Spain.
22
Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
23
Hospital Universitario Donostia, San Sebastian, Spain.
24
Hospital Universitario Central de Asturias, Oviedo, Spain.

Abstract

BACKGROUND & AIMS:

Clinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 infection. We aimed to investigate the effectiveness and safety of two oral DAA combination regimens, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OMV/PTV/r+DSV) and ledipasvir/sofosbuvir (LDV/SOF), in a real-world clinical practice.

METHODS:

Data from HCV genotype 1 patients treated with either OMV/PTV/r+DSV±ribavirin (RBV) (n=1567) or LDV/SOF±RBV (n=1758) in 35 centers across Spain between April 1, 2015 and February 28, 2016 were recorded in a large national database. Demographic, clinical and virological data were analyzed. Details of serious adverse events (SAEs) were recorded.

RESULTS:

The two cohorts were not matched with respect to baseline characteristics and could not be compared directly. The SVR12 rate was 96.8% with OMV/PTVr/DSV±RBV and 95.8% with LDV/SOF±RBV. No significant differences were observed in SVR according to HCV subgenotype (p=0.321 [OMV/PTV/r+DSV±RBV] and p=0.174 [LDV/SOF]) or degree of fibrosis (c0.548 [OMV/PTV/r/DSV±RBV] and p=0.085 [LDV/SOF]). Only baseline albumin level was significantly associated with failure to achieve SVR (p<0.05) on multivariate analysis. Rates of SAEs and SAE-associated treatment discontinuation were 5.4% and 1.7%, in the OMV/PTV/r+DSV subcohort and 5.5% and 1.5% in the LDV/SOF subcohort, respectively. Hepatocellular carcinoma (HCC) recurred in 30% of patients with a complete response to therapy for previous HCC. Incident HCC was reported in 0.93%.

CONCLUSIONS:

In this large cohort of patients managed in the real-world setting in Spain, OMV/PTV/r+DSV and LDV/SOF achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with similarly good safety profiles.

LAY SUMMARY:

In clinical trials, second-generation direct-acting antiviral agents (DAAs) have been shown to cure over 90% of patients chronically infected with the genotype 1 hepatitis C virus and have been better tolerated than previous treatment regimens. However, patients enrolled in clinical trials do not reflect the real patient population encountered in routine practice. The current study, which includes almost 4,000 patients, demonstrates comparable rates of cure with two increasingly used DAA combinations as those observed in the clinical trial environment, confirming that clinical trial findings with DAAs translate into the real-world setting, where patient populations are more diverse and complex.

KEYWORDS:

Antiviral agents; Dasabuvir; Genotype 1; Hepatitis C, Chronic; Ledipasvir; Ombitasvir; Paritaprevir; Randomized controlled trials; Real-world; Ritonavir; Sofosbuvir; Sustained virologic response

PMID:
28189751
DOI:
10.1016/j.jhep.2017.01.028
[Indexed for MEDLINE]

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