Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Summary

Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who show sustained virologic response (SVR) to treatment including direct-acting antivirals (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to determine the frequency of adverse events, including those that are severe and/or cause treatment interruption, in DAA-based therapy in this setting.

Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology (SEIMC).

Study population: HCV-monoinfected patients that initiate DAA-based treatment outside clinical trials.

Variables: The primary efficacy outcome variable is the proportion of patients who reach undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety outcome variable is the percentage of subjects who discontinue therapy due to adverse events.

Statistical analysis: A descriptive study will be performed, as well as a double sensibility analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment approach. Those variables that are associated with SVR12 with a p-value \<0.2 will be included in a logistic regression analysis in which SVR12 will be the dependent variable.

Conditions

• Chronic Hepatitis C Infection

Interventions

DRUG

Telaprevir

Initiation of a regimen containing TVR

DRUG

Boceprevir

Initiation of a regimen containing BOC

DRUG

Sofosbuvir

Initiation of a regimen containing SOF

DRUG

Simeprevir

Initiation of a regimen containing SMV

DRUG

Daclatasvir

Initiation of a regimen containing DCV

DRUG

Ledipasvir

Initiation of a regimen containing LDV

DRUG

ritonavir-boosted Paritaprevir/ Ombitasvir

Initiation of a drug combination of PTV/OTV

DRUG

Dasabuvir

Initiation of a regimen containing DBV

DRUG

Velpatasvir

Initiation of a regimen containing VPV

DRUG

Elbasvir

Initiation of a regimen containing EBV

DRUG

Grazoprevir

Initiation of a regimen containing GZR

Sponsors & Collaborators

• Hospital del SAS de Jerez

  collaborator OTHER

• Hospital General Universitario Elche

  collaborator OTHER

• Hospital La Línea de la Concepción

  collaborator UNKNOWN

• Complexo Hospitalario Universitario de A Coruña

  collaborator OTHER

• Hospital de Figueres

  collaborator UNKNOWN

• Hospital Universitario Puerto Real

  collaborator OTHER

• Hospital Universitario Virgen de la Victoria

  collaborator OTHER

• Hospital Universitario de Canarias

  collaborator OTHER

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Universitario Araba

  collaborator OTHER

• Hospital Royo Vilanova

  collaborator UNKNOWN

• Hospital Universitario de Burgos

  collaborator OTHER

• Complejo Hospitalario Universitario de Huelva

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Complejo Hospitalario Universitario de Vigo

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  collaborator OTHER

• Hospital Clinico Universitario San Cecilio

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital General Universitario de Valencia

  collaborator OTHER

• Hospital Universitario Infanta Leonor

  collaborator OTHER

• Hospital Universitario de Gran Canaria

  collaborator UNKNOWN

• Hospital General Universitario Santa Lucía

  collaborator OTHER

• Centro Penitenciario Alicante 1

  collaborator UNKNOWN

• Hospital Regional Universitario Carlos Haya

  collaborator OTHER

• Hospital Virgen de la Luz

  collaborator OTHER

• Hospital General Universitario de Castellón

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Valme University Hospital

  lead OTHER

Principal Investigators

• Karin I Neukam, Dr · Valme University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2016-12-31

Completion

2017-06-30

Countries

• Spain

Study Locations