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

NCT02333292 | Completed

• 2 other identifiers: GEHEP-MONOGEHEP-001
• Study Type: observational
• Target: 1,128
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients with Sustained Virological Response

  Efficacy of treatment against hepatitis C virus infection based on direct-acting antivirals in real-life conditions as reflected in proportion of patients who achieve sustained virological response 12 weeks after end of therapy.

  48 weeks

• Number of Participants with Adverse Events

  Safety of treatment against hepatitis C virus infection based on direct-acting antivirals in real-life conditions as reflected in the number of patients with adverse events.

  48 weeks

Secondary Outcomes (5)

• Identification of predictors of SVR

  48 weeks

• Analyze efficacy and safety in patients that receive methadone maintenance therapy

  48 weeks

• Analyze efficacy and safety according to previous treatment outcome

  48 weeks

• Analyze efficacy and safety in patients with cirrhosis

  48 weeks

• Evaluate impact of SVR on biological, elastographical and clinical parameters

  48 hours

Study Arms (2)

IFN

HCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing pegylated interferon in combination with any DAA

Drug: Telaprevir; Drug: Boceprevir; Drug: Sofosbuvir; Drug: Simeprevir

IFN-free

HCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing one or more DAA

Drug: Sofosbuvir; Drug: Simeprevir; Drug: Daclatasvir; Drug: Ledipasvir; Drug: ritonavir-boosted Paritaprevir/ Ombitasvir; Drug: Dasabuvir; Drug: Velpatasvir; Drug: Elbasvir; Drug: Grazoprevir

Interventions

Telaprevir DRUG

Initiation of a regimen containing TVR

Also known as: TVR

IFN

Boceprevir DRUG

Initiation of a regimen containing BOC

Also known as: BOC

IFN

Sofosbuvir DRUG

Initiation of a regimen containing SOF

Also known as: SOF

IFN; IFN-free

Simeprevir DRUG

Initiation of a regimen containing SMV

Also known as: SMV

IFN; IFN-free

Daclatasvir DRUG

Initiation of a regimen containing DCV

Also known as: DCV

IFN-free

Ledipasvir DRUG

Initiation of a regimen containing LDV

Also known as: LDV

IFN-free

ritonavir-boosted Paritaprevir/ Ombitasvir DRUG

Initiation of a drug combination of PTV/OTV

Also known as: PTV/OTV

IFN-free

Dasabuvir DRUG

Initiation of a regimen containing DBV

Also known as: DBV

IFN-free

Velpatasvir DRUG

Initiation of a regimen containing VPV

Also known as: VPV

IFN-free

Elbasvir DRUG

Initiation of a regimen containing EBV

Also known as: EBV

IFN-free

Grazoprevir DRUG

Initiation of a regimen containing GZR

Also known as: GZR

IFN-free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HCV-infected patients who initiated treatment against HCV including a direct-acting antiviral

You may qualify if:

• older than 18 years
• initiation of therapy including a direct-acting antiviral against HCV

You may not qualify if:

• HIV-infection
• unable to provide written informed consent

Sponsors & Collaborators

• Valme University Hospital: lead
• Hospital del SAS de Jerez: collaborator
• Hospital General Universitario Elche: collaborator
• Hospital La Línea de la Concepción: collaborator
• Complexo Hospitalario Universitario de A Coruña: collaborator
• Hospital de Figueres: collaborator
• Hospital Universitario Puerto Real: collaborator
• Hospital Universitario Virgen de la Victoria: collaborator
• Hospital Universitario de Canarias: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Universitario Araba: collaborator
• Hospital Royo Vilanova: collaborator
• Hospital Universitario de Burgos: collaborator
• Complejo Hospitalario Universitario de Huelva: collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator
• Hospital Universitario La Fe: collaborator
• Hospital General Universitario de Valencia: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Hospital Universitario de Gran Canaria: collaborator
• Hospital General Universitario Santa Lucía: collaborator
• Centro Penitenciario Alicante 1: collaborator
• Hospital Regional Universitario Carlos Haya: collaborator
• Hospital Virgen de la Luz: collaborator
• Hospital General Universitario de Castellón: collaborator
• Parc Taulí Hospital Universitari: collaborator

Study Sites (1)

Valme University Hospital

Seville, Andalusia, 41014, Spain

Location

Related Publications (8)

• Mancebo M, Real LM, Mira JA, Recio E, Perez E, Monje-Agudo P, Merchante N, Macias J, Neukam K, Pineda JA. Changes in the response to treatment against chronic hepatitis C between 1999 and 2015: data from a prospective cohort. Eur J Gastroenterol Hepatol. 2016 Nov;28(11):1253-7. doi: 10.1097/MEG.0000000000000705.

  PMID: 27415157 RESULT

• Macias J, Monge P, Mancebo M, Merchante N, Neukam K, Real LM, Pineda JA. High frequency of potential interactions between direct-acting antivirals and concomitant therapy in HIV/hepatitis C virus-coinfected patients in clinical practice. HIV Med. 2017 Aug;18(7):445-451. doi: 10.1111/hiv.12471. Epub 2016 Nov 24.

  PMID: 27882706 RESULT

• Neukam K, Morano-Amado LE, Rivero-Juarez A, Macias J, Granados R, Romero-Palacios A, Marquez M, Merino D, Ortega E, Alados-Arboledas JC, Cucurull J, Omar M, Ryan-Murua P, Pineda JA; Grupo de Estudio de Hepatitis Virica, of the Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica: GEHEP-SEIMC and Grupo de Estudio de Hepatitis Virica, of the Sociedad Andaluza de Enfermedades Infecciosas y Microbiologia Clinica: HEPAVIR/Red de Investigacion en SIDA (RIS-HEP07). Liver stiffness predicts the response to direct-acting antiviral-based therapy against chronic hepatitis C in cirrhotic patients. Eur J Clin Microbiol Infect Dis. 2017 May;36(5):853-861. doi: 10.1007/s10096-016-2871-x. Epub 2016 Dec 21.

  PMID: 28004322 RESULT

• Pineda JA, Morano-Amado LE, Granados R, Macias J, Tellez F, Garcia-Deltoro M, Rios MJ, Collado A, Delgado-Fernandez M, Suarez-Santamaria M, Serrano M, Miralles-Alvarez C, Neukam K; Grupo de Estudio de Hepatitis Virica, of the Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica: GEHEP-SEIMC; Grupo de Estudio de Hepatitis Virica, of the Sociedad Andaluza de Enfermedades Infecciosas y Microbiologia Clinica: HEPAVIR / Red de Investigacion en SIDA (RIS-HEP07). Week 4 response predicts sustained virological response to all-oral direct-acting antiviral-based therapy in cirrhotic patients with hepatitis C virus genotype 3 infection. Clin Microbiol Infect. 2017 Jun;23(6):409.e5-409.e8. doi: 10.1016/j.cmi.2016.12.034. Epub 2017 Jan 28.

  PMID: 28137633 RESULT

• Neukam K, Morano-Amado LE, Rivero-Juarez A, Mancebo M, Granados R, Tellez F, Collado A, Rios MJ, de Los Santos-Gil I, Reus-Banuls S, Vera-Mendez F, Geijo-Martinez P, Montero-Alonso M, Suarez-Santamaria M, Pineda JA. HIV-coinfected patients respond worse to direct-acting antiviral-based therapy against chronic hepatitis C in real life than HCV-monoinfected individuals: a prospective cohort study. HIV Clin Trials. 2017 May;18(3):126-134. doi: 10.1080/15284336.2017.1330801.

  PMID: 28599618 RESULT

• Alvarez-Ossorio MJ, Sarmento E Castro R, Granados R, Macias J, Morano-Amado LE, Rios MJ, Merino D, Alvarez EN, Collado A, Perez-Perez M, Tellez F, Martin JM, Mendez J, Pineda JA, Neukam K; HEPAVIR-DAA, GEHEP-MONO, RIS-HEP07 and RIS-HEP13 Study Groups. Impact of interferon-free regimens on the glomerular filtration rate during treatment of chronic hepatitis C in a real-life cohort. J Viral Hepat. 2018 Jun;25(6):699-706. doi: 10.1111/jvh.12867. Epub 2018 Feb 27.

  PMID: 29377515 RESULT

• Gonzalez-Serna A, Corma-Gomez A, Tellez F, Corona-Mata D, Rios-Villegas MJ, Merino D, Galera C, Collado-Romacho AR, De Los Santos I, Cucurull J, Santos M, Garcia-Martin S, Rivero A, Real LM, Macias J. Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice. J Antimicrob Chemother. 2023 Oct 3;78(10):2591-2596. doi: 10.1093/jac/dkad278.

  PMID: 37671831 DERIVED

• Macias J, Morano LE, Tellez F, Granados R, Rivero-Juarez A, Palacios R, Rios M, Merino D, Perez-Perez M, Collado A, Figueruela B, Morano A, Freyre-Carrillo C, Martin JM, Rivero A, Garcia F, Pineda JA; HEPAVIR group from the Sociedad Andaluza de Enfermedades Infecciosas (SAEI) and the GEHEP group from the Sociedad Espanola de Enfermedades Infecciosas y Microbiologia (SEIMC). Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy. J Hepatol. 2019 Jul;71(1):45-51. doi: 10.1016/j.jhep.2019.02.018. Epub 2019 Mar 8.

  PMID: 30853642 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples

MeSH Terms

Interventions

telaprevir; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; Sofosbuvir; Simeprevir; daclatasvir; ledipasvir; ombitasvir; dasabuvir; velpatasvir; elbasvir; grazoprevir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Karin I Neukam, Dr

  Valme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 7, 2015
• Study Start: December 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: June 30, 2017
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

ES (1)