Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
NCT ID: NCT02333292
Last Updated: 2022-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1128 participants
OBSERVATIONAL
2014-12-31
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients
NCT02057003
Very Rapid and Rapid Virological Response as Predictors of Response of HCV Tretment
NCT03480269
Endothelial Dysfunction and Subclinical Atheromatosis in Chronic HCV Infection. Response to DAA Agents.
NCT02802280
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
NCT02202980
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
NCT01740791
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The next generation of DAAs offers increased response rates and, furthermore, a better safety pattern than TVR or BOC. Additionally, the dosing of the newer DAAs is easier and more convenient, and pharmacological interactions of the newer DAAs are easier to manage or even not relevant. The FDA has approved the second-generation PI simeprevir, the HCV non-structural (NS) protein NS 5B inhibitor sofosbuvir, as well as the inhibitors of NS 5A daclatasvir and ledipasvir. Apart from a better efficacy, safety and convenience, these new DAAs are active against HCV genotypes other than 1. Finally, some of the new DAAs can be administered in interferon-free regimens and therefore offer treatment options for interferon-intolerant individuals or for those with a contraindication for peg-IFN. Therefore, in the near future, the vast majority of HCV monoinfected patients will be treated with a combination including a DAA. Currently, the main problem is the high cost of the DAAs challenging the health systems.
In spite of the positive prospect regarding response rates to DAAs, there are a number of questions to be answered as soon as possible. On the one hand, the information on efficacy and safety of the DAAs available to date is derived from clinical trials that do not reflect the circumstances of the clinical practice. In this context, clinical trials usually include a considerably low proportion of patients with certain characteristics, such as cirrhotics. Data from the French cohort CUPIC reveal that this subgroup shows a lower tolerability of TVR or BOC than that reported in pivotal clinical trials. In fact, data obtained from this cohort resulted in a change of treatment guidelines for HCV monoinfected patients published by the Spanish Agency of Medicines. On the contrary, there is evidence based on observations made within the expanded access program study HEP3002 that individuals with advanced fibrosis show a efficacy and safety profile when treated with triple therapy that is more similar to that observed in clinical trials than within the CUPIC cohort. Nevertheless, in this study, exclusion criteria and follow-up were comparable to what is applied in clinical trials. Therefore, the study population may not reflect exactly the patient profile seen in real-life.
Currently, information on the distinct aspects of treatment against HCV including DAAs under real-life conditions in Spain is scarce. Clinicians at the Infectious Diseases Units treat a high number of HCV monoinfected patients. These physicians are confronted with a patient population in which a history of drug abuse is predominant, the majority of the individuals having consumed injecting drugs, who frequently suffer psychiatric pathology and who receive concomitant therapy that cause problems regarding drug-drug interactions and adherence. Also, the HCV genotype distribution is different to what is observed in Hepatology Units, being the genotype 1a predominant as compared to 1b, 3 and 4. Taken into account what was mentioned above, these factors could cause different rates of SVR to DAAs, interruptions and voluntary drop-outs as compared to what has been reported, especially in the difficult-to-treat population.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IFN
HCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing pegylated interferon in combination with any DAA
Telaprevir
Initiation of a regimen containing TVR
Boceprevir
Initiation of a regimen containing BOC
Sofosbuvir
Initiation of a regimen containing SOF
Simeprevir
Initiation of a regimen containing SMV
IFN-free
HCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing one or more DAA
Sofosbuvir
Initiation of a regimen containing SOF
Simeprevir
Initiation of a regimen containing SMV
Daclatasvir
Initiation of a regimen containing DCV
Ledipasvir
Initiation of a regimen containing LDV
ritonavir-boosted Paritaprevir/ Ombitasvir
Initiation of a drug combination of PTV/OTV
Dasabuvir
Initiation of a regimen containing DBV
Velpatasvir
Initiation of a regimen containing VPV
Elbasvir
Initiation of a regimen containing EBV
Grazoprevir
Initiation of a regimen containing GZR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telaprevir
Initiation of a regimen containing TVR
Boceprevir
Initiation of a regimen containing BOC
Sofosbuvir
Initiation of a regimen containing SOF
Simeprevir
Initiation of a regimen containing SMV
Daclatasvir
Initiation of a regimen containing DCV
Ledipasvir
Initiation of a regimen containing LDV
ritonavir-boosted Paritaprevir/ Ombitasvir
Initiation of a drug combination of PTV/OTV
Dasabuvir
Initiation of a regimen containing DBV
Velpatasvir
Initiation of a regimen containing VPV
Elbasvir
Initiation of a regimen containing EBV
Grazoprevir
Initiation of a regimen containing GZR
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* initiation of therapy including a direct-acting antiviral against HCV
Exclusion Criteria
* unable to provide written informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital del SAS de Jerez
OTHER
Hospital General Universitario Elche
OTHER
Hospital La Línea de la Concepción
UNKNOWN
Complexo Hospitalario Universitario de A Coruña
OTHER
Hospital de Figueres
UNKNOWN
Hospital Universitario Puerto Real
OTHER
Hospital Universitario Virgen de la Victoria
OTHER
Hospital Universitario de Canarias
OTHER
Hospital General Universitario de Alicante
OTHER
Hospital Universitario Araba
OTHER
Hospital Royo Vilanova
UNKNOWN
Hospital Universitario de Burgos
OTHER
Complejo Hospitalario Universitario de Huelva
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospital Universitario Virgen Macarena
OTHER
Complejo Hospitalario Universitario de Vigo
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Hospital Clinico Universitario San Cecilio
OTHER
Hospital Universitario La Fe
OTHER
Hospital General Universitario de Valencia
OTHER
Hospital Universitario Infanta Leonor
OTHER
Hospital Universitario de Gran Canaria
UNKNOWN
Hospital General Universitario Santa Lucía
OTHER
Centro Penitenciario Alicante 1
UNKNOWN
Hospital Regional Universitario Carlos Haya
OTHER
Hospital Virgen de la Luz
OTHER
Hospital General Universitario de Castellón
OTHER
Parc Taulí Hospital Universitari
OTHER
Valme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karin Neukam
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karin I Neukam, Dr
Role: PRINCIPAL_INVESTIGATOR
Valme University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Valme University Hospital
Seville, Andalusia, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GEHEP-001
Identifier Type: OTHER
Identifier Source: secondary_id
GEHEP-MONO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.