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Chronic Hepatitis C InfectionFPSMON201401NCT02333292

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

An observational study of Chronic Hepatitis C Infection, run by Valme University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
Telaprevir, Boceprevir and Sofosbuvir
How many people
1,128 participants
Where
1 siteSpain
Study dates
Dec 2014to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • HIV-infection
  • unable to provide written informed consent

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Valme University Hospital

    Seville, Andalusia, 41014

Other trials in Spain

About this study

Official title: Efficacy and Safety of Treatment Against Hepatitis C Virus Infection Based on Direct-acting Antivirals in Real-life Conditions: The GEHEP Cohort

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).

Read more

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.

Read the detailed description

The incidence of hepatic decompensations and mortality is reduced considerable in patients who achieve sustained virologic response (SVR) to therapy against hepatitis C virus (HCV) infection. With the arrival of direct-acting antivirals (AAD) against HCV, rates of SVR are significantly higher than what was achieved with pegylated interferon (peg-IFN) in combination with ribavirin (RBV). Therefore, AADs could have a high impact in this context. Therefore, triple therapy against HCV genotype 1 based on the first-generation protease inhibitors (PI) telaprevir (TVR) or boceprevir (BOC) plus peg-IFN/RBV became standard therapy in 2011 and SVR rates as high as 68%-75% were reached in treatment-naïve patients. In treatment-experienced subjects, retreatment with triple therapy resulted in higher SVR rates than what was observed with dual therapy alone, however, treatment success strongly depends on the previous response pattern. Unfortunately, combinations based on TVR or BOC are not well tolerated, treatments are complex, costs are high and pharmacological interactions are frequently observed.

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.

Being tested
Telaprevir, Boceprevir, Sofosbuvir, Simeprevir, Daclatasvir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaprevirDrug

    Also called TVR

    Initiation of a regimen containing TVR

  • BoceprevirDrug

    Also called BOC

    Initiation of a regimen containing BOC

  • SofosbuvirDrug

    Also called SOF

    Initiation of a regimen containing SOF

  • SimeprevirDrug

    Also called SMV

    Initiation of a regimen containing SMV

  • DaclatasvirDrug

    Also called DCV

    Initiation of a regimen containing DCV

  • LedipasvirDrug

    Also called LDV

    Initiation of a regimen containing LDV

  • ritonavir-boosted Paritaprevir/ OmbitasvirDrug

    Also called PTV/OTV

    Initiation of a drug combination of PTV/OTV

  • DasabuvirDrug

    Also called DBV

    Initiation of a regimen containing DBV

  • VelpatasvirDrug

    Also called VPV

    Initiation of a regimen containing VPV

  • ElbasvirDrug

    Also called EBV

    Initiation of a regimen containing EBV

  • GrazoprevirDrug

    Also called GZR

    Initiation of a regimen containing GZR

Study groups in NCT02333292
Study groupRoleWhat they receive
IFNHCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing pegylated interferon in combination with any DAA
Receives: Drug: Telaprevir; Drug: Boceprevir; Drug: Sofosbuvir; Drug: Simeprevir
IFN-freeHCV-infected patients, pre-treated or treatment-naïve, who start a regimen containing one or more DAA
Receives: Drug: Sofosbuvir; Drug: Simeprevir; Drug: Daclatasvir; Drug: Ledipasvir; Drug: ritonavir-boosted Paritaprevir/ Ombitasvir; Drug: Dasabuvir; Drug: Velpatasvir; Drug: Elbasvir; Drug: Grazoprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 weeks

  2. 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.

    Measured: 48 weeks

Secondary outcomes (5)

  1. Identification of predictors of SVR

    Measured: 48 weeks

  2. Analyze efficacy and safety in patients that receive methadone maintenance therapy

    Measured: 48 weeks

  3. Analyze efficacy and safety according to previous treatment outcome

    Measured: 48 weeks

  4. Analyze efficacy and safety in patients with cirrhosis

    Measured: 48 weeks

  5. Evaluate impact of SVR on biological, elastographical and clinical parameters

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completion31 Dec 2016
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02333292
Sponsor's protocol ID
GEHEP-MONO
Other IDs
GEHEP-001
Acronym
FPSMON201401
Status last verified
Jun 2022
First submitted
15 Dec 2014
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27415157

  • 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.

    PubMed 27882706

  • 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.

    PubMed 28004322

  • 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.

    PubMed 28137633

  • 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.

    PubMed 28599618

  • 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.

    PubMed 29377515

  • 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.

    PubMed 37671831

  • 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.

    PubMed 30853642

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C Infection, run by Valme University Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients with Sustained Virological Response (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02333292, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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