Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02969668
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2016-06-05
Brief Title:
Interferon-free Antiviral Treatment of Chronic Hepatitis C Virus Infection Among Opioid-substituted Patients
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Effectiveness and Safety of Interferon-free Antiviral Regimens for the Treatment of Chronic Hepatitis C Virus Infection Among Opioid-substituted Patients
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFO
Brief Summary:
The primary objective of study will be to evaluate the effectiveness of interferon-free direct acting antivirals IFN-free DAAs in the treatment of chronic hepatitis C virus HCV among patients in opioid-substitution treatment OST We hypothesize that rates of sustained virological response will be comparable to non-OST populations Secondary objectives include the evaluation of safety data patients adherence and patient reported outcome measures like functioning disability satisfaction with the treatment health status general health perceptions and health-related quality of life
Detailed Description:
The new interferon-free antiviral regimens for the treatment of chronic hepatitis C CHC infections achieve impressive sustained virological response SVR rates beyond 90 with shorter treatment duration and reduced side effects irrespective of previous treatment history or presence of advanced liver diseases
In Europe the majority of HCV infections have been acquired and transmitted through injecting drug use - therefore people who inject drugs PWID represent the majority of individuals with CHC infections in the Western industrialized cultures There are excellent therapeutic options for those PWID who are in OST as the frequent treatment provider-patient contact allows regular diagnoses a continuing monitoring and a sustainable management of HCV-infection among these patients However despite the growing evidence that patients in OST can successfully be treated for HCV the treatment uptake among this predominant risk group is still very low The current evidence from non-drug using populations only have a limited impact on the willingness of physicians providing opioid substitution treatment OST hepatologists and infectiologists to provide antiviral HCV treatment with IFN-free DAAs and on the willingness of OST patients to enter such treatment Accordingly data on the effectiveness and safety of antiviral HCV treatment regimens with IFN-free DAAs among this relevant patient group are urgently needed The aim of this prospective cohort study is to assess the effectiveness safety and patient reported outcome measures of IFN-free DAAs for the treatment of CHC among OST patients
The primary objective of this open-label observational prospective cohort study will be to evaluate the effectiveness of IFN-free DAAs regimens for the treatment of chronic HCV-infection among OST patients in real life clinical settings
Patients will be treated for chronic HCV with any kind of registered IFN-free DAA protocol and in accordance with the respective SmPC This ensures that that dosing and schedule are supported by Phase I or later research The study physician will make any medical decisions with regard to type of medication and doses The individual treatment duration depends on the respective treatment protocol The study physician is responsible for any medical decision and will document treatment dosage treatment schedule treatment duration and outcome
Effectiveness is defined as sustained virological response at week 12 and week 24 after end of treatment SVR12 and SVR24 SVR rates will be compared with the literature on non-substance using populations on the basis of two-sided 95 confidence intervals The sample size calculation revealed that 295 OST patients HCV treatment naïveNon-responderRelapser eligible for treatment with IFN-free DAAs according to the summary of product SmPC have to be included To account for dropouts we consider an over-recruitment of 10 resulting in 325 patients to be recruited
Secondary objectives include the collection of safety data during the treatment phase until SVR12 patients adherence and patient reported outcome measures like functioning disability satisfaction with the treatment health status general health perceptions and health-related quality of life
All analyses - effectiveness and safety - will be conducted as intention-to-treat ITT as well as per protocol PP analyses The ITT sample is defined as the number of patients starting treatment first dose whereas the PP sample includes only patients with complete data for SVR24
In Europe the majority of HCV infections have been acquired and transmitted through injecting drug use - therefore people who inject drugs PWID represent the majority of individuals with CHC infections in the Western industrialized cultures There are excellent therapeutic options for those PWID who are in OST as the frequent treatment provider-patient contact allows regular diagnoses a continuing monitoring and a sustainable management of HCV-infection among these patients However despite the growing evidence that patients in OST can successfully be treated for HCV the treatment uptake among this predominant risk group is still very low The current evidence from non-drug using populations only have a limited impact on the willingness of physicians providing opioid substitution treatment OST hepatologists and infectiologists to provide antiviral HCV treatment with IFN-free DAAs and on the willingness of OST patients to enter such treatment Accordingly data on the effectiveness and safety of antiviral HCV treatment regimens with IFN-free DAAs among this relevant patient group are urgently needed The aim of this prospective cohort study is to assess the effectiveness safety and patient reported outcome measures of IFN-free DAAs for the treatment of CHC among OST patients
The primary objective of this open-label observational prospective cohort study will be to evaluate the effectiveness of IFN-free DAAs regimens for the treatment of chronic HCV-infection among OST patients in real life clinical settings
Patients will be treated for chronic HCV with any kind of registered IFN-free DAA protocol and in accordance with the respective SmPC This ensures that that dosing and schedule are supported by Phase I or later research The study physician will make any medical decisions with regard to type of medication and doses The individual treatment duration depends on the respective treatment protocol The study physician is responsible for any medical decision and will document treatment dosage treatment schedule treatment duration and outcome
Effectiveness is defined as sustained virological response at week 12 and week 24 after end of treatment SVR12 and SVR24 SVR rates will be compared with the literature on non-substance using populations on the basis of two-sided 95 confidence intervals The sample size calculation revealed that 295 OST patients HCV treatment naïveNon-responderRelapser eligible for treatment with IFN-free DAAs according to the summary of product SmPC have to be included To account for dropouts we consider an over-recruitment of 10 resulting in 325 patients to be recruited
Secondary objectives include the collection of safety data during the treatment phase until SVR12 patients adherence and patient reported outcome measures like functioning disability satisfaction with the treatment health status general health perceptions and health-related quality of life
All analyses - effectiveness and safety - will be conducted as intention-to-treat ITT as well as per protocol PP analyses The ITT sample is defined as the number of patients starting treatment first dose whereas the PP sample includes only patients with complete data for SVR24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None