Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02969668 |
| Other study ID # |
AI444-366 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Universitätsklinikum Hamburg-Eppendorf |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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
naïve/Non-responder/Relapser) 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.
