Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01841502 |
| Other study ID # |
AKF UMCN 12.02 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 2013 |
| Est. completion date |
September 2014 |
Study information
| Verified date |
December 2020 |
| Source |
Radboud University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction
of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV
infected patients.Telaprevir has been studied with one antidepressant, escitalopram: plasma
concentrations of the antidepressant were reduced by 35% and without dose adjustment this may
lead to inadequate treatment of depressive symptoms. There is a need for more data on
telaprevir drug interactions with other antidepressants.
For a number of reasons, paroxetine may be a good candidate for use together with
telaprevir-containing HCV treatment.
The interaction between paroxetine and telaprevir has not been studied before.
Description:
HCV infected patients are often in need for an antidepressant. Inadequate treatment of
depression during HCV treatment has a negative effect on adherence to HCV treatment, with
suboptimal response as a potential result.
The introduction of Direct Acting Antivirals such as telaprevir has greatly improved
treatment outcome of HCV infected patients. Telaprevir, however, causes some significant
drug-drug interactions and hence co-administration of other medications should preferably
only be done based on clinical evidence that such a combination is safe.
Telaprevir has been studied with one antidepressant, escitalopram: plasma concentrations of
the antidepressant were reduced by 35% and without dose adjustment this may lead to
inadequate treatment of depressive symptoms. Dose titration of escitalopram may be needed but
it may take several weeks before a patient has reached a therapeutic dose.
There is a need for more data on telaprevir drug interactions with other antidepressants.
First, the data above show that a negative interaction occurs with escitalopram and
dose-titration of the antidepressant may take too long to prevent the (re-)occurrence of
depressive symptoms. Second, not all patients benefit from escitalopram and those with
(prior) treatment failure on escitalopram may require an alternative agent. Third, although
escitalopram is generally well-tolerated, side effects may occur and necessitate treatment
discontinuation. Finally, especially in the previous intravenous drug users on methadone,
escitalopram might not be the antidepressant of choice, since escitalopram as well as
methadone are drugs that can lead to QTc interval prolongation and have a risk of Torsades de
Pointes.
For a number of reasons, paroxetine may be a good candidate for use together with
telaprevir-containing HCV treatment. First, paroxetine has been shown to prevent depressive
symptoms in patients initiating HCV treatment with elevated depressive symptoms at baseline.
Second, paroxetine is an inhibitor of and is metabolized by CYP2D6 while telaprevir is an
inhibitor of and is metabolized by CYP3A, and therefore no drug-drug interaction is expected.
Third, paroxetine is one of the most widely prescribed antidepressants with a
well-established efficacy and safety profile.
