A Phase 2 interventional study of Paroxetine and telaprevir in Hepatitis C Infection and Depression, sponsored by Radboud University Medical Center. Terminated at 7 sites in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Other
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.
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 3 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
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Exclusion Criteria:
paroxetine 20 mg tablet once daily oral
Drug: Paroxetine
paroxetine 20 mg tablet once daily + telaprevir 1125 mg (3 tablets 375mg) twice daily oral
Drug: Paroxetine · Drug: telaprevir
paroxetine 20 mg once daily
telaprevir 1125 mg twice daily
paroxetine area under the curve (AUC)
paroxetine AUC will be compared intrasubject: day 14 + telaprevir / day -1 (without telaprevir)
Time frame: day -1 and day 14
paroxetine Cmax and C24
Comparison of Cmax and C24 of paroxetine intrasubject. Day 14 (+telaprevir) / Day -1 (without telaprevir)
Time frame: Day -1 and Day 14
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse events will be scored during the study
Time frame: Day -1 to Day 28
short term HCV RNA response
At week 4 HCV RNA will be determined
Time frame: week 4
telaprevir area under the curve (AUC)
Telaprevir pharmacokinetics (PK) will be determined with paroxetine concomitant use. To be compared to historical data
Time frame: Day 14
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center