Armodafinil for Patients Starting Hepatitis C Virus Treatment
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/5/2014 |
| Start Date: | October 2011 |
| End Date: | June 2015 |
| Contact: | Judith G. Rabkin, Ph.D., MPH |
| Email: | jgr1@columbia.edu |
| Phone: | 212.543.5762 |
Armodafinil for Patients Starting Hepatitis C Treatment
Fatigue is one of the most common side effects of the treatment of hepatitis C infection
with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.
Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and
shift-work sleep disorder. This is a randomized placebo controlled study to determine
whether patients assigned to armodafinil have fewer missed doses, dose reductions or
treatment discontinuation due to side effects in the first 12 weeks of treatment for
hepatitis C infection than do placebo patients. Placebo patients are offered 14 weeks of
open label armodafinil after Week 12.
with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.
Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and
shift-work sleep disorder. This is a randomized placebo controlled study to determine
whether patients assigned to armodafinil have fewer missed doses, dose reductions or
treatment discontinuation due to side effects in the first 12 weeks of treatment for
hepatitis C infection than do placebo patients. Placebo patients are offered 14 weeks of
open label armodafinil after Week 12.
Four million Americans have chronic hepatitis C (HCV), and 30% of HIV+ patients are
co-infected with HCV. Until May 2011, the standard treatment for HCV was the combination of
alpha interferon (injected weekly) and ribavirin (daily pills) (IFN/RBV) for 48 weeks in
order to achieve sustained virologic remission (cure). HCV treatment initiation was low,
often because of concern about severe treatment side effects as well as high rates of
virologic failure. Among the minority of medically eligible HCV+ patients (with or without
co-morbid HIV/AIDS) who actually began treatment with IFN/RBV, side effects cause
substantial attrition (about 20% by Week 12, 40% by Week 24). The most common adverse events
are flu-like symptoms, of which fatigue is most prominent. Depressed mood is also common
(mostly somatic symptoms).
Two new medications, telaprevir and boceprevir (protease inhibitors) have been successful in
treatment of HCV in clinical trials, and both were approved by the FDA for those patients
with genotype 1 HCV, and are marketed as of May 2011. One of the new drugs will be added to
the current regimen for genotype 1 infection. Because both drugs are protease inhibitors,
which develop rapid resistance when administered alone, they must be added to the current
standard of care rather than replace it. This is expected to vastly increase willingness of
doctors to recommend treatment, and for patients to agree to treatment. The investigators
expect that most hepatologists will recommend, and patients agree to the addition of one of
these medications from now on. However, it should be noted that both commonly cause fatigue
if it isn't already present because of HCV itself, or peginterferon or ribavirin. The major
adverse event associated with telaprevir is rash, and with boceprevir, anemia.
This is a 14-week placebo controlled double blind trial of armodafinil for patients about to
begin HCV treatment, starting armodafinil or placebo 2 weeks prior to initiation of HCV
treatment. Patients are recruited from the hepatology clinics at the respective sites.
Randomization is 1:1. Placebo patients who continue HCV treatment are offered 14 weeks of
armodafinil starting at Week 12 of HCV treatment when the armodafinil/placebo blind is
broken.
Patients will be seen weekly for the first 4 weeks to titrate armodafinil dose and manage
side effects, if any, and then biweekly, with telephone contact on the intervening weeks
through Week 12. After that, monthly telephone calls through Week 24 will be conducted with
patients randomized to armodafinil, and biweekly visits with placebo patients beginning
armodafinil at Week 12.
The primary outcome measures concern non-adherence to INF/RBV treatment: 1) missed doses;
2) dose reductions, and 3) attrition due to side effects. Secondary outcomes include ratings
of fatigue on the Fatigue Severity Scale, depression on the Patient Health Questionnaire
(PHQ-9), and quality of life on the Endicott Quality of Life Enjoyment and Satisfaction
Questionnaire.
co-infected with HCV. Until May 2011, the standard treatment for HCV was the combination of
alpha interferon (injected weekly) and ribavirin (daily pills) (IFN/RBV) for 48 weeks in
order to achieve sustained virologic remission (cure). HCV treatment initiation was low,
often because of concern about severe treatment side effects as well as high rates of
virologic failure. Among the minority of medically eligible HCV+ patients (with or without
co-morbid HIV/AIDS) who actually began treatment with IFN/RBV, side effects cause
substantial attrition (about 20% by Week 12, 40% by Week 24). The most common adverse events
are flu-like symptoms, of which fatigue is most prominent. Depressed mood is also common
(mostly somatic symptoms).
Two new medications, telaprevir and boceprevir (protease inhibitors) have been successful in
treatment of HCV in clinical trials, and both were approved by the FDA for those patients
with genotype 1 HCV, and are marketed as of May 2011. One of the new drugs will be added to
the current regimen for genotype 1 infection. Because both drugs are protease inhibitors,
which develop rapid resistance when administered alone, they must be added to the current
standard of care rather than replace it. This is expected to vastly increase willingness of
doctors to recommend treatment, and for patients to agree to treatment. The investigators
expect that most hepatologists will recommend, and patients agree to the addition of one of
these medications from now on. However, it should be noted that both commonly cause fatigue
if it isn't already present because of HCV itself, or peginterferon or ribavirin. The major
adverse event associated with telaprevir is rash, and with boceprevir, anemia.
This is a 14-week placebo controlled double blind trial of armodafinil for patients about to
begin HCV treatment, starting armodafinil or placebo 2 weeks prior to initiation of HCV
treatment. Patients are recruited from the hepatology clinics at the respective sites.
Randomization is 1:1. Placebo patients who continue HCV treatment are offered 14 weeks of
armodafinil starting at Week 12 of HCV treatment when the armodafinil/placebo blind is
broken.
Patients will be seen weekly for the first 4 weeks to titrate armodafinil dose and manage
side effects, if any, and then biweekly, with telephone contact on the intervening weeks
through Week 12. After that, monthly telephone calls through Week 24 will be conducted with
patients randomized to armodafinil, and biweekly visits with placebo patients beginning
armodafinil at Week 12.
The primary outcome measures concern non-adherence to INF/RBV treatment: 1) missed doses;
2) dose reductions, and 3) attrition due to side effects. Secondary outcomes include ratings
of fatigue on the Fatigue Severity Scale, depression on the Patient Health Questionnaire
(PHQ-9), and quality of life on the Endicott Quality of Life Enjoyment and Satisfaction
Questionnaire.
Inclusion Criteria:
- HCV+ patients medically cleared for IFN/RBV treatment -HIV+ or HIV-
- Speaks English
- Able and willing to give informed consent
- Fecund women: use barrier method of contraception
Exclusion Criteria:
- Untreated and uncontrolled hypertension
- Left ventricular hypertrophy
- Currently taking stimulant medication
- Uncontrolled mental health problems including: MDD, suicidal or homicidal ideation,
bipolar disorder, or schizophrenia
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