A Pilot Trial of Safety and Efficacy of Telaprevir +Peginterferon +Ribavirin +Vitamin D3 v. Telaprevir +Peginterferon +Ribavirin Among Treatment-naive Veterans With Genotype 1 Hepatitis C Virus



Status:Not yet recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:July 2013
Contact:Aliya Asghar, MPH
Email:aliya.asghar@va.gov
Phone:562-826-5212

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A Pilot Trial of Safety and Efficacy of Telaprevir +Peginterferon +Ribavirin +Vitamin D3 v. Telaprevir + Peginterferon +Ribavirin in Increasing the Proportion of Patients Who Achieve an RVR Among Treatment-naive Veterans Infected With Genotype 1 Hepatitis C Virus

This study is for people who have been diagnosed with chronic hepatitis C, specifically
those who have a certain type of the virus, genotype 1, and who have not yet received
treatment for hepatitis C. This pilot study is designed to test whether the addition of
vitamin D, to the three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and
ribavirin) that are approved by the Food and Drug Administration (FDA) for the treatment of
hepatitis C, can help eliminate the HCV from the body. Currently, doctors are unsure if the
addition of vitamin D to prescribed hepatitis C therapy will have any effects on how the
body clears the virus.

Once enrolled, participants will be randomly assigned (like flipping a coin) to receive
telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir
+ peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all
races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 -
20 participants/site).

Participants assigned to the treatment group will begin a lead-in phase where they will
receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase,
participants will be tested to determine the Vitamin D level in their blood, as well as
other tests, including HCV RNA (to determine the amount of virus present) and calcium
levels. Once an adequate level of Vitamin D is detected in participants' blood, participants
will begin treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3
(15,000 IU/week) for 12 weeks.

Participants randomized to the control group will immediately begin treatment with
telaprevir + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the
participants' involvement in the study will be complete.

Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical
history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at
Screening, Day 1, Week 2, 4, 8 and 12.


Inclusion Criteria:

- Chronic Hepatitis C genotype 1 infection with serum HCV RNA quantifiable at ≥ 10,000
IU/ml at time of screening and a positive anti-HCV antibody test or evidence of
chronic infection.

- No prior treatment (treatment naïve) with peginterferon, ribavirin or any other
anti-HCV drugs.

- Age greater or equal to18 years

- Agree to genetic testing for IFN-λ3 (formerly called IL-28B) genotype associated with
response to peginterferon/ribavirin treatment

Exclusion Criteria:

- Liver disease other than from hepatitis C (e.g., hepatitis B, NASH, hemochromatosis,
autoimmune hepatitis, etc.).

- HCV infection with mixed genotypes (e.g., genotypes 1&2, 1&3, or 1&4)

- Decompensated liver disease (current or past history of clinically detectable
ascites, bleeding esophageal varices, hepatic encephalopathy, or hepatocellular
carcinoma)

- AFP>100ng/ml. Subjects with AFP ≥ 25 and ≤ 100 ng/mL can be enrolled if they have
had a high quality US, CT or MRI within the past 3 months demonstrating no evidence
of a mass in the liver suggestive of hepatocellular carcinoma

- Known HIV infection

- Serum 25(OH)D less than 12ng/ml or greater than 30ng/ml at screening

- Regular vitamin D supplement use (either alone or in combination with other vitamins
or minerals; calcium intake not exceeding 400 IU/day acceptable) or use of a sun
tanning bed, within 3 months prior to the start of the study

- Regular calcium supplement use (either alone or in combination with other vitamins or
minerals; multivitamin dose not exceeding 200mg/day acceptable) within 30 days prior
to the start of the study

- Refusal to abstain from vitamin D supplementation (multivitamin dose not exceeding
400 IU/day acceptable), calcium supplementation (multivitamin dose not exceeding
200mg/day acceptable), prolonged sunbathing (>1 hour/week), and the use of a sun
tanning bed throughout the study

- Current or past history of kidney stones

- Current use of any of the prohibited medications listed in section 5.5 and the
INCIVEK® package insert.

- Need for therapeutic vitamin D or calcium (e.g. treatment for osteoporosis,
osteomalacia, hyperparathyroidism etc.), in the opinion of the investigator

- Significant substance abuse within the past 6 months, excluding the use of marijuana,
or ongoing alcohol use exceeding 1 drink/day (in the opinion of the investigator)

- Suicidal attempt in the past 10 years or suicidal ideation in past 3 months, or any
other psychiatric condition that the investigator deems would make a subject unsuited
for treatment with peginterferon or ribavirin. (Subjects with mild or moderate
depression or other psychiatric conditions who obtain written clearance for HCV
treatment from their VA psychiatrist would be eligible for the study.)

- Confirmed or suspected malignancy, or history of malignancy within the past 3 years
(except treated basal cell carcinoma of the skin or in situ carcinoma of the uterine
cervix)

- Any autoimmune disease not easily controlled (in the opinion of the investigator)

- Any condition resulting in malabsorption (celiac disease, amyloidosis, chronic
pancreatitis, IBD, cystic fibrosis etc) or significant gastric resection (e.g.,
Bilroth II)

- Poorly controlled thyroid disorder, or diabetes mellitus (HbA1c > 9)

- Glomerular diseases (e.g., glomerulosclerosis or glomerulonephritis) associated with
a serum creatinine >1.5 times the upper limit of normal

- Current or history of any clinically significant cardiac abnormalities/dysfunction
(eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension,
complex congenital heart disease, cardiomyopathy, significant arrhythmia) including
current uncontrolled hypertension or history of use of antianginal agents for cardiac
conditions (Inclusion will be considered if clearance by a cardiologist is
obtained.)

- Receipt of an investigational drug within the past 30 days

- Females who have a positive pregnancy test at the time of screening, are
breastfeeding or who anticipate pregnancy within the next 18 months, or men with
pregnant partners

- Lack of agreement from subject to use two forms of acceptable contraception

- History or other evidence of any significant illness which, in the opinion of the
investigator, would make the patient, unsuitable for the study

- Laboratory Exclusions

Hemoglobin: <12gm/dl male or female

Neutrophil: <1,200/mm3

Platelets: <90,000/mm3

INR: >1.5

Albumin: <3.2gm/dl

Total Bilirubin: >2.0mg/dl

HbA1c: >9.5%

Serum Creatinine: >1.5 times the upper limit of normal

Alpha-fetoprotein: >100ng/ml If AFP >25ng/ml yet <100ng/ml a recent (<3months) US, CT, or
MRI showing no mass suggestive of HCC is required

Serum Calcium Within local laboratory normal range

Parathyroid hormone (PTH) <10 or >55 pg/mL
We found this trial at
4
sites
Kansas City, Missouri 64128
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Long Beach, California 90822
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Minneapolis, Minnesota 55417
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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