IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | September 30, 2026 |
| Contact: | Thomas R O'Brien, M.D. |
| Email: | obrient@epndce.nci.nih.gov |
| Phone: | (301) 435-4728 |
IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California
Background:
Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma and
end-stage liver disease. Ledipasvir/sofosbuvir is used to treat chronic HCV. The drug name
for it is Harvoni. It is a very effective treatment, but it is expensive. Researchers have
found a genetic variation that predicts how people will respond to this treatment. They want
to learn more about this genetic link. It could help develop better treatments for HCV.
Objective:
To study if certain inherited genetic differences and other factors affect the different ways
patients respond to treatment with Harvoni.
Eligibility:
Adults ages 18 who are members of the Kaiser Health Plan and have recently been treated for
hepatitis C with Harvoni
Design:
Researchers will review medical records to identify a group of people who could be in the
study.
Participants will provide a saliva sample at home. They will get instructions and kit to
collect it in.
Participants will spit into a funnel until it reaches a mark on the funnel. It will be about
1 teaspoon of saliva with no bubbles.
They will return the sample in a prepaid mailer.
Researchers will do genetic tests on the samples. The participant data will be kept
confidential. It will not be given to insurance companies.
Participants will not be given any test results.
Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma and
end-stage liver disease. Ledipasvir/sofosbuvir is used to treat chronic HCV. The drug name
for it is Harvoni. It is a very effective treatment, but it is expensive. Researchers have
found a genetic variation that predicts how people will respond to this treatment. They want
to learn more about this genetic link. It could help develop better treatments for HCV.
Objective:
To study if certain inherited genetic differences and other factors affect the different ways
patients respond to treatment with Harvoni.
Eligibility:
Adults ages 18 who are members of the Kaiser Health Plan and have recently been treated for
hepatitis C with Harvoni
Design:
Researchers will review medical records to identify a group of people who could be in the
study.
Participants will provide a saliva sample at home. They will get instructions and kit to
collect it in.
Participants will spit into a funnel until it reaches a mark on the funnel. It will be about
1 teaspoon of saliva with no bubbles.
They will return the sample in a prepaid mailer.
Researchers will do genetic tests on the samples. The participant data will be kept
confidential. It will not be given to insurance companies.
Participants will not be given any test results.
Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma (HCC) and
end stage liver disease - successful treatment markedly reduces those risks.
Ledipasvir/sofosbuvir is a highly effective, but expensive, treatment for chronic hepatitis
C. Previously, we demonstrated that genetic variation in IFNL4 predicts response to this
regimen. We now propose to examine the association between genotype for the functional
IFNL4-DeltaG/TT polymorphism and treatment response among patients enrolled in a large
managed care organization. In a two-stage design, limited demographic and clinical data for
patients who have been treated with ledipasvir/sofosbuvir will be ascertained from an
electronic database. In the second stage, additional demographic and clinical data will be
extracted from medical records and consented patients will provide a specimen for IFNL4
genotyping. These data will be combined to examine associations of IFNL4-DeltaG/TT genotype
and other variables with response to ledipasvir/sofosbuvir. We will also develop a clinical
prediction model for response to ledipasvir/sofosbuvir treatment. These results could inform
more efficient treatment of HCV in the United States and globally.
end stage liver disease - successful treatment markedly reduces those risks.
Ledipasvir/sofosbuvir is a highly effective, but expensive, treatment for chronic hepatitis
C. Previously, we demonstrated that genetic variation in IFNL4 predicts response to this
regimen. We now propose to examine the association between genotype for the functional
IFNL4-DeltaG/TT polymorphism and treatment response among patients enrolled in a large
managed care organization. In a two-stage design, limited demographic and clinical data for
patients who have been treated with ledipasvir/sofosbuvir will be ascertained from an
electronic database. In the second stage, additional demographic and clinical data will be
extracted from medical records and consented patients will provide a specimen for IFNL4
genotyping. These data will be combined to examine associations of IFNL4-DeltaG/TT genotype
and other variables with response to ledipasvir/sofosbuvir. We will also develop a clinical
prediction model for response to ledipasvir/sofosbuvir treatment. These results could inform
more efficient treatment of HCV in the United States and globally.
- INCLUSION CRITERIA:
Subject Inclusion Criteria:
- At least 18 years of age
- Chronic HCV VGT-1 infection
- Completed treatment with ledipasvir/sofosbuvir (with or without ribavirin) for either
8, 12 or 24 weeks at a participating KP-NC clinical site
- Data available to determine virological relapse and SVR12
EXCLUSION CRITERIA:
Subject Exclusion Criteria:
- Otherwise eligible subjects who have left KPNC will not be included in the study
- Otherwise eligible subjects who cannot provide informed consent in English will not be
included in the study
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