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IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir

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ClinicalTrials.gov Identifier: NCT03639207
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.


Condition or disease
Hepatitis C Virus

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California
Estimated Study Start Date : December 19, 2018
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort
1
Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California



Primary Outcome Measures :
  1. IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir [ Time Frame: 12 weeks post treatment ]
    virological relapse



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639207


Contacts
Contact: Thomas R O'Brien, M.D. (301) 435-4728 obrient@epndce.nci.nih.gov

Locations
United States, California
Kaiser Permanente Northern California Not yet recruiting
Oakland, California, United States, 94612
Contact: David Witt, M.D.    415-444-2940    david.j.witt@kp.org   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas R O'Brien, M.D. National Cancer Institute (NCI)

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03639207     History of Changes
Other Study ID Numbers: 999918134
18-C-N134
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: August 15, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
IFNL4
Genetics
Ledipasvir/Sofosbuvir Treatment

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents