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IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03639207
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : June 25, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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.


To study if certain inherited genetic differences and other factors affect the different ways patients respond to treatment with Harvoni.


Adults ages 18 who are members of the Kaiser Health Plan and have recently been treated for hepatitis C with Harvoni


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.

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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 : June 28, 2019
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

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

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


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 identifier (NCT number): NCT03639207

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Contact: Thomas R O'Brien, M.D. (301) 435-4728

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

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT03639207     History of Changes
Other Study ID Numbers: 999918134
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: August 15, 2018

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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) ):
Ledipasvir/Sofosbuvir Treatment

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