Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

NCT01987453 | Completed Phase 2 Results

• 2 other identifiers: GS-US-337-11182014-001245-24
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 43

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Conditions

HCV Infection

Keywords

genotype 1

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

  Post-treatment Week 12

• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

  Up to 24 Weeks

Secondary Outcomes (4)

• Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

  Posttreatment Weeks 4 and 24

• Percentage of Participants With HCV RNA < LLOQ While on Treatment

  Baseline to Week 24

• Change in HCV RNA From Baseline

  Baseline to Week 8

• Percentage of Participants With Virologic Failure

  Up to posttreatment Week 24

Study Arms (3)

LDV/SOF+RBV 12 weeks (Group 1)

EXPERIMENTAL

Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.

Drug: LDV/SOF; Drug: RBV

LDV/SOF 24 weeks (Group 2)

EXPERIMENTAL

Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.

Drug: LDV/SOF

LDV/SOF+RBV 24 weeks (Group 3)

EXPERIMENTAL

Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.

Drug: LDV/SOF; Drug: RBV

Interventions

LDV/SOF DRUG

Tablet(s) administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977

LDV/SOF 24 weeks (Group 2); LDV/SOF+RBV 12 weeks (Group 1); LDV/SOF+RBV 24 weeks (Group 3)

RBV DRUG

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.

LDV/SOF+RBV 12 weeks (Group 1); LDV/SOF+RBV 24 weeks (Group 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Infection with HCV genotype 1
• HCV RNA \> LLOQ at screening
• Participation in a prior Gilead-sponsored study
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male
• Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
• Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

You may not qualify if:

• Pregnant or nursing female or male with pregnant female partner
• Co-infection with HIV or hepatitis B virus (HBV)
• Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
• Hepatocellular carcinoma (HCC)
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (43)

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Beverly Hills, California, 90210, United States

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La Jolla, California, 92037, United States

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Los Angeles, California, 90027, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90069, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80045, United States

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Washington D.C., District of Columbia, 20009, United States

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Gainesville, Florida, 32610, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32803, United States

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Wellington, Florida, 33414, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60611, United States

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Downers Grove, Illinois, 60515, United States

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Indianapolis, Indiana, 46237, United States

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Bowling Green, Kentucky, 42101, United States

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Baton Rouge, Louisiana, 70809, United States

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Baltimore, Maryland, 21229, United States

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Boston, Massachusetts, 02215, United States

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Springfield, Massachusetts, 01105, United States

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Minneapolis, Minnesota, 55414, United States

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Kansas City, Missouri, 64131, United States

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Hillsborough, New Jersey, 08844, United States

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Albuquerque, New Mexico, 87131, United States

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Binghamton, New York, 13903, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10029, United States

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Asheville, North Carolina, 28801, United States

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Winston-Salem, North Carolina, 27103, United States

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Philadelphia, Pennsylvania, 19104, United States

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Germantown, Tennessee, 38138, United States

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San Antonio, Texas, 78215, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23226, United States

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Seattle, Washington, 98111, United States

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Camperdown, New South Wales, 2050, Australia

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Clichy, 92110, France

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San Juan, 00927, Puerto Rico

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Barcelona, 08028, Spain

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Related Publications (3)

• Lawitz E, Pockros PJ, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Ledipasvir/sofosbuvir regimens for the retreatment of patients who failed sofosbuvir-based regimens [Abstract 10868]. Presented at: The 25th Conference of the Asian Pacific Association for the Study of Liver (APASL); 2016 February 20-24; Tokyo, Japan.

  BACKGROUND

• Lawitz E, Flamm S, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks [Abstract 1627]. Presented at: The 50th Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2015 April 22-26; Vienna, Austria

  BACKGROUND

• Wyles D, Pockros P, Morelli G, Younes Z, Svarovskaia E, Yang JC, Pang PS, Zhu Y, McHutchison JG, Flamm S, Lawitz E. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27.

  PMID: 25846014 RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 19, 2018
• Results First Posted: January 10, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

AU (1); ES (1); PR (1); US (39); FR (1)