Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

NCT02021656 | Completed Phase 3 Results

• 1 other identifier: GS-US-337-0131
• Study Type: interventional
• Target: 384
• Locations: 3 countries
• Sites: 45

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Conditions

Chronic HCV Infection

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; ie, \< 25 IU/mL in Korea and Taiwan and \< 15 IU/mL in China) 12 weeks following the last dose of study drug.

  Posttreatment Week 12

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

  Up to 12 weeks

Secondary Outcomes (4)

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

  Posttreatment Weeks 4 and 24

• Percentage of Participants Experiencing Viral Breakthrough

  Up to 12 weeks

• Percentage of Participants Experiencing Viral Relapse

  Week 12 to Posttreatment Week 24

• HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only

  Baseline; Week 12

Study Arms (1)

LDV/SOF

EXPERIMENTAL

Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

90/400 mg FDC tablet administered orally once daily without regard to food

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

LDV/SOF

Eligibility Criteria

• Age: 20 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
• HCV RNA ≥ 10\^4 IU/mL at screening
• HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
• Genotype 1 HCV at screening
• HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

You may not qualify if:

• Pregnant or nursing female
• Chronic liver disease of a non-HCV etiology
• Current or prior history of any clinically-significant illness (other than HCV)
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (45)

Unknown Facility

Beijing, 100015, China

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Beijing, 100034, China

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Beijing, 100044, China

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Beijing, 100050, China

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Beijing, 100069, China

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Chongqing, 400010, China

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Guangdong, 510515, China

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Guangxi, 530021, China

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Hubei, 430030, China

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Hunan, 410011, China

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Jiangxi, 210029, China

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Jiangxi, 330006, China

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Jilin, 130021, China

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Shandong, 250021, China

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Shanghai, 200025, China

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Shanghai, 200083, China

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Shijiazhuang, 050051, China

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Sichuan, 610041, China

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Ansan-si, Gyeonggi-do, 425-707, South Korea

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Bucheon-si, Gyeonggi-do, 420-767, South Korea

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Incheon, Gyeonggi-do, 405-760, South Korea

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Seongnam-si, Gyeonggi-do, 467-707, South Korea

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Busan, 602-715, South Korea

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Busan, 602-739, South Korea

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Busan, 614-735, South Korea

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Daegu, 700-721, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-720, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Seoul, 152-703, South Korea

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Seoul, 735-710, South Korea

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Changhua, 50006, Taiwan

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Kaohsiung City, 80708, Taiwan

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Kaohsiung City, 82445, Taiwan

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Kaohsiung City, 83301, Taiwan

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Keelung, 20401, Taiwan

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Taichung, 40447, Taiwan

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Tainan, 70457, Taiwan

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Tainan, 73657, Taiwan

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Taipei, 10048, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 11217, Taiwan

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Unknown Facility

Taoyuan District, 33305, Taiwan

Location

Related Publications (4)

• Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial. Poster No. 1191, AASLD 2017.

  RESULT

• Lim YS, Ahn SH, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Garrison KL, Gao B, Knox SJ, Pang PS, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatol Int. 2016 Nov;10(6):947-955. doi: 10.1007/s12072-016-9726-5. Epub 2016 May 20.

  PMID: 27198664 RESULT

• Chuang WL, Chien RN, Peng CY, Chang TT, Lo GH, Sheen IS, Wang HY, Chen JJ, Yang JC, Knox SJ, Gao B, Garrison KL, Mo H, Pang PS, Hsu YC, Hu TH, Chu CJ, Kao JH. Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. J Gastroenterol Hepatol. 2016 Jul;31(7):1323-9. doi: 10.1111/jgh.13305.

  PMID: 26841930 RESULT

• Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial., [Abstract 1191]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.

  RESULT

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: December 10, 2013
• Primary Completion: July 8, 2017
• Study Completion: September 29, 2017
• Last Updated: March 5, 2020
• Results First Posted: December 28, 2018

Record last verified: 2019-01

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

CN (18); KR (15); TW (12)