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

Chronic HCV Infection Clinical Trial

Official title:

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021656
• Other study ID #: GS-US-337-0131
• Status: Completed
• Phase: Phase 3
• Start date: December 10, 2013
• Est. completion date: September 29, 2017

Study information

• Verified date: January 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: September 29, 2017
• Est. primary completion date: July 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic HCV Infection
• Communicable Diseases
• Hepatitis C
• Infection

Intervention

Drug:
• LDV/SOF
90/400 mg FDC tablet administered orally once daily without regard to food

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

References & Publications (4)

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 — View Citation

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 tab — View Citation

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.

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 Associati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants Experiencing Viral Breakthrough	Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).	Up to 12 weeks
Secondary	Percentage of Participants Experiencing Viral Relapse	Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.	Week 12 to Posttreatment Week 24
Secondary	HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only		Baseline; Week 12