Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487030
• Other study ID #: GS-US-337-1643
• Status: Completed
• Phase: Phase 3
• Start date: September 7, 2015
• Est. completion date: February 4, 2017

Study information

• Verified date: November 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: February 4, 2017
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Willing and able to provide written informed consent

• Chronic HCV infection (= 6 months) documented by medical history or liver biopsy

• HCV genotype 4 at screening

• HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)

• Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)

• Body mass index (BMI) = 18 kg/m^2

• Screening laboratory values within defined thresholds

• Use of effective protocol-approved contraception methods

Key Exclusion Criteria:

• History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Pregnant or nursing females or male with pregnant female partner

• Clinically-relevant drug or alcohol abuse within 12 months of screening

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• LDV/SOF
90/400 mg FDC tablet administered orally once daily
• RBV
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 20

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) 12 weeks following the last dose of study drug.	Posttreatment Week 12
Primary	Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)		12 weeks
Secondary	Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With Overall Virologic Failure	Virologic failure was defined as; On-treatment virologic failure; confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),; confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),; HCV RNA persistently = LLOQ through 8 weeks of treatment (ie, nonresponse); Relapse; HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement	Up to Posttreatment Week 24