Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

Chronic Hepatitis C Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826981
• Other study ID #: GS-US-337-0122
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic genotype 1, 2, 3, or 6 HCV infection

• Cirrhosis determination; a liver biopsy may be required

• Screening laboratory values within defined thresholds

• Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)

• Chronic use of systemic immunosuppressive agents

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
• SOF
SOF 400 mg tablet administered orally once daily
• RBV
Ribavirin (RBV) 200 mg 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)
• Peg-IFN
pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
• GS-9669
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
• VEL
Velpatasvir (VEL) tablet(s) administered orally once daily

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies Ltd.	Auckland
New Zealand	Christchurch Clinical Studies Trust	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 1 — View Citation

Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)		Up to 24 weeks plus 30 days
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment		Weeks 1 and 2
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment		Weeks 4, 6, and 8
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment		Week 10
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment		Week 12
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment		Weeks 16, 20, and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)		Posttreatment Weeks 2, 4, 8, and 24
Secondary	For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)		Posttreatment Weeks 16 and 20
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as: Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)	Up to Posttreatment Week 24
Secondary	Percentage of Participants Experiencing Viral Relapse	Viral relapse is defined as HCV RNA = LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.	Up to Posttreatment Week 24