Phase 2 N=359 Randomized Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT01826981 ↗

Enrolled (actual)

359

Serious AEs

3.6%

Results posted

Sep 2016

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 100; 90; 100; 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LDV/SOF (Drug); SOF (Drug); RBV (Drug); Peg-IFN (Drug); GS-9669 (Drug); VEL (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100; 90; 100; 100; 64.0; 100	—
PRIMARY Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0; 0; 4.0; 0; 4.0; 0	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0; 100.0; 100.0	—
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)	100.0; 100.0; 100.0; 100.0; 72.0; 100.0	—
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)	100; 100	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Experiencing Viral Relapse	0; 10.0; 0; 0; 33.3; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01826981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.