Phase 2 N=273 Treatment

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT02202980 ↗

Enrolled (actual)

273

Serious AEs

4.8%

Results posted

Nov 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 92.9; 96.2; 74.1; 100.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LDV/SOF (Drug); RBV (Drug); SOF/VEL (Drug); VOX (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	92.9; 96.2; 74.1; 100.0; 76.9; 93.3	—
PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	7.1; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	92.9; 96.2; 81.5; 100.0; 76.9; 100.0	—
SECONDARY Percentage of Participants With Virologic Failure	7.1; 0; 22.2; 0; 23.1; 6.7	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit	7.1; 28.0; 7.4; 9.4; 7.7; 26.7	—

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Eligibility Criteria

Key Inclusion Criteria

Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key Exclusion Criteria

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02202980). 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.