Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL; Drug: VOX; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02378935

GS-US-367-1168

Details and patient eligibility

About

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Individuals with chronic HCV infection
• HCV RNA ≥10^4 IU/mL at screening
• HCV genotype 1
• Cirrhosis determination; a liver biopsy may be required
• Screening laboratory values within defined thresholds
• Use of two contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female
• Current or prior history of hepatic decompensation
• Hepatocellular carcinoma (HCC) or other clinically significant malignancy
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

205 participants in 10 patient groups

VOX+SOF/VEL 6 wk, TN, without cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 8 wk, TN, without cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 6 wk, TN, with cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 8 wk, TN, with cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis

Experimental group

Description:

VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)

Treatment:

Drug: RBV

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis

Experimental group

Description:

VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis

Experimental group

Description:

GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis

Experimental group

Description:

GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)

Treatment:

Drug: VOX

Drug: SOF/VEL

VOX+SOF/VEL 12 wk (GS-US-338-1121)

Experimental group

Description:

VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)

Treatment:

Drug: VOX

Drug: SOF/VEL