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VOX

Phase 2

Hepatitis C Virus Infection | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Mar 6, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment333

FDA Designations

No designations recorded

Clinical trial landscape

VOX · 2 trials · 1 indication

Phase 2 2
NCT02378935Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV InfectionHepatitis C Virus Infection
COMPLETED205 Analytics
NCT02378961Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV InfectionHepatitis C Virus Infection
COMPLETED128 Analytics
PHASE2COMPLETED
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Hepatitis C Virus InfectionUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Hepatitis C Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 Weeks

Secondary Endpoints

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VOX+SOF/VEL 6 wk, TN, without cirrhosisEXPERIMENTALVOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
VOX+SOF/VEL 8 wk, TN, without cirrhosisEXPERIMENTALVOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
VOX+SOF/VEL 6 wk, TN, with cirrhosisEXPERIMENTALVOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, TN, with cirrhosisEXPERIMENTALVOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosisEXPERIMENTALVOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosisEXPERIMENTALVOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosisEXPERIMENTALVOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosisEXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosisEXPERIMENTALGS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX+SOF/VEL 12 wk (GS-US-338-1121)EXPERIMENTALVOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
GS-9857+SOF/VEL 6 wk, TN, with cirrhosisEXPERIMENTALGS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk,TE, without cirrhosisEXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
VOX+SOF/VEL 12 wk, TE, without cirrhosisEXPERIMENTALVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
GS-9857+SOF/VEL 8 wk, TE, with cirrhosisEXPERIMENTALGS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
VOX+SOF/VEL 12 wk, TE, with cirrhosisEXPERIMENTALVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)

Interventions

NameTypeDescription
VOXDRUG100 mg tablet(s) administered orally once daily with food
SOF/VELDRUG400/100 mg FDC tablet administered orally once daily with food
RBVDRUGTablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

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 potent...

Countries:United StatesNew ZealandPuerto Rico
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Frequently asked questions about VOX

What is VOX used for?

VOX is an investigational small molecule being studied for the treatment of Hepatitis C Virus Infection. It is in Phase 2 clinical development and is being evaluated in combination with sofosbuvir and velpatasvir as a fixed dose combination in adults with chronic HCV infection.

Who makes VOX?

VOX is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker GILD. The company is conducting clinical trials of VOX in combination with other antiviral agents for the treatment of Hepatitis C Virus Infection.

What phase is VOX in?

VOX is in Phase 2 clinical development. Two Phase 2 trials of VOX have been completed, both evaluating the drug in combination with sofosbuvir and velpatasvir for the treatment of chronic Hepatitis C Virus Infection in adults.

What clinical trials is VOX in?

VOX has been studied in two completed Phase 2 clinical trials. NCT02378935 evaluated VOX plus sofosbuvir and velpatasvir in adults with chronic genotype 1 HCV infection, enrolling 205 participants. NCT02378961 evaluated the same combination in adults with chronic non-genotype 1 HCV infection, enrolling 128 participants.

Is VOX the same as voxilaprevir?

VOX is the abbreviated name for voxilaprevir, an investigational small molecule being developed by Gilead Sciences for the treatment of Hepatitis C Virus Infection. It is being studied in combination with sofosbuvir and velpatasvir as a fixed dose combination therapy.