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SOF/VEL

Phase 3

Hepatitis C Virus Infection | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Apr 20, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials24
Total Enrollment4,369
FDA Designations
No designations recorded
Clinical Trials (24)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04211909Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) InfectionPHASE3 COMPLETED 87 — — Jan 3, 2020Nov 12, 2020Oct 27, 202122 South Korea
NCT04112303Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated CirrhosisPHASE3 COMPLETED 37 — — Oct 16, 2019Jun 25, 2021Apr 20, 202222 Japan
NCT03118843Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment StudyPHASE3 COMPLETED 31 — — Apr 25, 2017Mar 19, 2018Apr 3, 201927 United States, Australia +5
NCT03074331Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) InfectionPHASE3 COMPLETED 130 — — Mar 23, 2017Feb 7, 2018Mar 19, 201916 India
NCT02996682Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated CirrhosisPHASE3 COMPLETED 102 — — Dec 26, 2016May 8, 2018Feb 26, 201933 Japan
NCT02822794Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing RegimenPHASE3 COMPLETED 117 — — Jul 25, 2016Aug 25, 2017Nov 14, 201818 Japan
NCT02671500Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCVPHASE3 COMPLETED 375 — — Apr 19, 2016Mar 27, 2018Jan 8, 201938 China, Malaysia +3
NCT02722837Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus InfectionPHASE3 COMPLETED 119 — — Apr 4, 2016Sep 13, 2017Nov 16, 201815 Russia, Sweden
NCT02639247Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A InhibitorPHASE3 COMPLETED 333 — — Dec 23, 2015Jan 18, 2017Mar 5, 201978 United States, Australia +6
NCT02639338Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and CirrhosisPHASE3 COMPLETED 220 — — Dec 23, 2015Jan 2, 2017Mar 5, 201970 United States, Australia +6
NCT02480712Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 CoinfectionPHASE3 COMPLETED 107 — — Jul 1, 2015Jun 22, 2016Nov 16, 201815 United States
NCT02346721Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV InfectionPHASE3 COMPLETED 111 — — Feb 23, 2015Jun 15, 2016Nov 16, 201861 United States, Belgium +7
NCT02220998Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV InfectionPHASE3 COMPLETED 269 — — Sep 1, 2014Sep 1, 2015Nov 15, 201851 United States, Puerto Rico
NCT02201953Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV InfectionPHASE3 COMPLETED 558 — — Jul 1, 2014Dec 1, 2015Nov 16, 201876 United States, Australia +7
NCT02201940Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV InfectionPHASE3 COMPLETED 741 — — Jul 1, 2014Sep 1, 2015Nov 15, 201880 United States, Belgium +7
NCT02201901Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B CirrhosisPHASE3 COMPLETED 268 — — Jul 1, 2014Nov 1, 2015Nov 15, 201850 United States, Puerto Rico
NCT03022981Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV InfectionPHASE2 COMPLETED 216 — — Jan 26, 2017Feb 26, 2020Oct 8, 202027 United States, Belgium +2
NCT02994056Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C CirrhosisPHASE2 COMPLETED 32 — — Jan 23, 2017Dec 12, 2018Mar 2, 202012 United States, France
NCT02781558Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and CirrhosisPHASE2 COMPLETED 204 — — Jul 29, 2016Oct 27, 2017Nov 27, 201828 Spain
NCT02781571Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver TransplantPHASE2 COMPLETED 79 — — Jul 27, 2016Jul 28, 2017Nov 14, 201815 Spain, Switzerland +1
NCT02728206Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver TransplantationPHASE2 COMPLETED 9 — — Jun 12, 2016Jan 16, 2018Feb 6, 20191 New Zealand
NCT02536313Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral RegimenPHASE2 COMPLETED 49 — — Jul 29, 2015Jun 28, 2016Feb 25, 20191 United States
NCT02300103Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment StudyPHASE2 COMPLETED 69 — — Dec 1, 2014Sep 15, 2016Nov 16, 201830 United States, Australia +2
NCT02175758Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV InfectionPHASE2 COMPLETED 106 — — Jul 7, 2014Sep 13, 2018Apr 30, 201937 United States, Australia +6
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
Posttreatment Week 12

SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
First dose date up to 12 weeks plus 30 days
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
Posttreatment Week 12

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
First dose date up to Week 12.1

TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to Week 12
Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Up to 12 weeks
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Up to 12 weeks
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
Up to 12 weeks
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 drug.

PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)
Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).

PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)
Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).

PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)
Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)
From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.

Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
First dose date up to Week 12
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
Posttreatment Week 12

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
Up to 12 weeks
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)
6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
Up to 24 weeks
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Secondary Endpoints
Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
Posttreatment Week 4
Percentage of Participants With Virologic Failure
Baseline up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2, Week 4, Week 8, Week 12
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SOF/VELEXPERIMENTALParticipants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks.
SOF/VEL/VOXEXPERIMENTALParticipants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks.
SOF/VEL + RBVEXPERIMENTALSOF/VEL + RBV for 12 weeks
SOF/VEL FDC + RBV 12 weeksEXPERIMENTALSOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL FDC + RBV 24 weeksEXPERIMENTALSOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
SOF+RBVEXPERIMENTALSOF+RBV for 12 weeks
SOF/VEL 12 WeeksEXPERIMENTALSOF/VEL FDC for 12 weeks
SOF+RBV 24 WeeksEXPERIMENTALSOF+RBV for 24 weeks
PlaceboPLACEBO_COMPARATORSOF/VEL placebo for 12 weeks
SOF/VEL+RBV 12 weeksEXPERIMENTALParticipants will receive SOF/VEL FDC plus RBV for 12 weeks.
SOF/VEL 24 weeksEXPERIMENTALParticipants will receive SOF/VEL FDC for 24 weeks.
12 to < 18 Years OldEXPERIMENTALPK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks.
6 to < 12 Years OldEXPERIMENTALPK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks.
3 to < 6 Years OldEXPERIMENTALPK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh \< 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh \< 17 kg.
SOF/VEL+ RBVEXPERIMENTALSOF/VEL FDC plus RBV for 12 weeks
SOF/VEL/VOX + RBVEXPERIMENTALSOF/VEL/VOX + RBV for 12 weeks
SOF/VEL+RBVEXPERIMENTALParticipants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)EXPERIMENTALParticipants between 12 to \< 18 years of age with genotype (GT) 2 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.
12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)EXPERIMENTALParticipants between 12 to \< 18 years of age with genotype 3 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.
6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)EXPERIMENTALParticipants between 6 to \< 12 years of age with genotype 2 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.
6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)EXPERIMENTALParticipants between 6 to \< 12 years of age with genotype 3 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.
3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)EXPERIMENTALParticipants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks.
3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)EXPERIMENTALParticipants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks.
Interventions
NameTypeDescription
SOF/VELDRUG400/100 mg FDC tablet orally once daily.
SOF/VEL/VOXDRUG400/100/100 mg FDC tablet orally once daily.
RBVDRUGCapsules administered orally in a divided daily dose
SOFDRUGSOF 400 mg tablet administered orally once daily
PlaceboDRUGTablet administered orally once daily
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Key Inclusion Criteria: * Chronic HCV infected males and non-pregnant/non-lactating females * Treatment-naive or treatment-experienced individuals * Non-cirrhosis or compensated cirrhosis at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Countries:South KoreaJapanUnited StatesAustraliaCanadaFranceGermanyNew ZealandUnited KingdomIndiaChinaMalaysiaSingaporeThailandVietnamRussiaSwedenPuerto RicoBelgiumHong KongItalySpainSwitzerland
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