Trial Outcomes & Findings for Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816 (NCT NCT02468648)

NCT ID: NCT02468648

Last Updated: 2020-03-19

Results Overview

Absence of detectable virus 12 weeks after completion of antiviral therapy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	Combination of Sofosbuvir and GS-5816 Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
Overall Study STARTED	72
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Combination of Sofosbuvir and GS-5816 Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
Overall Study Death	1

Baseline Characteristics

Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Baseline characteristics by cohort

Measure	Combination of Sofosbuvir and GS-5816 n=72 Participants Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
Age, Continuous	58.1 years STANDARD_DEVIATION 10.2 • n=93 Participants
Sex: Female, Male Female	36 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	19 Participants n=93 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks

Absence of detectable virus 12 weeks after completion of antiviral therapy

Outcome measures

Measure

Combination of Sofosbuvir and GS-5816 n=71 Participants Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.

Number of Participants With Sustained Virologic Response

70 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure

Combination of Sofosbuvir and GS-5816 n=71 Participants Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.

Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)

55 Participants

SECONDARY outcome

Timeframe: 24 weeks

Absence of detectable virus 24 weeks after completion of antiviral therapy

Outcome measures

Measure

Combination of Sofosbuvir and GS-5816 n=71 Participants Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.

Number of Participants Who Sustained Virologic Response

70 Participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Measure

Combination of Sofosbuvir and GS-5816 n=71 Participants Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.

Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)

70 Participants

Adverse Events

Combination of Sofosbuvir and GS-5816

Serious events: 2 serious events

Other events: 67 other events

Deaths: 1 deaths

Serious adverse events

Measure	Combination of Sofosbuvir and GS-5816 n=72 participants at risk Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
Surgical and medical procedures Pain after a radiological biopsy and direct cannulation of the portal vein	1.4% 1/72 • Number of events 1 • 24 months
Gastrointestinal disorders Small bowel obstruction	1.4% 1/72 • Number of events 1 • 24 months

Other adverse events

Measure	Combination of Sofosbuvir and GS-5816 n=72 participants at risk Combination of sofosbuvir and GS-5816 agent into a single pill will be used. Sofosbuvir: An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection GS-5816: An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
General disorders Fatigue	61.1% 44/72 • Number of events 204 • 24 months
Nervous system disorders Headache	65.3% 47/72 • Number of events 171 • 24 months
Nervous system disorders Trouble sleeping	50.0% 36/72 • Number of events 159 • 24 months
Musculoskeletal and connective tissue disorders Muscle pain	50.0% 36/72 • Number of events 142 • 24 months
Skin and subcutaneous tissue disorders Iching	43.1% 31/72 • Number of events 84 • 24 months
Metabolism and nutrition disorders Loss of appetite	29.2% 21/72 • Number of events 38 • 24 months
Gastrointestinal disorders Nausea	22.2% 16/72 • Number of events 37 • 24 months
Gastrointestinal disorders Diarrhea	23.6% 17/72 • Number of events 36 • 24 months
Gastrointestinal disorders Constipation	36.1% 26/72 • Number of events 86 • 24 months
Gastrointestinal disorders Sore throat	27.8% 20/72 • Number of events 38 • 24 months
Respiratory, thoracic and mediastinal disorders Stuffy nose	48.6% 35/72 • Number of events 85 • 24 months
General disorders Fever	22.2% 16/72 • Number of events 19 • 24 months
General disorders Chills	26.4% 19/72 • Number of events 32 • 24 months
Skin and subcutaneous tissue disorders Rash	18.1% 13/72 • Number of events 24 • 24 months
Psychiatric disorders Irritability	41.7% 30/72 • Number of events 76 • 24 months

Additional Information

Marc Ghany, MD, MHSc

NIDDK

Phone: 301-402-5115

Email: marcg@intra.niddk.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place