Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection (NCT NCT01910636)

NCT ID: NCT01910636

Last Updated: 2015-03-24

Results Overview

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: Posttreatment Week 12
• Results posted on: 2015-03-24

Participant Flow

Participants were enrolled at a total of 20 study sites in Japan. The first participant was screened on 28 June 2013. The last study visit occurred on 09 June 2014.

188 participants were screened.

Participant milestones

Measure	SOF+RBV Treatment Naive Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Overall Study STARTED	90	63
Overall Study COMPLETED	90	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Baseline characteristics by cohort

Measure	SOF+RBV Treatment Naive n=90 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced n=63 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)	Total n=153 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 10.6 • n=5 Participants	60 years STANDARD_DEVIATION 8.8 • n=7 Participants	57 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	26 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Cirrhosis Status No	82 participants n=5 Participants	54 participants n=7 Participants	136 participants n=5 Participants
Cirrhosis Status Yes	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
IL28b Status CC	73 participants n=5 Participants	48 participants n=7 Participants	121 participants n=5 Participants
IL28b Status CT	17 participants n=5 Participants	11 participants n=7 Participants	28 participants n=5 Participants
IL28b Status TT	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
HCV RNA	6.2 log10 IU/mL STANDARD_DEVIATION 0.92 • n=5 Participants	6.5 log10 IU/mL STANDARD_DEVIATION 0.66 • n=7 Participants	6.3 log10 IU/mL STANDARD_DEVIATION 0.84 • n=5 Participants
HCV RNA Category < 800,000 IU/mL	26 participants n=5 Participants	12 participants n=7 Participants	38 participants n=5 Participants
HCV RNA Category ≥ 800,000 IU/mL	64 participants n=5 Participants	51 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: Posttreatment Week 12

Population: Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Outcome measures

Measure	SOF+RBV Treatment Naive n=90 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced n=63 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)	97.8 percentage of participants	95.2 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug

The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.

Outcome measures

Measure	SOF+RBV Treatment Naive n=153 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 percentage of participants	—

SECONDARY outcome

Timeframe: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Outcome measures

Measure	SOF+RBV Treatment Naive n=90 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced n=63 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) SVR4	98.9 percentage of participants	95.2 percentage of participants
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) SVR24	97.8 percentage of participants	95.2 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.

Outcome measures

Measure	SOF+RBV Treatment Naive n=90 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced n=63 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Percentage of Participants Experiencing Viral Breakthrough	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to Posttreatment Week 24

Population: Full Analysis Set

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Outcome measures

Measure	SOF+RBV Treatment Naive n=90 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)	SOF+RBV Treatment Experienced n=63 Participants SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
Percentage of Participants Experiencing Viral Relapse	2.2 percentage of participants	4.8 percentage of participants

Adverse Events

SOF+RBV

Serious events: 2 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	SOF+RBV n=153 participants at risk SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
Blood and lymphatic system disorders Anaemia	0.65% 1/153 • Up to 12 weeks plus 30 days Safety Analysis Set
Immune system disorders Allergy to arthropod sting	0.65% 1/153 • Up to 12 weeks plus 30 days Safety Analysis Set

Other adverse events

Measure	SOF+RBV n=153 participants at risk SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
Blood and lymphatic system disorders Anaemia	11.8% 18/153 • Up to 12 weeks plus 30 days Safety Analysis Set
General disorders Malaise	7.2% 11/153 • Up to 12 weeks plus 30 days Safety Analysis Set
Infections and infestations Nasopharyngitis	29.4% 45/153 • Up to 12 weeks plus 30 days Safety Analysis Set
Nervous system disorders Headache	9.8% 15/153 • Up to 12 weeks plus 30 days Safety Analysis Set
Skin and subcutaneous tissue disorders Pruritus	5.9% 9/153 • Up to 12 weeks plus 30 days Safety Analysis Set

Additional Information

Clinical Trial Disclosures

Gilead Sciences

Email: ClinicalTrialDisclosures@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER